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How to Write Recommendations in Research | Examples & Tips

Published on September 15, 2022 by Tegan George . Revised on July 18, 2023.

Recommendations in research are a crucial component of your discussion section and the conclusion of your thesis , dissertation , or research paper .

As you conduct your research and analyze the data you collected , perhaps there are ideas or results that don’t quite fit the scope of your research topic. Or, maybe your results suggest that there are further implications of your results or the causal relationships between previously-studied variables than covered in extant research.

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Table of contents

What should recommendations look like, building your research recommendation, how should your recommendations be written, recommendation in research example, other interesting articles, frequently asked questions about recommendations.

Recommendations for future research should be:

• Concrete and specific
• Supported with a clear rationale
• Directly connected to your research

Overall, strive to highlight ways other researchers can reproduce or replicate your results to draw further conclusions, and suggest different directions that future research can take, if applicable.

Relatedly, when making these recommendations, avoid:

• Undermining your own work, but rather offer suggestions on how future studies can build upon it
• Suggesting recommendations actually needed to complete your argument, but rather ensure that your research stands alone on its own merits
• Using recommendations as a place for self-criticism, but rather as a natural extension point for your work

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There are many different ways to frame recommendations, but the easiest is perhaps to follow the formula of research question   conclusion  recommendation. Here’s an example.

Conclusion An important condition for controlling many social skills is mastering language. If children have a better command of language, they can express themselves better and are better able to understand their peers. Opportunities to practice social skills are thus dependent on the development of language skills.

As a rule of thumb, try to limit yourself to only the most relevant future recommendations: ones that stem directly from your work. While you can have multiple recommendations for each research conclusion, it is also acceptable to have one recommendation that is connected to more than one conclusion.

These recommendations should be targeted at your audience, specifically toward peers or colleagues in your field that work on similar subjects to your paper or dissertation topic . They can flow directly from any limitations you found while conducting your work, offering concrete and actionable possibilities for how future research can build on anything that your own work was unable to address at the time of your writing.

See below for a full research recommendation example that you can use as a template to write your own.

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While it may be tempting to present new arguments or evidence in your thesis or disseration conclusion , especially if you have a particularly striking argument you’d like to finish your analysis with, you shouldn’t. Theses and dissertations follow a more formal structure than this.

All your findings and arguments should be presented in the body of the text (more specifically in the discussion section and results section .) The conclusion is meant to summarize and reflect on the evidence and arguments you have already presented, not introduce new ones.

The conclusion of your thesis or dissertation should include the following:

• A restatement of your research question
• A summary of your key arguments and/or results
• A short discussion of the implications of your research

For a stronger dissertation conclusion , avoid including:

• Important evidence or analysis that wasn’t mentioned in the discussion section and results section
• Generic concluding phrases (e.g. “In conclusion …”)
• Weak statements that undermine your argument (e.g., “There are good points on both sides of this issue.”)

Your conclusion should leave the reader with a strong, decisive impression of your work.

In a thesis or dissertation, the discussion is an in-depth exploration of the results, going into detail about the meaning of your findings and citing relevant sources to put them in context.

The conclusion is more shorter and more general: it concisely answers your main research question and makes recommendations based on your overall findings.

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• GETTING STARTED
• Introduction
• FUNDAMENTALS
• Acknowledgements
• Research questions & hypotheses
• Concepts, constructs & variables
• Research limitations
• Getting started
• Sampling Strategy
• Research Quality
• Research Ethics
• Data Analysis

FUTURE RESEARCH

Types of future research suggestion.

The Future Research section of your dissertation is often combined with the Research Limitations section of your final, Conclusions chapter. This is because your future research suggestions generally arise out of the research limitations you have identified in your own dissertation. In this article, we discuss six types of future research suggestion. These include: (1) building on a particular finding in your research; (2) addressing a flaw in your research; examining (or testing) a theory (framework or model) either (3) for the first time or (4) in a new context, location and/or culture; (5) re-evaluating and (6) expanding a theory (framework or model). The goal of the article is to help you think about the potential types of future research suggestion that you may want to include in your dissertation.

Before we discuss each of these types of future research suggestion, we should explain why we use the word examining and then put or testing in brackets. This is simply because the word examining may be considered more appropriate when students use a qualitative research design; whereas the word testing fits better with dissertations drawing on a quantitative research design. We also put the words framework or model in brackets after the word theory . We do this because a theory , framework and model are not the same things. In the sections that follow, we discuss six types of future research suggestion.

Addressing research limitations in your dissertation

Building on a particular finding or aspect of your research, examining a conceptual framework (or testing a theoretical model) for the first time, examining a conceptual framework (or testing a theoretical model) in a new context, location and/or culture.

• Expanding a conceptual framework (or testing a theoretical model)

Re-evaluating a conceptual framework (or theoretical model)

In the Research Limitations section of your Conclusions chapter, you will have inevitably detailed the potential flaws (i.e., research limitations) of your dissertation. These may include:

An inability to answer your research questions

Theoretical and conceptual problems

Limitations of your research strategy

Problems of research quality

Identifying what these research limitations were and proposing future research suggestions that address them is arguably the easiest and quickest ways to complete the Future Research section of your Conclusions chapter.

Often, the findings from your dissertation research will highlight a number of new avenues that could be explored in future studies. These can be grouped into two categories:

Your dissertation will inevitably lead to findings that you did not anticipate from the start. These are useful when making future research suggestions because they can lead to entirely new avenues to explore in future studies. If this was the case, it is worth (a) briefly describing what these unanticipated findings were and (b) suggesting a research strategy that could be used to explore such findings in future.

Sometimes, dissertations manage to address all aspects of the research questions that were set. However, this is seldom the case. Typically, there will be aspects of your research questions that could not be answered. This is not necessarily a flaw in your research strategy, but may simply reflect that fact that the findings did not provide all the answers you hoped for. If this was the case, it is worth (a) briefly describing what aspects of your research questions were not answered and (b) suggesting a research strategy that could be used to explore such aspects in future.

You may want to recommend that future research examines the conceptual framework (or tests the theoretical model) that you developed. This is based on the assumption that the primary goal of your dissertation was to set out a conceptual framework (or build a theoretical model). It is also based on the assumption that whilst such a conceptual framework (or theoretical model) was presented, your dissertation did not attempt to examine (or test) it in the field . The focus of your dissertations was most likely a review of the literature rather than something that involved you conducting primary research.

Whilst it is quite rare for dissertations at the undergraduate and master's level to be primarily theoretical in nature like this, it is not unknown. If this was the case, you should think about how the conceptual framework (or theoretical model) that you have presented could be best examined (or tested) in the field . In understanding the how , you should think about two factors in particular:

What is the context, location and/or culture that would best lend itself to my conceptual framework (or theoretical model) if it were to be examined (or tested) in the field?

What research strategy is most appropriate to examine my conceptual framework (or test my theoretical model)?

If the future research suggestion that you want to make is based on examining your conceptual framework (or testing your theoretical model) in the field , you need to suggest the best scenario for doing so.

More often than not, you will not only have set out a conceptual framework (or theoretical model), as described in the previous section, but you will also have examined (or tested) it in the field . When you do this, focus is typically placed on a specific context, location and/or culture.

If this is the case, the obvious future research suggestion that you could propose would be to examine your conceptual framework (or test the theoretical model) in a new context, location and/or culture. For example, perhaps you focused on consumers (rather than businesses), or Canada (rather than the United Kingdom), or a more individualistic culture like the United States (rather than a more collectivist culture like China).

When you propose a new context, location and/or culture as your future research suggestion, make sure you justify the choice that you make. For example, there may be little value in future studies looking at different cultures if culture is not an important component underlying your conceptual framework (or theoretical model). If you are not sure whether a new context, location or culture is more appropriate, or what new context, location or culture you should select, a review the literature will often help clarify where you focus should be.

Expanding a conceptual framework (or theoretical model)

Assuming that you have set out a conceptual framework (or theoretical model) and examined (or tested) it in the field , another series of future research suggestions comes out of expanding that conceptual framework (or theoretical model).

We talk about a series of future research suggestions because there are so many ways that you can expand on your conceptual framework (or theoretical model). For example, you can do this by:

Examining constructs (or variables) that were included in your conceptual framework (or theoretical model) but were not focused.

Looking at a particular relationship aspect of your conceptual framework (or theoretical model) further.

Adding new constructs (or variables) to the conceptual framework (or theoretical model) you set out (if justified by the literature).

It would be possible to include one or a number of these as future research suggestions. Again, make sure that any suggestions you make have are justified , either by your findings or the literature.

With the dissertation process at the undergraduate and master's level lasting between 3 and 9 months, a lot a can happen in between. For example, a specific event (e.g., 9/11, the economic crisis) or some new theory or evidence that undermines (or questions) the literature (theory) and assumptions underpinning your conceptual framework (or theoretical model). Clearly, there is little you can do about this. However, if this happens, reflecting on it and re-evaluating your conceptual framework (or theoretical model), as well as your findings, is an obvious source of future research suggestions.

What is a Literature Review? How to Write It (with Examples)

A literature review is a critical analysis and synthesis of existing research on a particular topic. It provides an overview of the current state of knowledge, identifies gaps, and highlights key findings in the literature. 1 The purpose of a literature review is to situate your own research within the context of existing scholarship, demonstrating your understanding of the topic and showing how your work contributes to the ongoing conversation in the field. Learning how to write a literature review is a critical tool for successful research. Your ability to summarize and synthesize prior research pertaining to a certain topic demonstrates your grasp on the topic of study, and assists in the learning process. 

Table of Contents

What is the purpose of literature review , a. habitat loss and species extinction: , b. range shifts and phenological changes: , c. ocean acidification and coral reefs: , d. adaptive strategies and conservation efforts: .

• Choose a Topic and Define the Research Question: 
• Decide on the Scope of Your Review: 
• Select Databases for Searches: 
• Conduct Searches and Keep Track: 
• Review the Literature: 
• Organize and Write Your Literature Review: 
• How to write a literature review faster with Paperpal? 

Frequently asked questions 

What is a literature review .

A well-conducted literature review demonstrates the researcher’s familiarity with the existing literature, establishes the context for their own research, and contributes to scholarly conversations on the topic. One of the purposes of a literature review is also to help researchers avoid duplicating previous work and ensure that their research is informed by and builds upon the existing body of knowledge.

A literature review serves several important purposes within academic and research contexts. Here are some key objectives and functions of a literature review: 2  

1. Contextualizing the Research Problem: The literature review provides a background and context for the research problem under investigation. It helps to situate the study within the existing body of knowledge. 

2. Identifying Gaps in Knowledge: By identifying gaps, contradictions, or areas requiring further research, the researcher can shape the research question and justify the significance of the study. This is crucial for ensuring that the new research contributes something novel to the field.

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3. Understanding Theoretical and Conceptual Frameworks: Literature reviews help researchers gain an understanding of the theoretical and conceptual frameworks used in previous studies. This aids in the development of a theoretical framework for the current research. 

4. Providing Methodological Insights: Another purpose of literature reviews is that it allows researchers to learn about the methodologies employed in previous studies. This can help in choosing appropriate research methods for the current study and avoiding pitfalls that others may have encountered. 

5. Establishing Credibility: A well-conducted literature review demonstrates the researcher’s familiarity with existing scholarship, establishing their credibility and expertise in the field. It also helps in building a solid foundation for the new research. 

6. Informing Hypotheses or Research Questions: The literature review guides the formulation of hypotheses or research questions by highlighting relevant findings and areas of uncertainty in existing literature. 

Literature review example 

Let’s delve deeper with a literature review example: Let’s say your literature review is about the impact of climate change on biodiversity. You might format your literature review into sections such as the effects of climate change on habitat loss and species extinction, phenological changes, and marine biodiversity. Each section would then summarize and analyze relevant studies in those areas, highlighting key findings and identifying gaps in the research. The review would conclude by emphasizing the need for further research on specific aspects of the relationship between climate change and biodiversity. The following literature review template provides a glimpse into the recommended literature review structure and content, demonstrating how research findings are organized around specific themes within a broader topic. 

Literature Review on Climate Change Impacts on Biodiversity:  

Climate change is a global phenomenon with far-reaching consequences, including significant impacts on biodiversity. This literature review synthesizes key findings from various studies: 

Climate change-induced alterations in temperature and precipitation patterns contribute to habitat loss, affecting numerous species (Thomas et al., 2004). The review discusses how these changes increase the risk of extinction, particularly for species with specific habitat requirements. 

Observations of range shifts and changes in the timing of biological events (phenology) are documented in response to changing climatic conditions (Parmesan & Yohe, 2003). These shifts affect ecosystems and may lead to mismatches between species and their resources. 

The review explores the impact of climate change on marine biodiversity, emphasizing ocean acidification’s threat to coral reefs (Hoegh-Guldberg et al., 2007). Changes in pH levels negatively affect coral calcification, disrupting the delicate balance of marine ecosystems. 

Recognizing the urgency of the situation, the literature review discusses various adaptive strategies adopted by species and conservation efforts aimed at mitigating the impacts of climate change on biodiversity (Hannah et al., 2007). It emphasizes the importance of interdisciplinary approaches for effective conservation planning. 

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How to write a good literature review 

Writing a literature review involves summarizing and synthesizing existing research on a particular topic. A good literature review format should include the following elements. 

Introduction: The introduction sets the stage for your literature review, providing context and introducing the main focus of your review. 

• Opening Statement: Begin with a general statement about the broader topic and its significance in the field. 
• Scope and Purpose: Clearly define the scope of your literature review. Explain the specific research question or objective you aim to address. 
• Organizational Framework: Briefly outline the structure of your literature review, indicating how you will categorize and discuss the existing research. 
• Significance of the Study: Highlight why your literature review is important and how it contributes to the understanding of the chosen topic. 
• Thesis Statement: Conclude the introduction with a concise thesis statement that outlines the main argument or perspective you will develop in the body of the literature review. 

Body: The body of the literature review is where you provide a comprehensive analysis of existing literature, grouping studies based on themes, methodologies, or other relevant criteria. 

• Organize by Theme or Concept: Group studies that share common themes, concepts, or methodologies. Discuss each theme or concept in detail, summarizing key findings and identifying gaps or areas of disagreement. 
• Critical Analysis: Evaluate the strengths and weaknesses of each study. Discuss the methodologies used, the quality of evidence, and the overall contribution of each work to the understanding of the topic. 
• Synthesis of Findings: Synthesize the information from different studies to highlight trends, patterns, or areas of consensus in the literature. 
• Identification of Gaps: Discuss any gaps or limitations in the existing research and explain how your review contributes to filling these gaps. 
• Transition between Sections: Provide smooth transitions between different themes or concepts to maintain the flow of your literature review. 

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Conclusion: The conclusion of your literature review should summarize the main findings, highlight the contributions of the review, and suggest avenues for future research. 

• Summary of Key Findings: Recap the main findings from the literature and restate how they contribute to your research question or objective. 
• Contributions to the Field: Discuss the overall contribution of your literature review to the existing knowledge in the field. 
• Implications and Applications: Explore the practical implications of the findings and suggest how they might impact future research or practice. 
• Recommendations for Future Research: Identify areas that require further investigation and propose potential directions for future research in the field. 
• Final Thoughts: Conclude with a final reflection on the importance of your literature review and its relevance to the broader academic community. 

Conducting a literature review 

Conducting a literature review is an essential step in research that involves reviewing and analyzing existing literature on a specific topic. It’s important to know how to do a literature review effectively, so here are the steps to follow: 1  

Choose a Topic and Define the Research Question:  

• Select a topic that is relevant to your field of study. 
• Clearly define your research question or objective. Determine what specific aspect of the topic do you want to explore? 

Decide on the Scope of Your Review:  

• Determine the timeframe for your literature review. Are you focusing on recent developments, or do you want a historical overview? 
• Consider the geographical scope. Is your review global, or are you focusing on a specific region? 
• Define the inclusion and exclusion criteria. What types of sources will you include? Are there specific types of studies or publications you will exclude? 

Select Databases for Searches:  

• Identify relevant databases for your field. Examples include PubMed, IEEE Xplore, Scopus, Web of Science, and Google Scholar. 
• Consider searching in library catalogs, institutional repositories, and specialized databases related to your topic. 

Conduct Searches and Keep Track:  

• Develop a systematic search strategy using keywords, Boolean operators (AND, OR, NOT), and other search techniques. 
• Record and document your search strategy for transparency and replicability. 
• Keep track of the articles, including publication details, abstracts, and links. Use citation management tools like EndNote, Zotero, or Mendeley to organize your references. 

Review the Literature:  

• Evaluate the relevance and quality of each source. Consider the methodology, sample size, and results of studies. 
• Organize the literature by themes or key concepts. Identify patterns, trends, and gaps in the existing research. 
• Summarize key findings and arguments from each source. Compare and contrast different perspectives. 
• Identify areas where there is a consensus in the literature and where there are conflicting opinions. 
• Provide critical analysis and synthesis of the literature. What are the strengths and weaknesses of existing research? 

Organize and Write Your Literature Review:  

• Literature review outline should be based on themes, chronological order, or methodological approaches. 
• Write a clear and coherent narrative that synthesizes the information gathered. 
• Use proper citations for each source and ensure consistency in your citation style (APA, MLA, Chicago, etc.). 
• Conclude your literature review by summarizing key findings, identifying gaps, and suggesting areas for future research. 

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How to write a literature review faster with Paperpal?  

Paperpal, an AI writing assistant, integrates powerful academic search capabilities within its writing platform. With the Research | Cite feature, you get 100% factual insights, with citations backed by 250M+ verified research articles, directly within your writing interface. It also allows you auto-cite references in 10,000+ styles and save relevant references in your Citation Library. By eliminating the need to switch tabs to find answers to all your research questions, Paperpal saves time and helps you stay focused on your writing.   

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The literature review sample and detailed advice on writing and conducting a review will help you produce a well-structured report. But remember that a good literature review is an ongoing process, and it may be necessary to revisit and update it as your research progresses. By combining effortless research with an easy citation process, Paperpal Research streamlines the literature review process and empowers you to write faster and with more confidence. Try Paperpal Research now and see for yourself.  

A literature review is a critical and comprehensive analysis of existing literature (published and unpublished works) on a specific topic or research question and provides a synthesis of the current state of knowledge in a particular field. A well-conducted literature review is crucial for researchers to build upon existing knowledge, avoid duplication of efforts, and contribute to the advancement of their field. It also helps researchers situate their work within a broader context and facilitates the development of a sound theoretical and conceptual framework for their studies.

Literature review is a crucial component of research writing, providing a solid background for a research paper’s investigation. The aim is to keep professionals up to date by providing an understanding of ongoing developments within a specific field, including research methods, and experimental techniques used in that field, and present that knowledge in the form of a written report. Also, the depth and breadth of the literature review emphasizes the credibility of the scholar in his or her field.  

Before writing a literature review, it’s essential to undertake several preparatory steps to ensure that your review is well-researched, organized, and focused. This includes choosing a topic of general interest to you and doing exploratory research on that topic, writing an annotated bibliography, and noting major points, especially those that relate to the position you have taken on the topic. 

Literature reviews and academic research papers are essential components of scholarly work but serve different purposes within the academic realm. 3 A literature review aims to provide a foundation for understanding the current state of research on a particular topic, identify gaps or controversies, and lay the groundwork for future research. Therefore, it draws heavily from existing academic sources, including books, journal articles, and other scholarly publications. In contrast, an academic research paper aims to present new knowledge, contribute to the academic discourse, and advance the understanding of a specific research question. Therefore, it involves a mix of existing literature (in the introduction and literature review sections) and original data or findings obtained through research methods. 

Literature reviews are essential components of academic and research papers, and various strategies can be employed to conduct them effectively. If you want to know how to write a literature review for a research paper, here are four common approaches that are often used by researchers.  Chronological Review: This strategy involves organizing the literature based on the chronological order of publication. It helps to trace the development of a topic over time, showing how ideas, theories, and research have evolved.  Thematic Review: Thematic reviews focus on identifying and analyzing themes or topics that cut across different studies. Instead of organizing the literature chronologically, it is grouped by key themes or concepts, allowing for a comprehensive exploration of various aspects of the topic.  Methodological Review: This strategy involves organizing the literature based on the research methods employed in different studies. It helps to highlight the strengths and weaknesses of various methodologies and allows the reader to evaluate the reliability and validity of the research findings.  Theoretical Review: A theoretical review examines the literature based on the theoretical frameworks used in different studies. This approach helps to identify the key theories that have been applied to the topic and assess their contributions to the understanding of the subject.  It’s important to note that these strategies are not mutually exclusive, and a literature review may combine elements of more than one approach. The choice of strategy depends on the research question, the nature of the literature available, and the goals of the review. Additionally, other strategies, such as integrative reviews or systematic reviews, may be employed depending on the specific requirements of the research.

The literature review format can vary depending on the specific publication guidelines. However, there are some common elements and structures that are often followed. Here is a general guideline for the format of a literature review:  Introduction:   Provide an overview of the topic.  Define the scope and purpose of the literature review.  State the research question or objective.  Body:   Organize the literature by themes, concepts, or chronology.  Critically analyze and evaluate each source.  Discuss the strengths and weaknesses of the studies.  Highlight any methodological limitations or biases.  Identify patterns, connections, or contradictions in the existing research.  Conclusion:   Summarize the key points discussed in the literature review.  Highlight the research gap.  Address the research question or objective stated in the introduction.  Highlight the contributions of the review and suggest directions for future research.

Both annotated bibliographies and literature reviews involve the examination of scholarly sources. While annotated bibliographies focus on individual sources with brief annotations, literature reviews provide a more in-depth, integrated, and comprehensive analysis of existing literature on a specific topic. The key differences are as follows: 

References 

• Denney, A. S., & Tewksbury, R. (2013). How to write a literature review.  Journal of criminal justice education ,  24 (2), 218-234. 
• Pan, M. L. (2016).  Preparing literature reviews: Qualitative and quantitative approaches . Taylor & Francis. 
• Cantero, C. (2019). How to write a literature review.  San José State University Writing Center . 

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• Published: 18 September 2024

Endogenous opioid signalling regulates spinal ependymal cell proliferation

• Wendy W. S. Yue   ORCID: orcid.org/0000-0002-7736-4262 1 ,
• Kouki K. Touhara 1 ,
• Kenichi Toma 2 ,
• Xin Duan   ORCID: orcid.org/0000-0001-5260-8972 2 &
• David Julius   ORCID: orcid.org/0000-0002-6365-4867 1  

Nature ( 2024 ) Cite this article

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• Neurophysiology
• Spinal cord injury

After injury, mammalian spinal cords develop scars to confine the lesion and prevent further damage. However, excessive scarring can hinder neural regeneration and functional recovery 1 , 2 . These competing actions underscore the importance of developing therapeutic strategies to dynamically modulate scar progression. Previous research on scarring has primarily focused on astrocytes, but recent evidence has suggested that ependymal cells also participate. Ependymal cells normally form the epithelial layer encasing the central canal, but they undergo massive proliferation and differentiation into astroglia following certain injuries, becoming a core scar component 3 , 4 , 5 , 6 , 7 . However, the mechanisms regulating ependymal proliferation in vivo remain unclear. Here we uncover an endogenous κ-opioid signalling pathway that controls ependymal proliferation. Specifically, we detect expression of the κ-opioid receptor, OPRK1, in a functionally under-characterized cell type known as cerebrospinal fluid-contacting neuron (CSF-cN). We also discover a neighbouring cell population that expresses the cognate ligand prodynorphin (PDYN). Whereas κ-opioids are typically considered inhibitory, they excite CSF-cNs to inhibit ependymal proliferation. Systemic administration of a κ-antagonist enhances ependymal proliferation in uninjured spinal cords in a CSF-cN-dependent manner. Moreover, a κ-agonist impairs ependymal proliferation, scar formation and motor function following injury. Together, our data suggest a paracrine signalling pathway in which PDYN + cells tonically release κ-opioids to stimulate CSF-cNs and suppress ependymal proliferation, revealing an endogenous mechanism and potential pharmacological strategy for modulating scarring after spinal cord injury.

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Data availability

All data generated or analysed during this study are included in the manuscript and its extended data. The sequencing results have been deposited at the NCBI under the accession number GSE255883 . The reference genome was built based on the annotated mouse reference genome (mm10) available as Genome assembly GRCm38 on the NCBI at: https://www.ncbi.nlm.nih.gov/datasets/genome/GCF_000001635.20/ . Source data are provided with this paper.

Silver, J. & Miller, J. H. Regeneration beyond the glial scar. Nat. Rev. Neurosci. 5 , 146–156 (2004).

Article   CAS   PubMed   Google Scholar  

Tran, A. P., Warren, P. M. & Silver, J. New insights into glial scar formation after spinal cord injury. Cell Tissue Res. 387 , 319–336 (2021).

Article   PubMed   PubMed Central   Google Scholar  

Johansson, C. B. et al. Identification of a neural stem cell in the adult mammalian central nervous system. Cell 96 , 25–34 (1999).

Meletis, K. et al. Spinal cord injury reveals multilineage differentiation of ependymal cells. PLoS Biol. 6 , e182 (2008).

Sabelström, H. et al. Resident neural stem cells restrict tissue damage and neuronal loss after spinal cord injury in mice. Science 342 , 637–640 (2013).

Article   ADS   PubMed   Google Scholar  

Barnabé-Heider, F. et al. Origin of new glial cells in intact and injured adult spinal cord. Cell Stem Cell 7 , 470–482 (2010).

Article   PubMed   Google Scholar  

Lacroix, S. et al. Central canal ependymal cells proliferate extensively in response to traumatic spinal cord injury but not demyelinating lesions. PLoS ONE 9 , e85916 (2014).

Article   ADS   PubMed   PubMed Central   Google Scholar  

New, L. E., Yanagawa, Y., McConkey, G. A., Deuchars, J. & Deuchars, S. A. GABAergic regulation of cell proliferation within the adult mouse spinal cord. Neuropharmacology 223 , 109326 (2023).

Vigh, B., Vigh-Teichmann, I., Manzano e Silva, M. J. & van den Pol, A. N. Cerebrospinal fluid-contacting neurons of the central canal and terminal ventricle in various vertebrates. Cell Tissue Res. 231 , 615–621 (1983).

Huang, A. L. et al. The cells and logic for mammalian sour taste detection. Nature 442 , 934–938 (2006).

Article   ADS   CAS   PubMed   PubMed Central   Google Scholar  

Orts-Del’immagine, A. et al. Properties of subependymal cerebrospinal fluid contacting neurones in the dorsal vagal complex of the mouse brainstem. J. Physiol. 590 , 3719–3741 (2012).

Prendergast, A. E. et al. CSF-contacting neurons respond to Streptococcus pneumoniae and promote host survival during central nervous system infection. Curr. Biol . https://doi.org/10.1016/J.CUB.2023.01.039 (2023).

Böhm, U. L. et al. CSF-contacting neurons regulate locomotion by relaying mechanical stimuli to spinal circuits. Nat. Commun. 7 , 10866 (2016).

Sternberg, J. R. et al. Pkd2l1 is required for mechanoception in cerebrospinal fluid-contacting neurons and maintenance of spine curvature. Nat. Commun. 9 , 3804 (2018).

Orts-Del’Immagine, A. et al. A single polycystic kidney disease 2-like 1 channel opening acts as a spike generator in cerebrospinal fluid-contacting neurons of adult mouse brainstem. Neuropharmacology 101 , 549–565 (2016).

Johnson, E. et al. Graded spikes differentially signal neurotransmitter input in cerebrospinal fluid contacting neurons of the mouse spinal cord. iScience 26 , 105914 (2023).

Article   ADS   CAS   PubMed   Google Scholar  

Gerstmann, K. et al. The role of intraspinal sensory neurons in the control of quadrupedal locomotion. Curr. Biol. 32 , 2442–2453.e4 (2022).

Djenoune, L. et al. The dual developmental origin of spinal cerebrospinal fluid-contacting neurons gives rise to distinct functional subtypes. Sci Rep. 7 , 719 (2017).

Nakamura, Y. et al. Cerebrospinal fluid-contacting neuron tracing reveals structural and functional connectivity for locomotion in the mouse spinal cord. eLife 12 , e83108 (2023).

Article   CAS   PubMed   PubMed Central   Google Scholar  

Stoeckel, M.-E. et al. Cerebrospinal fluid-contacting neurons in the rat spinal cord, a γ-aminobutyric acidergic system expressing the P2X2 subunit of purinergic receptors, PSA-NCAM, and GAP-43 immunoreactivities: light and electron microscopic study. J. Comp. Neurol. 457 , 159–174 (2003).

Chavkin, C. Dynorphin — still an extraordinarily potent opioid peptide. Mol. Pharmacol. 83 , 729–736 (2013).

Khachaturian, H. et al. Dynorphin immunocytochemistry in the rat central nervous system. Peptides 3 , 941–954 (1982).

Veldman, M. B. et al. Brainwide genetic sparse cell labeling to illuminate the morphology of neurons and glia with Cre-dependent MORF mice. Neuron 108 , 111–127.e6 (2020).

