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Stanford Center for Biomedical Informatics Research

We Connect Data to Health

Welcome to BMIR

The Stanford Center for Biomedical Informatics Research (BMIR) uses advanced research techniques to discover, apply, translate, and organize data that make a difference for health and healthcare. With its expertise in clinical and translational informatics research and biostatistics, the division works to uncover new ways to advance personalized medicine and to enhance human health and wellness. 

As a collaborative team we: 

• Develop and evaluate computational methods for biomedical discovery and decision making
• Enhance clinical care and biomedical research through information management
• Integrate research, training, and adoption of information technology in biomedicine

Collaboration is in our DNA

We are excited about the prospect of working with other experts who share our goal to connect data to health and medicine.

We have world-class researchers

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Director’s Message: RADx Tribal Data Repository

RADx TDR establishes a data repository for responsible data access and sharing of RADx AI/AN research data.

Announcing the Launch of the RADx Tribal Data Repository | Data Science at NIH

Friday, December 1, 2023

Certification of Health IT

Health information technology advisory committee (hitac), health equity, hti-1 final rule, hti-2 proposed rule, information blocking, interoperability, patient access to health records, clinical quality and safety, health it and health information exchange basics, health it in health care settings, health it resources, laws, regulation, and policy, onc funding opportunities, onc hitech programs, privacy, security, and hipaa, scientific initiatives, standards & technology, usability and provider burden.

Funding Announcements

Current funding announcements, assessing use of health it by u.s. physicians providing outpatient care.

On June 6, the Office of the National Coordinator (ONC) announced a Notice of Funding Opportunity (NOFO) titled “Assessing Use of Health IT by U.S. Physicians Providing Outpatient Care”

This cooperative agreement will fund a single award with a 5-year program period to conduct surveys to measure the use and impacts of health IT and interoperability among U.S. physicians providing outpatient care nationally. These data shall provide insights on the implementation and effects of federal health IT policies and identify disparities or unintended consequences resulting from their implementation.

This program will be funded $425,000  for the first year. Additional funds outside of the first year are subject to availability and progress made against the program.

Applications will be accepted until 12:00 pm ET on July 22, 2024.

Anticipated program period: August 6, 2024 – August 5, 2029  

View Notice of Funding Opportunity [PDF - 575 KB]

Apply on Grants.gov

View Program Applicant Questions and Answers

View Information Session Recording

Info Session Slides [PDF - 6 MB]

2024 Special Emphasis Notice (SEN)

ONC published a Special Emphasis Notice (SEN) under the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT)  funding opportunity NAP-AX-22-001 . In 2024, ONC is particularly interested in applications whose specific aims address one of the following areas of interest:

• Area 1:  Develop innovative ways to improve healthcare-data quality to support responsible development of artificial intelligence (AI) tools in healthcare
• Area 2:  Accelerate adoption of health IT in behavioral health settings

The application period closed on  July 12, 2024 .

View the full Special Emphasis Notice [370 KB]

  Funding Opportunity NAP-AX-22-001

Previous Funding Announcements

2023 special emphasis notice (sen).

ONC published a Special Emphasis Notice (SEN) under the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT)  funding opportunity NAP-AX-22-001 . In 2023, ONC is particularly interested in applications whose specific aims address one of the following areas of interest:

• Area 1:  Exploring the Use of Advanced Fast Health Care Interoperability Resources (FHIR®) Capabilities
• Area 2:  Identifying Data Quality Improvements for USCDI Data Elements

The application period closed on June 12, 2023.

Read the Notice

Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT)

ONC published a notice of funding opportunity (NOFO) under the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT)  funding opportunity NAP-AX-22-001 . The goal of the funding opportunity is to advance health IT standards and tools to improve social determinants of health data (SDOH) exchange and research, and to develop tools for making electronic health record (EHR) data for research and artificial intelligence (AI)-ready.

In 2022, ONC is particularly interested in applications whose specific aims address one of the following areas of interest:

• Area 1:  Address Health Equity and Social Determinants of Health (SDOH)Through Innovative, Open-Source Technology Tools, and Electronic Health Records (EHRs)
• Area 2:  Demonstrate the Use of Equity-Enhancing Patient-Generated Health Data (PGHD) for Clinical Care and Research

View the funding opportunity

Health Information Exchange (HIE) and Immunization Information System (IIS) COVID-19 Data Management:  Immunization Data Exchange, Advancement and Sharing (IDEAS)

This is a sole source Notice of Funding Opportunity intended to improve and help increase data sharing capabilities between health information exchanges (HIEs) and Immunization Information Systems (IISs). The program will facilitate exchange of immunization data with local/state HIEs using protected, safe and secure methods will provide enhanced opportunities for matching and identity verification to benefit patients, their health care providers, public health agencies, and others.

The NOFO will fund a single award with a 2-year period of performance for a maximum award of $10,000,000.

View Press Release

Public Health Emergency Response Related HL7® Standards, Solutions and Future Pandemics

This is a sole source Notice of Funding Opportunity (NOFO) intended to prioritize and expedite the accelerated development and deployment of five (5) gap and opportunity areas specifically identified by ONC that advances the diagnoses, treatment, and care of patients of COVID-19 and other public health emergencies.  Specifically, these five areas are:

• Expanding the clinical domains supported by HL7® Standards
• Privacy, Security, and Consent
• Application Programming Interface (API) for Population Level Services
• Social Determinants of Health (SDOH) Standards
• Advancing Public Health Standards

This NOFO will fund a single award with a 4-year program period of performance for a maximum award of $2,000,000.

View Notice of Funding Opportunity [PDF – 492 KB]

View on Grants.gov

Accelerating and Expanding LOINC® Development to Support Public Health Needs

This is a sole source Notice of Funding Opportunity (NOFO) intended to provide time sensitive support to increase the development and pre-release of LOINC® Special Use codes, and updating the technical infrastructure necessary in order to support the searchability and rapid dissemination of the codes to IVD manufacturers, laboratories, and other entities both nationally and internationally. Combined with the deployment of corresponding technical and educational resources, the outcomes of this cooperative agreement will ensure all affected stakeholders can adequately respond to the COVID-19 pandemic, in addition to future public health needs. This cooperative agreement will fund a single award with a 5-year program period of performance for a maximum amount of $1,500,000.

View Notice of Funding Opportunity [PDF – 538 KB]

Tracking Use and Impacts of Health IT on U.S. Office Based Physicians

On August 12, the Office of the National Coordinator (ONC) announced a Notice of Funding Opportunity (NOFO) titled “Tracking Use and Impacts of Health IT on U.S. Office-Based Physicians.” This cooperative agreement will fund a single award with a 3-year program period to measure the use and impacts of health IT among a nationally representative sample of U.S. office-based physicians. It is also intended to produce national-level data on interoperability among office-based physicians. These data shall provide insights on the implementation and effects of federal health IT policies as well as identify disparities or unintended consequences resulting from their implementation.

This program will be funded $290,000 for the first year. Additional funds outside of the first year are subject to availability and progress made against the program.

Anticipated program period: September 30, 2020 – September 29, 2023

View Notice of Funding Opportunity [PDF – 500 KB]

Watch the Information Session Recording

Download Information Session Slides [PDF - 804 KB]

Read the Press Release About Awardees.

Strengthening the Technical Advancement and Readiness of Public Health via Health Information Exchange Program (STAR HIE Program)

On August 12, 2020, ONC released the STAR HIE Program Notice of Funding Opportunity (NOFO). The cooperative agreements under this NOFO will be funded through the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This competitive NOFO is designed to strengthen and accelerate innovative uses of health information via health information exchanges (HIEs) within states, communities, and regions to support public health agencies’ abilities to advance data-driven prevention of, response to, and recovery from public health events, including disasters and pandemics. Funding will be focused toward strengthening existing HIE infrastructure so that public health agencies are able to better access, share, and use health information.

Applicants must propose activities that benefit a public health agency. The cooperative agreements will fund up to five (5) awards with a period of performance of up to two (2) years to accelerate the interoperability of health information to advance data-driven prevention of, response to, and recovery from public health emergencies and disasters, including pandemics such as COVID-19.

Cooperative Agreement Funding: $2,500,000. Approximate Amount of Each Award: $500,000 Program Period: 9/30/2020 – 9/30/2022

View More Information

View Press Release Announcing Awardees

Trusted Exchange Framework and Common Agreement – Recognized Coordinating Entity

On April 19, 2019, the Office of the National Coordinator for Health Information Technology (ONC) released the Trusted Exchange Framework and Common Agreement – Recognized Coordinating Entity (RCE) Notice of Funding Opportunity (NOFO). The purpose of this NOFO is to support the 21st Century Cures Act’s efforts to advance the establishment of nationwide interoperability of Electronic Health Information (EHI) through a Trusted Exchange Framework and Common Agreement. This Cooperative Agreement will fund a single award with a 4-year program period to select a RCE to develop, update, implement, and maintain the Common Agreement component of the Trusted Exchange Framework for ONC approval. The RCE will also work with ONC to designate and monitor Qualified Health Information Networks (QHINs), modify and update an accompanying QHIN Technical Framework, engage with public stakeholders through virtual public listening sessions, adjudicate noncompliance with the Common Agreement, and propose sustainability strategies for an RCE to continue to support trusted data exchange through QHIN connectivity at the expiration of the term of the Cooperative Agreement.