Furube, E. et al. Neural stem cell phenotype of tanycyte-like ependymal cells in the circumventricular organs and central canal of adult mouse brain. Sci. Rep. 10 , 2826 (2020).

Brust, T. F. Biased ligands at the κ opioid receptor: fine-tuning receptor pharmacology. Handb. Exp. Pharmacol. 271 , 115–135 (2022).

Bruchas, M. R. & Chavkin, C. Kinase cascades and ligand-directed signaling at the κ opioid receptor. Psychopharmacology 210 , 137–147 (2010).

Eriksson, P. S., Nilsson, M., Wågberg, M., Hansson, E. & Rönnbäck, L. κ-Opioid receptors on astrocytes stimulate l-type Ca 2+ channels. Neuroscience 54 , 401–407 (1993).

Gurwell, J. A. et al. κ-Opioid receptor expression defines a phenotypically distinct subpopulation of astroglia: relationship to Ca 2+ mobilization, development, and the antiproliferative effect of opioids. Brain Res. 737 , 175–187 (1996).

Pan, Z. Z. Opioid receptor-mediated enhancement of the hyperpolarization-activated current (Ih) through mobilization of intracellular calcium in rat nucleus raphe magnus. J. Physiol. 548 , 765–775 (2003).

Lai, J. et al. Dynorphin A activates bradykinin receptors to maintain neuropathic pain. Nat. Neurosci. 9 , 1534–1540 (2006).

Laughlin, T. M. et al. Spinally administered dynorphin A produces long-lasting allodynia: involvement of NMDA but not opioid receptors. Pain 72 , 253–260 (1997).

Bakshi, R. & Faden, A. I. Competitive and non-competitive NMDA antagonists limit dynorphin A-induced rat hindlimb paralysis. Brain Res. 507 , 1–5 (1990).

Zhang, S. et al. Dynorphin A as a potential endogenous ligand for four members of the opioid receptor gene family. J. Pharmacol. Exp. Ther. 286 , 136–141 (1998).

CAS   PubMed   Google Scholar  

Riondel, P. et al. Evidence for two subpopulations of cerebrospinal-fluid contacting neurons with opposite GABAergic signaling in adult mouse spinal cord. J. Neurosci . https://doi.org/10.1523/JNEUROSCI.2289-22.2024 (2024).

Corns, L. F. et al. Cholinergic enhancement of cell proliferation in the postnatal neurogenic niche of the mammalian spinal cord. Stem Cells 33 , 2864–2876 (2015).

Hussein, S. A. Functional characterization of the TRP-type channel PKD2L1. ERA https://doi.org/10.7939/R3P84495F (2015).

Felix, R. Molecular regulation of voltage-gated Ca 2+ channels. J. Recept. Signal Transduct. 25 , 57–71 (2008).

Article   Google Scholar  

Barber, R. P., Vaughn, J. E. & Roberts, E. The cytoarchitecture of GABAergic neurons in rat spinal cord. Brain Res. 238 , 305–328 (1982).

Djenoune, L. et al. Investigation of spinal cerebrospinal fluid-contacting neurons expressing PKD2L1: evidence for a conserved system from fish to primates. Front. Neuroanat. 8 , 26 (2014).

Matson, K. J. E. et al. Single cell atlas of spinal cord injury in mice reveals a pro-regenerative signature in spinocerebellar neurons. Nat. Commun. 13 , 5628 (2022).

Ren, Y. et al. Ependymal cell contribution to scar formation after spinal cord injury is minimal, local and dependent on direct ependymal injury. Sci Rep. 7 , 41122 (2017).

Corns, L. F., Deuchars, J. & Deuchars, S. A. GABAergic responses of mammalian ependymal cells in the central canal neurogenic niche of the postnatal spinal cord. Neurosci. Lett. 553 , 57–62 (2013).

Kozono, H., Yoshitani, H. & Nakano, R. Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch® capsules 2.5 μg) in 3,762 hemodialysis patients with intractable pruritus. Int. J. Nephrol. Renovasc. Dis. 11 , 9–24 (2018).

Bloodgood, D. W. et al. κ Opioid receptor and dynorphin signaling in the central amygdala regulates alcohol intake. Mol. Psychiatry 26 , 2187–2199 (2021).

Madisen, L. et al. A robust and high-throughput Cre reporting and characterization system for the whole mouse brain. Nat. Neurosci. 13 , 133–140 (2010).

Krashes, M. J. et al. An excitatory paraventricular nucleus to AgRP neuron circuit that drives hunger. Nature 507 , 238–242 (2014).

Gee, J. M. et al. Imaging activity in neurons and glia with a Polr2a-based and Cre-dependent GCaMP5G-IRES-tdTomato reporter mouse. Neuron 83 , 1058–1072 (2014).

Buch, T. et al. A Cre-inducible diphtheria toxin receptor mediates cell lineage ablation after toxin administration. Nat. Methods 2 , 419–426 (2005).

Arnold, K. et al. Sox2 + adult stem and progenitor cells are important for tissue regeneration and survival of mice. Cell Stem Cell 9 , 317–329 (2011).

Edelstein, A. D. et al. Advanced methods of microscope control using μManager software. J. Biol. Methods 1 , e10 (2014).

Renier, N. et al. iDISCO: a simple, rapid method to immunolabel large tissue samples for volume imaging. Cell 159 , 896–910 (2014).

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Acknowledgements

We thank C. Zuker for the Tg(PKD2L1-Cre) mouse line; R. Palmiter for the Pdyn fl/fl mice; N. Ingolia for computational resources for sequencing analyses; K. Lindquist for statistical advice; J. Poblete for technical support; R. Nicoll, M. Beattie, J. Bresnahan, A. Basbaum, J. Braz, M. Bruchas, H. Ingraham, A. Alvarez-Buylla, M. Delling, N. Bellono, Z. Jiang, K. Yackle and all current members of the Julius laboratory for discussion and critical reading of the manuscript; and support from staff in UCSF’s core facilities, including the Laboratory for Cell Analysis (S. Elmes; NIH Cancer Center Support grant P30CA082103), the Center for Advanced Light Microscopy (D. Larsen, K. Herrington and S. Y. Kim; S10 Shared Instrumentation grant 1S10OD017993-01A1 for the Nikon CSU-W1 spinning disk confocal microscope), the Center for Advanced Technology (E. Chow and D. Martinez) as well as the Mouse Microsurgery Core (M. Looney and L. Qiu; financial support from the UCSF Bakar ImmunoX Initiative). This work was supported by a Howard Hughes Medical Institute Hanna Gray Fellowship and a Croucher Fellowship for Postdoctoral Research (to W.W.S.Y.), a Damon Runyon Cancer Research Foundation Fellowship (DRG-(2387-30) to K.K.T.), the UCSF Program for Breakthrough Biomedical Research: New Frontier Research Award (to D.J.) and NIH grants (R01EY030138 to X.D. and R35 NS105038 to D.J.).

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Wendy W. S. Yue, Kouki K. Touhara & David Julius

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Contributions

W.W.S.Y., K.K.T. and D.J. conceived and designed the experiments. W.W.S.Y. characterized the expression of the κ-opioid receptor and ligand, performed calcium imaging of CSF-cNs, and conducted the histological and functional analyses related to in vivo pharmacological interventions of the κ-opioid signalling pathway. W.W.S.Y. and K.K.T. performed the electrophysiological recordings of CSF-cNs. W.W.S.Y., K.K.T. and D.J. analysed the data. K.T. and X.D. contributed essential AAV resources. W.W.S.Y., K.K.T. and D.J. wrote the manuscript with input and suggestions from all authors.

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Correspondence to Wendy W. S. Yue or David Julius .

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Extended data figures and tables

Extended data fig. 1 characterization of csf-cns and pdyn + cells in the spinal cord..

a , Labelling of spinal cord cells by the Tg(PKD2L1-Cre);Rosa26 LSL-tdTomato mouse line. The tdTomato reporter (magenta) was expressed in many other spinal cord cells in addition to the CSF-cNs (magnified on right), which were identified by their strong immunostaining signal for PKD2L1 (green), particularly in their bulbous projections within the central canal (CC). b , Labelling of spinal cord cells by the Tg(PKD2L1-Cre) mouse line when tdTomato reporter was delivered by intracerebroventricular AAV injection after adulthood. The PHP.eB serotype labels cells beyond the ependymal region (e.g., arrow in magnified view on right). c , Projection pattern of CSF-cNs at different levels of the spinal cord. Coronal spinal cord and brain sections from a mouse that had received intracerebroventricular injection of an AAV carrying the PLAP transgene. Sections were stained with NBT/BCIP to reveal the ventral projections of CSF-cNs. d , Longitudinal projection of CSF-cNs. Sagittal section of the spinal cord showing the nerve bundle formed by CSF-cNs’ projections that travel rostrocaudally within the ventral white matter. Cell bodies of CSF-cNs are found in the ependyma. e , Morphology of a single PLAP-labelled CSF-cN. Spinal cord was cleared by the iDisco method 51 after NBT/BCIP staining. f , Morphology of Pdyn + cells. Arrowheads trace the long processes of sparsely labelled Pdyn + cells situated at the dorsal or ventral pole of the ependyma. Dotted lines mark the boundary between grey and white matters. g , Schematic depicting the projection pattern of CSF-cNs (green) and PDYN + cells (magenta). h , Spinal cord sections from Pdyn Cre ;Rosa26 LSL-tdTomato mice immunostained with antibodies against known markers (cyan) for various subsets of ependymal cells. SOX2 is expressed in PDYN + cells (magenta) in the ependymal region but not in PDYN + cells in the dorsal horn. Ependymal PDYN + cells are also positive for NESTIN but not GFAP. All experiments have been repeated for at least 3 times with similar results.

Extended Data Fig. 2 Expression of transcripts of interest in preparations of acutely dissociated and FACS-enriched CSF-cNs.

CSF-cNs were labelled by tdTomato via i.c.v. AAV injection and were fluorescently sorted for bulk mRNA sequencing. Columns represent 4 separate preparations with increasing level of enrichment in CSF-cNs, as reflected by the expression level of tdTomato transcript. Colour scale is based on median-of-ratios calculation by DESeq2. a , Marker genes for oligodendrocytes ( Plp1 and Mbp ), migroglia ( P2ry12 ) and astrocytes ( Gfap ), showing the degree of glial contamination. b , Genes typically involved in GABA metabolism. c , Genes related to neurotransmission. d , Genes for receptors proposed to be sensitive to κ opioid ligands. e , TRP and Ca v channel genes.

Extended Data Fig. 3 Ca 2+ responses of GCaMP5G-expressing CSF-cNs to OPRK1 agonists.

ai , Example ΔF/F traces showing the responses of CSF-cNs to local application of the κ agonist, Nalfurafine, in the absence (black) or presence (red) of the antagonist, DIPPA, in the bath. Local application of a high K + solution was used to reveal all responsive neurons. Each trace is from a single cell. aii , ΔF/F images for the spinal cord slices in ai . Images are temporal averages over 10 sec of baseline or for the duration of the stimuli. CC: central canal. Scale bars are 20 μm. aiii , Collective data comparing CSF-cNs’ responses to Nalfurafine in the absence (black) and presence (red) of DIPPA. Each dot shows the integral DYNA response of a single cell normalized to the high-K + response. Two-sided Mann-Whitney test: P  = 0.0445; n = 29 and 28 cells. b , Same as a except that BRL-52537 was used as the agonist and Nor-BNI as the antagonist. Two-sided Mann-Whitney test: P  = 0.0150; n = 20 and 12 cells. In all bar graphs, data are mean ± s.d. * P ≤ 0.05.

Source Data

Extended Data Fig. 4 Pharmacological experiments to delineate the downstream pathway of OPRK1 signaling.

a , CSF-cNs showed significant responses only to κ agonist (DYNA, 0.5 μM, 1 min) but not to agonists of the bradykinin receptors (bradykinin, 0.5 μM, 1 min), the delta opioid receptor (SNC162, 0.5 μM, 1 min) and the mu opioid receptor (Endomorphin-1, 0.5 μM, 1 min). Calcium imaging of acutely harvested spinal cord slices in the presence of TTX. Each colour represents one cell. Agonists were applied without gaps in the order displayed on the graph. Because comparisons were done within the same cell, responses were raw area under ΔF/F traces and were not baseline-subtracted nor normalized to high-K + responses as in other figures. Repeated measures Friedman non-parametric test and Dunn’s posthoc pairwise comparisons with baseline: Bradykinin ( P  = 0.5466), SNC162 ( P  > 0.9999), Endomorphin-1 ( P  > 0.9999), and DYNA ( P  < 0.0001); n = 13. b , Normalized integral DYNA response (mean ± s.d.) as in Fig. 2e , but in the presence of various inhibitors or in different ionic conditions. Molecular targets of the drugs are indicated in brackets. Routes of drug application are detailed in Methods . Kruskal-Wallis non-parametric test and Dunn’s posthoc pairwise comparisons with control, which is same as –Nor-BNI in Fig. 2d and Fig. 2e : YM254890 ( P  < 0.0001), U73122 ( P  = 0.0133), U73343 ( P  = 0.3874, not significant), Thapsigargin ( P  > 0.9999, not significant), Ivabradine ( P  > 0.9999, not significant), Chelerythrine Cl ( P  = 0.0149), Nifedipine ( P  = 0.4256, not significant), ω-Agatoxin ( P  < 0.0001), ω-Conotoxin ( P  = 0.0005), SNX482 ( P  > 0.9999, not significant) and NNC 55-0396 ( P  = 0.0004). Numbers of cells analyzed are in brackets above bars. c , Proposed signalling pathway downstream of OPRK1 in CSF-cNs. * P ≤ 0.05; *** P ≤ 0.001; **** P ≤ 0.0001.

Extended Data Fig. 5 Voltage-clamp recording on CSF-cNs during DYNA application.

ai , Representative voltage-clamp recordings of CSF-cNs. Membrane potential was held at −80 mV in the absence or presence of the κ antagonist, Nor-BNI, in the bath. No macroscopic current was observed during local DYNA application (line above trace). aii , Expanded view of the boxed regions of traces in ai , showing single channel openings at baseline or during DYNA application. b , Example of a single channel opening event and a spontaneous postsynaptic event to show the clear distinction between the two waveforms. c , Amplitude histogram of spontaneous single channel opening events detected at baseline. Two peaks at amplitude ~5 pA and ~11 pA were detected. The ~11 pA events resembled those described in earlier reports 11 , 15 , which were shown to originate from PKD2L1 channels 15 . d , Open probability of the ~11 pA channel before and after DYNA application with or without Nor-BNI in bath. Each pair of light-coloured dots is from a single cell. Group averages are in dark colours. Repeated measures two-way ANOVA: DYNA × Nor-BNI ( F 1,10  = 0.01981, P  = 0.8909, not significant); n = 6 and 5. We did not analyse the ~5 pA events because they were not clearly discernible from background noise. e , Rate of postsynaptic events before and during DYNA application in normal aCSF bath. Each pair of light-coloured dots is from a single cell. Group averages are in dark colours. Wilcoxon matched-pairs signed rank non-parametric test: P  = 0.8750, not significant; n = 7 and 7.

Extended Data Fig. 6 Ca v current recording from CSF-cNs during DYNA application.

a , Representative voltage-clamp recordings of CSF-cNs. Membrane potential was held at −100 mV, and 20 mV voltage steps from −100 mV to 60 mV were applied before, during, and after DYNA application. Voltage-gated sodium and potassium channels were inhibited by NMDG and TTX in the external solution and by caesium in the internal solution. Ba 2+ (10 mM) was supplemented to the external buffer to increase the conductance of Ca v channels. b , Current-voltage relationship recorded under the 3 conditions in a . The general Ca v channel blocker, Cadmium (Cd 2+ ), was added to one cell to verify that the recorded current was through Ca v channels. Current responses were normalized to membrane capacitance, represented as mean ± s.d. Mixed-effect analyses with Šidák correction for pairwise comparisons: statistical significance reported in table; n = 10 for baseline and DYNA conditions and n = 8 for washout (data from 2 cells were excluded due to unstable recording). * P ≤ 0.05.

Extended Data Fig. 7 CSF-cNs, Pdyn + cells and scar formation in injured spinal cords.

Following dorsal hemisection, no EdU signal (white) was detected in ( a ) CSF-cNs labelled in the Tg(PKD2L1-Cre) mouse line and ( b ) Pdyn + cells labelled in the Pdyn Cre line on Day 9. EdU injection scheme as in Fig. 4b . c , Immunohistochemical detection of PDYN in the ependymal region of sham-operated and injured mice 9 days after surgery. d , Effect of long-term κ agonist treatment (Nalfurafine, 0.027 mg/pellet with 60-day release rate, 5-6 weeks of treatment) on scar components. (Left) Representative images of the lesion sites in spinal cords harvested from placebo- or Nalfurafine-treated mice 5-8 weeks after dorsal hemisection. Sections were immunostained with antibody against GFAP (astrocytes), SOX9 (expressed in ependymal lineage), OLIG2 (oligodendrocytes) and CD68 (activated microglia and macrophages), which label components of scar tissues. (Right) Intensity of immunosignal or cell number was quantified and normalized to the volume of the region of interest. Two-sided Welch’s t-test: GFAP ( P  = 0.0005; n = 9 and 6), SOX9 ( p  = 0.0358; n = 12 and 10), and OLIG2 ( P  = 0.5756, not significant; n = 12 and 10). Two-sided Mann-Whitney test: CD68 ( P  = 0.9546, not significant; n = 9 and 6). * P ≤ 0.05; *** P ≤ 0.001.

Extended Data Fig. 8 Expression of the κ opioid receptor in various cell types.

a , Transcript expression of Oprk1 in various cell types that are known to participate in the injury response. Expression data and cluster identities were from ref. 40 . The authors used contusion instead of dorsal hemisection as their injury model. The injury was inflicted at the thoracic level and spinal cord tissues were collected at the lumbar level. Color scale shows the average expression value. b , Protein expression of OPRK1 in various cell types identified by immunohistochemical markers. OPRK1 expression was detected only in CSF-cNs in the ependymal region (arrows) but not in other cell types in both sham-operated and injured animals 9 days after dorsal hemisection. Similar results were obtained from 3 experiments.

Extended Data Fig. 9 Effect of Nalfurafine (0.027 mg/pellet with 60-day release rate, 5-8 weeks of treatment) on rotarod performance.

Amount of time individual mice from each treatment group stayed on rotarod. Datapoints are the 3 highest scores; corresponding averages are represented by bars. The cutoff time is 10 min. Pie charts (black) indicate the fraction of animals that reached the cutoff time in at least 2 trials (i.e., censored). Number of animals tested are given in brackets.

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Yue, W.W.S., Touhara, K.K., Toma, K. et al. Endogenous opioid signalling regulates spinal ependymal cell proliferation. Nature (2024). https://doi.org/10.1038/s41586-024-07889-w

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"Further Research is Needed!"

The phrase ‘further research is needed’ is often found in both research articles and in policymaking, where the quest for more ‘evidence’ has become a mantra. But is research really lacking, or can there be other forces behind policymakers’ request for more research?

Why ask for more research?

The motivations behind requesting more research in policymaking processes are many. Less noble or cynical motives include asking for more research to postpone decisions or hoping that later research will come to conclusions that are more in line with own interests. Sometimes more research is requested to delegitimize existing knowledge, as was the case with much tobacco research. Requesting research can also have symbolic effects, by signalizing vigour and that one takes knowledge seriously.

The need for ‘further research’ is perhaps more often driven by the potential problem-solving or instrumental contributions of research to policymaking. Research is expected to contribute to more informed and rational decisions. It can propose means and measures to fulfill the goals set by policymakers and provide a range of possible options to choose from in decision-making processes. Research can help to explain the causes and drivers of societal issues, and thus help to develop more accurate interventions and point out unintended consequences of policies. One example is found in the recently published report of the Stoltenberg-commission on gender differences in school performance and education (NOU 2019:3). The commission concludes that the causes of such differences are not yet resolved, and further research is therefore needed.

Research is expected to contribute to more informed and rational decisions.

The unread articles

But may the demand for more research also stem from not knowing the research that already exists? As the volume of information from research increases, the challenge of keeping up to date on research findings becomes greater. This is a challenge for researchers, but even more for policy makers with little time left to familiarize themselves with developments in research. A recent survey by Taran Thune (2019) suggest that policymakers seldom seek out research via formal channels, such as research databases. Rather, they prefer informal channels, including googling and asking colleagues to get access to research.

Other surveys into the uses of research in policy making, suggest that it is only a minimal fraction of research that ends up being cited in policy documents. For example, one study found that less that 0,5% of the papers published in different subject categories in the Web of Science were mentioned at least once in policy-related documents (Haunschild and Bornmann, 2017) .

Tracing the impacts of research – or not

The seemingly weak link between research being done and research being used is one backdrop to the rise of the ‘impact agenda’, which has been launched to address the contribution of research to society. The focus is on highlighting the societal benefits of research in contrast to academic impact, which was previously the dominant concern of research funders. Although the concept of societal impact is fairly new, research on the uptake and uses of research in society still goes back decades.

One body of previous research blames the apparently weak uptake of research on the differences between the spheres of research and policymaking, outlining them as separate communities, unable to communicate with each other. A milder version of this hypothesis suggests that knowledge needs translation in order to become relevant to users. In other words - the quest for further research could be interpreted as a quest for more relevant or brokered knowledge.

The quest for further research could be interpreted as a quest for more relevant or brokered knowledge.

However, the seemingly weak link between research and policymaking can be a result of research having an impact in diffuse and incremental ways. One central insight of previous research on impact, is that research often contributes in non-linear ways. Research and policies are shaped and reshaped by each other through repeated interactions and institutional arrangements suspending the boundaries between research and policies.

Impact takes time

An example of the latter is the introduction of the fiscal rule in Norway which states that that a maximum of 3% of the Government Pension Fund ’s value should be allocated to the yearly government budget. The history of the fiscal rule and the pension fund can be written as a story about bureaucratic flair and political foresight, when a group of economists in the Ministry of Finance secretly prepared the guidelines for future economic policy adopted in White paper 29 (2000-2001) in 2001. The work was initiated and implemented by the bureaucratic elite in the Ministry of Finance in 2000 with support from the political leadership, including prime minister Jens Stoltenberg, who presented the fiscal rule to the public.

But this is also a story about how economic research made an impact on Norwegian monetary policy and the management of the petroleum wealth. The fiscal rule builds on a large body of economic research on the benefits of long-term policy rules, of which the paper “Rules Rather than Discretion: The Inconsistency of Optimal Plans” by Finn E. Kydland and Edward C. Prescott is regarded as a key contribution.

This paper was central when Kydland and Prescott received the Nobel Prize in Economics in 2004 . The paper argues that it can be better for politicians to be tied to the mast - by following regular policy rules - rather than manoeuvring freely from day to day.

The paper was published in 1977, but it took decades before this insight became part of Norwegian public policy in the form of the fiscal rule. The fiscal rule can be seen as an outcome of long-term interactions between academic economists and bureaucrats in the Ministry of finance. The reports of the public commissions preceding the establishment of the pension fund include tails of attachments to economic research. But a better interpretation could be that the impact of the research was even more a result of competent policymakers, who were able to make use of and apply insights of research that was produced in an entirely different context.

[...] the impact of the research was even more a result of competent policymakers, who were able to make use of and apply insights of research produced in an entirely different context.

Further research on impact is needed!

One conclusion to be drawn from the discussion above is (surprise!) that further research on impact is needed, but also that we should focus on the capacity of users to make use of and request further research. This activity is now in the pipeline. A reframing of the issue from the extent to which research is used to characteristics of the process of use is required.

In OSIRIS we examine the processes through which research makes an impact in society. Rather than to look exclusively on the research side of impact, as in the majority of earlier work, we focus on the user perspective. Our primary interest is to better understand under which conditions research is put into use in industry, health and care, policymaking and other contexts.

This blog post was first published in Teknovatøren #17: Interdisciplinarity in the Age of Uncertainty.

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• What do the users of research want? Oct. 26, 2020

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On the OSIRIS blog the members of the project team write about impact of research as our research on this topic progresses. We aim for a collection of posts that represent preliminary and conceptual findings and ideas, discussions from meetings and seminars, shorter analyses of empirical data and brief summaries of the vast literature on impact. Some of the posts will be shared with the Impact Blog at the London School of Economics, the most comprehensive web page devoted to this topic and a great source of interesting ideas about many topics within science policy and science in practice. The blog is also open for contributions from people outside of the OSIRIS team. Send us an email if you have a text that would fit into the blog.

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Donaldson MS, Mohr JJ; Institute of Medicine (US). Exploring Innovation and Quality Improvement in Health Care Micro-Systems: A Cross-Case Analysis. Washington (DC): National Academies Press (US); 2001.

Exploring Innovation and Quality Improvement in Health Care Micro-Systems: A Cross-Case Analysis.

• Hardcopy Version at National Academies Press

CONCLUSIONS AND DIRECTIONS FOR FURTHER RESEARCH AND POLICY

• Limitations of This Research

There are limitations to all sampling strategies and to qualitative research, in particular. The strength of this method was that the sample selection used input from a pool of reognized experts in the organization, delivery, and improvement of health care. Even with a pool of recognized experts, it is reasonable to expect that some high performing micro-systems were overlooked. It was also possible that less than high performing micro-systems were included. In fact, a concern was how to ensure that the micro-systems included in the study were high performing or successful micro-systems, and probes were included in the interview to assess what evidence micro-systems might offer to validate statements about their level of performance. We did not, however, seek validation from documents or other written materials. Although the intent of the sampling strategy was to study high performing micro-systems, a very small number of apparently negative cases were useful for comparison. More importantly, as expected, each site had some areas of very strong performance and other areas that were undistinguished, and they formed a natural cross-case comparison group. Although the sites were selected because of expert opinion, the database is limited by being self report. It is possible that the leaders of the micro-systems had an interest in making their micro-system appear to be better than it is, and we did not have any independent verification of their assertions. For this reason, we did not make any judgments about the validity of respondents' assertions and have limited the analysis to descriptive summaries and themes based on the respondents' own words.

TABLE 18 Micro-System Examples of Investment in Improvement

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TABLE 19 Micro-System Examples of Alignment of Role and Training

A second limitation of this study was that the interviews were not tape-recorded to provide a raw data “gold standard” for later reference. For this reason, we went to considerable effort to ensure the quality of note taking as described in the methods section, and we obtained respondents' consent to follow-up with them to clarify notes. Follow-up was necessary in only a few instances. The notes were voluminous and rich in detail.

A third limitation is that for most of the interviews, one respondent represented each of the forty-three micro-systems. A more comprehensive assessment would include interviews with at least one person from each of the key roles within the micro-system, including patients. Such tradeoffs in qualitative analysis between breadth and depth are inevitable, 31 but given that this was an exploratory study, we decided to include as many micro-systems as possible with follow-up in later studies.

Research currently underway will expand on this work by taking a more comprehensive look at individual micro-systems and the outcomes of care provided to determine if high performing micro-systems achieve superior results for patients.

• Directions for Further Research

This research has been exploratory in that it is the first systematic look at health care micro-systems. The power of the research is that it gave a voice to individual micro-systems and provided a way to explore them while creating constructs that may be generalizable to other micro-systems. It has begun the work of defining and characterizing health care micro-systems. The greater value of this analysis will be to go beyond the findings of this research to develop tools to help existing micro-systems improve and to replicate and extend the achievements of these micro-systems.

The basic concept of health care micro-systems—small, organized groups of providers and staff caring for a defined population of patients—is not new. The key components of micro-systems (patients, populations, providers, activities, and information technology) exist in every health care setting. However, current methods for organizing and delivering health care, preparing future health professionals, conducting health services research, and formulating policy have made it difficult to recognize the interdependence and function of the micro-system.

Further analysis of the database would likely yield additional themes. All can be the basis of hypothesis testing for continued work. For example, further work might establish criteria of effectiveness and test whether the features identified as the eight themes are predictive of effectiveness. More refined or additional questions might clarify aspects of the general themes that are critical. More intensive data gathering, for example, of multiple members of the micro-system, including patients could validate results and expand our understanding of these micro-systems.

Two questions were central as we undertook this study: (1) would the term micro-system be meaningful to clinicians in the field? (2) Would they participate and give us detailed enough information to draw inferences? The answers to both questions were clearly: Yes.

Overall, we discovered that the idea of a micro-system was very readily understood by all we interviewed. They had no difficulty in identifying and describing their own micro-systems and, when appropriate because they directed several (such as several intensive care units), differentiating among them in terms of their characteristics.

The study was assisted in its work by an extremely able and distinguished steering group and Subcommittee whose reputations in the field unquestionably enabled us to secure the participation of nearly all who were invited despite our requesting an hour and a half of a busy clinician's time. Many of those interviewed willingly went on for a longer than the allotted 90 minutes and sent us additional materials. Some who were interrupted by urgent clinical business rescheduled time to complete the interviews.