The program will be funded $900,000 for the first year.

Program Period: 8/30/2019 – 8/29/2023

Integrating the Healthcare Enterprise (IHE) US Cooperative Agreement Program

On June 14, 2019, the Office of the National Coordinator for Health Information Technology (ONC) released the Integrating the Health Enterprise US (IHE) Cooperative Agreement Notice of Funding Opportunity (NOFO). This is a non-competitive funding opportunity and is restricted to the Integrating the Healthcare Enterprise USA. The purpose of this NOFO is to support advancements in the technical standards necessary to achieve interoperability among health IT systems and to reach the milestones identified in the Nationwide Interoperability Roadmap  and in support of section 4003 (Interoperability) of the Cures Act. This cooperative agreement will advance the implementation consistency and readiness of the current and new versions of IHE integration profiles that support the restful exchange of HL7 FHIR and other dependent technical standards for adoption by the healthcare industry.    

The program will be funded up to $500,000 for the first year.  Further funding is subject to the availability of funds.

Program Period: 8/30/2019 – 8/29/2024

View and download the notice of funding opportunity

Read More About This Announcement

Market Transparency Project for Health IT Interoperability Services Cooperative Agreement Program

On June 30, 2017, ONC released the Market Transparency Project for Health IT Interoperability Services Funding Opportunity Announcement (MTP FOA). This funding opportunity announcement is designed to improve transparency in the current market by funding the development of an independent, open, online resource (e.g., an interactive website containing crowdsourced and voluntarily submitted data), whose design features and functionality is to be guided by market research to be performed by the recipient on costs frequently associated with health IT interoperability services.

The total funding available under this FOA is $250,000.

View the MTP FOA

View the MTP FOA Information Session Slides [PDF - 772 KB]

View the MTP FOA Information Session Recorded Webinar

The Certified Health IT Surveillance Capacity and Infrastructure Improvement Cooperative Agreement Program

ONC is excited to announce a new cooperative agreement program called the Certified Health IT Surveillance Capacity and Infrastructure Improvement No. NAP-AX-17-003. This new approach is aimed at improving and expanding the surveillance capacity and infrastructure that exists for health IT certified under the ONC Health IT Certification Program. Awardees will be required to develop a Strategic Plan and an Operational Plan that will demonstrate how they will improve and expand the surveillance capacity and infrastructure that currently exists for health IT.

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ONC FUNDING FOR CYBER THREAT INFORMATION SHARING IN THE HEALTH CARE AND PUBLIC HEALTH (HPH) SECTOR

The purpose of this five-year cooperative agreement is to build the capacity of an information sharing and analysis organization (ISAO) to share CTI bi-directionally with the Health and Public Health (HPH) sector and HHS about cyber threats and provide outreach and education that improves cyber security awareness and equips. The recipient may anticipate a total budget of $250,000 from ONC for the first year. Continued funding will be contingent on the recipient continuing to meet all the milestones and the availability of funds.

Blockchain Challenge

Up to 15 winners will be awarded a cash prize and up to 8 winners may be invited to present their papers at an upcoming industry-wide workshop co-hosted with the National Institute of Standards and Technology (NIST), 

Visit the  Blockchain Challenge Web site  directly, or go to challenge.gov and click the Blockchain link.

12-15 white papers will be awarded a cash prize in the range of $1,500 - $5,000

The High Impact Pilots (HIP) Cooperative Agreement Program

ONC is excited to announce a new cooperative agreement program called the  High Impact Pilots  (HIP). This new approach implements HIT Standards Committee  recommendations , continues ONC’s investment toward implementing the Nationwide Interoperability Roadmap, and fits within the  ONC Tech Lab’s  focus on pilots for standards and technology.

The program is intended to catalyze the implementation of standards and technology that can be used to:

• Improve the sharing of health information among health care stakeholders
• Improve care delivery
• Demonstrate how health IT can positively impact patient experience.

The Standards Exploration Award (SEA) Cooperative Agreement Program

ONC is excited to announce a new cooperative agreement program called the  Standards Exploration Awards  (SEA).  This new approach implements HIT Standards Committee  recommendations , continues ONC’s investment toward implementing the Nationwide Interoperability Roadmap, and fits within the  ONC Tech Lab’s  focus on pilots for standards and technology. Awardees under this program will need to be ready to hit the ground running and produce results within one year.  Through this funding, awardees will be able to test solutions, evaluate scalability, and identify the potential impacts of their selected standards and technology solutions.

Standards Development Organization Collaboration to Enhance Standards Alignment, Testing, and Measurement

Community interoperability and health information exchange cooperative agreement program.

On April 14, 2015, ONC released the Community Interoperability and Health Information Exchange Cooperative Agreement Program (Community Interoperability and HIE Program) Funding Opportunity Announcement (FOA). The Community Interop & HIE Program will provide funds to entities (United States-based non-profit institution or organization, state or local government, agency or group in a designated community) to work collaboratively with non-eligible care providers to identify opportunities to support and extend the use of secure, interoperable health information technology (health IT) tools and health information exchange (HIE) services.

View the Community Interoperability and HIE Program FOA [PDF - 792 KB]

Advance Interoperable Health Information Technology Services to Support Health Information Exchange

On February 3, ONC released the Advance Interoperable Health Information Technology Services to Support Health Information Exchange Funding Opportunity Announcement (FOA). This funding opportunity announcement will leverage the investments and lessons learned from the original State HIE Program and accelerate the widespread adoption and use of health information exchange infrastructure. Furthermore, this funding opportunity supports the HHS-wide effort to achieve the safe and secure exchange and use of electronic health information to improve health and transform care as outlined in the Shared Nationwide Interoperability Roadmap, Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0 .

The total funding available under this FOA is $28M.

View the HIE FOA [PDF - 1.6 MB]

Blog post: HHS and ONC invest $28 Million in Health Information Exchange Grants

Workforce Training to Educate Health Care Professionals in Health Information Technology

On February 3, ONC released the Workforce Training to Educate Health Care Professionals in Health Information Technology Funding Opportunity Announcement (FOA). The Workforce Training Program will update training materials from the original Workforce Curriculum Development Program and train health care workers to use new health information technologies in a changing healthcare environment that is moving towards better care, smarter spending, and healthier people.

The total funding available under this FOA is $6.4M.

View the Workforce FOA [PDF - 707 KB]

Blog post: New ONC Grant Funding Opportunities Help Advance Health IT in Communities and Workforce Training

Closing the Gap between Standards Development and Implementation

On April 24, 2015 ONC released the Closing the Gap between Standards Development and Implementation Cooperative Agreement Funding Opportunity Announcement (FOA). This FOA aims to provide specific dedicated support to Health Level Seven International (HL7) for work on HL7-led standards development as well as corresponding implementation guidance and testing concepts of mutual interest to ONC and HL7. Initial tasks include collaboration with HL7 to advance the implementation consistency and readiness of the current versions of the Consolidated Clinical Document Architecture (C-CDA) (Releases 1.1 and 2.0) and supporting the implementation and governance of the Fast Healthcare Interoperability Resource (FHIR) standard and its accompanying resources and profiles.

Community Health Peer Learning Program

On February 3, ONC released the Community Health Peer Learning Program (CHP) Funding Opportunity Announcement (FOA). This two-year funding will establish a cooperative agreement to address health challenges at the population level through a community-based collaborative approach. The CHP Program helps address the national priority of better care, smarter spending, and healthier people. Achieving this goal requires a strong, flexible health IT ecosystem that can support transparency and decision-making through enhancing the use of data, reducing redundancy, and informing payment reform, all of which will help transform care delivery. The goal of the CHP Program is to identify data solutions, accelerate local progress, and disseminate local learning to other communities through the development of shared learning resources around population health challenges.

The total funding available under this FOA is $1.7M.

View the CHP FOA [PDF - 689 KB]

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Funding Opportunities: AI in Cancer Research

NCI funds and supports extramural research to advance the use of AI in cancer research. Find out more about funding opportunities and other ways to engage in advancing AI for cancer research.

AI research is funded through a wide variety of grant and contract programs across NCI, where the majority of cancer research is supported through broad-based, investigator-initiated grant opportunities. The following programs have a strong emphasis on AI:

• Informatics Technology for Cancer Research (ITCR)
• Cancer Systems Biology Consortium (CSBC)
• Small Business Innovation Research (SBIR)
• Smart Health and Biomedical Research in the Era of Artificial Intelligence and Advanced Data Science (SCH)  

Specific open Funding Opportunities and Requests for Information are listed in the table below.

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Fodeh-Jarad Awarded Major Grants for AI-Driven, Patient-Centered Research

Samah Fodeh-Jarad, PhD, associate professor of emergency medicine and of biostatistics (health informatics) and director of the Data Mining Lab, has received two major research grants to enhance health care for underrepresented populations through artificial intelligence (AI). Her work will focus on giving patients a stronger voice in their care.

In August, Fodeh-Jarad was awarded $1,049,990 by the Patient-Centered Outcomes Research Institute (PCORI) to develop PVminer, an AI tool designed to capture and analyze patient concerns and preferences in clinical narratives to assess their impact on mental health outcomes. Earlier, in May, she received an R01 award of about $3.5 million from the National Cancer Institute (NCI) for a project using EPPCminer, a machine learning tool, to study patient-provider communication in cancer care, leveraging messaging in the patient portals, and to assess its effects on outcomes such as adherence and hospitalizations.

Though focused on different health areas—mental health in the PCORI study and cancer in the NIH project—both studies share the goal of incorporating patient experiences into health care through AI. Each project will include national, multidisciplinary collaborations with investigators from Yale University, the Cleveland Clinic, Veterans Health Administration (VHA), and the Texas Association of Charitable Clinics (TXACC). Investigators bring expertise in design and analyses of observational studies using complex statistical modeling, as well as in the development and testing of novel technologies.

The studies will leverage data from diverse patient populations, including underserved groups like the uninsured and underinsured patients of TXACC member clinics, which serve a significant proportion of Hispanic and African American patients. Paula Walker, executive director of TXACC, expressed excitement about the partnership, which will provide de-identified patient messaging data to help train the AI tools. “An important part of our role will be to connect with clinics that will provide data with which to train the machine learning system. We will gather secure messages that the investigative team will help us de-identify. The messages will span across the diverse racial groups to ensure equity.”

At the Cleveland Clinic, from January to August 2023, more than 1.1 million messages were sent by patients using asynchronous messaging in the patient portal. More than 20% of patients using messaging are non-white, and among this group, more than half (52%) of patients using messaging were Black or African American. The study will develop PVminer to mine the patients’ voice representing their wants, needs, fears and preferences from big clinical data.

The NCI study will develop EPPCminer, a multi-class classifier based on a hybrid approach to improve the annotation of patient-provider communication categories, as well as evaluating EPPCminer by comparing its performance to existing models that use topic modeling or deep learning. “My interest in this type of research stems from my passion to better serve patients, address their needs and resolve barriers to seeking care,” says Fodeh-Jarad. “I embarked on this journey early in my career to capture the patients’ voice and translate it into structured format useful for broader data analytics”.

Arjun Venkatesh, MD, Chair of Yale’s Department of Emergency Medicine, highlighted Fodeh-Jarad’s expertise in language modeling and AI as key to advancing ethical research. Fodeh-Jarad aims to create tools that allow patients to express their needs, offering their personal perspectives, and ultimately improving patient-centered care. “I am confident that the project will lead to more grounded and ethical research for model development.” said Venkatesh. Fodeh-Jarad states that “The lived experience of patients and providers can embody subjectivities and randomness which will help developers create more ethical AI models that account for if not preserve space for human factors, outliers, and human agency and autonomy as the models ascribe predictions from large preexisting data sets.”

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McWilliams School of Biomedical Informatics researchers awarded $31M in grants for medical artificial intelligence innovation research

Written by: Chelsea Overstreet | Updated: November 14, 2023

McWilliams School of Biomedical Informatics at UTHealth Houston reached a funding landmark with 15 faculty members awarded 16 different grants totaling more than $31 million between August and October 2023. Each grant has a focus on medical artificial intelligence (AI) innovations and advancements in research or health care.

“This is an incredible achievement for McWilliams School of Biomedical Informatics; these grants play a key role in advancing informatics research while also expanding on the important role technology continues to play in medicine,” said Jiajie Zhang , PhD, dean and Glassell Family Foundation Distinguished Chair in Informatics Excellence at McWilliams School of Biomedical Informatics . “All of the newly awarded grants center around medical AI. Our world is at the start of the ‘Cognitive Revolution,’ which is driven by AI. There is no better time for these types of critically important research studies and developments.”

The 16 grants include 14 new awards and two supplemental awards for a total amount of $31,285,374. Five of the awards, including two U01 grants and three R01 grants, are from the National Institute on Aging, part of the National Institutes of Health (NIH), and total over $19 million.

National Institute on Aging grants

Yejin Kim, PhD, assistant professor with McWilliams School of Biomedical Informatics, was awarded an NIH grant of nearly $4 million. Xiaoqian Jiang, PhD, the Christopher Sarofim Family Professor in Biomedical Informatics and Bioengineering and chair in the Department of Health Data Science and Artificial Intelligence at the school, is also an investigator on this project aimed at identifying treatment efficacy of Alzheimer’s disease therapy.

“There is still a critical gap in our understanding of why some patients do not respond to treatment,” Kim said.

The research team will use the grant funds to develop machine learning models to identify patient subgroups who respond differently to treatments. “Not only can our proposed machine learning model identify an individual patient’s treatment efficacy, but the model is built in a privacy-preserving manner, without sharing patient-level data to an outside party,” Kim said.

Cui Tao, PhD, the Dr. Doris L. Ross Professor at the school, is contributing on three recently awarded grants, including serving as the contact principal investigator for a five-year NIH grant of more than $5.7 million. Collaborating on the grant is GQ Zhang, PhD, vice president and chief data scientist in the Office of Data Science at UTHealth Houston, and a professor with both McWilliams School of Biomedical Informatics and McGovern Medical School at UTHealth Houston, where he holds the Distinguished Chair in Digital Innovation. The project goal is to build the proposed Alzheimer’s Disease Clinical Trial Simulation framework — a standardized, accessible, and reusable platform for Alzheimer’s disease trial design and simulation.

“The pressing need to address the challenges in Alzheimer’s disease and related dementias research inspired our exploration of this topic,” Tao said. “The increasing prevalence of these illnesses and the limitations of traditional randomized clinical trials motivated us to seek innovative solutions, and we recognized that the integration of real-world data and clinical trial simulation could offer a transformative approach to advance our understanding and, potentially, lead to finding more effective treatments.”

Zhongming Zhao, PhD, professor, chair, and director of the Center for Precision Health at McWilliams School of Biomedical Informatics, serves as an investigator on three separate grants. The first is a newly awarded grant and joint project with Jiang. This NIH grant, which is the largest of the awards earned by faculty during this cycle, is for over $6.4 million. Zhao and Jiang aim to advance Alzheimer’s disease research by creating the “AIM-AI” genetic map. This tool has “the ability to transform the genetic catalog of Alzheimer’s disease in a way that is actionable, integrated, and multiscale,” Zhao said. Ultimately, AIM-AI will allow genetics to be integrated with other modalities and have clear utility for subsequent etiological and drug discovery studies.

Jiang is an investigator on six of the 16 awards; the most for faculty during this recent award period. He was also awarded an NIH grant for more than $3.4 million to establish a comprehensive informatics framework that integrates ontology and computational phenotyping to harmonize electronic health records (EHRs). “The aim is to build a digital patient profile over the trajectory of more than a decade. Alzheimer’s disease is gradual, and there are multiple evident sources that we can use to profile the degree of cognitive function changes influenced by multiple chronic conditions in different subpopulations,” Jiang said.

Degui Zhi, PhD, Glassell Family Professor with the school, was awarded a supplement to a current NIH project. The $381,000 budget will supplement a $4.8 million grant, as Zhi and his fellow researchers benchmark the AI algorithms they are developing on a standardized neuroimaging dataset.

National Library of Medicine grants

The NIH’s National Library of Medicine (NLM) awarded three new grants to McWilliams School of Biomedical Informatics faculty members, and another NLM grant was transferred to the school. Two-time alumna Laila Rasmy Bekhet, PhD, assistant professor, was awarded her first grant in August with a nearly $1.4 million grant from the NLM. Bekhet will contribute to the field of medical AI by creating enhanced training methods for clinical foundation models. These models have the potential to not only enhance the performance of a variety of clinical predictive models but also offer a viable solution to common issues that impede the acceptance of deep learning-based models in practice. Additionally, clinical foundation models can play a crucial role in providing accurate and comprehensive contextual and temporal representations of patients.

While Bekhet serves as the principal investigator, Tao and Zhi are additional investigators providing support. “I am eager to push the boundaries of scientific knowledge and contribute to the development of improved medical AI solutions that can further enhance health outcomes. I am confident that the world is eagerly awaiting our groundbreaking discoveries,” Bekhet said.