Although this was a selected—not a randomly sampled—group, and there was clearly great enthusiasm and of innovative work going on at the grass-roots level. Many of those interviewed expressed clear ideas about how they were reorganizing practices, their principles for doing so, and their commitment to an ongoing process. Respondents described their early limited successes or outright failures. We heard what had and had not been successful as they tried to disseminate their practices throughout their organizations. We believe there is much that could profitably learned and shared beyond the individual sites that has not been yet been pulled together by a unifying conceptual framework or effective mechanism for deploying what is being learned.

We were struck by two findings in particular: First, the importance of leadership at the macro-system as well as clinical level; and second, the general lack of information infrastructure in these practices. Micro-system leaders repeatedly stressed the importance of executive and governance-level support. This support was singled out repeatedly as a sine qua non to their ability to succeed. It was also apparent that although some steps have been taken to incorporate the explosion of information technologies that are being deployed for managing patient information, free-standing practices as well as much of clinical practice within hospitals have only begun to integrate data systems, use them for real-time clinical practice, or as information tools for improving the quality of care for a patient population. The potential is enormous, but as yet, almost untapped. They appear to be at a threshold of incorporating information technologies into daily practice. The potential created by the development of knowledge servers, decision support tools, consumer informatics 32 continuous electronic patient-clinician communication, and computer-based electronic health records puts most of these micro-systems almost at “time zero” for what will likely be dramatic changes in the integration of information for real-time patient care and a strong baseline for future comparison.

As research on micro-systems moves forward, it will be important to transfer what has been learned from research on teams and organizations to new research that will be conducted on micro-systems. For example, research that will be helpful includes information about the different stages of development and maturity of the organization, creating the organizational environment to support teams, socializing new members (clinicians and staff) to the team, environments that support micro-systems, the characteristics of effective leadership, and how micro-systems can build linkages that result in well-coordinated care within and across organizational boundaries.

• IOM Quality of Care Study

This study was intended to provide more than a database for research, however. It was undertaken to provide an evidence base for the IOM Committee on the Quality of Health Care in America in formulating its conclusions and recommendations. Because that committee was charged with the formulation of recommendations about changes that can lead to threshold improvement in the quality of care in this country, its members believed that it was extremely important to draw not only on their expertise and the literature but also on the best evidence it could find of excellent performance and to do so in a systematic way as exemplified by this study. As that study was not limited by type of health care, the goals of such a project necessitated drawing from a wide range of sites serving a variety of patient populations. It also suggests a sample size that for qualitative analytic methods was quite broad but not unwieldy. The number of sites interviewed—43—served these purposes well. We had several of each “kind” of micro-system (e.g., primary care, critical care) but they varied in location, composition, and in their own approaches to organizing and delivering care, thus providing a very rich database of observation. That report, which is expected to be published in early 2001, will use the responses and analysis described in this technical report to underpin its recommendations about how health care micro-systems, macro-systems, and other organizational forms that have not yet emerged, can improve their performance.

• Cite this Page Donaldson MS, Mohr JJ; Institute of Medicine (US). Exploring Innovation and Quality Improvement in Health Care Micro-Systems: A Cross-Case Analysis. Washington (DC): National Academies Press (US); 2001. CONCLUSIONS AND DIRECTIONS FOR FURTHER RESEARCH AND POLICY.
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What Is Research, and Why Do People Do It?

• Open Access
• First Online: 03 December 2022

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• James Hiebert 6 ,
• Jinfa Cai 7 ,
• Stephen Hwang 7 ,
• Anne K Morris 6 &
• Charles Hohensee 6  

Part of the book series: Research in Mathematics Education ((RME))

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Abstractspiepr Abs1

Every day people do research as they gather information to learn about something of interest. In the scientific world, however, research means something different than simply gathering information. Scientific research is characterized by its careful planning and observing, by its relentless efforts to understand and explain, and by its commitment to learn from everyone else seriously engaged in research. We call this kind of research scientific inquiry and define it as “formulating, testing, and revising hypotheses.” By “hypotheses” we do not mean the hypotheses you encounter in statistics courses. We mean predictions about what you expect to find and rationales for why you made these predictions. Throughout this and the remaining chapters we make clear that the process of scientific inquiry applies to all kinds of research studies and data, both qualitative and quantitative.

You have full access to this open access chapter,  Download chapter PDF

Part I. What Is Research?

Have you ever studied something carefully because you wanted to know more about it? Maybe you wanted to know more about your grandmother’s life when she was younger so you asked her to tell you stories from her childhood, or maybe you wanted to know more about a fertilizer you were about to use in your garden so you read the ingredients on the package and looked them up online. According to the dictionary definition, you were doing research.

Recall your high school assignments asking you to “research” a topic. The assignment likely included consulting a variety of sources that discussed the topic, perhaps including some “original” sources. Often, the teacher referred to your product as a “research paper.”

Were you conducting research when you interviewed your grandmother or wrote high school papers reviewing a particular topic? Our view is that you were engaged in part of the research process, but only a small part. In this book, we reserve the word “research” for what it means in the scientific world, that is, for scientific research or, more pointedly, for scientific inquiry .

Exercise 1.1

Before you read any further, write a definition of what you think scientific inquiry is. Keep it short—Two to three sentences. You will periodically update this definition as you read this chapter and the remainder of the book.

This book is about scientific inquiry—what it is and how to do it. For starters, scientific inquiry is a process, a particular way of finding out about something that involves a number of phases. Each phase of the process constitutes one aspect of scientific inquiry. You are doing scientific inquiry as you engage in each phase, but you have not done scientific inquiry until you complete the full process. Each phase is necessary but not sufficient.

In this chapter, we set the stage by defining scientific inquiry—describing what it is and what it is not—and by discussing what it is good for and why people do it. The remaining chapters build directly on the ideas presented in this chapter.

A first thing to know is that scientific inquiry is not all or nothing. “Scientificness” is a continuum. Inquiries can be more scientific or less scientific. What makes an inquiry more scientific? You might be surprised there is no universally agreed upon answer to this question. None of the descriptors we know of are sufficient by themselves to define scientific inquiry. But all of them give you a way of thinking about some aspects of the process of scientific inquiry. Each one gives you different insights.

Exercise 1.2

As you read about each descriptor below, think about what would make an inquiry more or less scientific. If you think a descriptor is important, use it to revise your definition of scientific inquiry.

Creating an Image of Scientific Inquiry

We will present three descriptors of scientific inquiry. Each provides a different perspective and emphasizes a different aspect of scientific inquiry. We will draw on all three descriptors to compose our definition of scientific inquiry.

Descriptor 1. Experience Carefully Planned in Advance

Sir Ronald Fisher, often called the father of modern statistical design, once referred to research as “experience carefully planned in advance” (1935, p. 8). He said that humans are always learning from experience, from interacting with the world around them. Usually, this learning is haphazard rather than the result of a deliberate process carried out over an extended period of time. Research, Fisher said, was learning from experience, but experience carefully planned in advance.

This phrase can be fully appreciated by looking at each word. The fact that scientific inquiry is based on experience means that it is based on interacting with the world. These interactions could be thought of as the stuff of scientific inquiry. In addition, it is not just any experience that counts. The experience must be carefully planned . The interactions with the world must be conducted with an explicit, describable purpose, and steps must be taken to make the intended learning as likely as possible. This planning is an integral part of scientific inquiry; it is not just a preparation phase. It is one of the things that distinguishes scientific inquiry from many everyday learning experiences. Finally, these steps must be taken beforehand and the purpose of the inquiry must be articulated in advance of the experience. Clearly, scientific inquiry does not happen by accident, by just stumbling into something. Stumbling into something unexpected and interesting can happen while engaged in scientific inquiry, but learning does not depend on it and serendipity does not make the inquiry scientific.

Descriptor 2. Observing Something and Trying to Explain Why It Is the Way It Is

When we were writing this chapter and googled “scientific inquiry,” the first entry was: “Scientific inquiry refers to the diverse ways in which scientists study the natural world and propose explanations based on the evidence derived from their work.” The emphasis is on studying, or observing, and then explaining . This descriptor takes the image of scientific inquiry beyond carefully planned experience and includes explaining what was experienced.

According to the Merriam-Webster dictionary, “explain” means “(a) to make known, (b) to make plain or understandable, (c) to give the reason or cause of, and (d) to show the logical development or relations of” (Merriam-Webster, n.d. ). We will use all these definitions. Taken together, they suggest that to explain an observation means to understand it by finding reasons (or causes) for why it is as it is. In this sense of scientific inquiry, the following are synonyms: explaining why, understanding why, and reasoning about causes and effects. Our image of scientific inquiry now includes planning, observing, and explaining why.

We need to add a final note about this descriptor. We have phrased it in a way that suggests “observing something” means you are observing something in real time—observing the way things are or the way things are changing. This is often true. But, observing could mean observing data that already have been collected, maybe by someone else making the original observations (e.g., secondary analysis of NAEP data or analysis of existing video recordings of classroom instruction). We will address secondary analyses more fully in Chap. 4 . For now, what is important is that the process requires explaining why the data look like they do.

We must note that for us, the term “data” is not limited to numerical or quantitative data such as test scores. Data can also take many nonquantitative forms, including written survey responses, interview transcripts, journal entries, video recordings of students, teachers, and classrooms, text messages, and so forth.

Exercise 1.3

What are the implications of the statement that just “observing” is not enough to count as scientific inquiry? Does this mean that a detailed description of a phenomenon is not scientific inquiry?

Find sources that define research in education that differ with our position, that say description alone, without explanation, counts as scientific research. Identify the precise points where the opinions differ. What are the best arguments for each of the positions? Which do you prefer? Why?

Descriptor 3. Updating Everyone’s Thinking in Response to More and Better Information

This descriptor focuses on a third aspect of scientific inquiry: updating and advancing the field’s understanding of phenomena that are investigated. This descriptor foregrounds a powerful characteristic of scientific inquiry: the reliability (or trustworthiness) of what is learned and the ultimate inevitability of this learning to advance human understanding of phenomena. Humans might choose not to learn from scientific inquiry, but history suggests that scientific inquiry always has the potential to advance understanding and that, eventually, humans take advantage of these new understandings.

Before exploring these bold claims a bit further, note that this descriptor uses “information” in the same way the previous two descriptors used “experience” and “observations.” These are the stuff of scientific inquiry and we will use them often, sometimes interchangeably. Frequently, we will use the term “data” to stand for all these terms.

An overriding goal of scientific inquiry is for everyone to learn from what one scientist does. Much of this book is about the methods you need to use so others have faith in what you report and can learn the same things you learned. This aspect of scientific inquiry has many implications.

One implication is that scientific inquiry is not a private practice. It is a public practice available for others to see and learn from. Notice how different this is from everyday learning. When you happen to learn something from your everyday experience, often only you gain from the experience. The fact that research is a public practice means it is also a social one. It is best conducted by interacting with others along the way: soliciting feedback at each phase, taking opportunities to present work-in-progress, and benefitting from the advice of others.

A second implication is that you, as the researcher, must be committed to sharing what you are doing and what you are learning in an open and transparent way. This allows all phases of your work to be scrutinized and critiqued. This is what gives your work credibility. The reliability or trustworthiness of your findings depends on your colleagues recognizing that you have used all appropriate methods to maximize the chances that your claims are justified by the data.

A third implication of viewing scientific inquiry as a collective enterprise is the reverse of the second—you must be committed to receiving comments from others. You must treat your colleagues as fair and honest critics even though it might sometimes feel otherwise. You must appreciate their job, which is to remain skeptical while scrutinizing what you have done in considerable detail. To provide the best help to you, they must remain skeptical about your conclusions (when, for example, the data are difficult for them to interpret) until you offer a convincing logical argument based on the information you share. A rather harsh but good-to-remember statement of the role of your friendly critics was voiced by Karl Popper, a well-known twentieth century philosopher of science: “. . . if you are interested in the problem which I tried to solve by my tentative assertion, you may help me by criticizing it as severely as you can” (Popper, 1968, p. 27).

A final implication of this third descriptor is that, as someone engaged in scientific inquiry, you have no choice but to update your thinking when the data support a different conclusion. This applies to your own data as well as to those of others. When data clearly point to a specific claim, even one that is quite different than you expected, you must reconsider your position. If the outcome is replicated multiple times, you need to adjust your thinking accordingly. Scientific inquiry does not let you pick and choose which data to believe; it mandates that everyone update their thinking when the data warrant an update.

Doing Scientific Inquiry

We define scientific inquiry in an operational sense—what does it mean to do scientific inquiry? What kind of process would satisfy all three descriptors: carefully planning an experience in advance; observing and trying to explain what you see; and, contributing to updating everyone’s thinking about an important phenomenon?

We define scientific inquiry as formulating , testing , and revising hypotheses about phenomena of interest.

Of course, we are not the only ones who define it in this way. The definition for the scientific method posted by the editors of Britannica is: “a researcher develops a hypothesis, tests it through various means, and then modifies the hypothesis on the basis of the outcome of the tests and experiments” (Britannica, n.d. ).

Notice how defining scientific inquiry this way satisfies each of the descriptors. “Carefully planning an experience in advance” is exactly what happens when formulating a hypothesis about a phenomenon of interest and thinking about how to test it. “ Observing a phenomenon” occurs when testing a hypothesis, and “ explaining ” what is found is required when revising a hypothesis based on the data. Finally, “updating everyone’s thinking” comes from comparing publicly the original with the revised hypothesis.

Doing scientific inquiry, as we have defined it, underscores the value of accumulating knowledge rather than generating random bits of knowledge. Formulating, testing, and revising hypotheses is an ongoing process, with each revised hypothesis begging for another test, whether by the same researcher or by new researchers. The editors of Britannica signaled this cyclic process by adding the following phrase to their definition of the scientific method: “The modified hypothesis is then retested, further modified, and tested again.” Scientific inquiry creates a process that encourages each study to build on the studies that have gone before. Through collective engagement in this process of building study on top of study, the scientific community works together to update its thinking.

Before exploring more fully the meaning of “formulating, testing, and revising hypotheses,” we need to acknowledge that this is not the only way researchers define research. Some researchers prefer a less formal definition, one that includes more serendipity, less planning, less explanation. You might have come across more open definitions such as “research is finding out about something.” We prefer the tighter hypothesis formulation, testing, and revision definition because we believe it provides a single, coherent map for conducting research that addresses many of the thorny problems educational researchers encounter. We believe it is the most useful orientation toward research and the most helpful to learn as a beginning researcher.

A final clarification of our definition is that it applies equally to qualitative and quantitative research. This is a familiar distinction in education that has generated much discussion. You might think our definition favors quantitative methods over qualitative methods because the language of hypothesis formulation and testing is often associated with quantitative methods. In fact, we do not favor one method over another. In Chap. 4 , we will illustrate how our definition fits research using a range of quantitative and qualitative methods.

Exercise 1.4

Look for ways to extend what the field knows in an area that has already received attention by other researchers. Specifically, you can search for a program of research carried out by more experienced researchers that has some revised hypotheses that remain untested. Identify a revised hypothesis that you might like to test.

Unpacking the Terms Formulating, Testing, and Revising Hypotheses

To get a full sense of the definition of scientific inquiry we will use throughout this book, it is helpful to spend a little time with each of the key terms.

We first want to make clear that we use the term “hypothesis” as it is defined in most dictionaries and as it used in many scientific fields rather than as it is usually defined in educational statistics courses. By “hypothesis,” we do not mean a null hypothesis that is accepted or rejected by statistical analysis. Rather, we use “hypothesis” in the sense conveyed by the following definitions: “An idea or explanation for something that is based on known facts but has not yet been proved” (Cambridge University Press, n.d. ), and “An unproved theory, proposition, or supposition, tentatively accepted to explain certain facts and to provide a basis for further investigation or argument” (Agnes & Guralnik, 2008 ).

We distinguish two parts to “hypotheses.” Hypotheses consist of predictions and rationales . Predictions are statements about what you expect to find when you inquire about something. Rationales are explanations for why you made the predictions you did, why you believe your predictions are correct. So, for us “formulating hypotheses” means making explicit predictions and developing rationales for the predictions.

“Testing hypotheses” means making observations that allow you to assess in what ways your predictions were correct and in what ways they were incorrect. In education research, it is rarely useful to think of your predictions as either right or wrong. Because of the complexity of most issues you will investigate, most predictions will be right in some ways and wrong in others.

By studying the observations you make (data you collect) to test your hypotheses, you can revise your hypotheses to better align with the observations. This means revising your predictions plus revising your rationales to justify your adjusted predictions. Even though you might not run another test, formulating revised hypotheses is an essential part of conducting a research study. Comparing your original and revised hypotheses informs everyone of what you learned by conducting your study. In addition, a revised hypothesis sets the stage for you or someone else to extend your study and accumulate more knowledge of the phenomenon.

We should note that not everyone makes a clear distinction between predictions and rationales as two aspects of hypotheses. In fact, common, non-scientific uses of the word “hypothesis” may limit it to only a prediction or only an explanation (or rationale). We choose to explicitly include both prediction and rationale in our definition of hypothesis, not because we assert this should be the universal definition, but because we want to foreground the importance of both parts acting in concert. Using “hypothesis” to represent both prediction and rationale could hide the two aspects, but we make them explicit because they provide different kinds of information. It is usually easier to make predictions than develop rationales because predictions can be guesses, hunches, or gut feelings about which you have little confidence. Developing a compelling rationale requires careful thought plus reading what other researchers have found plus talking with your colleagues. Often, while you are developing your rationale you will find good reasons to change your predictions. Developing good rationales is the engine that drives scientific inquiry. Rationales are essentially descriptions of how much you know about the phenomenon you are studying. Throughout this guide, we will elaborate on how developing good rationales drives scientific inquiry. For now, we simply note that it can sharpen your predictions and help you to interpret your data as you test your hypotheses.

Hypotheses in education research take a variety of forms or types. This is because there are a variety of phenomena that can be investigated. Investigating educational phenomena is sometimes best done using qualitative methods, sometimes using quantitative methods, and most often using mixed methods (e.g., Hay, 2016 ; Weis et al. 2019a ; Weisner, 2005 ). This means that, given our definition, hypotheses are equally applicable to qualitative and quantitative investigations.

Hypotheses take different forms when they are used to investigate different kinds of phenomena. Two very different activities in education could be labeled conducting experiments and descriptions. In an experiment, a hypothesis makes a prediction about anticipated changes, say the changes that occur when a treatment or intervention is applied. You might investigate how students’ thinking changes during a particular kind of instruction.

A second type of hypothesis, relevant for descriptive research, makes a prediction about what you will find when you investigate and describe the nature of a situation. The goal is to understand a situation as it exists rather than to understand a change from one situation to another. In this case, your prediction is what you expect to observe. Your rationale is the set of reasons for making this prediction; it is your current explanation for why the situation will look like it does.

You will probably read, if you have not already, that some researchers say you do not need a prediction to conduct a descriptive study. We will discuss this point of view in Chap. 2 . For now, we simply claim that scientific inquiry, as we have defined it, applies to all kinds of research studies. Descriptive studies, like others, not only benefit from formulating, testing, and revising hypotheses, but also need hypothesis formulating, testing, and revising.

One reason we define research as formulating, testing, and revising hypotheses is that if you think of research in this way you are less likely to go wrong. It is a useful guide for the entire process, as we will describe in detail in the chapters ahead. For example, as you build the rationale for your predictions, you are constructing the theoretical framework for your study (Chap. 3 ). As you work out the methods you will use to test your hypothesis, every decision you make will be based on asking, “Will this help me formulate or test or revise my hypothesis?” (Chap. 4 ). As you interpret the results of testing your predictions, you will compare them to what you predicted and examine the differences, focusing on how you must revise your hypotheses (Chap. 5 ). By anchoring the process to formulating, testing, and revising hypotheses, you will make smart decisions that yield a coherent and well-designed study.

Exercise 1.5

Compare the concept of formulating, testing, and revising hypotheses with the descriptions of scientific inquiry contained in Scientific Research in Education (NRC, 2002 ). How are they similar or different?

Exercise 1.6

Provide an example to illustrate and emphasize the differences between everyday learning/thinking and scientific inquiry.

Learning from Doing Scientific Inquiry

We noted earlier that a measure of what you have learned by conducting a research study is found in the differences between your original hypothesis and your revised hypothesis based on the data you collected to test your hypothesis. We will elaborate this statement in later chapters, but we preview our argument here.

Even before collecting data, scientific inquiry requires cycles of making a prediction, developing a rationale, refining your predictions, reading and studying more to strengthen your rationale, refining your predictions again, and so forth. And, even if you have run through several such cycles, you still will likely find that when you test your prediction you will be partly right and partly wrong. The results will support some parts of your predictions but not others, or the results will “kind of” support your predictions. A critical part of scientific inquiry is making sense of your results by interpreting them against your predictions. Carefully describing what aspects of your data supported your predictions, what aspects did not, and what data fell outside of any predictions is not an easy task, but you cannot learn from your study without doing this analysis.

Analyzing the matches and mismatches between your predictions and your data allows you to formulate different rationales that would have accounted for more of the data. The best revised rationale is the one that accounts for the most data. Once you have revised your rationales, you can think about the predictions they best justify or explain. It is by comparing your original rationales to your new rationales that you can sort out what you learned from your study.

Suppose your study was an experiment. Maybe you were investigating the effects of a new instructional intervention on students’ learning. Your original rationale was your explanation for why the intervention would change the learning outcomes in a particular way. Your revised rationale explained why the changes that you observed occurred like they did and why your revised predictions are better. Maybe your original rationale focused on the potential of the activities if they were implemented in ideal ways and your revised rationale included the factors that are likely to affect how teachers implement them. By comparing the before and after rationales, you are describing what you learned—what you can explain now that you could not before. Another way of saying this is that you are describing how much more you understand now than before you conducted your study.

Revised predictions based on carefully planned and collected data usually exhibit some of the following features compared with the originals: more precision, more completeness, and broader scope. Revised rationales have more explanatory power and become more complete, more aligned with the new predictions, sharper, and overall more convincing.

Part II. Why Do Educators Do Research?

Doing scientific inquiry is a lot of work. Each phase of the process takes time, and you will often cycle back to improve earlier phases as you engage in later phases. Because of the significant effort required, you should make sure your study is worth it. So, from the beginning, you should think about the purpose of your study. Why do you want to do it? And, because research is a social practice, you should also think about whether the results of your study are likely to be important and significant to the education community.

If you are doing research in the way we have described—as scientific inquiry—then one purpose of your study is to understand , not just to describe or evaluate or report. As we noted earlier, when you formulate hypotheses, you are developing rationales that explain why things might be like they are. In our view, trying to understand and explain is what separates research from other kinds of activities, like evaluating or describing.

One reason understanding is so important is that it allows researchers to see how or why something works like it does. When you see how something works, you are better able to predict how it might work in other contexts, under other conditions. And, because conditions, or contextual factors, matter a lot in education, gaining insights into applying your findings to other contexts increases the contributions of your work and its importance to the broader education community.

Consequently, the purposes of research studies in education often include the more specific aim of identifying and understanding the conditions under which the phenomena being studied work like the observations suggest. A classic example of this kind of study in mathematics education was reported by William Brownell and Harold Moser in 1949 . They were trying to establish which method of subtracting whole numbers could be taught most effectively—the regrouping method or the equal additions method. However, they realized that effectiveness might depend on the conditions under which the methods were taught—“meaningfully” versus “mechanically.” So, they designed a study that crossed the two instructional approaches with the two different methods (regrouping and equal additions). Among other results, they found that these conditions did matter. The regrouping method was more effective under the meaningful condition than the mechanical condition, but the same was not true for the equal additions algorithm.

What do education researchers want to understand? In our view, the ultimate goal of education is to offer all students the best possible learning opportunities. So, we believe the ultimate purpose of scientific inquiry in education is to develop understanding that supports the improvement of learning opportunities for all students. We say “ultimate” because there are lots of issues that must be understood to improve learning opportunities for all students. Hypotheses about many aspects of education are connected, ultimately, to students’ learning. For example, formulating and testing a hypothesis that preservice teachers need to engage in particular kinds of activities in their coursework in order to teach particular topics well is, ultimately, connected to improving students’ learning opportunities. So is hypothesizing that school districts often devote relatively few resources to instructional leadership training or hypothesizing that positioning mathematics as a tool students can use to combat social injustice can help students see the relevance of mathematics to their lives.

We do not exclude the importance of research on educational issues more removed from improving students’ learning opportunities, but we do think the argument for their importance will be more difficult to make. If there is no way to imagine a connection between your hypothesis and improving learning opportunities for students, even a distant connection, we recommend you reconsider whether it is an important hypothesis within the education community.

Notice that we said the ultimate goal of education is to offer all students the best possible learning opportunities. For too long, educators have been satisfied with a goal of offering rich learning opportunities for lots of students, sometimes even for just the majority of students, but not necessarily for all students. Evaluations of success often are based on outcomes that show high averages. In other words, if many students have learned something, or even a smaller number have learned a lot, educators may have been satisfied. The problem is that there is usually a pattern in the groups of students who receive lower quality opportunities—students of color and students who live in poor areas, urban and rural. This is not acceptable. Consequently, we emphasize the premise that the purpose of education research is to offer rich learning opportunities to all students.

One way to make sure you will be able to convince others of the importance of your study is to consider investigating some aspect of teachers’ shared instructional problems. Historically, researchers in education have set their own research agendas, regardless of the problems teachers are facing in schools. It is increasingly recognized that teachers have had trouble applying to their own classrooms what researchers find. To address this problem, a researcher could partner with a teacher—better yet, a small group of teachers—and talk with them about instructional problems they all share. These discussions can create a rich pool of problems researchers can consider. If researchers pursued one of these problems (preferably alongside teachers), the connection to improving learning opportunities for all students could be direct and immediate. “Grounding a research question in instructional problems that are experienced across multiple teachers’ classrooms helps to ensure that the answer to the question will be of sufficient scope to be relevant and significant beyond the local context” (Cai et al., 2019b , p. 115).

As a beginning researcher, determining the relevance and importance of a research problem is especially challenging. We recommend talking with advisors, other experienced researchers, and peers to test the educational importance of possible research problems and topics of study. You will also learn much more about the issue of research importance when you read Chap. 5 .

Exercise 1.7

Identify a problem in education that is closely connected to improving learning opportunities and a problem that has a less close connection. For each problem, write a brief argument (like a logical sequence of if-then statements) that connects the problem to all students’ learning opportunities.

Part III. Conducting Research as a Practice of Failing Productively

Scientific inquiry involves formulating hypotheses about phenomena that are not fully understood—by you or anyone else. Even if you are able to inform your hypotheses with lots of knowledge that has already been accumulated, you are likely to find that your prediction is not entirely accurate. This is normal. Remember, scientific inquiry is a process of constantly updating your thinking. More and better information means revising your thinking, again, and again, and again. Because you never fully understand a complicated phenomenon and your hypotheses never produce completely accurate predictions, it is easy to believe you are somehow failing.

The trick is to fail upward, to fail to predict accurately in ways that inform your next hypothesis so you can make a better prediction. Some of the best-known researchers in education have been open and honest about the many times their predictions were wrong and, based on the results of their studies and those of others, they continuously updated their thinking and changed their hypotheses.

A striking example of publicly revising (actually reversing) hypotheses due to incorrect predictions is found in the work of Lee J. Cronbach, one of the most distinguished educational psychologists of the twentieth century. In 1955, Cronbach delivered his presidential address to the American Psychological Association. Titling it “Two Disciplines of Scientific Psychology,” Cronbach proposed a rapprochement between two research approaches—correlational studies that focused on individual differences and experimental studies that focused on instructional treatments controlling for individual differences. (We will examine different research approaches in Chap. 4 ). If these approaches could be brought together, reasoned Cronbach ( 1957 ), researchers could find interactions between individual characteristics and treatments (aptitude-treatment interactions or ATIs), fitting the best treatments to different individuals.

In 1975, after years of research by many researchers looking for ATIs, Cronbach acknowledged the evidence for simple, useful ATIs had not been found. Even when trying to find interactions between a few variables that could provide instructional guidance, the analysis, said Cronbach, creates “a hall of mirrors that extends to infinity, tormenting even the boldest investigators and defeating even ambitious designs” (Cronbach, 1975 , p. 119).

As he was reflecting back on his work, Cronbach ( 1986 ) recommended moving away from documenting instructional effects through statistical inference (an approach he had championed for much of his career) and toward approaches that probe the reasons for these effects, approaches that provide a “full account of events in a time, place, and context” (Cronbach, 1986 , p. 104). This is a remarkable change in hypotheses, a change based on data and made fully transparent. Cronbach understood the value of failing productively.

Closer to home, in a less dramatic example, one of us began a line of scientific inquiry into how to prepare elementary preservice teachers to teach early algebra. Teaching early algebra meant engaging elementary students in early forms of algebraic reasoning. Such reasoning should help them transition from arithmetic to algebra. To begin this line of inquiry, a set of activities for preservice teachers were developed. Even though the activities were based on well-supported hypotheses, they largely failed to engage preservice teachers as predicted because of unanticipated challenges the preservice teachers faced. To capitalize on this failure, follow-up studies were conducted, first to better understand elementary preservice teachers’ challenges with preparing to teach early algebra, and then to better support preservice teachers in navigating these challenges. In this example, the initial failure was a necessary step in the researchers’ scientific inquiry and furthered the researchers’ understanding of this issue.