For one of his six grants, Jiang was awarded $3.2 million from the NLM to foster data sharing and collaborative research in the field of genomics, while maintaining stringent data privacy standards. The project will work toward integrating genomic data sharing with institutional review boards, which are responsible for approving clinical trials, for easier ethical review.

Zhao is also working with Xiangning Chen, PhD, professor, on their NLM grant, which received a $620,000 supplement. Those funds will help the researchers continue developing deep learning methods to transform genetic and genomic data into image-like objects and custom vocabulary for better data use in genetic research.

In September, Hongfang Liu, PhD, chair ad interim in the Department of Bioinformatics and Systems Medicine at McWilliams School of Biomedical Informatics and a distinguished Cancer Prevention and Research Institute of Texas (CPRIT) Scholar, transferred an NLM grant worth almost $1.9 million to the school. The project focuses on advancing informatics research on cohort discovery and identification with a goal of enhancing applications of EHR data for clinical research. The results will positively impact EHR data applications like learning health care systems, predictive modeling, and AI in health care.

National Human Genome Research Institute grants

The NIH’s National Human Genome Research Institute issued two awards to faculty during this recent cycle. Zhi earned a $2.5 million competitive renewal award for his grant originally awarded in 2018. Zhi’s team has spent the last few years building a new informatics tool that reveals detailed genetic relationships between humans. With the new funds, the researchers plan to further their work with “RaPID” — the first computationally feasible method for inferring identity-by-descent segments among individuals in a biobank-scale cohort.

Liu was awarded a new grant worth $2.8 million to address the diagnostic odysseys that patients with rare diseases experience. According to the NIH, an estimated 25 to 30 million Americans are affected by rare diseases. Liu says that due to the lack of clinical evidence and empirical knowledge, awareness of rare diseases remains low among health care providers. Liu’s research aims to address the translation gap by building an innovative, end-to-end informatics framework to accelerate the diagnosis of rare diseases.

Additional NIH grants

Two of Jiang’s awards are part of the NIH’s Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD) Program. These grants are collaborations with Historically Black Colleges and Universities and Hispanic Serving Institutions. For the first AIM-AHEAD project, Kai Zhang, PhD, assistant professor,, Jiang and research colleagues will utilize machine learning and AI tools to examine the role donor-recipient blood type mismatches play in heart transplantations and help reduce health disparities by formulating interventions. The second AIM-AHEAD award includes Arif Harmanci, PhD, assistant professor, and Han Chen, PhD, associate professor with UTHealth Houston School of Public Health, as part of the team of researchers. For that collaborative grant, Jiang and colleagues will work with faculty from Tuskegee University to strengthen data governance and facilitate the adoption of artificial intelligence/machine learning technologies, while ensuring the ethical treatment and representation of minority populations.

Zhao is collaborating with two other researchers outside of the school on a $2.3 million National Cancer Institute grant. The project, which focuses on personalized immunotherapy for the lymphatic system, aims to advance cancer treatment research by utilizing state-of the-art imaging technologies, expertise in cancer vaccine design and production, single-cell RNA sequencing, immunoprofiling, and multiplex immunofluorescence.

Toufeeq Syed, PhD, associate professor and assistant dean of education informatics at McWilliams School of Biomedical Informatics, was awarded a one-year, $270,000 grant from the NIH’s National Institute of General Medical Sciences. Syed, who joined the school this summer, will use the funds to develop an online, asynchronous course that is open and accessible via the Internet to the larger biomedical research community.

A National Science Foundation “Infrastructure Innovation for Biological Research” grant worth over $515,000 was awarded to Xiaobo Zhou, PhD, the Dr. and Mrs. Carl V. Vartian Professor in Clinical Informatics at McWilliams School of Biomedical Informatics; Jianguo Wen, PhD, assistant professor; and Jiajia Liu, PhD, a postdoctoral research fellow. The funds will be used to create novel machine-learning approaches to advance the study of cell development.

Many of the grants will result in research and job opportunities for new faculty or current UTHealth Houston students.

“In order to deliver on all of these projects, our school will need motivated researchers to work side by side with the faculty members. The grants serve as a platform to propel the next generation of informatics leaders,” Dean Zhang said.

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Technology of Supporting Medical Decision-Making Using Evidence-Based Medicine and Artificial Intelligence

Georgy lebedev.

a I.M. Sechenov First Moscow State Medical University, 2-4 Bolshaya Pirogovskaya st., Moscow, 119991, Russia

b Federal Research Institute for Health Organization and Informatics, 11, Dobrolubova street, Moscow, 127254, Russia

c V.I.Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology. 4 Oparin st., 117997 Moscow, Russia

Eduard Fartushnyi

Igor fartushnyi, igor shaderkin, herman klimenko, pavel kozhin, konstantin koshechkin, ilya ryabkov, vadim tarasov, evgeniy morozov, irina fomina.

Currently, Medical errors are a serious problem when examining patients. Creating information systems that use the capabilities of evidence-based medicine and artificial intelligence methods will allow the doctor to make an informed and proven decision. In this article, the authors offer a description of an information system that solves the problem of supporting medical decision making based on evidence-based medicine. This is achieved by using artificial intelligence methods. This work was supported by a grant from the Ministry of Education and Science of the Russian Federation, a unique project identifier RFMEFI60819X0278.

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Changes in software as a medical device based on artificial intelligence technologies

Affiliations.

• 1 The Department of Innovative Technologies, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia.
• 2 The Department of Medical Informatics, Radiomics and Radiogenomics, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia.
• 3 The Department of Innovative Technologies, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia. [email protected].
• 4 Deputy Director for Science, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia.
• 5 Department of Physics and Engineering, ITMO University, Kronverkskiy Prospekt, 49, 197101, Saint Petersburg, Russia.
• 6 Radiology, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia.
• PMID: 35691995
• PMCID: PMC9188918
• DOI: 10.1007/s11548-022-02669-1

Purpose: to develop a procedure for registering changes, notifying users about changes made, unifying software as a medical device based on artificial intelligence technologies (SaMD-AI) changes, as well as requirements for testing and inspections-quality control before and after making changes.

Methods: The main types of changes, divided into two groups-major and minor. Major changes imply a subsequent change of a SaMD-AI version to improve efficiency and safety, to change the functionality, and to ensure the processing of new data types. Minor changes imply those that SaMD-AI developers can make due to errors in the program code. Three types of SaMD-AI testings are proposed to use: functional testing, calibration testing or control, and technical testing.

Results: The presented approaches for validation SaMD-AI changes were introduced. The unified requirements for the request for changes and forms of their submission made this procedure understandable for SaMD-AI developers, and also adjusted the workload for the Experiment experts who checked all the changes made to SaMD-AI.

Conclusion: This article discusses the need to control changes in the module of SaMD-AI, as innovative products influencing medical decision making. It justifies the need to control a module operation of SaMD-AI after making changes. To streamline and optimize the necessary and sufficient control procedures, a systematization of possible changes in SaMD-AI and testing methods was carried out.

Keywords: Artificial intelligence; Changes; Medical software based on artificial intelligence technologies; Modifications; Software as a medical device; Validation.

© 2022. CARS.

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Conflict of interest statement

The authors declare they have no financial interests. Morozov S.P. was an unpaid president European Society of Medical Imaging Informatics (till 2018). Morozov S.P. is an unpaid chairman of SC 01 “Artificial Intelligence in Healthcare”.

Variants of SaMD-AI changes

SaMD-AI No.1 operation results after…

SaMD-AI No.1 operation results after making a change. Errors – localization of pathology…

SaMD-AI No.2 operation results before…

SaMD-AI No.2 operation results before making changes ( a ) and after (…

SaMD-AI operation results No.3: a…

SaMD-AI operation results No.3: a defects in the first version of SaMD-AI No.3…

“Changes in SaMD-AI efficiency and…

“Changes in SaMD-AI efficiency and safety”

“Changes related to input data…

“Changes related to input data without changes in the functional purpose of the…

“Changes in the functional purpose…

“Changes in the functional purpose of the SaMD-AI”

“Changes related to the elimination…

“Changes related to the elimination of errors and program code modifications of the…

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New initiative for early career researchers and community health centers

Published September 16, 2024

ARPA-H launches initiative for early career researchers and community health centers 

Agency releases network survey to learn from next generation of health innovators  

The Advanced Research Projects Agency for Health ( ARPA-H ), an agency within the U.S. Department of Health and Human Services (HHS), today announced the ARPA-H Emerging Health Innovators (EHI) Initiative to increase access to government research funding and address health care gaps in the U.S. The EHI Initiative begins with a Network Survey, which will gather information and insights from early career investigators, community innovators, and administrators at academic institutions, including minority-serving institutions (MSIs) and community-based organizations (CBOs). 