We present another example of failing productively in Chap. 2 . That example emerges from recounting the history of a well-known research program in mathematics education.

Making mistakes is an inherent part of doing scientific research. Conducting a study is rarely a smooth path from beginning to end. We recommend that you keep the following things in mind as you begin a career of conducting research in education.

First, do not get discouraged when you make mistakes; do not fall into the trap of feeling like you are not capable of doing research because you make too many errors.

Second, learn from your mistakes. Do not ignore your mistakes or treat them as errors that you simply need to forget and move past. Mistakes are rich sites for learning—in research just as in other fields of study.

Third, by reflecting on your mistakes, you can learn to make better mistakes, mistakes that inform you about a productive next step. You will not be able to eliminate your mistakes, but you can set a goal of making better and better mistakes.

Exercise 1.8

How does scientific inquiry differ from everyday learning in giving you the tools to fail upward? You may find helpful perspectives on this question in other resources on science and scientific inquiry (e.g., Failure: Why Science is So Successful by Firestein, 2015).

Exercise 1.9

Use what you have learned in this chapter to write a new definition of scientific inquiry. Compare this definition with the one you wrote before reading this chapter. If you are reading this book as part of a course, compare your definition with your colleagues’ definitions. Develop a consensus definition with everyone in the course.

Part IV. Preview of Chap. 2

Now that you have a good idea of what research is, at least of what we believe research is, the next step is to think about how to actually begin doing research. This means how to begin formulating, testing, and revising hypotheses. As for all phases of scientific inquiry, there are lots of things to think about. Because it is critical to start well, we devote Chap. 2 to getting started with formulating hypotheses.

Agnes, M., & Guralnik, D. B. (Eds.). (2008). Hypothesis. In Webster’s new world college dictionary (4th ed.). Wiley.

Google Scholar  

Britannica. (n.d.). Scientific method. In Encyclopaedia Britannica . Retrieved July 15, 2022 from https://www.britannica.com/science/scientific-method

Brownell, W. A., & Moser, H. E. (1949). Meaningful vs. mechanical learning: A study in grade III subtraction . Duke University Press..

Cai, J., Morris, A., Hohensee, C., Hwang, S., Robison, V., Cirillo, M., Kramer, S. L., & Hiebert, J. (2019b). Posing significant research questions. Journal for Research in Mathematics Education, 50 (2), 114–120. https://doi.org/10.5951/jresematheduc.50.2.0114

Article   Google Scholar  

Cambridge University Press. (n.d.). Hypothesis. In Cambridge dictionary . Retrieved July 15, 2022 from https://dictionary.cambridge.org/us/dictionary/english/hypothesis

Cronbach, J. L. (1957). The two disciplines of scientific psychology. American Psychologist, 12 , 671–684.

Cronbach, L. J. (1975). Beyond the two disciplines of scientific psychology. American Psychologist, 30 , 116–127.

Cronbach, L. J. (1986). Social inquiry by and for earthlings. In D. W. Fiske & R. A. Shweder (Eds.), Metatheory in social science: Pluralisms and subjectivities (pp. 83–107). University of Chicago Press.

Hay, C. M. (Ed.). (2016). Methods that matter: Integrating mixed methods for more effective social science research . University of Chicago Press.

Merriam-Webster. (n.d.). Explain. In Merriam-Webster.com dictionary . Retrieved July 15, 2022, from https://www.merriam-webster.com/dictionary/explain

National Research Council. (2002). Scientific research in education . National Academy Press.

Weis, L., Eisenhart, M., Duncan, G. J., Albro, E., Bueschel, A. C., Cobb, P., Eccles, J., Mendenhall, R., Moss, P., Penuel, W., Ream, R. K., Rumbaut, R. G., Sloane, F., Weisner, T. S., & Wilson, J. (2019a). Mixed methods for studies that address broad and enduring issues in education research. Teachers College Record, 121 , 100307.

Weisner, T. S. (Ed.). (2005). Discovering successful pathways in children’s development: Mixed methods in the study of childhood and family life . University of Chicago Press.

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Hiebert, J., Cai, J., Hwang, S., Morris, A.K., Hohensee, C. (2023). What Is Research, and Why Do People Do It?. In: Doing Research: A New Researcher’s Guide. Research in Mathematics Education. Springer, Cham. https://doi.org/10.1007/978-3-031-19078-0_1

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Home » Research Process – Steps, Examples and Tips

Research Process – Steps, Examples and Tips

Table of Contents

Research Process

Definition:

Research Process is a systematic and structured approach that involves the collection, analysis, and interpretation of data or information to answer a specific research question or solve a particular problem.

Research Process Steps

Research Process Steps are as follows:

Identify the Research Question or Problem

This is the first step in the research process. It involves identifying a problem or question that needs to be addressed. The research question should be specific, relevant, and focused on a particular area of interest.

Conduct a Literature Review

Once the research question has been identified, the next step is to conduct a literature review. This involves reviewing existing research and literature on the topic to identify any gaps in knowledge or areas where further research is needed. A literature review helps to provide a theoretical framework for the research and also ensures that the research is not duplicating previous work.

Formulate a Hypothesis or Research Objectives

Based on the research question and literature review, the researcher can formulate a hypothesis or research objectives. A hypothesis is a statement that can be tested to determine its validity, while research objectives are specific goals that the researcher aims to achieve through the research.

Design a Research Plan and Methodology

This step involves designing a research plan and methodology that will enable the researcher to collect and analyze data to test the hypothesis or achieve the research objectives. The research plan should include details on the sample size, data collection methods, and data analysis techniques that will be used.

Collect and Analyze Data

This step involves collecting and analyzing data according to the research plan and methodology. Data can be collected through various methods, including surveys, interviews, observations, or experiments. The data analysis process involves cleaning and organizing the data, applying statistical and analytical techniques to the data, and interpreting the results.

Interpret the Findings and Draw Conclusions

After analyzing the data, the researcher must interpret the findings and draw conclusions. This involves assessing the validity and reliability of the results and determining whether the hypothesis was supported or not. The researcher must also consider any limitations of the research and discuss the implications of the findings.

Communicate the Results

Finally, the researcher must communicate the results of the research through a research report, presentation, or publication. The research report should provide a detailed account of the research process, including the research question, literature review, research methodology, data analysis, findings, and conclusions. The report should also include recommendations for further research in the area.

Review and Revise

The research process is an iterative one, and it is important to review and revise the research plan and methodology as necessary. Researchers should assess the quality of their data and methods, reflect on their findings, and consider areas for improvement.

Ethical Considerations

Throughout the research process, ethical considerations must be taken into account. This includes ensuring that the research design protects the welfare of research participants, obtaining informed consent, maintaining confidentiality and privacy, and avoiding any potential harm to participants or their communities.

Dissemination and Application

The final step in the research process is to disseminate the findings and apply the research to real-world settings. Researchers can share their findings through academic publications, presentations at conferences, or media coverage. The research can be used to inform policy decisions, develop interventions, or improve practice in the relevant field.

Research Process Example

Following is a Research Process Example:

Research Question : What are the effects of a plant-based diet on athletic performance in high school athletes?

Step 1: Background Research Conduct a literature review to gain a better understanding of the existing research on the topic. Read academic articles and research studies related to plant-based diets, athletic performance, and high school athletes.

Step 2: Develop a Hypothesis Based on the literature review, develop a hypothesis that a plant-based diet positively affects athletic performance in high school athletes.

Step 3: Design the Study Design a study to test the hypothesis. Decide on the study population, sample size, and research methods. For this study, you could use a survey to collect data on dietary habits and athletic performance from a sample of high school athletes who follow a plant-based diet and a sample of high school athletes who do not follow a plant-based diet.

Step 4: Collect Data Distribute the survey to the selected sample and collect data on dietary habits and athletic performance.

Step 5: Analyze Data Use statistical analysis to compare the data from the two samples and determine if there is a significant difference in athletic performance between those who follow a plant-based diet and those who do not.

Step 6 : Interpret Results Interpret the results of the analysis in the context of the research question and hypothesis. Discuss any limitations or potential biases in the study design.

Step 7: Draw Conclusions Based on the results, draw conclusions about whether a plant-based diet has a significant effect on athletic performance in high school athletes. If the hypothesis is supported by the data, discuss potential implications and future research directions.

Step 8: Communicate Findings Communicate the findings of the study in a clear and concise manner. Use appropriate language, visuals, and formats to ensure that the findings are understood and valued.

Applications of Research Process

The research process has numerous applications across a wide range of fields and industries. Some examples of applications of the research process include:

• Scientific research: The research process is widely used in scientific research to investigate phenomena in the natural world and develop new theories or technologies. This includes fields such as biology, chemistry, physics, and environmental science.
• Social sciences : The research process is commonly used in social sciences to study human behavior, social structures, and institutions. This includes fields such as sociology, psychology, anthropology, and economics.
• Education: The research process is used in education to study learning processes, curriculum design, and teaching methodologies. This includes research on student achievement, teacher effectiveness, and educational policy.
• Healthcare: The research process is used in healthcare to investigate medical conditions, develop new treatments, and evaluate healthcare interventions. This includes fields such as medicine, nursing, and public health.
• Business and industry : The research process is used in business and industry to study consumer behavior, market trends, and develop new products or services. This includes market research, product development, and customer satisfaction research.
• Government and policy : The research process is used in government and policy to evaluate the effectiveness of policies and programs, and to inform policy decisions. This includes research on social welfare, crime prevention, and environmental policy.

Purpose of Research Process

The purpose of the research process is to systematically and scientifically investigate a problem or question in order to generate new knowledge or solve a problem. The research process enables researchers to:

• Identify gaps in existing knowledge: By conducting a thorough literature review, researchers can identify gaps in existing knowledge and develop research questions that address these gaps.
• Collect and analyze data : The research process provides a structured approach to collecting and analyzing data. Researchers can use a variety of research methods, including surveys, experiments, and interviews, to collect data that is valid and reliable.
• Test hypotheses : The research process allows researchers to test hypotheses and make evidence-based conclusions. Through the systematic analysis of data, researchers can draw conclusions about the relationships between variables and develop new theories or models.
• Solve problems: The research process can be used to solve practical problems and improve real-world outcomes. For example, researchers can develop interventions to address health or social problems, evaluate the effectiveness of policies or programs, and improve organizational processes.
• Generate new knowledge : The research process is a key way to generate new knowledge and advance understanding in a given field. By conducting rigorous and well-designed research, researchers can make significant contributions to their field and help to shape future research.

Tips for Research Process

Here are some tips for the research process:

• Start with a clear research question : A well-defined research question is the foundation of a successful research project. It should be specific, relevant, and achievable within the given time frame and resources.
• Conduct a thorough literature review: A comprehensive literature review will help you to identify gaps in existing knowledge, build on previous research, and avoid duplication. It will also provide a theoretical framework for your research.
• Choose appropriate research methods: Select research methods that are appropriate for your research question, objectives, and sample size. Ensure that your methods are valid, reliable, and ethical.
• Be organized and systematic: Keep detailed notes throughout the research process, including your research plan, methodology, data collection, and analysis. This will help you to stay organized and ensure that you don’t miss any important details.
• Analyze data rigorously: Use appropriate statistical and analytical techniques to analyze your data. Ensure that your analysis is valid, reliable, and transparent.
• I nterpret results carefully : Interpret your results in the context of your research question and objectives. Consider any limitations or potential biases in your research design, and be cautious in drawing conclusions.
• Communicate effectively: Communicate your research findings clearly and effectively to your target audience. Use appropriate language, visuals, and formats to ensure that your findings are understood and valued.
• Collaborate and seek feedback : Collaborate with other researchers, experts, or stakeholders in your field. Seek feedback on your research design, methods, and findings to ensure that they are relevant, meaningful, and impactful.

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Partners in research: communities and nih working together to promote health for all.

This Director’s Message was written in collaboration with the  NIH Common Fund  Community Partnerships to Advance Science for Society (ComPASS) Program .

Have you heard about NIH’s innovative research program designed to create lasting change by addressing the underlying structural factors that shape health? Through the Community Partnerships to Advance Science for Society (ComPASS) Program , NIH is directly funding research projects led by community organizations. 

Instead of tackling health disparities one disease at a time, the ComPASS program addresses structural factors that contribute to multiple diseases and health conditions. The projects study interventions that focus on factors that can promote health, such as improving economic stability, employment opportunities, access to healthy food, safe spaces, transportation, and quality healthcare. Communities and researchers work together as equal partners throughout the research process — from developing and launching structural interventions to sustaining and disseminating findings.

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• Unlike traditional research studies, ComPASS projects are led by community organizations that collaborate with academic researchers and other community partners. 
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How to write the part scope for further research?

The part scope for further research is essential in every academic study such as a thesis , dissertation or journal paper . The main purpose of this part is to make the readers aware of the findings emerging from the study, and its shortcomings. The shortcomings of the research gap guide future researchers on a domain that they must consider to save time and avoid repetitive outcomes.

Furthermore, this section also gives guidelines to researchers on other dimensions and critical estimations from which the topic can be explored.

Emphasize the significance of further research

There are no specific rules or guidelines for this part. However, since it is expected to be brief and informative, the following format is recommended.

Start this section by reflecting on the significance of the present study in brief. Answering questions such as:

• Whether the research deviated from its initial objectives?
• What was the original idea behind the research?
• From where was the inspiration drawn?

Answering such questions is important because the reader should connect to the idea of the research.

Limitations of the study

Furthermore, briefly explain the limitations of the study. This step proves significant for scholars who wish to address areas that can enrich the research topic further. The limitations can either be presented separately, in an independent section called “Limitations of the research”, or can be integrated within the future scope. Also, the limitations should be scalable and relatable, i.e. something that other researchers feel can be accomplished under different circumstances. This is also the key to setting recommendations for future studies.

Justify the future scope

Furthermore, provide justifications for the reasons why the mentioned areas have not been covered in the current study. Identify the probable bottlenecks other researchers might encounter while considering future research related to the topic. This will help them formulate an achievable or practically applicable plan for their own research, including the scope, aim and methodology.

Suggestions

Finally, the approach of the researcher becomes more direct. To be specific, some direct research suggestions should be given to other scholars for future studies. Be precise so that the reader is confident to undertake future studies in the suggested areas.

Answering the following questions can help:

• What should be explored by others?
• Why is it worth exploring?
• What can be achieved from it?
• Will the suggested study be relevant five to ten years down the line?
• How does it add to the overall body of the literature?

Types of writing a future scope

There are different types of future research scope, based on the kind of writing, such as:

• The future scope is focused solely on study findings.
• The future scope is focused on the theory or theoretical model misused.
• The future scope from lack of literary support.
• The future scope of geographical outreach.
• The future scope of testing methods and statistics.
• The future scope on the complete redesigning of methodology.

Points to keep in mind

The most important aspect of writing the future scope part is to present it in an affirmative way. As identified in the former section, it is crucial to identify if the limitations are methods-based or researcher based. It should be concise and critical to the field of study. Refrain from using a reference in the scope for the future research part.

Make sure the points discussed remain achievable in a proximal time frame. In addition, make sure that they are in relation to the theoretical development of the study in focus.

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Public Health Service Policies on Research Misconduct

A Rule by the Health and Human Services Department on 09/17/2024

This document has been published in the Federal Register . Use the PDF linked in the document sidebar for the official electronic format.

• Document Details Published Content - Document Details Agency Department of Health and Human Services CFR 42 CFR 93 Document Citation 89 FR 76280 Document Number 2024-20814 Document Type Rule Pages 76280-76309 (30 pages) Publication Date 09/17/2024 RIN 0937-AA12 Published Content - Document Details
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• Document Dates Published Content - Document Dates Effective Date 01/01/2025 Dates Text Effective Date: This final rule is effective January 1, 2025. Published Content - Document Dates

This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect.

FOR FURTHER INFORMATION CONTACT:

Supplementary information:, i. background, ii. overview of comments and significant changes in final rule, subpart a summary of significant public comments and changes, subpart b summary of significant public comments and changes, subpart c summary of significant public comments and changes, subpart d summary of significant public comments and changes, subpart e summary of significant public comments and changes, iii. section-by-section description of changes in the final rule, a. application of effective date to research misconduct proceedings, final rule § 93.75, b. applicability, nprm § 93.102(a), c. applicability, nprm § 93.102(d), d. research misconduct, nprm secs. 93.103, e. requirements for findings of research misconduct, nprm secs. 93.104(a), (b), and (c), f. time limitations, nprm § 93.105(b), g. confidentiality, nprm § 93.106, h. appeal, nprm § 93.204, i. charge letter, nprm § 93.206, j. difference of opinion, nprm § 93.211, k. honest error, nprm § 93.217, l. institutional record, nprm § 93.223, m. recklessly, nprm § 93.234, n. investigation, nprm § 93.225, o. research integrity, nprm § 93.236, p. research misconduct proceedings, nprm § 93.239, q. research record, nprm § 93.240, r. small institution, nprm § 93.244, s. suspension and debarment, nprm § 93.245, t. institutional policies and procedures, nprm § 93.304, u. general conduct of research misconduct proceedings—sequestration of research records and other evidence, nprm § 93.305(a), v. general conduct of research misconduct proceedings—multiple respondents, nprm § 93.305(d), w. general conduct of research misconduct proceedings—pursue leads, nprm § 93.305(f), x. general conduct of research misconduct proceedings—interviews, nprm § 93.305(g), y. conduct of research misconduct proceedings—using a committee, consortium, or other person for research misconduct proceedings, nprm § 93.305(h), z. institutional assessment, nprm § 93.306, aa. institutional inquiry, nprm § 93.307, bb. reporting to ori on the decision to initiate an investigation, nprm § 93.309, cc. institutional investigation, nprm § 93.310, dd. investigation report, nprm § 93.313(k), ee. investigation report, nprm § 93.313(l)(2), ff. institutional appeals, nprm § 93.314, gg. decision by the institutional deciding official, final rule § 93.314, hh. completing the research misconduct process, nprm § 93.316(a), ii. institutional standards of conduct, nprm § 93.318, jj. interaction with other entities and interim actions, nprm § 93.401, kk. final hhs actions, nprm § 93.406, ll. hhs administrative actions, nprm § 93.407, mm. mitigating and aggravating factors in hhs administrative actions, nprm § 93.408, nn. final hhs action with no settlement or finding of research misconduct, nprm § 93.410(a), oo. final hhs action with no settlement or finding of research misconduct, nprm § 93.410(b), pp. final hhs action with a settlement or finding of misconduct, nprm § 93.411, qq. hhs compliance actions, nprm § 93.413, rr. notice, nprm § 93.414, ss. general policy, nprm § 93.500, tt. conferences, nprm § 93.510, uu. hearing to resolve genuine factual dispute, nprm § 93.511, vv. the administrative law judge's ruling, nprm § 93.512, iv. significant comments not resulting in changes, a. accepted practices of the relevant research community, nprm § 93.200, b. allegation, nprm § 93.203, c. assessment, nprm § 93.205, d. complainant, nprm § 93.207, e. contract, nprm § 93.208, f. day, nprm § 93.209, g. departmental appeals board, nprm § 93.210, h. evidence, nprm § 93.212, i. falsification, nprm § 93.214, j. good faith, nprm § 93.216, k. institution, nprm § 93.219, l. institutional deciding official, nprm § 93.221, m. institutional member, nprm § 93.222, n. intentionally, nprm § 93.224, o. knowingly, nprm § 93.226, p. notice, nprm § 93.227, q. office of research integrity or ori, nprm § 93.228, r. plagiarism, nprm § 93.230, s. preponderance of evidence, nprm § 93.231, t. research integrity officer or rio, nprm § 93.237, u. research misconduct, nprm § 93.238, v. retaliation, nprm § 93.242, w. general responsibilities for compliance, nprm § 93.300(g), x. research integrity assurances, nprm § 93.301, y. maintaining active research integrity assurances, nprm § 93.302(a), z. general conduct of research misconduct proceedings—sequestration of research records and other evidence, nprm § 93.305(a), aa. general conduct of research misconduct proceedings—multiple institutions, nprm § 93.305(e), bb. general conduct of research misconduct proceedings—interviews, nprm § 93.305(g), dd. investigation time limits, nprm § 93.311, ee. interaction with other entities and interim actions, nprm § 93.401(b), ff. ori allegation assessments, nprm § 93.402, gg. final hhs action with no settlement or finding of research misconduct, nprm § 93.410(b), hh. rights of the parties, nprm § 93.505, v. effective date, vi. required regulatory analyses, baseline and summary of impacts, one-time costs associated with updating policies and procedures, recurring costs attributable to the final rule, summary and timing of costs of the final rule, regulatory flexibility act, paperwork reduction act, subpart a—general, section 93.104, subpart c—responsibilities of institutions, compliance and assurances, section 93.305, the institutional assessment, section 93.306, the institutional inquiry, section 93.307, section 93.308, section 93.309, the institutional investigation, section 93.310, section 93.312, section 93.313, section 93.315, section 93.316, section 93.317, section 93.318, list of subjects in 42 cfr part 93, part 93—public health service policies on research misconduct, subpart b—definitions, other institutional responsibilities, subpart d—responsibilities of the u.s. department of health and human services, general information, research misconduct issues, institutional compliance issues, disclosure of information.

• Subpart E—Opportunity to Contest ORI Findings of Research Misconduct and Proposed HHS Administrative Actions

Process for Contesting Research Misconduct Findings and/or Proposed HHS Administrative Actions

Subpart e—opportunity to contest ori findings of research misconduct and proposed hhs administrative actions.

Comments are no longer being accepted. See DATES for details.

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Department of Health and Human Services

• 42 CFR Part 93
• RIN 0937-AA12

U.S. Department of Health and Human Services (HHS).

Final rule.

This final rule revises the regulations governing Public Health Service Policies on Research Misconduct. The final rule reflects both substantive and non-substantive revisions in response to public comments and to improve clarity. The purpose of the final rule is to implement policy changes and respond to technological changes that occurred over the past several years applicable to research misconduct.

Effective Date: This final rule is effective January 1, 2025.

Applicability Date: All regulatory requirements are applicable beginning on or after January 1, 2026.

Address any comments or questions regarding the final rule to Sheila R. Garrity, JD, MPH, MBA, Director, Office of Research Integrity (ORI), 1101 Wootton Parkway, Suite 240, Rockville, MD 20852. Some commonly asked questions and answers will be posted on the ORI website prior to the effective date of the final rule. The URL for the ORI website is https://ori.hhs.gov .

Justina Lawrence, (240) 453-8200.

The Office of Research Integrity (ORI) within the Department of Health and Human Services (HHS) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the HHS Secretary, with the exception of the regulatory research integrity activities of the Food and Drug Administration.

ORI was established in 1993 by amendment to section 493 of the Public Health Service Act ( 42 U.S.C. 289b ). The HHS Secretary has authority under section 493 to promulgate a regulation that provides an administrative process for entities that apply for or receive PHS funding for biomedical or behavioral research to respond to research misconduct allegations in connection with such research and to provide assurances to the Department that the entities have an administrative process in place to respond to research misconduct allegations, investigate research misconduct allegations, and comply with the Department's regulation. Section 493 also authorizes the HHS Secretary to promulgate a regulation addressing ORI's actions, including appropriate remedies, with respect to research misconduct.

In 2005, HHS updated regulations implementing section 493 that predated ORI's establishment. Specifically, HHS removed 42 Code of Federal Regulations (CFR) part 50, subpart A and added 42 CFR part 93 , Public Health Service Policies on Research Misconduct. Since 2005, ORI and regulated entities experienced policy developments and technological changes applicable to research misconduct, such as the 2008 NIH Public Access policy; the 2023 NIH Data Management and Sharing policy; the shift to saving data on the cloud; and the ability to use artificial intelligence to detect image falsification, among many other developments. Therefore, ORI decided to revise part 93.

On October 6, 2023, ORI issued a Notice of Proposed Rulemaking (NPRM) that proposed revisions to 42 CFR part 93 based on the experience ORI and institutions gained with the regulation since it was promulgated in 2005 ( 88 FR 69583 ). In addition, the NPRM was issued in response to increasing public concerns about research integrity in science and institutional questions about research misconduct review proceedings. The NPRM proposed several changes to provide clarity, transparency, and a better streamlined process.

The NPRM proposed changes to subpart A. These changes included requiring grant recipients to take responsibility for the research integrity assurances of their subrecipients; adding ORI oversight of and increasing reporting requirements for subsequent use exception determinations; reducing disclosure limitations; and expanding institutional reporting obligations.

Proposed changes to subpart B in the NPRM included adding or revising definitions of commonly used terms such as institutional record, administrative record, honest error, intentionally, knowingly, recklessly, and accepted practices of the relevant research community.

Proposed changes to subpart C in the NPRM included clarification for maintaining active institutional research integrity assurances and addressing apparent or actual conflicts of interest. The NPRM also proposed changes to the institutional research misconduct review process, including assessments, sequestration of research records, inquiries, investigations, and the maintenance of institutional records.

Proposed changes to subpart D in the NPRM included clarification of institutional assembly of administrative records and potential ORI actions for institutional noncompliance. In addition, ORI proposed clarifying that the lack of an ORI finding of research misconduct does not overturn an institution's determination of research misconduct. Other proposed changes to subpart D included when and how ORI may disclose information about a research misconduct proceeding.

Proposed changes to subpart E in the NPRM included a streamlined process for contesting ORI findings of research misconduct and HHS administrative actions. The proposed appeals process included Administrative Law Judge (ALJ) review of an administrative record, rather than a de novo review of evidence presented at a hearing before an ALJ.

The NPRM sought comments from individuals, institutional officials, organizations, institutions, research funding agencies, and other members of the public on the proposed revisions and how to improve the clarity of the existing regulation.

ORI received 269 comments via Regulations.gov . ORI also received comments as part of its interagency review process. ORI received 199 relevant comments representing the views of two main constituent groups: institutions and individuals. In several instances, duplicative comments were posted by the same institution or individual. ORI received 171 unique comments submitted by 123 institutions and 46 individuals. In two cases, an institution submitted two separate sets of comments; since the content of each submission was distinct, ORI counted each submission as a unique comment. In addition, some comments were endorsed by multiple individuals or institutions. For example, one institutional comment was explicitly supported by 70 separate commenters. Another institutional comment was explicitly supported by 83 separate commenters. Ten commenters supported an additional institutional statement, and three commenters supported other representative groups' statements.

Most comments addressed multiple sections of the proposed rule. Many commenters made general statements supporting the more efficient execution and oversight of research misconduct proceedings proposed in the NPRM; ( print page 76281) however, most commenters recommended changes to enhance the clarity of the proposed regulation. These comments generally involved maintaining the balance between ensuring a complete review of misconduct allegations and protecting the rights of respondents and recognizing the potential for administrative burden and cost on institutions.

Most commenters anticipated administrative burden resulting from various parts of the NPRM. These comments were divided among five topics: burden related to the assessment phase, burden related to determining honest error, burden related to transcribing interviews, burden related to reporting, and burdens placed on small institutions. Several commenters requested more time to implement the final rule, and the amount of time requested varied widely. A majority requested one year, while others requested different timelines.

Many commenters recommended revisions to or removal of proposed definitions. Commenters also made general comments on the proposed rule, with most commenters recommending additions, revisions, or removal of various sections.

Commenters expressed a variety of concerns about potential conflicts of interest but did not recommend the removal or revision of any particular section of the proposed regulation. Commenters also expressed concerns about harm to respondents' reputation; these concerns included ORI's access to assessment reports and potential breaches of confidentiality when sharing transcripts. Commenters also expressed concerns about the effects of the proposed regulation on whistleblowers. These concerns included fears of retaliation, negative effects on reporting misconduct, and breaches of confidentiality.

The NPRM proposed several substantive changes in which commenters provided feedback that informed the drafting of the final rule. The following paragraphs provide an overview of the feedback received from commenters. More detailed descriptions of comments on specific sections of the proposed regulation are addressed below in section III.

Proposed § 93.102(a) would require primary PHS grant recipients to take responsibility for the compliance of their subrecipients. A number of commenters recommended removing the proposed requirement making each PHS funding recipient responsible for the compliance of their subrecipients, because institutional responsibility for regulatory compliance was not clarified. ORI did not intend to impose a new burden on prime funding recipients; in the final rule subrecipients are required to have their own assurances filed with ORI. Proposed § 93.105(b), which involved time limitations for research misconduct proceedings, required more reporting requirements and established that ORI makes the final determination of when a subsequent use exception can be applied. Commenters recommended revising this section to state that institutions should be afforded discretion in applying the subsequent use exceptions. ORI agreed institutions should be able to determine whether the subsequent use exception applies to a given situation. Proposed § 93.106 would require increased institutional reporting obligations to ORI related to institutional confidentiality obligations. Commenters found the language of the proposed regulation in this section overcomplicated institutional confidentiality obligations, added problematic provisions, and contained information more appropriate for guidance. ORI recognized institutions' concerns about implementing the confidentiality requirements in the proposed rule and changed the final rule to provide latitude for institutions to decide confidentiality requirements for themselves. A number of commenters disapproved omitting the 2005 regulation's Evidentiary Standards section from the NPRM, and asked ORI to maintain the burden of proof language from the 2005 regulation. ORI had proposed removing this section because evidentiary standards were discussed in several other parts of the NPRM; however, ORI concurred with commenters, restored and updated aspects of the Evidentiary Standards section, and revised the final rule to clarify specific situations in which an adverse inference can be made but did not address all situations in which an adverse inference can be made. Nothing in the final rule precludes an institution or HHS from drawing an adverse inference under a different set of facts if appropriate.

Proposed Secs. 93.205, 93.211, 93.217, 93.236 and 93.245 set forth definitions for Appeal, Difference of Opinion, Honest Error, Research Integrity, Suspension and Debarment to provide definitions of commonly used terms. Several commenters recommended removing these definitions because they did not enhance the clarity of the regulation. ORI agreed and removed these definitions. Proposed Secs. 93.223, 93.217, and 93.234, which set forth definitions for Institutional Record, Recklessly, and Small Institution, were also added to provide definitions for commonly used terms. Commenters recommended revisions to clarify these definitions. ORI concurred and revised these definitions, described in detail in the next section.

Proposed § 93.304 regarding institutional policies and procedures removed a provision that was in the 2005 regulation requiring institutions to have policies and procedures in place to protect the rights of respondents. Commenters were concerned about protecting these rights and ORI restored the language from the 2005 regulation that institutions provide for all reasonable and practical efforts, if requested and as appropriate, to protect or restore the reputation of persons alleged to have engaged in research misconduct but against whom no finding of research misconduct is made.

Proposed § 93.305 was meant to provide details on institutional responsibilities in the general conduct of misconduct proceedings. Some commenters appreciated the provision that permits an institution to add respondents to an ongoing misconduct case without conducting a separate inquiry for each new respondent. Other commenters were concerned that listing the types of researchers the institutions should consider as potential respondents created a confusing standard and could be detrimental to those individuals. ORI concurred and removed the list of potential co-respondents as well as the parenthetical list of additional research records to examine, because these lists were intended to be exemplary rather than prescriptive. Some commenters found the section on pursuing leads overly prescriptive, while others found it overly broad. Many commenters were concerned that pursuing all leads during an inquiry would be burdensome and costly—as well as cause reputational harm to innocent researchers. ORI concurred and moved the requirement to pursue all leads to § 93.310(j), which details the investigation requirements.

Commenters also objected to the proposed requirement to transcribe all interviews in § 93.305 of the NPRM, especially interviews conducted during the assessment or inquiry phase, because it could discourage reporting of ( print page 76282) allegations and contribute to institutional burden. ORI concurred, revised the section, and moved it to § 93.310(g), which details the investigation requirements. The revised section removes the requirement for transcribed interviews during the assessment and inquiry phases. Some commenters noted this section may not provide fair procedures to respondents. Other commenters recommended removing the section entirely, stating that institutions should be allowed to institute best practices without regulatory oversight. A few commenters favored retaining the section as proposed. ORI removed all portions of the proposed subsection that did not specify requirements—that is, sections on the institution's choice to use a committee, consortium, or person to conduct, support, or participate in proceedings; what a consortium might be comprised of; and the institution's choice to allow respondents/complainants to object to committee or consortium member(s). The information was intended to be exemplary, not prescriptive. ORI intends to issue guidance on this topic.

Proposed § 93.306, which describes the institutional assessment of research misconduct allegations, increased reporting requirements, and time limitations were added to ensure prompt institutional response in addressing allegations of misconduct. Commenters were concerned about the burden of increased pre-investigation reporting requirements. ORI concurred and revised this section to simplify the assessment phase and require institutions to document their assessment process rather than write a formal report. The final rule clarifies that, if an institution determines to close a research misconduct proceeding after the assessment, it must retain documentation of its rationale sufficient to permit a later review by ORI.

Proposed § 93.307, which involves the institutional inquiry, increased reporting requirements, and time limitations were added to ensure prompt institutional response in addressing allegations of misconduct. The NPRM proposed to prohibit an institution from determining honest error during the inquiry stage. Some commenters requested clarification because the process for notifying additional respondents of an institutional inquiry appeared unclear. ORI concurred and revised this section to simplify the language. Commenters also recommended removing proposed § 93.307(f)(2) because they conveyed the requirement that institutions determine honest error only at the investigation stage would unfairly burden both respondents and institutions. ORI agreed and removed § 93.307(f)(2). Several commenters recommended removing proposed § 93.307(h), which set a 60-day timeframe for completing an inquiry, stating that institutions should have more flexibility in the timeframe to thoroughly conduct an inquiry. ORI concurred and lengthened the inquiry timeline from 60 to 90 days. If the inquiry takes longer than 90 days to complete, the inquiry report must document the reasons for exceeding the 90-day period.

The institutional investigation phase described in proposed § 93.310 was meant to provide additional institutional responsibilities in the conduct of an institutional investigation of research misconduct, including additional reporting and proposed rules about sequestration of evidence, multiple respondents, and multiple institutions. A few commenters recommended removal of proposed § 93.310(c)(2) because they conveyed their concern that the regulation infringes on the rights of respondents who are added to an ongoing investigation without an additional inquiry. ORI clarified § 93.310(c)(2) that when a new respondent is added to an ongoing proceeding, institutions may but are not required to conduct a separate inquiry for additional respondents, and additional respondents must be notified of allegation(s) and provided an opportunity to respond.

Proposed § 93.313(k) and (l)(2) describing the institutional investigation report was meant to clarify the requirements for an investigation report. The section included lists of examples of sequestered materials. The section also included a prohibition against split decisions by an investigation committee. Commenters recommended removing proposed § 93.313(k), which included a requirement that institutions identify any research records and other evidence obtained and sequestered but not reviewed, because it was deemed resource-intensive and an unnecessary burden. ORI concurred and removed § 93.313(k) as duplicative of 93.313(e). ORI notes that the inventory requirement described in 93.313(e) does not require identification of specific files or emails but allows for a broader summary of the types of files or emails sequestered. Commenters also recommended removing language in proposed § 93.313(l)(2) prohibiting investigation committees from making a split decision. ORI removed that prohibition and included language that the report must clearly state the investigation committee's conclusions regarding whether research misconduct occurred.

The institutional appeals process described in proposed § 93.314 would require that institutional appeals be completed within 120 days or apply for an extension. Commenters recommended deleting or significantly revising § 93.314, contending the institutional appeal was within the institution's purview, not ORI's. ORI concurred and removed most of the requirements in § 93.314 and added § 93.315 to acknowledge institutional purview. ORI recognizes the potential inefficiency of starting oversight review while an institutional appeal is ongoing that could reverse or modify the institutional findings of research misconduct. The final rule clarifies that institutions should not transmit their institutional record until the conclusion of any institutional appeals. If an appeal is filed after the institution has transmitted the institutional record, the institution must promptly notify ORI so the agency can postpone oversight review until the institutional appeal is complete.

Proposed § 93.410(b) would allow ORI to publish notice of institutional research misconduct proceedings that did not result in ORI findings. Many commenters urged ORI to remove § 93.410(b), which proposed that ORI may publish notice of institutional investigations and actions. Commenters cited regulatory overreach, breaches of confidentiality, and inconsistency with other agencies' policies. ORI removed 93.410(b) from the final rule, ensuring institutions have discretion in this area. Proposed § 93.411 would require HHS to provide notification and publish final HHS actions that result in a finding of research misconduct. One commenter objected to replacing “may” with “shall,” regarding ORI's publication of findings and settlements. ORI restored the 2005 regulatory language of “may” to retain flexibility.

Proposed § 93.512 provided for a simpler and more expedient appeals process, which would entail ALJ review of an administrative record to determine whether ORI's findings and HHS's proposed administrative actions (other than suspension or debarment) are reasonable and not based on a material error of law or fact. The proposed appeals process also provided for the possibility of a limited hearing if the ( print page 76283) ALJ determines that there is a genuine dispute over material fact. One commenter, in response to the NPRM's request for comments on the scope of and need for limited hearings, suggested the research misconduct process allows for sufficient procedures to make such limited hearings unnecessary. ORI agreed, removed proposed § 93.512 from the final rule, made clarifying edits throughout subpart E, including removing language concerning suspension and debarment and adding the qualifiers “proposed” or “HHS” before the phrase “administrative actions.”

ORI made other changes in the final rule to generally provide clarity requested by the commenters. In addition to specific changes discussed below, ORI changed “will” to “may” in places throughout the final rule, as appropriate, to add flexibility. ORI made nonsubstantive edits throughout the final rule in accordance with the Plain Writing Act of 2010. ORI also merged or separated content within sections of the final rule to improve clarity and readability. ORI streamlined language to avoid repeatedly distinguishing research misconduct proceedings subject to part 93 from suspension and debarment actions governed by regulations separate and distinct from part 93. These changes either were nonsubstantive or increased the flexibility accorded to regulated entities.

Commenters suggested delaying the effective date of the final rule, citing the time required for institutions to update their policies and procedures and train staff, with many commenters recommending an effective date 18 months after the publication date. ORI retained the proposed effective date of January 1, 2025, but clarified that all regulatory requirements are applicable on or after January 1, 2026, in order to provide ample time for institutions to prepare for the final rule. ORI will not require institutions to implement and submit revised policies and procedures that comply with the final rule until the submission of their annual report covering 2025, which is due on or before April 30, 2026. ORI believes that this approach balances the need to promptly implement improvements made by the final rule with the time for institutions to update their policies and procedures. ORI added § 93.75 to clarify the applicability date, specifying that beginning on January 1, 2026, an institution must follow the final rule for allegations received by the institution on or after January 1, 2026. For allegations received by an institution before January 1, 2026, an institution must follow 42 CFR part 93 as published in the 2005 edition of the Code of Federal Regulations, unless the respondent and institution both elect in writing to follow the new final rule.

A number of commenters recommended removing the proposed requirement making each PHS funding recipient responsible for the compliance of their subrecipients, because institutional responsibility for regulatory compliance was not clarified. A few commenters recommended revision for the same reason, adding that subrecipients should have assurances on file with ORI to ensure compliance by all recipients of PHS funding. ORI removed the sentence, “Further, each recipient of such support is responsible for the compliance of their subrecipients with this part,” because ORI did not intend to impose a new burden on prime funding recipients; subrecipients are required to have their own assurances filed with ORI.

Revisions clarify that suspension and debarment at HHS are governed by regulations separate and distinct from part 93. As noted above, corresponding revisions throughout the final rule streamline language because there is no need to repeatedly distinguish research misconduct proceedings subject to this part from suspension and debarment actions subject to separate and distinct regulations. ORI also revised the language in this section to confirm that the Suspension and Debarment Official (SDO) and ORI may coordinate actions to the extent consistent with the SDO's and ORI's respective authorities. Such coordination includes jointly issuing notices or seeking settlements of actions and proceedings.

Commenters recommended deleting this section, because it duplicated information found elsewhere, specifically the definitions of fabrication, falsification, and plagiarism. ORI concurred and deleted this section in its entirety.

Commenters expressed appreciation that the proposed regulation clarified the three requirements for findings of research misconduct and confirmed three elements must be met. ORI made one change for grammatical consistency across all subsections.

Commenters recommended revising this section to state that institutions should be allowed to determine their own timeframe for applying subsequent use exceptions. ORI agreed institutions should be able to determine whether the subsequent use exception applies to a given case. To have a consistent regulatory standard across all institutions, ORI retained the six-year limitation. Commenters also expressed concern about the potential cost and burdens of the proposed requirement that institutions inform ORI of the relevant facts before concluding the subsequent use exception does not apply. ORI concurred and revised the section to require institutions to document how they determined the exception did or did not apply and to retain that information in the institutional record. ORI may address the application of the subsequent use exception for institutional reporting requirements through future policymaking.

In response to commenters mentioning circumstances in which institutions may have a legitimate need to inform persons outside the institution about a pending research misconduct proceeding, ORI clarified that institutions may alert journal editors and others who need to know of potentially inaccurate data in a timely manner, and the final rule specifies that institutions are not prohibited from managing published data or acknowledging that data may be unreliable. In addition, to prevent some institutions from keeping research-related information confidential longer than necessary, the final rule now clarifies the length of time an institution is bound by the confidentiality provision. Commenters also stated that the language proposed in this section overcomplicated institutional confidentiality obligations and contained information more appropriate for guidance. ORI recognized institutions' concerns about overly prescriptive language and changed the final rule to provide greater latitude for ( print page 76284) institutions to decide how to meet confidentiality requirements. ORI also removed the subsections that discussed what constitutes “those who need to know.”

Commenters recommended deleting this definition because it was unnecessary. ORI concurred and removed this definition.

ORI removed specific language addressing joint charge letters, because § 93.102(d) of the final rule addresses situations in which ORI and the SDO may jointly issue notices. ORI also revised proposed § 93.206 to remove references to the SDO in the definition and avoid redundancy in subpart A.

Several commenters recommended removing this definition because it did not enhance the clarity of the regulation. ORI agreed and removed this definition.

Several commenters requested revision of this definition of honest error. A minority of commenters asked ORI to add a reference to good faith and intent and to provide examples. Most commenters recommended removing the definition because they conveyed that it was unnecessary. ORI concurred and removed this definition.

Commenters generally supported including this definition but expressed concerns about the institutional burden of sequestering irrelevant records and conveyed that the institutional investigation committee should have autonomy to decide which records to consider. While ORI understands sequestration imposes an institutional burden, ORI has found that records originally not considered by an institution may be relevant to the research misconduct proceeding. ORI balanced these concerns by revising the proposed definition of institutional record and retaining a maintenance requirement in § 93.318 for sequestered evidence that is not part of the institutional record. ORI revised the proposed definition to clarify that the institutional record comprises all records the institution compiled or generated during the research misconduct proceeding, except for the records the institution did not consider or rely on. The institutional record index does not need to include records the institution did not consider or rely on. ORI revised the proposed definition to include a requirement for a general description of records sequestered but not considered or relied on. Additionally, ORI revised wording to clarify that assessments are to be documented, but an assessment report is not required. ORI intends to issue guidance on this topic.

Many commenters proposed revisions to this definition. Some commenters requested clarification of and distinction between the definitions of “knowingly” and “recklessly,” as well as a definition of “harm.” Several commenters requested guidance with examples to help institutions distinguish between “careless” and “reckless” supervision. One commenter approved of the existing definition. ORI revised the definition in response to these comments to make it easier to apply in the research misconduct context. In particular, ORI revised the definition to make it specific to proposing, performing, or reviewing research, or reporting research results, rather than “acting” more generally, and specific to a risk of fabrication, falsification, or plagiarism.

Commenters proposed revising this definition to provide further clarification. ORI agreed and revised the definition by removing unnecessary language for clarity.

Many commenters recommended removing this definition because they found it narrow, unclear, and inconsistent with the National Academies of Sciences, Engineering, and Medicine (NASEM) definition. One commenter recommended retaining the proposed definition. ORI decided to remove this definition and may provide future guidance on this topic.

Regarding the appeals process and involvement of an ALJ, ORI added clarifying language, “appeals under subpart E,” to avoid ambiguity and to distinguish this process from institutional appeals.

Commenters requested clarification of this definition. ORI added “records of” before “oral presentations” to exclude from the definition any records of completely internal presentations where problems were potentially identified and corrected before outside reporting. ORI also changed the phrase “internal reports” to “lab meeting reports” to clarify the meaning of this phrase, which may be part of the research record. Additionally, ORI removed “internet” from “internet and online” content because of the repetitive meaning of the two words. ORI intends to issue guidance on this definition.

Several commenters recommended revisions to the definition because they conveyed that the criteria used to designate a small institution were overly restrictive. ORI agreed and removed the statement that a small institution typically has “a total of 10 or fewer institutional members” and may address this topic through future policymaking.

ORI removed this proposed definition of “suspension and debarment” and merged significant aspects of the definition with “Suspension and Debarment Official or SDO” to reduce redundancy.

One commenter commended ORI for requiring all institutions to file an assurance to apply for PHS support. Commenters expressed concern about omitting the 2005 regulation's requirement to make all reasonable and practical efforts to restore the reputation of respondents not found to have committed research misconduct. Commenters requested restoring proposed § 93.304 to the 2005 wording. ORI concurred and restored the 2005 wording regarding policies and procedures to protect the reputation of respondents when no finding has been made.

ORI noted the requirement to sequester all research records and other evidence was mentioned more than once in the NPRM. To reduce redundancy, this requirement is explained in full only once in the final rule, under General Conduct of Research Misconduct Proceedings.

Some commenters appreciated the provision that permits an institution to add respondents to an ongoing research misconduct case without conducting a separate inquiry for each new ( print page 76285) respondent. Others expressed the provision could set a precedent that infringes on respondents' rights. To address this concern, the final rule specifies that each additional respondent must be provided notice of the allegations and an opportunity to respond, consistent with subpart C. Some commenters were also concerned that listing the types of researchers the institutions should consider as potential respondents created a confusing standard and could be detrimental to those individuals. ORI concurred and removed the list of potential co-respondents as well as the parenthetical list of additional research records to examine, because these lists were intended to be exemplary rather than prescriptive. Some commenters suggested changing “must consider whether any additional researchers are responsible” to “may consider whether any additional researchers are responsible.” ORI revised this section to allow institutions the flexibility to use their own judgment.

Some commenters found this section overly prescriptive while others found it overly broad. Many commenters were concerned that pursuing all leads during an inquiry would be burdensome and costly—as well as cause reputational harm to innocent researchers. ORI concurred and moved the requirement to pursue all leads to § 93.310(j), which details the investigation requirements. ORI also removed the parenthetical list of additional research records to examine, because it was intended to be exemplary, not prescriptive. ORI intends to provide further guidance specifying recommended practices for pursuing leads.

Commenters objected to the proposed requirement to transcribe all interviews, especially interviews conducted during the assessment or inquiry phase, because it could discourage reporting of allegations and contribute to institutional burden. Some commenters expressed that if transcriptions are mandatory, they should be required only during the investigation. ORI concurred, revised the proposed section, and moved it to § 93.310(g), which details the investigation requirements. The revised section removes the requirement for transcribed interviews during the assessment and inquiry phases.

Some commenters noted a concern that this section may not provide fair procedures to respondents. Other commenters recommended removing the section entirely, stating that institutions should be allowed to institute best practices without regulatory oversight. A few commenters favored retaining the section as proposed. ORI removed all portions of the proposed subsection that did not specify requirements—that is, sections on the institution's choice to use a committee, consortium, or person to conduct, support, or participate in proceedings; what a consortium might be comprised of; and the institution's choice to allow respondents/complainants to object to committee or consortium member(s). The information was intended to be exemplary, not prescriptive.

A number of commenters were concerned about the burden of increased pre-investigation reporting requirements. ORI concurred and revised this section to simplify the assessment phase and require institutions to document their assessment process rather than write a formal report. Commenters also expressed concern about potential harm to respondents' reputations if ORI is permitted to read an institution's assessment documentation. In response to the concern about reputational harm, ORI notes that any assessment documentation obtained by ORI will be subject to the Privacy Act, 5 U.S.C. 552a . Many commenters asked ORI to remove § 93.306(e), which proposed requiring institutions to complete the assessment within 30 days. Commenters expressed that this timeline was unrealistic, would be burdensome for institutions, and could undermine the rigor and utility of the sequestration process. One commenter was concerned about the impact of this assessment timeframe on respondents' mental health. ORI concurred and removed the 30-day assessment timeline requirement.

Some commenters requested clarification because the process for notifying additional respondents of an institutional inquiry appeared unclear. ORI concurred and revised this section to simplify the language. Commenters also recommended removing proposed § 93.307(f)(2) because they conveyed that the requirement that institutions determine honest error only at the investigation stage would unfairly burden both respondents and institutions. ORI agreed and removed proposed § 93.307(f)(2). Several commenters recommended removing proposed § 93.307(h), which set a 60-day timeframe for completing an inquiry, stating that institutions should have more flexibility in the timeframe to thoroughly conduct an inquiry. ORI concurred and lengthened the inquiry timeline from 60 to 90 days. If the inquiry takes longer than 90 days to complete, the inquiry report must document the reasons for exceeding the 90-day period. ORI also revised references to “research records” throughout the final rule to ensure consistency with § 93.307(d), which describes “research records and other evidence.” In addition, ORI removed proposed § 93.307(e)(5) in the final rule to eliminate redundancy, because § 93.310(j) specifically addresses the institutional responsibility to pursue all leads.

ORI removed the proposed requirement that the Institutional Deciding Official review the inquiry report and provide a written decision to proceed to an investigation, to eliminate potential administrative burden.

A few commenters recommended removal of § 93.310(c)(2) because they expressed a concern that the regulation infringes on the rights of respondents who are added to an ongoing investigation without an additional inquiry. ORI clarified in § 93.310(c)(2) that when a new respondent is added to an ongoing proceeding, institutions may but are not required to conduct a separate inquiry for additional respondents, and additional respondents must be notified of allegation(s) and provided an opportunity to respond consistent with subpart C. In response to commenters requesting additional clarity for regulated entities, ORI moved proposed § 93.310(h) regarding the institutional responsibility to pursue leads to § 93.310(j) and streamlined the language, including clarifying the respondent notification requirement. ( print page 76286)

Commenters requested clarity on how the investigation report should identify sequestered evidence. Commenters also recommended removing § 93.313(k), which included a requirement that institutions identify any research records and other evidence obtained and sequestered but not reviewed, because it was deemed resource-intensive and an unnecessary burden. ORI revised § 93.313 to replace proposed Secs. 93.313(e) and (k) with a single requirement in § 93.313(e) to include in the investigation report an inventory of sequestered research records and other evidence, except records the institution did not consider or rely on. ORI made a corresponding revision to § 93.220(c) of the final rule requiring that the institutional record include a general description of the records that were sequestered but not considered or relied on. ORI notes that the general description in § 93.220(c) does not require identification of specific files or emails but allows for a broader summary of the types of files or emails sequestered.

Commenters recommended removing language in proposed § 93.313(l)(2) prohibiting investigation committees from making a split decision. ORI removed that prohibition and included language that the report must clearly state the investigation committee's conclusions regarding whether research misconduct occurred for each separate allegation.

Commenters recommended deleting or significantly revising proposed § 93.314, which requires institutions to complete any institutional appeals within 120 days or seek an extension, contending the institutional appeal was within the institution's purview, not ORI's. ORI concurred and removed most of the requirements in § 93.314. ORI recognizes the potential inefficiency of starting oversight review while an institutional appeal is ongoing that could reverse or modify the institutional findings of research misconduct. The final rule clarifies that institutions should not transmit their institutional record until the conclusion of any institutional appeals. If an appeal is filed after the institution has transmitted the institutional record, the institution must promptly notify ORI so the agency can postpone oversight review until the institutional appeal is complete.

ORI added this section to clearly identify the responsibilities of the Institutional Deciding Official at the conclusion of an investigation and to respond to commenters generally requesting additional clarity.

ORI revised the requirement that institutions notify ORI in advance if an institution plans to close research misconduct proceedings to omit “or for any other reason” to eliminate unnecessary burden.

This section was intended to indicate that ORI findings of research misconduct or HHS settlements of research misconduct proceedings, or the absence thereof, do not affect institutional findings or actions taken based on an institution's standards of conduct. ORI combined (a) and (b) of this section and clarified language accordingly.

ORI added language to clarify the relationship between ORI and the HHS official authorized to impose suspension and debarment.

ORI removed unnecessary language regarding suspension and debarment.

ORI revised this section to clarify that, for purposes of this regulation, HHS administrative actions do not include suspension and debarment. However, the HHS official authorized to impose suspension and debarment remains free to pursue those actions under applicable regulations, as stated in § 93.407(d).

ORI removed the phrase “as it deems necessary” in § 93.410(a) because it does not add further meaning to the section.

Many commenters urged ORI to remove § 93.410(b), which proposed that ORI publish notice of institutional investigations and actions. Commenters cited regulatory overreach, breaches of confidentiality, and inconsistency with other agencies' policies. One commenter noted that ORI's publication of institutional reports and findings would be inconsistent with the confidentiality provisions established in the clinical research context. A minority of commenters recommended revising the section to redact respondents' identifying information to ensure confidentiality. A few commenters recommended retaining the section as proposed. ORI removed proposed § 93.410(b) from the final rule, ensuring institutions have discretion in this area.

One commenter objected to replacing “may” with “shall,” regarding ORI's publication of findings and settlements. ORI restored the 2005 regulatory language of “may” to retain flexibility.

ORI revised this section to clarify the process for making a discretionary referral to the HHS official authorized to impose suspension and debarment under separate and distinct regulations. In addition, ORI changed the section's name to “ORI compliance actions” for accuracy.

One commenter objected to replacing “may” with “shall” regarding ORI's publication of findings and settlements. ORI restored the 2005 regulatory language of “may” to retain flexibility. Commenters were concerned this portion of the proposed regulation weakens respondents' confidentiality protections and runs counter to the remedial purpose of regulations and HHS administrative actions. One commenter requested adding language to protect the institution's confidentiality in subsection (b). Numerous commenters recommended requiring ORI to notify the relevant institution when it closes a case without a settlement or a finding of research misconduct. One commenter expressed that ORI should attempt to restore the reputation of respondents not found to have committed research misconduct; they also expressed that if a complainant is found to have conflicts ( print page 76287) of interest with the respondent, ORI should consider taking action against the complainant. Another commenter was concerned about § 93.414(f), which provides that any publications or disclosures pursuant to this section are not considered appealable “administrative actions.” ORI revised this section for clarity and removed proposed subsections 93.414(c)-(f) in response to the comments.

ORI revised this section to clarify that a respondent must exhaust administrative remedies under this part prior to seeking judicial review in Federal court.

ORI revised this section to restore in subsection 93.510(e) the phrase “Whenever possible” from the 2005 regulation to retain flexibility for the ALJ.

One commenter, in response to the NPRM's request for comments on the scope of and need for limited hearings, suggested the research misconduct process allows for sufficient procedures to make such limited hearings unnecessary. ORI agreed, removed proposed § 93.511 from the final rule, and made corresponding edits throughout subpart E.

To promote consistency in agency decision making, ORI reinstated and updated from the 2005 regulation an opportunity for the Assistant Secretary for Health (ASH) to review the ALJ's decision under subpart E. Although §  93.511 in the final rule explicitly provides that the ASH may review the ALJ's recommended decision before it becomes final, the ASH and the Secretary also have the ability to review ORI findings of research misconduct and/or proposed HHS administrative actions before a charge letter is issued under § 93.405 and to act as final decision maker before a charge letter is issued, if either of them so chooses.

Commenters supported retaining this proposed definition but found it overly expansive. Commenters recommended revised language, including practices specific to PHS-funded research. ORI left this definition unchanged to acknowledge the expanding universe of research disciplines.

Commenters supported revising this definition to clarify purposeful disclosure of possible research misconduct. After consideration, ORI left the definition as proposed, to avoid adding another element to the definition that may discourage reporting possible research misconduct.

Many commenters recommended deleting this definition because they conveyed that it was unnecessary. Some commenters' recommended revisions were related to concerns about the proposed description of the assessment phase in subpart C. A minority of commenters supported the inclusion of the definition but sought clarification for what constitutes readily available information. ORI made changes to subpart C and left the definition of “assessment” as proposed because there was no consensus among the comments and because it was satisfied that the proposed definition served the purpose of explaining the term to those who may be unfamiliar with the term in the research misconduct context. ORI may address this topic through future policymaking.

Commenters recommended revising this definition to add details about complainant anonymity. ORI agreed on the importance of anonymity and addressed confidentiality elsewhere in subpart A of the final rule. ORI left the definition of complainant unchanged.

One commenter proposed removing this definition because it is a commonly understood term. ORI opted to leave the definition as proposed, because it is helpful to those who are not familiar with contracts under the Federal Acquisition Regulation.

Some commenters recommended removing or revising this definition to factor in academic calendars. Since academic calendars vary, ORI retained the definition in its proposed form.

One commenter recommended removing this definition because it is a commonly understood term. ORI retained the definition in its proposed form because it is helpful to those who are not familiar with that organization.

A small number of commenters provided contradictory recommendations about removing or enhancing the definition. ORI retained the definition in its proposed form because there was no consensus among the comments and because it was satisfied that the proposed definition served the purpose of explaining the term to those who may be unfamiliar with the term in the research misconduct context.

One commenter recommended revising this definition to include allegations of misconduct and intent. ORI retained the definition in its proposed form because it is consistent with the definition found in the 2000 Office of Science and Technology Policy's Federal Policy on Research Misconduct, 65 FR 76260 (Dec. 6, 2000).

Some commenters recommended revising this definition to express nuance without fundamentally altering its meaning. ORI retained the definition in its proposed form because commenters were not opposed to the meaning expressed in the definition.