“ARPA-H was built to drive breakthroughs in health, including finding a cure for cancer and addressing other health care gaps. To succeed, we need the best ideas from every corner of the country, including from those traditionally not given opportunities in research,” said HHS Secretary Xavier Becerra. "The Biden-Harris Administration is making it easier for early career investigators, researchers, and administrators from minority-serving institutions and community-based organizations to be included and supported. The result will be the creation of new opportunities and game-changing results that benefit all Americans.” 

Through the EHI Network Survey, ARPA-H seeks to learn from these emerging health innovators about their specific needs, challenges, and concerns. These responses will inform a forthcoming funding solicitation, anticipated to be available in late 2024. ARPA-H intends the solicitation to offer two tracks: 

• Technology-driven Innovation (track 1) supports early career investigators in developing innovative health technologies. Eligible applicants: early career researchers, within 10 years of earning their final degree, in academic or research institutions including U.S.-based MSIs. 
• Community-center Innovation (track 2) empowers community innovators to develop technology that addresses specific community needs. Eligible applicants: community innovators, including but not limited to community health care workers, medical professionals, nurses, social workers at community health centers, non-profit organizations, and/or faith-based organizations. 

“ARPA-H seeks to accelerate better health outcomes for everyone, so it’s vital to partner with these emerging health trailblazers who are working every day to develop solutions for and in their communities,” said ARPA-H Director Renee Wegrzyn, Ph.D. “We are strengthened when our performers include those with fresh perspectives, deep technical expertise, and wide-ranging networks – all key ingredients in solving the toughest challenges in human health. The ARPA-H EHI Initiative is opening new doors to community-based innovations and inclusive solutions to improve health outcomes for all Americans.” 

In remarks at the announcement event at San José State University, ARPA-H Deputy Director Susan Monarez, Ph.D. notes, “ARPA-H understands that we have a responsibility to remove as many barriers as possible to work with us. The EHI Initiative aims to do just that by making it easier for everyone, regardless of any demographic differentiator, to contribute to achieving our mission.” 

View the full Network Survey . The deadline to respond is October 25, 2024, 11:59 PM ET. The EHI solicitation is anticipated to be available later in 2024. Future EHI awards would generally be in the form of other transaction agreements. Exact award amounts depend on meeting aggressive milestones, typical to the ARPA-H model .  

The ARPA-H EHI Initiative is in collaboration with the Customer Experience (CX) Hub of ARPANET-H , the agency’s nationwide health innovation network that connects people, innovators, and institutions to accelerate better health outcomes for everyone. Organizations interested in becoming a part of the CX Hub can view the member application process on the CX Hub website . 

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DHS Awards $18 Million to Law Enforcement, Public Health, and Nonprofits in Underserved Communities to Help Prevent Targeted Violence and Terrorism

Today, the Department of Homeland Security (DHS) awarded 35 grants, totaling $18 million, under the Targeted Violence and Terrorism Prevention (TVTP) Grant Program for Fiscal Year 2024 (FY24). The TVTP Grant Program provides financial assistance to eligible applicants to develop sustainable, multidisciplinary targeted violence and terrorism prevention capabilities in local communities, to pilot innovative prevention approaches, and to identify prevention best practices that can be replicated in communities across the country. 

"In our current dynamic threat environment, any town, anywhere can be a target,” said Secretary of Homeland Security Alejandro N. Mayorkas . “The Department of Homeland Security’s Targeted Violence and Terrorism Prevention grant awards announced today will help local communities pilot, strengthen, and share evidence-based prevention strategies, significantly expanding our nation’s counterterrorism capacity and making all of us safer.”

Leveraging a public health-informed approach, the Center for Prevention Programs and Partnerships (CP3) brings together behavioral and mental health providers, educators, faith leaders, social service providers, nonprofits, law enforcement, and other state, local, and community partners to address systemic factors that can lead to violence while strengthening protective factors at the local level that support the safety, well-being, and resiliency of communities in the U.S. This focus has also led to an increase in public health organizations applying for the grant program. In FY24, 35 public health entities applied and 7 were selected, compared to 3 applicants and 2 awardees in FY23. Public health organizations receiving an award include:

• Boston Children’s Hospital
• Indiana Family and Social Services Administration, Division of Mental Health and Addiction
• Oakland Community Health Network
• Parents for Peace
• Rhode Island Department of Health
• Safe States Alliance
• University of Nebraska Medical Center
• Weber-Morgan Health Department
• Wood County Alcohol, Drug Addiction, and Mental Service Board

Given widespread concern regarding youth involvement in targeted violence nationally, CP3 selected 20 grantees focused wholly or in part on prevention in youth settings, including grants to improve clinical practice with at-risk youth (Boston Children’s Hospital) and upskilling behavioral threat assessment and management tools for at-risk youth (Safe States Alliance). Awardees include:

• Auburn University
• Board of Regents, Nevada System of Higher Education
• Dillard University
• Elizabeth City State University
• Green River Educational Cooperative
• Independent Production Fund
• Jewish Federation of Greater Pittsburgh
• North Carolina State University
• School Administrative Unit #18
• Southern University
• Southern Illinois University
• The Research Foundation for the State University of New York on behalf of the Rockefeller Institute of Government
• The Research Foundation for the State University of New York on behalf of the University at Buffalo
• Trustees of Indiana University
• University of Southern Maine

DHS prioritizes targeted violence and terrorism prevention in underserved communities and has continued its outreach to these areas in recent award cycles, including FY24. This year, the TVTP Grant Program received 39 applications from, or proposing to do work with, underserved communities. CP3 awarded 8 grants that provide services to underserved populations, including one tribal government, three Historically Black Colleges and Universities (HBCUs), one LGBTQ+ serving institution, one organization serving religious minorities, and two organizations serving rural communities. Awardees include:

• Otoe-Missouria Tribe

CP3’s financial and technical assistance helps grow the TVTP community of practice. The FY24 awards have created approximately 50 new prevention jobs in addition to the dozens of existing positions that will be partially or fully funded by these awards.

Launched in 2020, the program, administered by the DHS CP3 and the Federal Emergency Management Agency (FEMA), is the only federal grant program solely dedicated to helping local communities develop and strengthen their targeted violence and terrorism prevention capabilities in this area. DHS awarded nearly $90 million via 178 awards to organizations working to prevent violence in 41 states plus the District of Columbia.

To date, TVTP grant programs have conducted training sessions that built prevention capacity among 38,250 attendees. This program has also funded projects that directly address and manage cases involving individuals with behavioral indicators for violence. As of August 2024, grantees from FY20-FY23 have opened 1,172 cases and referred them to partners or provided direct mental health counseling, social services, and other services to increase protective factors in these clients.

The anticipated next round of TVTP grant funding will be announced in spring 2025. Additional information about current and previous TVTP grantees, such as programs, tools, resources, accomplishments, closeout reports, award grants, and more can be found on the TVTP Grant Program webpage . These resources support prevention practitioners in advancing their work and reaffirm DHS’s commitment to transparency.

• Preventing Terrorism and Targeted Violence
• Center for Prevention Programs and Partnerships (CP3)
• Grant Funding
• Targeted Violence and Terrorism Prevention (TVTP)
• Targeted Violence and Terrorism Prevention (TVTP) Grant Program

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NLM's University-based Biomedical Informatics and Data Science Research Training Programs

The National Library of Medicine supports research training in biomedical informatics and data science at 18 educational institutions in the United States. NLM’s T15 program offers graduate education and postdoctoral training and research experiences in a wide range of areas including health care informatics, translational bioinformatics, clinical informatics, public health informatics, and consumer health informatics. Trainees will receive exposure to a core curriculum focused on biomedical data science concepts and methods as well as develop skills needed to lead independent future research. Some T15 programs offer an additional area of training in HIV/AIDS.

Each NLM research training program makes special efforts to recruit individuals from underrepresented racial and ethnic groups, individuals with disabilities, women, and those from economically, socially, culturally, or educationally disadvantaged backgrounds. Those interested in receiving predoctoral or postdoctoral training are encouraged to reach out to T15 institutions directly.

Please contact T15 awarded institutions for questions related to trainee selection, eligibility, program specifics, and levels of support. The location of NLM T15 training institutions and contact information for awardees is provided below. For general information about NLM's University-based Biomedical Informatics and Data Science Research Training Programs, please contact: Meryl Sufian, PhD,  [email protected] .

T15 Biomedical Informatics and Data Science Research Training Program Sites

Information can be found by clicking on each site’s geographical location. Site numbers correspond to the list of T15 Awarded Sites located under the map.