One commenter recommended revising this definition to clarify that institutions are not persons. ORI retained the definition in its proposed form. While the definition refers to “any person,” the term “person” is defined in § 93.226 of the final rule to include both individuals and other legal entities that are not individuals.

Commenters recommended revising this definition to permit the Research Integrity Officer, or RIO, to serve as the Institutional Deciding Official. ORI retained the definition in its proposed form, because requiring a different individual to serve in each role will better ensure a fair and unbiased outcome.

Commenters recommended revising the definition to remove the inclusion of subcontractors and subrecipients. ORI retained the definition in its proposed form and clarified related wording under “Applicability” in subpart A, because an individual's duty to protect PHS funds from misuse should not depend on the individual's employment status with a specific institution. ( print page 76288)

Commenters suggested revising this definition to provide further clarification. One commenter also suggested better harmonization with definitions used by other Federal agencies. ORI retained the definition in its proposed form to avoid including additional terms that could introduce ambiguity. ORI intends to explore opportunities to harmonize policy across Federal entities.

Many commenters generally supported retaining this proposed definition; however, several commenters requested clarification on distinctions among “knowingly,” “recklessly,” and “intentionally.” ORI retained the definition in its proposed form to avoid including additional terms that could introduce ambiguity.

One commenter recommended removing this definition. Another commenter recommended revision to remove the word “serve.” ORI retained the definition because it describes an essential part of the process of notifying respondents. ORI retained the word “serve” for clarity and notes that the definition does not require the use of a process server.

One commenter recommended removing this definition because it is a commonly understood term. ORI retained the definition in its proposed form because it is helpful to the public.

Commenters recommended revising this definition, particularly to clarify “self-plagiarism.” ORI retained the definition in its proposed form. Because “plagiarism” is defined as the appropriation of “another person's” ideas, processes, results, or words, without giving appropriate credit, the exclusion of a “self-plagiarism” definition was intended to confirm that the appropriation must be of “another person's” rather than one's own ideas, processes, results, or words. Thus, ORI does not believe it necessary to further define “self-plagiarism” in its regulation, but ORI may address this topic through future policymaking.

One commenter supported the inclusion of the definition. Another commenter recommended revision to clarify the definition. ORI retained the definition because there was no consensus among the comments and because it was satisfied that the proposed definition served the purpose of explaining the term to those who may be unfamiliar with the term in the research misconduct context.

Several commenters provided feedback on this definition. Many commenters supported the inclusion of this definition. A minority of commenters recommended its removal because they conveyed that it was unnecessary or confusing. ORI retained the definition in its proposed form because it is helpful to the public and clarifies the specific responsibilities of this role.

Commenters recommended revision of the definition to include questionable research practices. One commenter conveyed that the definition was unnecessary. One commenter requested retention of the proposed definition. ORI decided to retain this definition because it is consistent with the definition found in the 2000 Office of Science and Technology Policy's Federal Policy on Research Misconduct, 65 FR 76260 (Dec. 6, 2000).

Commenters recommended revision of this definition to make it more expansive. ORI retained the definition in its proposed form as a more limited definition is needed to accommodate HHS components that address retaliation in other contexts.

Commenters proposed removing the portion of § 93.300(g) that requires institutions to address deficiencies or additional allegations, noting that ORI already has a broad mandate to ensure compliance. One commenter asked ORI to add a requirement that institutions take precautions to ensure that complainants do not have unresolved conflicts of interest with the respondent. Some commenters recommended retaining the section as proposed. Commenters also requested more guidance on fostering an environment of research integrity and developing and evaluating effective training programs; one commenter offered suggestions about how to improve Responsible Conduct of Research training. ORI acknowledges the compliance process can be complex. ORI left this section unchanged because providing guidance rather than stipulating additional regulatory requirements reduces institutional burden. ORI intends to issue further guidance on these topics.

One commenter noted changing the title of this section from “Institutional Assurances” to “Research Integrity Assurances” was confusing and could be misread as materially altering the nature of institutional assurances. One commenter expressed it was inappropriate to require the person who coordinates an institution's compliance assurances and Responsible Conduct of Research program to also be responsible for fostering an environment that supports research integrity, because that is a leadership-level responsibility. There was a request for more specific guidance on how institutions can foster research integrity, with examples focused not only on research but also the concept of “research integrity” more broadly. ORI acknowledges the compliance process can be complex. ORI left this section unchanged because providing guidance rather than stipulating additional regulatory requirements reduces institutional burden. ORI intends to issue further guidance on these topics.

One commenter requested greater clarity in proposed § 93.302(a)(4)(ii) on the scope of policies and procedures that institutions are required to make publicly available. ORI intends to issue guidance on this topic.

Most commenters approved of proposed § 93.305(a) and expressed appreciation that institutions may sequester copies of records if they are substantially equivalent in evidentiary value. ORI retained the language as proposed.

Commenters appreciated ORI's addition of this subsection because there has been an increase in complex cases involving more than one institution. However, they requested further guidance on how to handle such cases, including how to determine a lead institution. ORI intends to issue further guidance on this topic. ( print page 76289)

Some commenters suggested revising NPRM section § 93.305(g)(5) to require institutions to redact all interview transcripts before forwarding them to the respondent, to protect interviewees' identities. ORI left this section unchanged and moved it to § 93.310(g) because policies regarding interview transcriptions prior to the investigation phase should be left to the discretion of institutions.

Commenters recommended revising § 93.310(a) to extend the time to begin an investigation. ORI retained the proposed language because it is important to proceed promptly after an institution decides an investigation is warranted.

Several commenters approved of ORI's increasing the investigation period from 120 to 180 days; however, a significant number of commenters expressed that 180 days is inadequate to conduct a thorough investigation. These commenters requested timeframes ranging up to a year or more. ORI retained the proposed 180-day timeline, because the timeframe balances the needs of institutions and the need of respondents to have investigations conclude within a reasonable amount of time, and institutions have the opportunity to request extensions. ORI will continue to work closely with institutions that request and substantiate the need for an extension.

Commenters recommended revising § 93.401(b) to require ORI to notify the RIO or the Institutional Deciding Official if ORI makes a determination to refer a case to the Department of Justice or other Federal agencies while the institution's research misconduct proceedings are pending. ORI retained the language of this section because such referrals are nonpublic.

One commenter was concerned about the removal of language that was in the 2005 regulation specifying the requirements for ORI to conduct an assessment. ORI did not restore the language because it is redundant with § 93.204 of the final rule.

One commenter stated that the institutional investigation report is part of a PHS-supported research process and should be made public; they suggested copies of or links to all institutional investigation reports should be posted on the ORI website. ORI retained the language as proposed because the institutional investigation report is not a public document and is protected by the Privacy Act, 5 U.S.C. 552a .

One commenter suggested that discovery and de novo review are not needed; all that should be required is consideration of all the evidence available to the ALJ, including the institutional record and additional testimony and other evidence provided during the appeal. ORI did not make further changes because ORI already proposed removing the discovery and de novo review provisions in the NPRM.

The final rule will become effective January 1, 2025, and all regulatory requirements will be applicable on January 1, 2026, which will apply prospectively. The effect of the prospective application to research misconduct proceedings will depend on when allegations are received by institutions. The final rule applies to research misconduct proceedings based on allegations received by institutions on or after January 1, 2026. For allegations received by an institution prior to January 1, 2026, an institution must follow 42 CFR part 93 as published in the 2005 edition of the Code of Federal Regulations, unless a respondent and institution agree in writing to apply the final rule to a particular research misconduct proceeding. Institutions must implement and submit revised policies and procedures that comply with the final rule along with their annual report covering 2025, which must be received by ORI on or before April 30, 2026.

We examined the impacts of the final rule under Executive Order 12866 , Executive Order 13563 , Executive Order 14094 , the Regulatory Flexibility Act ( 5 U.S.C. 601-612 ), the Unfunded Mandates Reform Act of 1995 ( Pub. L. 104-4 ), and the Congressional Review Act ( 5 U.S.C. 801-808 ).

Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). A “significant regulatory action” under Executive Order 12866 Section 3(f)(1) (as amended by Executive Order 14094 ) includes a “regulatory action likely to result in a rule that may have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of [the Office of Information and Regulatory Affairs (OIRA)] for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” The analysis below concludes that this final rule is not a significant regulatory action under Executive Order 12866 Section 3(f)(1). OIRA has determined that this final rule is a significant regulatory action, but that it does not meet the criteria set forth in 5 U.S.C. 804(2) under the Congressional Review Act.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small institutions. The analysis below concludes that the final rule will not have a significant economic impact on a substantial number of small institutions.

The Unfunded Mandates Reform Act of 1995 (UMRA) generally requires that each agency conduct a cost-benefit analysis, identify and consider a reasonable number of regulatory alternatives, and select the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule before promulgating any proposed or final rule that includes a Federal mandate that may result in expenditures of more than $100 million (adjusted for inflation) in at least one year by State, local, and tribal governments, or by the private sector. Each agency must also seek input from State, local, and tribal governments. The current threshold after adjustment for inflation using the Implicit Price Deflator for the Gross Domestic Product is $183 million, reported in 2023 dollars. Per the analysis below, this final rule will not result in an unfunded mandate in any year that meets or exceeds this amount.

Under the current regulatory requirements, all recipients of PHS ( print page 76290) support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training must comply with certain reporting and record keeping requirements. However, since many of these impacts have not been comprehensively quantified and monetized in a previously published regulatory impact analysis, when considering the potential impacts of this final rule, we adopt an analytic baseline that excludes many ongoing activities associated with the existing requirements. For example, absent any further regulatory action, we anticipate that covered entities would continue to incur costs (inclusive of the opportunity costs of staff time and other resources) associated with filing an annual statement of assurance (research integrity assurance) and an annual report on allegations received; costs associated with submitting reports and evidence to support their results and conclusions of inquiries or investigations of research misconduct; and costs associated with obtaining all research records and other evidence when there is an allegation of research misconduct and engaging persons to handle the process for addressing the allegations of research misconduct.

We anticipate that the final rule will likely reduce the burden of compliance by institutions through reduced confusion and uncertainty. Thus, the benefits of this final rule stem from reduced confusion for research institutions to understand the requirements that apply to them. This final rule will reduce the potential for lengthy back-and-forth discussions between ORI and institutions to ensure that institutions conduct complete and fair investigations of allegations of research misconduct. It will also streamline the process for respondents to appeal ORI findings of research misconduct and proposed HHS administrative actions. We anticipate that these revisions will reduce the burden across the affected research community. This final rule will also help foster an environment of responsible conduct of research.

We anticipate that this final rule will likely result in one-time costs associated with covered institutions updating their policies and procedures for responding to allegations of research misconduct. For institutions that undertake proceedings to address allegations of research misconduct, we identify and monetize additional recurring costs associated with documenting aspects of those proceedings. We quantify and monetize these costs in the next section.

In support of the NPRM, we performed an initial threshold analysis to assess the approximate magnitude of the impacts of the proposed rule to determine whether it would result in a significant regulatory action per section 3(f)(1) of Executive Order 12866 . We identified the potential costs associated with covered institutions updating their policies and procedures for responding to allegations of research misconduct as the largest impact under the proposed rule. To quantify this impact, we adopted a count of 5,910 institutions holding research integrity assurances that would update their policies and procedures. For the purposes of the initial threshold analysis, we adopted 16 hours as an estimate for the average time across all covered entities for these tasks. Across all covered entities, this was 94,560 total hours spent updating policies and procedures.

To monetize the change in time use associated with these activities, we adopted an hourly value of time based on the cost of labor, including wages and benefits, and also indirect costs, which “reflect resources necessary for the administrative oversight of employees and generally include time spent on administrative personnel issues ( e.g., human resources activities such as hiring, performance reviews, personnel transfers, affirmative action programs), writing administrative guidance documents, office expenses ( e.g., space rental, utilities, equipment costs), and outreach and general training ( e.g., employee development).”  [ 1 ]

For these tasks, we identified a pre-tax hourly wage for Education Administrators, Postsecondary. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for these individuals was $53.49 per hour. [ 2 ] We assumed that benefits plus indirect costs equal approximately 100 percent of pre-tax wages, and adjusted this hourly rate by multiplying by two, for a fully loaded hourly wage rate of $106.98. We multiplied this fully loaded hourly wage rate by the 94,560 total hours across covered entities spent updating policies and procedures and estimated a total cost in the first year of about $10.1 million.

We received public comments suggesting it will take institutions more than 16 hours to update their policies and procedures, [ 3 ] with alternative estimates including between 17-26 hours, between 27-40 hours, or more than 40 hours. We appreciate these comments, and in response, we present an additional threshold analysis, following the same approach described above, but adopting several revised assumptions and updated data. This threshold analysis helps to determine whether it will result in a significant regulatory action per section 3(f)(1) of Executive Order 12866 and to determine whether any effects will exceed the UMRA threshold. For this analysis, we adopt a more recent estimate that 6,394 institutions holding research integrity assurances. Consistent with an upper-bound estimate from public comments, we adopt 40 hours as the average hours per covered entity. We updated the pre-tax hourly wage to $55.38 per hour, [ 4 ] for a fully loaded hourly wage rate of $110.76. The modified assumptions indicate that, across all covered entities, 255,760 hours would be spent updating policies and procedures. Monetizing this impact using the fully loaded hourly wage rate, this would represent a cost in the first year of about $28.3 million. Thus, our modified threshold analysis indicates that the largest economic impact of the final rule would not exceed the monetary threshold for significant regulatory actions per section 3(f)(1) of Executive Order 12866 or the UMRA threshold. We emphasize that this estimate corresponds to an upper-bound estimate of the potential impacts based on public comments to the proposed rule.

As discussed in greater detail in the Preamble, this final rule includes several revisions that generally reduce the burden on the institutions covered, compared to the proposed rule. To estimate the costs associated with covered institutions updating their policies and procedures, we adopt 16 hours as an estimate for the average time per covered entity and apply the updated fully loaded hourly wage ( print page 76291) estimate ($110.76) and covered entity count (6,394 institutions). Combining these assumptions results in an estimate of the total cost associated with updating policies and procedures in the first year of about $11.3 million.

For institutions that address allegations of research misconduct, we identify additional recurring costs associated with the final rule's reporting, recordkeeping, and third-party disclosure requirements related to institutions responding to allegations of research misconduct. To quantify these impacts, we adopt an estimate of 230 cases per year, matching the most recent annual count of cases reported to HHS.

Consistent with our estimates in the Paperwork Reduction Act section of this Preamble, we believe that institutions will spend a total of 221,030 hours per year on these requirements, which is about 961 hours per case. To monetize these impacts, we adopt the fully loaded hourly value of time of $110.76 per hour for postsecondary education administrators. Across all 230 cases, we compute an annual cost associated with these regulatory requirements of $24,481,283 per year. The Paperwork Reduction Act section of this Preamble contains additional details on the annual burden estimates and total costs associated with each of these requirements.

Across all covered institutions, we anticipate that the final rule will result in about $11.3 million in one-time costs associated with institutions updating policies and procedures. We account for timing of these impacts by assuming they will occur in 2025. We also identify incremental costs of about $24.5 million associated with the final rule's reporting, recordkeeping, and third-party disclosure requirements related to institutions responding to allegations of research misconduct. Consistent with the implementation schedule of the final rule, we account for timing of these recurring impacts by assuming they will occur in 2026 and in subsequent years. Over a 5-year time horizon, we report a present value of total costs attributable to the final rule of about $102.5 million, or annualized costs of about $21.7 million, both calculated using a constant 2% real discount rate.

Table 1—Costs of the Final Rule

[Constant 2023 dollars, 2% discount rate]

Year Cost 2025 $11,331,191 2026 24,481,283 2027 24,481,283 2028 24,481,283 2029 24,481,283 Present Value 102,499,288 Annualized 21,746,084

The Regulatory Flexibility Act ( 5 U.S.C. 601-612 ) requires agencies to prepare a regulatory flexibility analysis describing the impact of the final rule on small entities (“institutions” for purposes of the final rule) unless they certify that a final rule will not, if promulgated, have a significant economic impact on a substantial number of small institutions. HHS generally considers a rule to have a significant impact on a substantial number of small institutions if it has at least a 3% impact on revenue on at least 5% of small institutions. We considered whether the final rule would result in effects that exceed these thresholds. This analysis below concludes, and the Secretary certifies that this final rule will not have a significant impact on a substantial number of small institutions, as defined by the Regulatory Flexibility Act, based on the following facts.

As of March 1, 2024, approximately 22 percent (1,412) of 6,394 institutions holding research integrity assurances are small institutions. The primary impact of the final rule on covered institutions results from the reporting and record keeping provisions, which are analyzed in detail under the heading “The Paperwork Reduction Act.” Potentially significant annual burdens apply only if an institution learns of possible research misconduct and begins an inquiry, investigation, or both.

Institutions covered by 42 CFR part 93 reported having conducted a total of 124 inquiries and 121 investigations during the 2023 reporting period. In total, one inquiry and three investigations were conducted by small institutions. Small institutions may be able to avoid developing and filing the full policies and procedures for addressing allegations of research misconduct required by § 93.304 by filing a Small Institution Statement. Under the 2005 regulation, this is called a Small Organization Statement. ORI or another appropriate HHS office will work with small institutions to develop and/or advise on a process for handling allegations of research misconduct consistent with 42 CFR part 93 . The burden of filing the Small Institution Statement is 0.5 hour. Thus, the burden of developing and filing the full policies and procedures for addressing allegations of research misconduct required by § 93.304 will not fall on a substantial number of small entities.

A small entity that files the Small Institution Statement must still report allegations of research misconduct to ORI and comply with all provisions of the final rule except as described in § 93.303. The most significant burden that could fall on an entity filing a Small Institution Statement is in addressing allegations of research misconduct, which would include obtaining all research records and other evidence when there is an allegation of research misconduct, engaging persons to handle the process for addressing the allegations of research misconduct, and submitting reports and evidence to support the small institution's results and conclusions of inquiries or investigations of research misconduct. The average burden per response is estimated at 40 hours. Based on reports of research misconduct over the past five years, fewer than five small institutions will have to incur that burden in any year. Based on this analysis, HHS concludes that the regulations set forth in the final rule will not impose a significant burden on a substantial number of small institutions.

Sections 104, 301-303, 305-313, and 315-318 of this final rule contain information collection requirements that are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 ( 44 U.S.C. 3501-3521 ). These provisions involve the following institutional activities in addressing allegations of misconduct involving PHS-funded research:

Title: The title of the section of the Public Health Service Policies on Research Misconduct involving institutional activities.

Description: The relevant passage(s) of the section describing the institutional information collection requirements.

Description of Respondents: The “respondents” for the collection of information described in this regulation are institutions that apply for or receive PHS support through grants, contracts, or cooperative agreements for any project or program that involves the conduct of biomedical or behavioral research, biomedical or behavioral research training, or activities related to ( print page 76292) that research or training (see definition of “Institution” at § 93.216).

(ii) For research misconduct that appears subject to the subsequent use exception, institutions must document their determination that the subsequent use exception does not apply. Such documentation must be retained in accordance with § 93.318.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —40 hours.

Total Annual Burden —9,200 hours.

(b) Access to research records. Where appropriate, an institution must give the respondent copies of, or reasonable supervised access to, the research records that are sequestered in accordance with paragraph (a) of this section.

Annual Average Burden per Response —25 hours.

Total Annual Burden —5,750 hours.

(c) Maintenance of sequestered research records and other evidence. An institution must maintain the sequestered research records and other evidence as required by § 93.318.

Annual Average Burden per Response —80 hours.

Total Annual Burden —18,400 hours.

(g) Notifying ORI of special circumstances. At any time during a research misconduct proceeding, as defined in § 93.235, an institution must notify ORI immediately if it has reason to believe that any of the following conditions exist:

(1) Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.

(2) HHS resources or interests are threatened.

(3) Research activities should be suspended.

(4) There is reasonable indication of possible violations of civil or criminal law.

(5) Federal action is required to protect the interests of those involved in the research misconduct proceeding.

(6) HHS may need to take appropriate steps to safeguard evidence and protect the rights of those involved.

Annual Average Burden per Response —1 hour.

Total Annual Burden —230 hours.

(c) Assessment results.

(2) If the RIO or another designated institutional official determines that requirements for an inquiry are met, they must: (i) document the assessment;

(ii) promptly sequester all research records and other evidence, consistent with § 93.305(a), and promptly initiate the inquiry.

Annual Average Burden per Response —160 hours.

Total Annual Burden —36,800 hours.

(3) If the RIO or another designated institutional official determines that requirements for an inquiry are not met, they must keep sufficiently detailed documentation of the assessment to permit a later review by ORI of the reasons why the institution did not conduct an inquiry. Such documentation must be retained in accordance with § 93.318.

Annual Average Burden per Response —10 hours.

Total Annual Burden —2,300 hours.

(d) Sequestration of records. An institution must obtain all research records and other evidence needed to conduct the research misconduct proceeding, consistent with § 93.305(a).

(a) Notice to respondent. The institution must notify the respondent whether the inquiry found that an investigation is warranted. The notice must include a copy of the inquiry report and include a copy of or refer to this part and the institution's policies and procedures adopted under its research integrity assurance.

Annual Average Burden per Response —2 hours.

Total Annual Burden —460 hours.

(a) Within 30 days of determining that an investigation is warranted, the institution must provide ORI with a copy of the inquiry report, which includes the following information:

(1) The names, professional aliases, and positions of the respondent and complainant;

(2) A description of the allegation(s) of research misconduct;

(3) The PHS support, including, for example, grant numbers, grant applications, contracts, and publications listing PHS support;

(4) The composition of the inquiry committee, if used, including name(s), position(s), and subject matter expertise;

(5) Inventory of sequestered research records and other evidence and description of how sequestration was conducted;

(6) Transcripts of any transcribed interviews;

(7) Timeline and procedural history;

(8) Any scientific or forensic analyses conducted;

(9) The basis for recommending that the allegation(s) warrant an investigation;

(10) The basis on which any allegation(s) do not merit an investigation;

(11) Any comments on the inquiry report by the respondent or the complainant; and

(12) Any institutional actions implemented, including communications with journals or funding agencies.

Annual Average Burden per Response —4 hours.

Total Annual Burden —920 hours.

(b) Institutions must keep detailed documentation of inquiries to permit a later assessment by ORI of the reasons why the institution decided not to investigate. Such documentation must be retained in accordance with § 93.318.

Number of Responses per Respondent —1. ( print page 76293)

Annual Average Burden per Response —0 hours. Burden accounted for in § 93.316(a)(2).

Total Annual Burden —0 hours.

(c) In accordance with § 93.305(g), institutions must notify ORI of any special circumstances that may exist.

Institutions conducting research misconduct investigations must: (b) Notify ORI of the decision to begin an investigation on or before the date the investigation begins and provide an inquiry report that meets the requirements of § 93.307 and § 93.309.

Annual Average Burden per Response —0 hours. Burden accounted for in § 93.309(a).

(d) Notice to the respondent. Notify the respondent in writing of the allegation(s) within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins.

Annual Average Burden per Response —0 hours. Burden accounted for in § 93.308(a).

(g) Interviews. During the investigation, an institution must interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent. (1) Interviews during the investigation must be recorded and transcribed.

Annual Average Burden per Response —300 hours.

Total Annual Burden —69,000 hours.

(3) The transcript of the interview must be made available to the relevant interviewee for correction.

(5) The respondent must be provided a transcript of the interview.

(j) Pursue leads. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.

(b) Extension of time limit. If unable to complete the investigation in 180 days, the institution must ask ORI for an extension in writing that includes the circumstances or issues warranting additional time.

(c) Progress reports. If ORI grants an extension, it may direct the institution to file periodic progress reports.

(a) The institution must give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the research records and other evidence that the investigation committee considered or relied on. The respondent must submit any comments on the draft report to the institution within 30 days of receiving the draft investigation report.

A final investigation report for each respondent must be in writing and include:

(a) Description of the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding.

(b) Description and documentation of the PHS support, including, for example, any grant numbers, grant applications, contracts, and publications listing PHS support.

(c) Description of the specific allegation(s) of research misconduct for consideration in the investigation of the respondent.

(d) Composition of investigation committee, including name(s), position(s), and subject matter expertise.

(e) Inventory of sequestered research records and other evidence, except records the institution did not consider or rely on; and a description of how any sequestration was conducted during the investigation. This inventory must include manuscripts and funding proposals that were considered or relied on during the investigation.

(f) Transcripts of all interviews conducted, as described in § 93.310(g).

(g) Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other research records that allegedly contained the falsified, fabricated, or plagiarized material.

(h) Any scientific or forensic analyses conducted.

(i) If not already provided to ORI, the institutional policies and procedures under which the investigation was conducted.

(j) Any comments made by the respondent and complainant on the draft investigation report and the investigation committee's consideration of those comments.

(k) A statement for each separate allegation of whether the investigation committee recommends a finding of research misconduct.

(1) If the investigation committee recommends a finding of research misconduct for an allegation, the investigation report must, for that allegation:

(i) Identify the individual(s) who committed the research misconduct.

(ii) Indicate whether the research misconduct was falsification, fabrication, and/or plagiarism.

(iii) Indicate whether the research misconduct was committed intentionally, knowingly, or recklessly.

(iv) State whether the other requirements for a finding of research misconduct, as described in § 93.103, have been met.

(v) Summarize the facts and the analysis which support the conclusion ( print page 76294) and consider the merits of any explanation by the respondent.

(vi) Identify the specific PHS support.

(vii) Identify whether any publications need correction or retraction.

(2) If the investigation committee does not recommend a finding of research misconduct for an allegation, the investigation report must provide a detailed rationale.

(l) List of any current support or known applications or proposals for support that the respondent has pending with PHS and non-PHS Federal agencies.

(a) If a respondent appeals an institution's finding(s) of research misconduct or institutional actions, the institution must promptly notify ORI.

(b) If the institution has not transmitted its institutional record to ORI in accordance with § 93.316 prior to the appeal, the institution must wait until the appeal is concluded to transmit its institutional record. The institution must ensure that the complete record of the appeal is included in the institutional record consistent with § 93.220(a)(5).

Annual Average Burden per Response —0 hours. Burden accounted for in § 93.316(a).

(c) If the institution has transmitted its institutional record to ORI in accordance with § 93.316 prior to the appeal, the institution must provide ORI a complete record of the appeal once the appeal is concluded.

After the Institutional Deciding Official has made a final determination of research misconduct findings in accordance with § 93.314, the institution must transmit the institutional record to ORI. The institutional record must be consistent with § 93.220 and logically organized.

Per § 93.220: The institutional record comprises:

(a) The records that the institution compiled or generated during the research misconduct proceeding, except records the institution did not consider or rely on. These records include, but are not limited to:

(1) Documentation of the assessment as required by § 93.306(c).

(2) If an inquiry is conducted, the inquiry report and all records (other than drafts of the report) considered or relied on during the inquiry, including, but not limited to, research records and the transcripts of any transcribed interviews conducted during the inquiry, information the respondent provided to the institution, and the documentation of any decision not to investigate as required by § 93.309(c).

(3) If an investigation is conducted, the investigation report and all records (other than drafts of the report) considered or relied on during the investigation, including, but not limited to, research records, the transcripts of each interview conducted pursuant to § 93.310(g), and information the respondent provided to the institution.

(4) Decision(s) by the Institutional Deciding Official, such as the written decision from the Institutional Deciding Official under § 93.314.

(5) The complete record of any institutional appeal consistent with § 93.315.

(b) A single index listing all the research records and evidence that the institution compiled during the research misconduct proceeding, except records the institution did not consider or rely on.

(c) A general description of the records that were sequestered but not considered or relied on.

(a) Institutions must notify ORI in advance if the institution plans to close a research misconduct proceeding at the assessment, inquiry, investigation, or appeal stage on the basis that the respondent has admitted to committing research misconduct or a settlement with the respondent has been reached.

(b) The [respondent's written] admission statement must meet all elements required for a research misconduct finding under § 93.103 and must be provided to ORI before the institution closes its research misconduct proceeding.

(b—continued): The institution must also provide a statement to ORI describing how it determined that the scope of the misconduct was fully addressed by the admission and confirmed the respondent's culpability.

(a) Maintenance of institutional record and all sequestered evidence. An institution must maintain the institutional record and all sequestered evidence including physical objects (regardless of whether the evidence is part of the institutional record) in a secure manner for seven years after completion of the proceeding or the completion of any HHS proceeding involving the research misconduct allegation under subparts D and E of this part, whichever is later, unless custody has been transferred to HHS under paragraph (b) of this section or ORI advises otherwise in writing.

Annual Average Burden per Response —8 hours.

Total Annual Burden —1,840 hours. ( print page 76295)

Estimated Annualized Burden Hour Table (9/3/2024)

Forms (If necessary)	Type of respondent	Number of respondents	Number of responses per respondent	Average burden hours per response	Total burden Hours
§ 93.104	Institutions	230	1	40	9,200
§ 93.305.b	Institutions	230	1	25	5,750
§ 93.305.c	Institutions	230	1	80	18,400
§ 93.325	Institutions	230	1	1	230
§ 93.306.c.2.i	Institutions	230	1	80	18,400
§ 93.306.c.2.ii	Institutions	230	1	160	36,800
§ 93.306.c.2.iii	Institutions	230	1	10	2,300
§ 93.307	Institutions	230	1	80	18,400
§ 93.308	Institutions	230	1	2	460
Sec 93.309.a	Institutions	230	1	4	920
Sec 93.309.c	Institutions	230	1	2	460
§ 93.310.g.1	Institutions	230	1	300	69,000
§ 93.310.g.3	Institutions	230	1	4	920
§ 93.310.g.5	Institutions	230	1	4	920
§ 93.310.j	Institutions	230	1	2	460
§ 93.310.b	Institutions	230	1	1	230
§ 93.310.c	Institutions	230	1	1	230
§ 93.312	Institutions	230	1	2	460
§ 93.313	Institutions	230	1	160	36,800
§ 93.315.a	Institutions	230	1	1	230
§ 93.315.c	Institutions	230	1	2	460
Total					221,030

Estimated annualized cost to respondents (9/3/2024) Forms (If necessary)	Type of respondent	Total burden hours	Hourly wage rate	Total respondent cost
§ 93.104	Institutions	9,200	$111	$1,018,992
§ 93.305.b	Institutions	5,750	111	636,870
§ 93.305.c	Institutions	18,400	111	2,037,984
§ 93.325	Institutions	230	111	25,475
§ 93.306.c.2.i	Institutions	18,400	111	2,037,984
§ 93.306.c.2.ii	Institutions	36,800	111	4,075,968
§ 93.306.c.2.iii	Institutions	2,300	111	254,748
§ 93.307	Institutions	18,400	111	2,037,984
§ 93.308	Institutions	460	111	50,950
Sec 93.309.a	Institutions	920	111	101,899
Sec 93.309.c	Institutions	460	111	50,950
§ 93.310.g.1	Institutions	69,000	111	7,642,440
§ 93.310.g.3	Institutions	920	111	101,899
§ 93.310.g.5	Institutions	920	111	101,899
§ 93.310.j	Institutions	460	111	50,950
§ 93.310.b	Institutions	230	111	25,475
§ 93.310.c	Institutions	230	111	25,475
§ 93.312	Institutions	460	111	50,950
§ 93.313	Institutions	36,800	111	4,075,968
§ 93.315.a	Institutions	230	111	25,475
§ 93.315.c	Institutions	460	111	50,950
Total				24,481,283

Following publication of the final rule, ORI will publish 60-day and 30-day notices in the Federal Register seeking public comment on these information collection requirements and associated burden estimates, and ORI will submit an Information Collection Request (ICR) to OMB seeking approval for these requirements under existing OMB Control Number 0937-0198, which currently covers the assurance and annual reporting requirements of 42 CFR part 93 (the Institutional Assurance and Annual Report on Possible Research Misconduct, PHS-6349, and the Assurance of Compliance by Sub-Award Recipients, PHS-6315). Before the applicability date of this final rule, ORI anticipates publishing a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove this ICR. This final rule does not make any substantive revisions to the Assurance or Annual Report that would require clearance under the PRA, but ORI anticipates making minor updates to these forms as part of the upcoming revision to 0937-0198.

An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

• Government contracts
• Grant programs
• Reporting and recordkeeping requirements
• Science and technology

For reasons discussed in the preamble, HHS is revising 42 CFR part 93 to read as follows:

Authority: 42 U.S.C. 216 and 289b

This part is subdivided into five subparts. Each subpart contains information related to a broad topic or specific audience with special responsibilities as shown in the following table.

Table 1 to § 93.25

In subpart . . . You will find sections related to . . . A General information about this part. B Definitions used in this part. C Responsibilities of institutions with PHS support. D Responsibilities of the U.S. Department of Health and Human Services and the Office of Research Integrity. E Information on how to contest ORI research misconduct findings and proposed HHS administrative actions.

This part uses terms throughout the text that have special meaning. Those terms are defined in subpart B of this part.

(a) An institution must follow this part for allegations received by the institution on or after January 1, 2026, except for the policies and procedures required under §§ 93.300(a) and 93.302(b), which must be implemented and submitted by due date of the annual report covering the 2025 reporting year, as specified by ORI.

(b) For allegations received by an institution before January 1, 2026, unless the institution and the respondent both elect in writing to follow this part, an institution must follow this part as published in the 2005 edition of the Code of Federal Regulations.

(a) Research misconduct involving Public Health Service (PHS) support is contrary to the interests of the PHS and the Federal Government, to the health and safety of the public, to the integrity of research, and to the conservation of public funds.

(b) The U.S. Department of Health and Human Services (HHS) and institutions that apply for or receive PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training share responsibility for the integrity of the research process. HHS has ultimate oversight authority for PHS-supported research, and for taking other actions as appropriate or necessary, including the right to assess allegations and to perform inquiries or investigations at any time. Institutions and institutional members have an affirmative duty to protect PHS funds from misuse by ensuring the integrity of all PHS-supported work, and primary responsibility for responding to and reporting allegations of research misconduct, as provided in this part.

The purpose of this part is to—

(a) Establish the responsibilities of HHS, the Office of Research Integrity (ORI), and institutions in addressing allegations of research misconduct;

(b) Define what constitutes research misconduct in PHS-supported research;

(c) Establish the requirements for a finding of research misconduct;

(d) Define the general types of administrative actions HHS may take in response to research misconduct;

(e) Require institutions to:

(1) Develop and implement policies and procedures for reporting and addressing allegations of research misconduct covered by this part;

(2) Provide HHS with the assurances necessary to permit institutions to participate in PHS-supported research;

(f) Protect the health and safety of the public, promote the integrity of PHS-supported research and the research process, and conserve public funds.

(a) Every extramural or intramural institution that applies for or receives PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training must comply with this part.

(b) This part applies to allegations of research misconduct involving:

(1) Applications or proposals for PHS support for biomedical or behavioral extramural or intramural research, biomedical or behavioral research training, or activities related to that research or research training;

(2) PHS-supported biomedical or behavioral extramural or intramural research;

(3) PHS-supported biomedical or behavioral extramural or intramural research training programs;

(4) PHS-supported extramural or intramural activities that are related to biomedical or behavioral research or research training, such as, but not limited to, the operation of tissue and data banks or the dissemination of research information;

(5) Research records produced during PHS-supported research, research training, or activities related to that research or research training; and

(6) Research proposed, performed, reviewed, or reported, as well as any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in an awarded grant, contract, cooperative agreement, subaward, or other form of PHS support.

(c) This part does not supersede or establish an alternative to any applicable statutes, regulations, policies, or procedures for handling fiscal improprieties, the ethical treatment of human or animal subjects, criminal matters, personnel actions against Federal employees, or addressing whistleblowers and/or retaliation.

(d) This part does not supersede or establish an alternative to the HHS suspension and debarment regulations set forth at 2 CFR part 180 , as implemented by HHS at 2 CFR part 376 ; and 48 CFR part 9, subpart 9.4 , as supplemented by HHS at 48 CFR part 309, subpart 309.4 . The Suspension and Debarment Official SDO and ORI may coordinate actions to the extent consistent with the SDO's and ORI's respective authorities. Such coordination includes jointly issuing notices or seeking settlements of actions and proceedings.

(e) This part does not prohibit or otherwise limit how institutions handle allegations of misconduct that do not fall within this part's definition of research misconduct or that do not involve PHS support.

A finding of research misconduct made under this part requires that:

(a) There be a significant departure from accepted practices of the relevant research community; and

(b) The misconduct be committed intentionally, knowingly, or recklessly; and

(c) The allegation be proven by a preponderance of the evidence.

(a) Six-year limitation. This part applies only to research misconduct occurring within six years of the date HHS or an institution receives an allegation of research misconduct.

(b) Exceptions to the six-year limitation. Paragraph (a) of this section does not apply in the following instances:

(1) Subsequent use exception. The respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the use of, republication of, or citation to the portion(s) of the research record ( e.g., processed data, journal articles, funding proposals, data repositories) alleged to have been fabricated, falsified, or plagiarized, for the potential benefit of the respondent.

(i) When the respondent uses, republishes, or cites to the portion(s) of the research record that is alleged to have been fabricated, falsified, or plagiarized, in submitted or published manuscripts, submitted PHS grant applications, progress reports submitted to PHS funding components, posters, presentations, or other research records within six years of when the allegations were received by HHS or an institution, this exception applies.

(2) Exception for the health or safety of the public. If ORI or the institution, following consultation with ORI, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public, this exception applies.

(a) Standard of proof. An institutional or HHS finding of research misconduct must be proved by a preponderance of the evidence.

(b) Burden of proof. (1) The institution or HHS has the burden of proof for making a finding of research misconduct. A respondent's destruction of research records documenting the questioned research is evidence of research misconduct where the institution or HHS establishes by a ( print page 76298) preponderance of the evidence that the respondent intentionally or knowingly destroyed records after being informed of the research misconduct allegations. A respondent's failure to provide research records documenting the questioned research is evidence of research misconduct where the respondent claims to possess the records but refuses to provide them upon request.

(2) The respondent has the burden of going forward with and proving, by a preponderance of the evidence, all affirmative defenses raised. In determining whether HHS or the institution has carried the burden of proof imposed by this part, the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.

(3) The respondent has the burden of going forward with and proving, by a preponderance of the evidence, any mitigating factors relevant to a decision to impose administrative actions after a research misconduct proceeding.

(a) Disclosure of the identity of respondents, complainants, and witnesses while conducting the research misconduct proceedings is limited, to the extent possible, to those who need to know, as determined by the institution, consistent with a thorough, competent, objective, and fair research misconduct proceeding, and as allowed by law. Those who need to know may include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions. This limitation on disclosure of the identity of respondents, complainants, and witnesses no longer applies once an institution has made a final determination of research misconduct findings. The institution, however, must disclose the identity of respondents, complainants, or other relevant persons to ORI pursuant to an ORI review of research misconduct proceedings under this part.

(b) Except as may otherwise be prescribed by applicable law, confidentiality must be maintained for any records or evidence from which research subjects might be identified. Disclosure is limited to those who need to know to carry out a research misconduct proceeding.

(c) This section does not prohibit institutions from managing published data or acknowledging that data may be unreliable.

(a) When more than one agency of the Federal Government has jurisdiction over a research misconduct allegation, HHS will cooperate with the other agencies in designating a lead agency to coordinate the response of the agencies to the allegation. Where HHS is not the lead agency, it may, in consultation with the lead agency, take appropriate action.

(b) In research misconduct proceedings involving more than one agency, HHS may refer to the other agency's (or agencies') evidence or reports if HHS determines that the evidence or reports will assist in resolving HHS issues. In appropriate cases, HHS may seek to resolve allegations jointly with the other agency or agencies.

Accepted practices of the relevant research community means those practices established by 42 CFR part 93 and by PHS funding components, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive PHS awards.

Administrative action means an HHS action, consistent with § 93.407, taken in response to a research misconduct proceeding to protect the health and safety of the public, to promote the integrity of PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, or to conserve public funds.

Administrative record comprises: the institutional record; any information provided by the respondent to ORI, including but not limited to the transcript of any virtual or in-person meetings under § 93.403(b) between the respondent and ORI, and correspondence between the respondent and ORI; any additional information provided to ORI while the case is pending before ORI; and any analysis or additional information generated or obtained by ORI. Any analysis or additional information generated or obtained by ORI will also be made available to the respondent.

Allegation means a disclosure of possible research misconduct through any means of communication and brought directly to the attention of an institutional or HHS official.

Assessment means a consideration of whether an allegation of research misconduct appears to fall within the definition of research misconduct; appears to involve PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training; and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The assessment only involves the review of readily accessible information relevant to the allegation.

Charge letter means the written notice, as well as any amendments to the notice, sent to the respondent stating the findings of research misconduct and any proposed HHS administrative actions.

Complainant means an individual who in good faith makes an allegation of research misconduct.

Contract means an acquisition instrument awarded under the Federal Acquisition Regulation (FAR), 48 CFR chapter 1 .

Day means calendar day unless otherwise specified. If a deadline falls on a Saturday, Sunday, or Federal holiday, the deadline will be extended to the next day that is not a Saturday, Sunday, or Federal holiday.

Departmental Appeals Board or DAB means the organization, within the HHS Office of the Secretary, established to conduct hearings and provide impartial review of disputed decisions made by HHS operating components.

Evidence means anything offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact. Evidence includes documents, whether in hard copy or electronic form, information, tangible items, and testimony.

Fabrication means making up data or results and recording or reporting them.

Falsification means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Funding component means any organizational unit of the PHS authorized to award grants, contracts, or cooperative agreements for any activity covered by this part involving research or research training; funding components may be agencies, bureaus, centers, institutes, divisions, offices, or other awarding units within the PHS.

(a) Good faith as applied to a complainant or witness means having a reasonable belief in the truth of one's allegation or testimony, based on the information known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowledge of or reckless disregard for information that would negate the allegation or testimony.

(b) Good faith as applied to an institutional or committee member means cooperating with the research misconduct proceeding by impartially carrying out the duties assigned for the purpose of helping an institution meet its responsibilities under this part. An institutional or committee member does not act in good faith if their acts or omissions during the research misconduct proceedings are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.

Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of § 93.307 through § 93.309.

Institution means any person that applies for or receives PHS support for any activity or program that involves the conduct of biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training. This includes, but is not limited to, colleges and universities, PHS intramural biomedical or behavioral research laboratories, research and development centers, national user facilities, industrial laboratories or other research institutes, research institutions, and independent researchers.

Institutional Certifying Official means the institutional official responsible for assuring on behalf of an institution that the institution has written policies and procedures for addressing allegations of research misconduct, in compliance with this part; and complies with its own policies and procedures and the requirements of this part. The Institutional Certifying Official is responsible for certifying the content of the institution's annual report, which contains information specified by ORI on the institution's compliance with this part, and ensuring the report is submitted to ORI, as required.

Institutional Deciding Official means the institutional official who makes final determinations on allegations of research misconduct and any institutional actions. The same individual cannot serve as the Institutional Deciding Official and the Research Integrity Officer.

Institutional member or members means an individual (or individuals) who is employed by, is an agent of, or is affiliated by contract or agreement with an institution. Institutional members may include, but are not limited to, officials, tenured and untenured faculty, teaching and support staff, researchers, research coordinators, technicians, postdoctoral and other fellows, students, volunteers, subject matter experts, consultants, or attorneys, or employees or agents of contractors, subcontractors, or sub-awardees.

The institutional record comprises:

To act intentionally means to act with the aim of carrying out the act.

Investigation means the formal development of a factual record and the examination of that record that meets the criteria and follows the procedures of §§ 93.310 through 93.317.

To act knowingly means to act with awareness of the act.

Notice means a written or electronic communication served in person or sent by mail or its equivalent to the last known street address, facsimile number, or email address of the addressee.

Office of Research Integrity or ORI means the office established by Public Health Service Act section 493 ( 42 U.S.C. 289b ) and to which the HHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS-supported activities.

Person means any individual, corporation, partnership, institution, association, unit of government, or other legal entity, however organized.

Plagiarism means the appropriation of another person's ideas, processes, results, or words, without giving appropriate credit.

(a) Plagiarism includes the unattributed verbatim or nearly verbatim copying of sentences and paragraphs from another's work that ( print page 76300) materially misleads the reader regarding the contributions of the author. It does not include the limited use of identical or nearly identical phrases that describe a commonly used methodology.

(b) Plagiarism does not include self-plagiarism or authorship or credit disputes, including disputes among former collaborators who participated jointly in the development or conduct of a research project. Self-plagiarism and authorship disputes do not meet the definition of research misconduct.

Preponderance of the evidence means proof by evidence that, compared with evidence opposing it, leads to the conclusion that the fact at issue is more likely true than not.

Public Health Service or PHS consists of the following components within HHS: the Office of the Assistant Secretary for Health, the Office of Global Affairs, the Administration for Strategic Preparedness and Response, the Advanced Research Projects Agency for Health, the Agency for Healthcare Research and Quality, the Agency for Toxic Substances and Disease Registry, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, and any other components of HHS designated or established as components of the Public Health Service.

PHS support means PHS funding, or applications or proposals for PHS funding, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through: funding for PHS intramural research; PHS grants, cooperative agreements, or contracts; subawards, contracts, or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements, or contracts.

To act recklessly means to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.

Research means a systematic experiment, study, evaluation, demonstration, or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) by establishing, discovering, developing, elucidating, or confirming information or underlying mechanisms related to biological causes, functions, or effects; diseases; treatments; or related matters to be studied.

Research Integrity Officer or RIO refers to the institutional official responsible for administering the institution's written policies and procedures for addressing allegations of research misconduct in compliance with this part.

Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.

Research misconduct proceeding means any actions related to alleged research misconduct taken under this part, including allegation assessments, inquiries, investigations, ORI oversight reviews, and appeals under subpart E of this part.

Research record means the record of data or results that embody the facts resulting from scientific inquiry. Data or results may be in physical or electronic form. Examples of items, materials, or information that may be considered part of the research record include, but are not limited to, research proposals, raw data, processed data, clinical research records, laboratory records, study records, laboratory notebooks, progress reports, manuscripts, abstracts, theses, records of oral presentations, online content, lab meeting reports, and journal articles.

Respondent means the individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.

Retaliation means an adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to:

(a) A good faith allegation of research misconduct; or

(b) Good faith cooperation with a research misconduct proceeding.

Secretary or HHS means the Secretary of HHS or any other official or employee of HHS to whom the Secretary delegates authority.

Small institution means an institution that may be too small to conduct an inquiry or investigation into an allegation of research misconduct as required by this part without actual or apparent conflicts of interest.

Suspension and Debarment Official (SDO) means the HHS official authorized to impose suspension and debarment, which are the actions that Federal agencies take to disqualify persons deemed not presently responsible from doing business with the Federal Government.

Institutions must:

(a) Have written policies and procedures for addressing allegations of research misconduct that meet the requirements of this part;

(b) Respond to each allegation of research misconduct for which the institution is responsible under this part in a thorough, competent, objective, and fair manner, including taking precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the complainant, respondent, or witnesses;

(c) Foster a research environment that promotes research integrity and the responsible conduct of research, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct;

(d) Take all reasonable and practical steps to protect the positions and reputations of good faith complainants, witnesses, and committee members and to protect these individuals from retaliation by respondents and/or other institutional members;

(e) Provide confidentiality consistent with § 93.106 to all respondents, complainants, and witnesses in a research misconduct proceeding, and to ( print page 76301) research subjects identifiable from research records or other evidence;

(f) Take all reasonable and practical steps to ensure the cooperation of respondents and other institutional members with research misconduct proceedings, including, but not limited to, their providing information, research records, and other evidence;

(g) Cooperate with HHS during any research misconduct proceeding or compliance review, including addressing deficiencies or additional allegations in the institutional record if directed by ORI;

(h) Assist in administering and enforcing any HHS administrative actions imposed on its institutional members; and

(i) Have an active research integrity assurance.

(a) General policy. (1) An institution that applies for or receives PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, must provide HHS with an assurance of compliance with this part by establishing and then maintaining an active research integrity assurance.

(2) PHS funding components may only authorize release of funds for extramural biomedical and behavioral research, biomedical and behavioral research training, or activities related to that research or research training, to institutions with an active research integrity assurance on file with ORI.

(b) Research integrity assurance. The Institutional Certifying Official must assure on behalf of the institution, initially and then annually thereafter, that the institution:

(1) Has written policies and procedures for addressing allegations of research misconduct, in compliance with this part.

(2) Complies with its policies and procedures for addressing allegations of research misconduct.

(3) Complies with all provisions of this part.

(a) Compliance with this part. ORI considers an institution in compliance with this part when it:

(1) Has policies and procedures for addressing allegations of research misconduct according to this part, keeps those policies in compliance with this part, and upon request, provides them to ORI and other HHS components.

(4) Takes all reasonable and practical specific steps to foster research integrity consistent with § 93.300, including but not limited to:

(i) Informing the institution's members about its policies and procedures for addressing allegations of research misconduct, and the institution's commitment to compliance with the policies and procedures; and

(ii) Making its policies and procedures for addressing allegations of research misconduct publicly available.

(b) Annual report. An institution must file an annual report with ORI, which contains information specified by ORI, on the institution's compliance with this part. The Institutional Certifying Official is responsible for certifying the content of this report and for ensuring the report is submitted as required.

(c) Additional information. Along with its annual report, an institution must send ORI such other information as ORI may request on the institution's research misconduct proceedings covered by this part and the institution's compliance with the requirements of this part.

(a) Small institutions may file a Small Institution Statement with ORI in place of the institutional policies and procedures required by §§ 93.300(a), 93.301, and 93.304, upon approval by ORI.

(b) The Small Institution Statement does not relieve the institution from complying with any other provision of this part.

(c) By submitting a Small Institution Statement, the institution agrees to report all allegations of research misconduct to ORI. ORI or another appropriate HHS office will work with the institution to develop and/or advise on a process for handling allegations of research misconduct consistent with this part.

(d) If a small institution has or believes it has a conflict of interest during any phase of a research misconduct proceeding, the small institution may contact ORI for guidance.

Institutions seeking an approved research integrity assurance must have written policies and procedures for addressing allegations of research misconduct. Such policies and procedures must:

(a) Address and be consistent with all applicable requirements pertaining to institutional responsibilities included in this part;

(b) Include and be consistent with applicable definitions in this part; and

(c) Provide for all reasonable and practical efforts, if requested and as appropriate, to protect or restore the reputation of persons alleged to have engaged in research misconduct but against whom no finding of research misconduct is made.

(a) Sequestration of research records and other evidence. An institution must promptly take all reasonable and practical steps to obtain all research records and other evidence, which may include copies of the data or other evidence so long as those copies are substantially equivalent in evidentiary value, needed to conduct the research misconduct proceeding; inventory the research records and other evidence; and sequester them in a secure manner. Where the research records or other evidence are located on or encompass scientific instruments shared by multiple users, institutions may obtain copies of the data or other evidence from such instruments, so long as those copies are substantially equivalent in evidentiary value to the instruments. Whenever possible, the institution must obtain the research records or other evidence:

(1) Before or at the time the institution notifies the respondent of the allegation(s); and

(2) Whenever additional items become known or relevant to the inquiry or investigation.

(d) Multiple respondents. If an institution identifies additional respondents during an inquiry or investigation, the institution is not required to conduct a separate inquiry for each new respondent. However, each additional respondent must be provided notice of and an opportunity to respond to the allegations, consistent with this subpart.

(e) Multiple institutions. When allegations involve research conducted at multiple institutions, one institution must be designated as the lead ( print page 76302) institution if a joint research misconduct proceeding is conducted. In a joint research misconduct proceeding, the lead institution should obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institutions. By mutual agreement, the joint research misconduct proceeding may include committee members from the institutions involved. The determination of whether further inquiry and/or investigation is warranted, whether research misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution.

(f) Using a committee, consortium, or other person for research misconduct proceedings. (1) An institution must address any potential, perceived, or actual personal, professional, or financial conflicts of interest between members of the committee or consortium, or other person, and the complainant, respondent, or witnesses.

(2) An institution must ensure that a committee, consortium, or person acting on its behalf conducts research misconduct proceedings in compliance with the requirements of this part.

(a) Purpose. An assessment's purpose is to determine whether an allegation warrants an inquiry.

(b) Conducting the institutional assessment. Upon receiving an allegation of research misconduct, the RIO or another designated institutional official must promptly assess the allegation to determine whether the allegation:

(1) Falls within the definition of research misconduct under this part;

(2) Is within the applicability criteria of § 93.102; and

(3) Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

(c) Assessment results. (1) An inquiry must be conducted if the allegation meets the three assessment criteria in paragraph (b) of this section.

(2) If the RIO or another designated institutional official determines that requirements for an inquiry are met, they must:

(i) Document the assessment; and

(ii) Promptly sequester all research records and other evidence, consistent with § 93.305(a), and promptly initiate the inquiry.

(a) Criteria warranting an inquiry. An inquiry is warranted if the allegation meets the following three criteria:

(b) Purpose. An inquiry's purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation. An inquiry does not require a full review of the evidence related to the allegation.

(c) Notice to the respondent. At the time of or before beginning an inquiry, an institution must make a good faith effort to notify in writing the presumed respondent, if any. If the inquiry subsequently identifies additional respondents, the institution must notify them. Only allegations specific to a particular respondent are to be included in the notification to that respondent. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.

(e) Conducting the inquiry —(1) Multiple institutions. A joint research misconduct proceeding must be conducted consistent with § 93.305(e).

(2) Person conducting the inquiry. Institutions may convene committees of experts to conduct reviews at the inquiry stage to determine whether an investigation is warranted. The inquiry review may be done by a RIO or another designated institutional official in lieu of a committee, with the caveat that if needed, these individuals may utilize one or more subject matter experts to assist them in the inquiry.

(3) Interviews. Institutions may interview witnesses or respondents that would provide additional information for the institution's review.

(f) Inquiry results —(1) Criteria warranting an investigation. An investigation is warranted if:

(i) There is a reasonable basis for concluding that the allegation falls within the definition of research misconduct under this part and involves PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, as provided in § 93.102; and

(ii) Preliminary information-gathering and fact-finding from the inquiry indicates that the allegation may have substance.

(2) Findings of research misconduct. Findings of research misconduct, including the determination of whether the alleged misconduct is intentional, knowing, or reckless, cannot be made at the inquiry stage.

(g) Inquiry report. (1) The institution must prepare a written report that meets the requirements of this section and § 93.309.

(2) If there is potential evidence of honest error or difference of opinion, the institution must note this in the inquiry report.

(3) The institution must provide the respondent an opportunity to review and comment on the inquiry report and attach any comments received to the report.

(h) Time for completion. (1) The institution must complete the inquiry within 90 days of its initiation unless circumstances warrant a longer period.

(2) If the inquiry takes longer than 90 days to complete, the inquiry report must document the reasons for exceeding the 90-day period.

(a) Notice to respondent. The institution must notify the respondent whether the inquiry found that an ( print page 76303) investigation is warranted. The notice must include a copy of the inquiry report and include a copy of or refer to this part and the institution's policies and procedures adopted under its research integrity assurance.

(b) Notice to complainant. The institution is not required to notify a complainant whether the inquiry found that an investigation is warranted. The institution may, but is not required to, provide relevant portions of the report to a complainant for comment. If an institution provides notice to one complainant in a case, it must provide notice, to the extent possible, to all complainants in the case.

(b) The institution must provide the following information to ORI whenever requested:

(1) The institutional policies and procedures under which the inquiry was conducted; and

(2) The research records and other evidence reviewed, and copies of all relevant documents.

(c) Institutions must keep detailed documentation of inquiries to permit a later assessment by ORI of the reasons why the institution decided not to investigate. Such documentation must be retained in accordance with § 93.318.

(d) In accordance with § 93.305(g), institutions must notify ORI of any special circumstances that may exist.

Institutions conducting research misconduct investigations must:

(a) Time. Begin the investigation within 30 days after deciding an investigation is warranted.

(b) Notice to ORI. Notify ORI of the decision to begin an investigation on or before the date the investigation begins and provide an inquiry report that meets the requirements of §§ 93.307 and § 93.309.

(c) Notice to the respondent. Notify the respondent in writing of the allegation(s) within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins.

(1) The institution must give the respondent written notice of any allegation(s) of research misconduct not addressed during the inquiry or in the initial notice of investigation within a reasonable amount of time of deciding to pursue such allegation(s).

(2) If the institution identifies additional respondents during the investigation, the institution may but is not required to conduct a separate inquiry for each new respondent. If any additional respondent(s) are identified during the investigation, the institution must notify them of the allegation(s) and provide them an opportunity to respond consistent with this subpart.

(3) While an investigation into multiple respondents can convene with the same investigation committee members, separate investigation reports and research misconduct determinations are required for each respondent.

(d) Sequestration of records. Obtain all research records and other evidence needed to conduct the investigation, consistent with § 93.305(a).

(e) Documentation. Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and other evidence relevant to reaching a decision on the merits of the allegation(s).

(f) Ensuring a fair investigation. Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable, including participation of persons with appropriate scientific expertise who do not have unresolved personal, professional, or financial conflicts of interest relevant to the investigation. An institution may use the same committee members from the inquiry in their subsequent investigation.

(g) Interviews. During the investigation, an institution must interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent.

(1) Interviews during the investigation must be recorded and transcribed.

(2) Any exhibits shown to the interviewee during the interview must be numbered and referred to by that number in the interview.

(4) The transcript(s) with any corrections and numbered exhibits must be included in the institutional record of the investigation.

(5) The respondent must not be present during the witnesses' interviews but must be provided a transcript of the interview.

(h) Multiple respondents. Consider, consistent with § 93.305(d), the prospect of additional researchers being responsible for the alleged research misconduct.

(i) Multiple institutions. A research misconduct proceeding involving multiple institutions must be conducted consistent with § 93.305(e).

(j) Pursue leads. Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.