T15 Sites and Contact Information (Principal Investigator)

• Columbia University (Noemie Elhadad/George Hripcsak)
• Harvard University (Nils Gehlenborg)
• Indiana University – Regenstreif Institute (Brian Dixon/Titus Schleyer)
• Johns Hopkins University (Christopher Chute and Hadi Kharrazi)
• Medical University of South Carolina (Alexander Alekseyenko/Brian Dean)
• Oregon Health & Science University (William Hersh)
• Rice University (Lydia Kavraki)
• Stanford University (Sylvia Plevritis)
• State University of New York at Buffalo (Peter Elkin)
• University of California Los Angeles (Alex Bui)
• University of California San Diego (Shamim Nemati)
• University of Colorado (Arjun Krishnan/Katerina Kechris)
• University of Pittsburgh (Harry Hochheiser)
• University of Utah (Karen Eilbeck)
• University of Washington (Peter Tarczy-Hornoch)
• University of Wisconsin (Mark Craven and Colin Dewey)
• Vanderbilt University (Jessica Ancker/Bradley Malin/Kim Unertl)
• Yale University (Cynthia Brandt/Mark Gerstein)

Last Reviewed: August 14, 2024

Part 1. Overview Information

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Office of AIDS Research ( OAR )

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Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD )

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R01 Research Project Grant

• April 4, 2024  - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice  NOT-OD-22-198 .
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice  NOT-OD-22-189 .

See Part 2, Section III. 3. Additional Information on Eligibility.

The purpose of this Notice of Funding Opportunity (NOFO) is to support research projects under Phase 3 of the U.S.-South Africa Program for Collaborative Biomedical Research.  Research areas supported under this program include HIV/AIDS, HIV/AIDS co-morbidities and co-infections, HIV/AIDS-associated implementation science, and HIV/AIDS-associated data science. The hallmark of the U.S.-South Africa program is the development of collaborative partnerships between South African investigators and United States (U.S.) investigators. Through international collaboration, this research will advance scientific discoveries, promote sharing of technologies and approaches, and serve local public health needs and priorities in support of global HIV/AIDS research.

30 days prior to the application due date.

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Not Applicable

It is critical that applicants follow the instructions in the Research (R) Instructions in the  How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

• An institutional system-to-system (S2S) solution
• Grants.gov Workspace

Part 2. Full Text of Announcement

Section i. notice of funding opportunity description.

The National Institutes of Health (NIH) of the United States (U.S.) Department of Health and Human Services (HHS) supports international collaborative biomedical research to advance science and expand biomedical knowledge.  Scientific cooperation between the U.S. and the Republic of South Africa was initiated in 1995 and has grown in recent years. Recognizing that enhanced cooperative biomedical research would be of mutual benefit to the U.S. and South Africa, the NIH Director and the President of the South African Medical Research Council (SAMRC) signed a Memorandum of Understanding (MOU) in January 2013 to develop the U.S.-South Africa Program for Collaborative Biomedical Research.  Phase 1 of this program included awards made in response to RFA-AI-14-009 ,  RFA-AI-14-010 , RFA-AI-14-018 , RFA-AI-16-039 , RFA-AI-16-040 , RFA-AI-16-082 , and  RFA-AI-16-083 . Phase 2 of this program included awards made in response to  RFA-AI-19-022 ,  RFA-AI-19-023 ,  RFA-AI-19-024 , and  RFA-AI-19-025 . The NIH and MRC have developed strategic plans for continued collaboration.  Both the NIH and SAMRC have allocated resources to support the third phase of this program.  Phase 3 will solicit applications for research on HIV/AIDS, HIV/AIDS co-morbidities and co-infections, HIV/AIDS-associated implementation science, and HIV/AIDS-associated data science.

The purpose of this Notice of Funding Opportunity (NOFO) is to establish Phase 3 of the U.S.-South Africa Program for Collaborative Biomedical Research.  Research areas supported under this program include HIV/AIDS, HIV/AIDS co-morbidities and co-infections, HIV/AIDS-associated implementation science, and HIV/AIDS-associated data science.

The intent of this NOFO is to foster, stimulate, and/or expand basic, translational, behavioral, and applied research that will advance scientific discovery and engage U.S. and South African researchers working collaboratively in the areas of HIV/AIDS, HIV/AIDS co-morbidities and co-infections, and HIV/AIDS and associated implementation science and data science. Proposed research should reflect the highest possible scientific standards, as well as shared interests, international and local public health needs and priorities, and involve mutually advantageous collaborations among institutions, including participating communities and other partners. U.S. and South African investigators working with their institutions and in collaborative partnership will prepare and submit a single joint application.  Applications must include at least one South African Program Director/Principal Investigator (PD/PI) from an eligible institution from South Africa (the applicant organization) and at least one collaborator from a U.S. institution/organization.

An overarching goal of this bilateral program is to engage scientists in South Africa from historically disadvantaged institutions (HDIs).  Despite tremendous advancements, there remains unequal participation in the national scientific research agenda in South Africa. NIH and SAMRC encourage South African institutions to enhance the participation of researchers from HDIs, including individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences. Underrepresented groups in South Africa include African, Coloured and Indian population groups in South Africa.  One of the major tenets of the SAMRC and the South Africa Department of Higher Education and Training is the development of  research capacity .  Transformation is central to the SAMRC’s strategy, especially transformation in the research landscape.

Scientists from South African HDIs and other South African Universities of Technology and/or scientists from the African, Coloured, or Indian population groups are encouraged to work with their institutions to apply as PD/PIs. In addition, and complementary to the proposed research project, applicants are highly encouraged to include in their applications an optional career enhancement partnership for fostering and enhancing research skills and experience of scientists from under-resourced institutions (HDIs and other South African Universities of Technology) that have a demonstrated commitment to biomedical research but have limited resources or experience. The goal is to develop collaborations that will expose scientists from these institutions to rigorous research experiences. Please note, however, that consistent with NIH practice and U.S. federal law, funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a prospective researcher as an eligibility or selection criteria. The race, ethnicity, or sex of researchers or prospective researchers will not be considered by NIH in the application review process or when making funding decisions.   

This NOFO encourages  New Investigators and Early Stage Investigators from the U.S. and South Africa to participate in this research program.

Research Objectives

Basic, translational, behavioral, clinical, preventive, data science, implementation, and/or epidemiological research may be proposed under this program.  HIV-related research is encouraged in accordance with the NIH Director's statement describing the  NIH's overarching HIV research priorities , and the accompanying  Guide NOTICE .

Specific Research Areas of interest include:

Reduce Incidence of HIV (Prevention)

• Understanding HIV transmission dynamics among different populations and age groups, and the geographic distribution of HIV prevalence and incidence.
• Informing development of new biomedical prevention strategies through understanding host/virus interactions associated with HIV acquisition, establishment of infection and disease progression.
• Prevention of perinatal HIV-transmission through primary prevention of HIV transmission, improvement in HIV viral suppression during perinatal periods, and enhanced infant prophylaxis and maternal viral suppression through the breastfeeding period.
• Voluntary medical male circumcision (VMMC) programs and impact in different populations, including culturally competent practices.
• Effects of maternal HIV and antiretroviral treatment on HIV-exposed uninfected children.
• HIV prevention among key and priority populations outlined in the  2023-2028 National Strategic Plan for HIV, TB, and Sexually Transmitted Infections (STIs) : adolescents and young people, particularly adolescent girls and young women (AGYW); survivors of sexual/gender-based violence; sex workers and their clients; sexual and gender minority populations; people who use alcohol and/or other substances; and people in prisons and other closed settings.
• HIV prevention in adolescent/young adult populations, including strategies to achieve high uptake and adherence to pre-exposure prophylaxis (PrEP).
• The role of food insecurity and nutrition, housing instability, and other social determinants of health in prevention, care, and treatment of HIV/AIDS.
• Novel strategies to enhance uptake of HIV testing and sustained linkage to care through differentiated service delivery, including community-based approaches, among key and priority populations in South Africa as outlined in the  2023-2028 National Strategic Plan for HIV, TB, and Sexually Transmitted Infections (STIs) .
• Risk factors, causes and sequelae of genital inflammation and its role in HIV acquisition in women.
• The potential role of broadly neutralizing antibodies in HIV prevention and treatment.
• The potential role of long-acting injectable technologies in HIV prevention and treatment.
• Tailored interventions for key populations.
• New HIV testing technologies for self-testing and viral load monitoring, and innovative testing strategies.
• Examination of pathophysiology and direction of effects between mental health and HIV acquisition as well as broader HIV outcomes.
• Motivations and reasons for age-disparate sexual partnering (>10 years age difference) and its role in HIV acquisition.
• Strategies that can reduce the impact of stigma, discrimination, gender bias, prejudice, homophobia, and transphobia on HIV prevention, care, and treatment.
• Strategies that can strengthen demand for HIV services that promote accurate information dissemination and counter disinformation among diverse populations.