(a) Time limit for completing an investigation. An institution must complete all aspects of an investigation within 180 days of beginning it, including conducting the investigation, preparing the draft investigation report for each respondent, providing the draft report to each respondent for comment in accordance with § 93.312, and transmitting the institutional record including the final investigation report and decision by the Institutional Deciding Official to ORI in accordance with § 93.316. ( print page 76304)

(d) Investigation report. If the investigation takes longer than 180 days to complete, the investigation report must include the reasons for exceeding the 180-day period.

(b) The institution may provide the complainant a copy of the draft investigation report or relevant portions of that report. The comments of the complainant, if any, must be submitted within 30 days of the date on which the complainant received the draft investigation report or relevant portions of it.

(v) Summarize the facts and the analysis which support the conclusion and consider the merits of any explanation by the respondent.

(3) List of any current support or known applications or proposals for support that the respondent has pending with PHS and non-PHS Federal agencies.

The Institutional Deciding Official is responsible for making a final determination of research misconduct findings. This determination must be provided in a written decision that includes:

(a) Whether the institution found research misconduct and, if so, who committed the misconduct; and

(b) A description of relevant institutional actions taken or to be taken.

(a) ORI expects institutions to carry inquiries and investigations through to completion and to pursue diligently all significant issues and credible allegations of research misconduct. Institutions must notify ORI in advance if the institution plans to close a research misconduct proceeding at the assessment, inquiry, investigation, or appeal stage on the basis that the respondent has admitted to committing research misconduct or a settlement with the respondent has been reached.

(b) A respondent's admission of research misconduct must be made in writing and signed by the respondent. An admission must specify the falsification, fabrication, and/or plagiarism that occurred and which research records were affected. The admission statement must meet all elements required for a research misconduct finding under § 93.103 and must be provided to ORI before the institution closes its research misconduct proceeding. The institution must also provide a statement to ORI ( print page 76305) describing how it determined that the scope of the misconduct was fully addressed by the admission and confirmed the respondent's culpability.

(c) After consulting with the institution on its basis for closing a case under paragraph (a) of this section, ORI may conduct an oversight review of the institution's handling of the case and take appropriate action including:

(1) Approving or conditionally approving closure of the case;

(2) Directing the institution to complete its process;

(3) Directing the institution to address deficiencies in the institutional record;

(4) Referring the matter for further investigation by HHS; or

(5) Taking a compliance action.

(b) Provision for HHS custody. On request, institutions must transfer custody, or provide copies, to HHS of the institutional record or any component of the institutional record and any sequestered evidence (regardless of whether the evidence is included in the institutional record) for ORI to conduct its oversight review, develop the administrative record, or present the administrative record in any proceeding under subparts D and E of this part.

Institutions may have standards of conduct different from the standards for research misconduct under this part. ORI findings of research misconduct or HHS settlements of research misconduct proceedings, or the absence thereof, do not affect institutional findings or actions taken based on an institution's standards of conduct.

(a) ORI review. ORI may respond directly to any allegation of research misconduct at any time before, during, or after an institution's response to the matter. The ORI response may include but is not limited to:

(1) Conducting allegation assessments;

(2) Determining independently whether jurisdiction exists under this part;

(3) Forwarding allegations of research misconduct to the appropriate institution or HHS component for inquiry or investigation;

(4) Requesting clarification or additional information, documentation, research records, or other evidence as necessary from an institution or its members or other persons or sources to carry out ORI's review;

(5) Notifying or requesting assistance and information from PHS funding components, other affected Federal and state offices and agencies, or institutions;

(6) Reviewing the institutional record and directing the institution to address deficiencies or additional allegations in the institutional record;

(7) Making a finding of research misconduct; and

(8) Taking actions as necessary to protect the health and safety of the public, to promote the integrity of PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, or to conserve public funds.

(b) ORI assistance to institutions. ORI may:

(1) Provide information, technical assistance, and procedural advice to institutional officials as needed regarding an institution's research misconduct proceedings and the sufficiency of the institutional record; and

(2) Issue guidance and provide information to support institutional implementation of and/or compliance with the requirements of this part.

(c) Review of institutional research integrity assurances. ORI will review institutional research integrity assurances and policies and procedures for compliance with this part.

(d) Institutional compliance. ORI may make findings and impose ORI compliance actions related to an institution's compliance with this part and with its policies and procedures, including an institution's participation in research misconduct proceedings.

(a) ORI may notify and consult with other entities, including government funding agencies, institutions, journals, publishers, and editors, at any time if those entities have a need to know about or have information relevant to a research misconduct proceeding.

(b) If ORI believes that a criminal or civil fraud violation may have occurred, it shall promptly refer the matter to the Department of Justice (DOJ), the HHS Office of Inspector General (OIG), or other appropriate investigative body.

(c) ORI may provide expertise and assistance to the DOJ, OIG, PHS offices, other Federal offices, and state or local offices involved in investigating or otherwise pursuing research misconduct allegations or related matters.

(d) ORI may notify affected PHS offices and funding components at any time to enable them to take appropriate interim actions.

(e) The information provided will not be disclosed as part of the peer review and advisory committee review processes but may be used by the Secretary in making decisions about the award or continuation of funding.

(f) ORI may refer a research misconduct matter to the SDO at any time for consideration under the HHS suspension and debarment regulations. ORI may provide technical assistance and share other information that the SDO needs to know to consider the referred matter.

(a) When ORI receives an allegation, it may conduct an assessment or refer the matter to the relevant institution for an assessment, inquiry, or other appropriate actions.

(b) If ORI conducts an assessment and determines an inquiry is warranted, it forwards the matter to the appropriate institution or HHS component.

(c) If ORI conducts an assessment and determines an inquiry is not warranted, it will close the case and forward the allegation in accordance with paragraph (d) in this section.

(d) ORI may refer allegations that do not fall within the jurisdiction of this part to the appropriate HHS component, Federal or state agency, institution, organization, journal, or other appropriate entity.

(a) In conducting its review of research misconduct proceedings, ORI will:

(1) Determine whether this part applies;

(2) Consider the institutional record and determine whether the institutional record is sufficient, provide instructions to the institution(s) if ORI determines that revisions are needed or additional allegations of research misconduct should be addressed, and require institutions to provide the respondent with an opportunity to respond to information or allegations added to the institutional record;

(3) Determine whether the institution conducted the proceedings in a timely and fair manner in accordance with this part with sufficient thoroughness, objectivity, and competence to support the conclusions; and

(4) After reviewing in accordance with paragraphs (a)(1) through (3) of this section, determine whether to close the case without further action or proceed with the case.

(b) If ORI determines to proceed with the case, ORI will:

(1) Obtain additional information or materials from the institution, the respondent, complainants, or other sources, as needed;

(2) Conduct additional analyses, as needed;

(3) Provide the respondent the opportunity to access the institutional record, any additional information provided to ORI while the case is pending before ORI, and any analysis or additional information generated or obtained by ORI;

(4) Provide the respondent the opportunity to submit information to ORI;

(5) Allow the respondent and the respondent's attorney, if represented, to meet virtually or in person with ORI to discuss the information that the respondent has provided to ORI;

(6) Have ORI's virtual or in-person meeting(s) with the respondent transcribed and provide a copy of the transcript to the respondent for review and suggested correction;

(7) Close the administrative record following paragraphs (b)(3) through (6) of this section;

(8) Provide the respondent the opportunity to access the complete administrative record; and

(9) Take any other actions necessary to complete ORI's review of the research misconduct proceedings.

(a) After completing its review of the administrative record, ORI may:

(1) Close the case without a separate ORI finding of research misconduct;

(2) Make findings of research misconduct and propose and take HHS administrative actions based on the administrative record; or

(3) Seek to settle the case.

(b) The lack of an ORI finding of research misconduct does not overturn an institution's determination that the conduct constituted professional or research misconduct warranting remediation under the institution's policy.

(a) When ORI makes a finding of research misconduct or proposes HHS administrative actions, it notifies the respondent in a charge letter. The charge letter:

(1) Includes ORI's findings of research misconduct, including the basis for such findings in the administrative record, and any proposed HHS administrative actions;

(2) Advises the respondent how to access the administrative record; and

(3) Informs the respondent of the opportunity to contest the findings and proposed HHS administrative actions under subpart E of this part.

(b) ORI sends the charge letter by certified mail, private delivery service, or electronic mail or other electronic means to the last known address of the respondent or the last known principal place of business of the respondent's attorney, if represented.

Unless the respondent contests the findings and/or the proposed HHS administrative actions contained in the charge letter within the 30-day period prescribed in § 93.501(a), the ORI findings and HHS administrative actions are final.

(a) Based on the administrative record, HHS may impose administrative actions that include but are not limited to:

(1) Clarification, correction, or retraction of the research record.

(2) Letter(s) of reprimand.

(3) Imposition of special certification or research integrity assurance requirements to ensure compliance with applicable regulations or terms of HHS grants, contracts, or cooperative agreements.

(4) Suspension of award activities under, or termination of, a PHS grant, contract, or cooperative agreement.

(5) Restriction on specific activities or expenditures under an active PHS grant, contract, or cooperative agreement.

(6) Special review of all the respondent's requests for PHS funding.

(7) Imposition of supervision requirements on a PHS grant, contract, or cooperative agreement.

(8) Certification of attribution or authenticity in all requests for support and reports to PHS.

(9) Prohibition of the respondent in participating in any advisory capacity with the PHS.

(10) Recommending that the relevant agency take adverse personnel action(s), if the respondent is a Federal employee, in compliance with relevant Federal personnel policies and laws.

(b) In connection with research misconduct findings, HHS also may seek to recover PHS funds spent supporting activities involving research misconduct.

(c) Any authorized HHS component may impose, administer, or enforce administrative actions separately or in coordination with other HHS components, including, but not limited to ORI, OIG, and the PHS funding component.

(d) HHS administrative actions under this part do not include suspension or debarment. Regardless of whether HHS administrative actions are imposed under this part, HHS may pursue suspension and debarment under the HHS suspension and debarment regulations.

The purpose of HHS administrative actions is remedial. The appropriate administrative action is commensurate with the seriousness of the misconduct and the need to protect the health and safety of the public, promote the integrity of the PHS-supported research and research process, and conserve public funds. ORI considers the following aggravating and mitigating factors in determining appropriate HHS administrative actions and their terms. The existence or nonexistence of any factor is not determinative.

(a) Knowing, intentional, or reckless. Were the respondent's actions knowing or intentional or were the actions reckless?

(b) Pattern. Was the research misconduct an isolated event or part of a continuing or prior pattern of dishonest conduct?

(c) Impact. Did the misconduct have significant impact on the proposed or ( print page 76307) reported research record, research subjects, other researchers, institutions, or the public health or welfare?

(d) Acceptance of responsibility. Has the respondent accepted responsibility for the misconduct by:

(1) Admitting the conduct;

(2) Cooperating with the research misconduct proceedings;

(3) Demonstrating remorse and awareness of the significance and seriousness of the research misconduct; and

(4) Taking steps to correct or prevent the recurrence of the research misconduct?

(e) Failure to accept responsibility. Does the respondent blame others rather than accepting responsibility for the actions?

(f) Retaliation. Did the respondent retaliate against complainants, witnesses, committee members, or other individuals?

(g) Continued risk to PHS funding. Does the respondent demonstrate responsible stewardship of research resources?

(h) Other factors. Are other factors relevant to the circumstances of a particular case?

(a) HHS may settle a research misconduct proceeding at any time it determines that settlement is in the best interests of the Federal Government and the public health or welfare.

(b) Settlement agreements are publicly available, regardless of whether ORI made a finding of research misconduct.

(c) A settlement agreement precludes the respondent from contesting any ORI findings of research misconduct, HHS administrative actions, or ORI's jurisdiction in handling the research misconduct proceeding.

When the final HHS action does not result in a settlement or finding of research misconduct, ORI may provide written notice to the respondent, the relevant institution, the complainant, and HHS officials.

When a final HHS action results in a settlement or research misconduct finding(s), ORI may:

(a) Provide final notification of any research misconduct findings and HHS administrative actions to the respondent, the relevant institution, and appropriate HHS officials.

(b) Provide final notification of any research misconduct findings and HHS administrative actions to the complainant(s).

(c) Send a notice to the relevant journal, publisher, data repository, or other similar entity identifying publications or research records that require correction or retraction.

(d) Publish notice of the research misconduct findings.

(e) Notify the respondent's current employer if the employer is an institution subject to this part.

ORI may determine an institution is not compliant with this part if the institution does not implement and follow the requirements of this part and its own research integrity assurance. In making this decision, ORI may consider, but is not limited to the following factors:

(a) Failure to establish and comply with policies and procedures under this part;

(b) Failure to respond appropriately when allegations of research misconduct arise;

(c) Failure to report to ORI all investigations and findings of research misconduct under this part;

(d) Failure to cooperate with ORI's review of research misconduct proceedings; or

(e) Other actions or omissions that have a material, adverse effect on reporting and responding to allegations of research misconduct.

(a) If ORI determines an institution is not compliant with this part, it may take a compliance action against the institution.

(b) If ORI determines an institution is not compliant with this part, ORI may take any or all of the following compliance actions:

(1) Require the institution to accept and/or implement technical assistance provided by ORI.

(2) Issue a letter of reprimand.

(3) Require the institution to take corrective actions.

(4) Place the institution on special review status. For a designated period, ORI will closely monitor the institution's activities for compliance with this part. Monitoring may consist of, but is not limited to, compliance reviews and/or audits.

(5) Direct that research misconduct proceedings be handled by HHS.

(6) Any other action appropriate to the circumstances.

(c) If an institution fails to comply with the requirements of this part, ORI may refer the institution to the SDO for consideration under the HHS suspension and debarment regulations.

(d) If the institution's actions constitute a substantial or recurrent failure to comply with this part, ORI may revoke the institution's research integrity assurance under § 93.301 or § 93.303.

(e) ORI may make public any findings of institutional noncompliance and ORI compliance actions.

(a) ORI may disclose information to other persons for the purpose of providing or obtaining information about research misconduct as permitted under the Privacy Act, 5 U.S.C. 552a and ORI's system of records notice for research misconduct proceedings.

(b) ORI may disclose or publish a notice regarding settlements, ORI findings of research misconduct, and HHS administrative actions, and release or withhold information as permitted by the Privacy Act and the Freedom of Information Act, 5 U.S.C. 552 .

(a) This subpart provides a respondent an opportunity to contest ORI findings of research misconduct and/or proposed HHS administrative actions included in a charge letter.

(b) A respondent may contest ORI's research misconduct findings and proposed HHS administrative actions by filing a notice of appeal with an Administrative Law Judge (ALJ) at the DAB.

(c) Based on the administrative record, the ALJ shall rule on whether ORI's research misconduct findings and any proposed HHS administrative actions are reasonable and not based on a material error of law or fact. The ALJ's ruling constitutes a recommended decision to the Assistant Secretary for Health (ASH) in accordance with § 93.511(b).

(d) A respondent must exhaust all available administrative remedies under this subpart before seeking judicial review of ORI's findings and/or HHS administrative actions. The contested findings and/or administrative actions shall be inoperative while the ( print page 76308) respondent is pursuing administrative remedies under this subpart.

(a) Time to file. A respondent may contest ORI's findings of research misconduct and/or proposed HHS administrative actions by filing a notice of appeal within 30 days of receipt of the charge letter provided under § 93.405.

(b) Form of a notice of appeal. The respondent's notice of appeal must be:

(1) In writing;

(2) Signed by the respondent or by the respondent's attorney; and

(3) Submitted to the DAB Chair through the DAB electronic filing system, with a copy sent to ORI by certified mail, electronic mail, or other equivalent ( i.e., with a verified method of delivery).

(c) Contents of a notice of appeal. The notice of appeal must:

(1) Admit or deny each ORI finding of research misconduct and each factual assertion made in support of each finding;

(2) Accept or challenge each proposed HHS administrative action;

(3) Provide detailed, substantive reasons for each denial or challenge with references to the administrative record;

(4) Identify any legal issues or defenses that the respondent intends to raise during the proceeding, with references to the administrative record; and

(5) Identify any mitigating factors in the administrative record.

(a) Within 30 days of receiving a notice of appeal, the DAB Chair, in consultation with the Chief ALJ, must designate an ALJ to determine whether the notice of appeal is timely filed and within the ALJ's jurisdiction under this subpart. If the appeal is determined to be timely and within the ALJ's jurisdiction, the ALJ shall decide the reasonableness of the ORI research misconduct findings and proposed HHS administrative actions in accordance with this subpart. The ALJ shall dismiss an appeal if it is untimely or not within the ALJ's jurisdiction under this subpart.

(b) No ALJ may serve in any proceeding under this subpart if they have any actual or apparent conflict of interest, bias, or prejudice that might reasonably impair their objectivity in the proceeding.

(c) Any party to the proceeding may request the ALJ to withdraw from the proceeding because of an actual or apparent conflict of interest, bias, or prejudice under paragraph (b) of this section. The motion to disqualify must be timely and state with particularity the grounds for disqualification. The ALJ may rule upon the motion or certify it to the Chief ALJ for decision. If the ALJ rules upon the motion, either party may appeal the decision to the Chief ALJ.

(d) An ALJ must withdraw from any proceeding for any reason found by the ALJ or Chief ALJ to be disqualifying.

(a) For appeals that are not dismissed under § 93.502(a), ORI will file the administrative record for the appeal.

(b) The ALJ's review will be based on the administrative record.

(c) The parties have no right to supplement the administrative record.

(a) The ALJ shall review the administrative record to determine whether the ORI research misconduct findings and proposed HHS administrative actions reflected in the charge letter are reasonable and not based on a material error of law or fact.

(b) The ALJ may permit the parties to file briefs making legal and factual arguments based on the administrative record.

(a) The parties to the appeal are the respondent and ORI. The investigating institution is not a party to the case unless it is a respondent.

(b) Except as otherwise limited by this subpart, the parties may:

(1) Be accompanied, represented, and advised by an attorney;

(2) Participate in any case-related conference held by the ALJ; and

(3) File motions or briefs in writing before the ALJ.

(c) The parties have no right to discovery before the ALJ.

(a) The ALJ assigned to the case must conduct a fair and impartial proceeding, avoid unnecessary delay, maintain order, and assure that a complete and accurate record of the proceeding is properly made. The ALJ is bound by, and may not refuse to follow or find invalid, all Federal statutes and regulations, Secretarial delegations of authority, and applicable HHS policies, as provided in paragraph (c)(5) of this section.

(b) Subject to review as provided elsewhere in this subpart, the ALJ may:

(1) Hold conferences with the parties to identify or simplify the issues, or to consider other matters that may aid in the prompt disposition of the proceeding;

(2) Rule on motions and other procedural matters;

(3) Except for the respondent's notice of appeal, modify the time for the filing of any document required or authorized under the rules in this subpart;

(4) Upon motion of a party, decide cases, in whole or in part, by summary judgment where there is no disputed issue of material fact;

(5) Regulate the course of the appeal and the conduct of representatives and parties; and

(6) Take action against any party for failing to follow an order or procedure or for disruptive conduct.

(c) The ALJ does not have the authority to:

(1) Enter an order in the nature of a directed verdict;

(2) Compel settlement negotiations;

(3) Enjoin any act of the Secretary;

(4) Review suspension or proposed debarment;

(5) Find invalid or refuse to follow Federal statutes or regulations, Secretarial delegations of authority, or HHS policies;

(6) Authorize the parties to engage in discovery; and

(7) Modify the time for filing the respondent's notice of appeal.

(d) The Federal Rules of Evidence and the Federal Rules of Civil Procedure do not govern the proceedings under this subpart.

(a) No party, attorney, or other party representative may communicate ex parte with the ALJ on any matter at issue in a case, unless both parties have notice and an opportunity to participate in the communication.

(b) If an ex parte communication occurs, the ALJ will disclose it to the other party and offer the other party an opportunity to comment.

(c) The provisions of this section do not apply to communications between an employee or contractor of the DAB and the ALJ.

(a) Filing. (1) Unless the ALJ provides otherwise, all submissions required or authorized to be filed in the proceeding must be filed with the ALJ.

(2) Submissions are considered filed when they are filed with the DAB according to the DAB's filing guidance.

(b) Format. (1) The ALJ may designate the format for copies of ( print page 76309) nondocumentary materials such as videotapes, computer disks, or physical evidence. This provision does not apply to the charge letter or other written notice provided under § 93.405.

(2) Every submission filed in the proceeding must include the title of the case, the docket number, and a designation of the nature of the submission.

(3) Every submission filed in the proceeding must be signed by and contain the address and telephone number of the party on whose behalf the document or paper was filed, or the attorney of record for the party.

(c) Service. Service of a submission on other parties is accomplished by filing the submission with the ALJ through the DAB electronic filing system.

(a) Parties must file all motions and requests for an order or ruling with the ALJ, serve them on the other party, state the nature of the relief requested, provide the legal authority relied upon, and state the facts alleged in support of the motion or request.

(b) All motions must be in writing.

(c) Within 10 days after being served with a motion, or other time as set by the ALJ, a party may file a response to the motion. The moving party may not file a reply to the response unless allowed by the ALJ.

(d) The ALJ may not grant a motion before the time for filing a response has expired, except with the parties' consent. However, the ALJ may overrule or deny any motion without awaiting a response.

(e) The ALJ must make a reasonable effort to dispose of all motions promptly.

(a) The ALJ must schedule an initial conference with the parties within 30 days of the DAB Chair's assignment of the case.

(b) The ALJ may use the initial conference to discuss:

(1) Identification and simplification of the issues, specification of genuine disputes of fact and their materiality to the ORI findings of research misconduct, and any proposed HHS administrative actions;

(2) Identification of material legal issues and any need for briefing;

(3) Scheduling dates for the filing of briefs based on the administrative record; and

(4) Other matters that may encourage the fair, just, and prompt disposition of the proceedings.

(c) The ALJ may schedule additional conferences as appropriate, upon reasonable notice to or request of the parties.

(d) All conferences will be recorded with copies provided to the parties upon request.

(e) Whenever possible, the ALJ shall memorialize in writing any oral rulings within 10 days after a conference is held.

(a) Based on the administrative record, the ALJ shall issue a ruling in writing within 60 days after the last submission by the parties in the case, setting forth whether ORI's research misconduct findings and proposed HHS administrative actions reflected in the charge letter are reasonable and not based on a material error of law or fact. If the ALJ is unable to meet the 60-day deadline, the ALJ must set a new deadline and promptly notify the parties. The ALJ shall serve a copy of the ruling upon the parties and the ASH.

(b) The ruling of the ALJ constitutes a recommended decision to the ASH. The ASH may review the ALJ's recommended decision and adopt, modify, or reject it (in whole or in part) as needed to ensure that the decision is reasonable and not based on a material error of law or fact. Within 30 days after service of the ALJ's recommended decision, the ASH shall notify the parties of the ASH's intent to review or not to review the ALJ's recommended decision. If the ASH does not provide notice of intent within the 30-day period or notifies the parties that the ASH does not intend to review the ALJ's recommended decision, the ALJ's recommended decision shall become final. An ALJ's recommended decision that becomes final in that manner or the ASH's decision after review constitutes the final HHS action on both ORI's findings of research misconduct and any HHS administrative actions.

Dated: September 9, 2024.

Xavier Becerra,

1.  U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. 2017. “Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices.” https://aspe.hhs.gov/​reports/​valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework . Page v. Accessed March 29, 2024.

2.  U.S. Bureau of Labor Statistics. Occupational Employment and Wages, May 2021. 11-9033 Education Administrators, Postsecondary. Mean hourly wage. https://www.bls.gov/​oes/​current/​oes119033.htm . Accessed March 29, 2024.

3.  For example, see “Comment from COGR, HHS-OASH-2023-0014, HHS-OASH-2023-0014-0001, 2023-21746.” https://www.regulations.gov/​comment/​HHS-OASH-2023-0014-0074 . Accessed March 29, 2024.

4.  U.S. Bureau of Labor Statistics. Occupational Employment and Wages, May 2022. 11-9033 Education Administrators, Postsecondary. Mean hourly wage. https://www.bls.gov/​oes/​current/​oes119033.htm . Accessed March 29, 2024.

[ FR Doc. 2024-20814 Filed 9-12-24; 8:45 am]

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Sentence examples for after further research from inspiring English sources

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After further research we felt confident that the laws and practices in the USA ensured that surrogate mothers were not being taken advantage of.

After further research , Tomas discovers the crucifix has been conveniently relocated to a small church in the High Mountains of Portugal.

After further research , on tens of millions of bacteria, the team's members used Dr. Alter's coded samples to prove they had identified the hepatitis C virus.

After further research , Dr. Kellaris theorized that one way to scratch what he called a "cognitive itch" is to sing the mental tune aloud.

Museum officials said that they may add to the list after further research and that they plan to post information about all 1,500 European paintings in the collection by December.

After further research in our free time we spotted that in the past 10 years there had been a lot of premiumisation and innovation within the chocolate sector but hardly any in the gummy/jelly confectionery market.

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King's College London

Job id: 095265 . Salary: £43,205 - £50,585 per annum, including London Weighting Allowance .

Posted: 18 September 2024 . Closing date: 09 October 2024 .

Business unit: Faculty of Life Sciences & Medicine . Department: Faculty Management Services .

Contact details: Louise Pacelli . [email protected]

Location: Guy's Campus . Category: Professional & Support Services .

Back to job search

At King’s, we continuously strive to be an inclusive, culturally aware and culturally competent organisation that respects the differences of our community by providing an environment that both acknowledges and celebrates diversity and embraces inclusion. 

The Faculty of Life Sciences and Medicine (FoLSM) is an internationally renowned centre of excellence in biomedical sciences, situated in the heart of London. We undertake ground-breaking research, basic science to translational, to improve the wellbeing of our communities, and engage with organisations around the world to create real value for society. There are presently nearly 500 academic staff, nearly 800 research staff and over 700 professional services staff within the Faculty. We have over 7000 students pursuing an extensive range of undergraduate programmes (including medicine, pharmacy, physiotherapy, biosciences, biomedical engineering) as well as masters and PhD programmes.

About the role

This is a new role within FoLSM working across the Faculty Research and People and Culture teams. If successful, you will support FoLSM to deliver a research culture project with the strategic goal to foster an open, flexible and inclusive environment, where all staff and students feel included. Specifically, the project focuses on capitalising on existing good practice and resources to consolidate and enhance our research staff support and embed this provision consistently across all our Departments and Schools.

Working with the Faculty Research Manager and Vice Deans, Research and Impact and People and Culture, you will be responsible for implementing a programme of research culture activities across the faculty focussing on improving career development for research staff. As Research Culture Project Manager, you will create clear ownership, expertise and accountability for delivery of initiatives and improvements to research culture. You will also work with the King’s central Research Culture team, the Centre for Research Staff Development, and similar posts in other faculties to ensure King’s initiatives are communicated and embedded within FoLSM and that examples of best practice are shared across the college.

It is an exciting time to join the team as we work towards establishing an open, positive, and inclusive research culture within FoLSM and across King’s. This role is a great opportunity if you are an energetic, enthusiastic, and collaborative worker interested in expanding your knowledge around research culture and equality, diversity and inclusion (EDI) in Higher Education.

This is a full time and you will be offered an a fixed term contract until 31st March 2027.

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

• Awareness and understanding of research culture
• Work collaboratively within a team and across a large, complex organisation with the ability to work with a broad range of stakeholders in a professional and assured manner
• Strong interpersonal and stakeholder engagement skills with the ability to manage sensitive information and situations to build collective ownership and change
• Excellent project management skills for managing a complex programme and ability to work under pressure in a busy environment with a high degree of accuracy and attention to detail
• Strong skills in planning and facilitating workshops, events and working groups
• Experience gathering, analysing, and interpreting quantitative and/or qualitative data, undertake desktop research and report writing
• Excellent written and verbal communication skills including the ability to clearly explain specialist matters, influence others thinking and build strong relationships
• Experience of developing innovative solutions and practical implementation for strategic change
• Experience of supporting and enabling continuous professional and staff development
• Highly proficient IT skills (including Excel, Word, Powerpoint) and experience of utilising advanced digital technology in day-to-day work

Desirable criteria

• Good understanding and experience of research careers within Higher Education
• Good understanding and experience of EDI and organisational development within Higher Education

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click “Apply Now”. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further Information

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers will review your application, please take a look at our ‘ How we Recruit ’ pages.

We are able to offer sponsorship for candidates who do not currently possess the right to work in the UK.

Further Research

1.1 what is sociology.

Sociology is a broad discipline. Different kinds of sociologists employ various methods for exploring the relationship between individuals and society. Check out more about sociology at this website. .

1.2 The History of Sociology

Many sociologists helped shape the discipline. To learn more, check out this site featuring prominent sociologists and how they changed sociology.

1.3 Theoretical Perspectives in Sociology

People often think of all conflict as violent, but many conflicts can be resolved nonviolently. To learn more about nonviolent methods of conflict resolution check out the Albert Einstein Institution .

1.4 Why Study Sociology?

Social communication is rapidly evolving due to ever improving technologies. Check out this website to learn more about how sociologists study the impact of these changes

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