Develop Next-Generation HIV Therapies (Treatment and Care Continuum)

• Best approaches to optimizing durability of antiretroviral therapy (ART) regimens and adherence support.
• Strategies on testing, linkage, adherence to HIV treatment, and retention in care, including in adolescent/young adult populations and programmatic combinations with contraception, and including use of mobile, digital, and telehealth technologies and platforms.
• Approaches to monitoring ART treatment, including consequences of long-acting injectable ART.
• Strategies to improve annual viral load testing rates for people on ART.
• Optimal programmatic combinations of HIV treatment and contraception.
• Differentiated care, including adherence clubs and alternate drug delivery.
• Laboratory-based research utilizing clinical samples collected from observational cohorts or clinical trials to advance testing of diagnostics and/or development of biomarkers applicable to HIV.

Research Toward HIV Cure

• Research toward a "functional cure" for adult and/or pediatric HIV and elimination of viral reservoirs.
• Basic research focused on persistent HIV infection and curative strategies.

Address HIV-Associated Co-Morbidities, Co-Infections, and Complications

• Impact and management of HIV and TB infection, along with strategies that promote the integration and support of combined HIV and TB care, including novel approaches to improve adherence to TB treatment among people with HIV (PWH).
• Understanding the immune and/or mycobacterial factors associated with TB pathogenesis among PWH, including subclinical TB and/or post-TB cardio-pulmonary disease.
• Chronic inflammation in treated HIV disease.
• Approaches to integrate chronic disease and mental health care into HIV/AIDS care services.
• Basic research focused on the influence of HIV infection on non-communicable diseases in PWH.
• Discovery, development, and/or testing of diagnostic and/or prognostic biomarkers, including markers of drug resistance, host directed therapies, and vaccines (both preventive and therapeutic) that can improve outcomes for PWH.
• Epidemiology of cancer in PWH in the era of antiretroviral therapy.
• Studies identifying biological differences between tumors occurring in PWH and without HIV.
• Understanding interactions of HIV with human papilloma virus (HPV), human herpes viruses (EBV and HHV-8), hepatitis B and C viruses, herpes simplex virus (HSV) and other oncogenic viral co-infections that lead to increased cancer risks.
• Studies on pathogenesis and pathobiology of virally associated cancers in PWH.
• Strategies for optimizing screening, diagnosis, prevention, and treatment of cancer in PWH.
• Studies on complications and outcomes of treating cancers among PWH.
• Studies that enhance our understanding of the role stigma plays in accessing cancer screening and care as well as its impact on survivorship in PWH.
• Studies identifying strategies for optimizing the integration of HIV care with cancer-related screening and treatment delivery.

Behavior, Mental Health, Substance Use, and HIV Risk

• Integrative approaches to treating and preventing mental health and substance abuse co-morbidities in HIV, especially in women exposed to violence or abuse, and youth.
• Studies to test novel approaches to integrate screening for mental symptoms or disorders into HIV prevention or care, with referral and linkages to appropriate levels of mental health care in South Africa.
• Studies on biomarkers to assess the status of mental health, HIV, and other comorbidities.
• Cost-effectiveness studies to assess economic benefits of the integration of HIV and mental health system approaches.
• Mechanisms (e.g., neurotoxic, epigenetic) underlying genetic, physiological, environmental, social, cultural, and economic factors and interactions that affect brain function or development and result in neurobehavioral outcomes (e.g., expression of cognitive impairment, coping, adaptation, response to intervention).
• Evaluation of the interaction among neuropsychiatric co-morbidities in HIV and age-related cognitive, physical, and functional decline; and how this is affected by socio-environmental and other factors.
• Neurobehavioral sequelae of perinatal and in utero exposure to HIV, other HIV co-infections, and antiretroviral and related treatments.
• Studies on the relationship between stress and HIV (e.g., 1. investigation of stress-induced immune changes and implications for HIV; 2. impact of stress and HIV on cognitive impairment; 3. psychosocial dynamics impacted by HIV and stress; and 4. implications of stress on HIV reservoirs).
• Longitudinal outcomes of the co-occurrence of HIV, alcohol and/or other substance use, and other mental health comorbidities (e.g., depression), and associated genetic, epigenetic, neurobiological, and environmental mechanisms.
• The role of alcohol and/or other substance use in physical and psychological trauma, including gender-based violence and rape.
• Evaluation of the effectiveness of integrating alcohol and/or harm reduction programs into HIV prevention, treatment and care programs, and their impact on the overall HIV epidemic.
• Studies on the link between alcohol use and adherence to HIV medication: 1. development of longer-lasting, less toxic medication regimens for PWH who continue to drink; and 2. assessment, reduction, and prevention of related pathophysiology for organ and tissue injury.
• Evaluation of the effectiveness of health system-based and/or policy-level interventions on HIV-related health outcomes.
• Studies on the prevalence and correlates of alcohol use among pregnant women with HIV in South Africa and how effective interventions may be disseminated to improve both maternal and fetal outcomes.
• Studies on the relationship between cognitive performance and alcohol consumption in people with HIV, and the impact on the development and uptake of interventions to prevent or treat HIV/AIDS.

Implementation Science/Data Science

• Implementation science research to improve the adoption, implementation, and sustainment of evidence-based or evidence-informed HIV prevention and/or care interventions aimed at improving health outcomes in the context of clinical and community settings for pediatric, adolescent, and young adult, and adult populations.
• Studies designed to enhance HIV prevention providers’ capacity to assist people in high-incidence or priority populations (e.g., via systems, providers, operational tools)
• Studies of systemic interventions to influence organizational structure, climate, and culture, to promote organizational readiness and capacity for intervention adoption, and implementation with fidelity and effectiveness.
• Studies to understand the benefit of varying training methodologies (e.g., didactic training, clerkship, on-site mentoring, on-going consultation, internet-based courses) to prepare providers to offer HIV prevention and treatment services.
• Studies to optimize the implementation (uptake, effectiveness, efficiency) of individual and/or combination prevention evidence-based interventions (e.g., behavioral risk-reduction, voluntary medical male circumcision [VMMC], PrEP, condom provision), designed to maximize the optimal targeting, uptake, coverage, effectiveness, and efficiency of service provision.
• Studies to optimize the implementation (uptake, effectiveness, efficiency) of individual and/or combination interventions designed to maximize HIV testing, linkage to HIV care, earlier ART initiation, adherence, and engagement HIV testing, which could include advancements in approaches and technologies.
• Studies of the impact of varying models of differentiated HIV care on HIV care continuum outcomes, which could include studies to evaluate optimal approaches to integrate community care delivery to include HIV prevention, care, and treatment with related services (mental health, substance use disorders, sexually transmitted infections, family planning, prenatal care, malaria, and/or tuberculosis).
• Studies to test and evaluate implementation of interventions that address social and structural determinants of health and their impact on HIV prevention, testing, treatment initiation, and continuity.
• Studies designed to enhance understanding of the epidemiologic contexts for targeted interventions (e.g., accurate rates of testing, linkage, initiation and viral suppression that indicates gaps and targets for intervention).
• Studies of cost and cost-effectiveness of intervention delivery in real-world settings, including the cost-effectiveness of alternative treatments, services, or payment structures for the provision of services
• Studies to inform the sustainment and/or sustainability of HIV interventions.
• Comparative effectiveness research focused on understanding factors related to early detection, patient engagement and retention in appropriate alcohol and HIV care and achieving and maintaining optimal treatment responses in diverse settings.
• Studies to improve outcomes for PWH accessing emergency care.
• Modeling and testing alternative implementation approaches to improve uptake and scaling-up of effective interventions and reduce HIV disease transmission and progression in key populations.
• Strategies to standardize use of unique patient identifiers for all patient records, tests, and health care engagement.
• Development of data harmonization strategies to build a robust data analysis infrastructure for the application of large-scale data science approaches and technologies.
• Implementation research to determine effective combination prevention strategies for both primary and secondary prevention.

Applications proposing the topics below will be considered non-responsive and will not be reviewed:

• Projects proposing Phase III or Phase IV clinical trials .
• Research using select agents .
• Applications without the required collaborative partnership (at least one South African PD/PI from an eligible institution from South Africa and at least one collaborator from a U.S. institution/organization).

For more information, please refer to specific Questions and Answers located at this link: https://www.niaid.nih.gov/grants-contracts/questions-and-answers-US-South-Africa-collaborative-biomedical-research-phase-3-HIV-AIDS .

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

The  OER Glossary  and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Issuing IC and partner components intend to commit an estimated total of $3.8 million to fund 8-10 awards.

Application budgets are not expected to exceed $400,000 in direct costs per year and should reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. eligible applicants eligible organizations non-domestic (non-u.s.) entities (foreign organizations) eligible applicant organizations must be from south africa, as described below an eligible national research foundation (nrf) south african institution is a recognized south african public higher education or research institution such as a university, university of technology, science council, museum or other research institution as declared by the  department of science and innovation .  historically disadvantaged institutions (hdis) include: mangosuthu university of technology sefako makgatho health science university university of fort hare university of limpopo university of the western cape university of venda university of zululand walter sisulu university south african universities of technology include: cape peninsula university of technology central university of technology durban university of technology sol plaatje university tshwane university of technology university of mpumalanga vaal university of technology foreign organizations non-domestic (non-u.s.) entities (foreign organizations) are eligible to apply. non-domestic (non-u.s.) components of u.s. organizations are not eligible to apply. foreign components, as  defined in the nih grants policy statement , are allowed. required registrations applicant organizations applicant organizations must complete and maintain the following registrations as described in the how to apply- application guide to be eligible to apply for or receive an award. all registrations must be completed prior to the application being submitted. registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the  nih grants policy statement section 2.3.9.2 electronically submitted applications  for additional information. system for award management (sam) – applicants must complete and maintain an active registration, which requires renewal at least annually . the renewal process may require as much time as the initial registration. sam registration includes the assignment of a commercial and government entity (cage) code for domestic organizations which have not already been assigned a cage code. nato commercial and government entity (ncage) code – foreign organizations must obtain an ncage code (in lieu of a cage code) in order to register in sam. unique entity identifier (uei) - a uei is issued as part of the sam.gov registration process. the same uei must be used for all registrations, as well as on the grant application. era commons - once the unique organization identifier is established, organizations can register with era commons in tandem with completing their grants.gov registrations; all registrations must be in place by time of submission. era commons requires organizations to identify at least one signing official (so) and at least one program director/principal investigator (pd/pi) account in order to submit an application. grants.gov – applicants must have an active sam registration in order to complete the grants.gov registration. program directors/principal investigators (pd(s)/pi(s)) all pd(s)/pi(s) must have an era commons account.  pd(s)/pi(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in era commons. if the pd/pi is also the organizational signing official, they must have two distinct era commons accounts, one for each role. obtaining an era commons account can take up to 2 weeks. eligible individuals (program director/principal investigator) any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the program director(s)/principal investigator(s) (pd(s)/pi(s)) is invited to work with their organization to develop an application for support. individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for nih support. see, reminder: notice of nih's encouragement of applications supporting individuals from underrepresented ethnic and racial groups as well as individuals with disabilities , not-od-22-019 and notice of nih's interest in diversity, not-od-20-031 . for institutions/organizations proposing multiple pds/pis, visit the multiple program director/principal investigator policy and submission details in the senior/key person profile (expanded) component of the how to apply-application guide. required collaborative partnership a south african investigator(s) must serve as the pd/pi. additional south african investigator(s) may serve as part of a multi- pd/pi team or collaborators. at least one u.s. investigator(s) must serve as collaborator with the south african pd/pi (or the south african multi-pd/pi team). the south african pd/pis must be either permanently employed at an eligible south african research institution or be in a long-term contract (at least for the minimum of the duration of the project).  postgraduate students, full or part-time, are not eligible to serve as pds/pis. 2. cost sharing.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms .

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see  NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications ).

Section IV. Application and Submission Information

1. requesting an application package.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the  How to Apply - Application Guide  except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Holly Curtis, PhD Office of Global Research National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 301-761-5666 Email: [email protected]  

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed with the following additional instructions:

Facilities and Other Resources : In a clearly labeled section, applicants should include a description of project-specific resources, naming those resources that are provided by the PD/PIs and the collaborating partners, and a describe the plan for sharing and distribution of project-specific resources among the individuals performing specific elements of the research project (e.g., individual contributions of specific reagents, patient samples, compounds, and access to populations for epidemiologic studies).

Other Attachments : Two separate attachments should be submitted for this section: a Collaboration Plan and a Financial Management and Oversight Plan.

A Collaboration Plan (pdf file named Collaboration Plan) should be included that describes the interactions among the recipients (the South African PD/PIs and collaborators) in terms of plans for communications, processes for making decisions on scientific direction and planning activities, procedures for resolving conflicts, and fostering collaborations with the community, if applicable. Outline the combined roles and responsibilities of all participating partners in the research, including contingency plans addressing solutions to setbacks or delays.  Describe how the U.S. and South African investigators will draw on their unique expertise related to the research project.

A Financial Management and Oversight Plan (pdf file named Financial Plan) should be included that describes plans for implementing subcontracts and collaborations with research partners. Describe subcontract oversight activities to ensure adequate fiscal management and project timeliness. In this paragraph describe the minimum experience required by organizational representatives of HDIs or Universities of Technology to serve as subcontractors for financial engagement on the research project.  Describe the internal institutional plans and procedures to ensure that recipients will comply fully with all applicable U.S. Federal regulations, policies, and Guidelines for research involving vertebrate animals and human subjects, including for human subjects the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects. 

SF424(R&R) Senior/Key Person Profile

R&r or modular budget.

In the budget justification section, applicants should demonstrate how the proposed budget will be distributed among the PD/PIs and collaborative partners.  Applicants are required to use the majority of funds to support work to be performed at the South African institution(s), with no less than fifty percent (50%) of the total budget costs directly supporting the South African component(s) of the research project. The 50% minimum applies to the entire project, not each budget year.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

Phs 398 research plan.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims of the project and indicate how the specific aims will be accomplished by the PD/PIs and collaborators.

Research Strategy:

• Describe how the outcomes from the research project support the global health efforts to monitor, understand, treat, or prevent disease.
• Provide the scope of research conducted by each member of the research team and discuss how the PD/PIs and collaborators, and key personnel will be involved in the execution of the research.
• If applicable, provide a description of the research activities or experiences provided through the proposed research project(s) that will engage scientists from under-resourced institutions (HDIs and other South African Universities of Technology) that have a demonstrated commitment to biomedical research but have limited resources or experience, leading to the establishment or enhancement of research skills and expertise. Describe the specific role of the participating scientist in the proposed project and how their role contributes to the overall success of the proposed research.   
• Provide a plan for monitoring the day-to-day activities of the research and remediating any identified delays or setbacks in the implementation of the research project.
• Describe potential collaborations and involvement of community groups, local organizations, or other institutions in the research project.

Letters of Support:  Applicants from the U.S. and South Africa must include a Letter of Support signed by the respective institutional official agreeing to provide institutional support for the proposed research project.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:  Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form

Foreign organizations.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures,  2 CFR 200.113 and  NIH Grants Policy Statement Section 4.1.35 .

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the  HHS Office of Inspector Grant Self Disclosure Program at  [email protected] .

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. criteria.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score. 

Significance

• Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
• Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.
• Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
• Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.
• Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).
• Evaluate the potential to produce unbiased, reproducible, robust data.
• Evaluate the rigor of experimental design and whether appropriate controls are in place.
• Evaluate whether the sample size is sufficient and well-justified.
• Assess the quality of the plans for analysis, interpretation, and reporting of results.
• Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
• the rigor of the intervention or study manipulation (if applicable to the study design).
• whether outcome variables are justified.
• whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
• whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
• For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

• Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
• For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex/gender categories.
• For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Specific to this NOFO:

• Evaluate to what extent the collaboration plan suits the proposed project.
• Evaluate how adequate the plans are for monitoring progress of the research. 
• Evaluate how well the applicant has provided remedies or solutions to potential setbacks or delays.

Investigator(s)

Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

• Evaluate how well the plans for integrating the proposed work of the U.S. and South African investigators draw on their unique expertise related to the research project.
• If proposed, evaluate the extent to which the experience of the combined collaborative partnership between the U.S. and South African PD/PIs with respect to providing unique research experiences for scientists from under-resourced institutions (HDIs and other South African Universities of Technology) to advance their own research expertise.
• Evaluate to what degree the applicant has described the plan for sharing and distribution of project-specific resources among all investigators working on the research project.
• Evaluate h ow well the objectives for financial management and oversight are defined, and how well the plan describes the process for engaging other institutions in the research funding process.

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the  Guidelines for the Review of Human Subjects .

When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the  Worksheet for Review of the Vertebrate Animals Section .

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

As applicable, evaluate the full application as now presented.

As applicable, evaluate the progress made in the last funding period.

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.

Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policies and practices , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons. As part of the scientific peer review, all applications will receive a written critique. Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score. Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO. Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions: Scientific and technical merit of the proposed project as determined by scientific peer review. Availability of funds. Relevance of the proposed project to program priorities. Geographic distribution of South African Institutions. If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the  NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures . This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships. 3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the  eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the  NIH Grants Policy Statement Section 2.4.4 Disposition of Applications .

Section VI. Award Administration Information

1. award notices.

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in  Section IV.6. Funding Restrictions . Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the  NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see  Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website ( https://register.clinicaltrials.gov ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200 , Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities .
• HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in  NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See  2 CFR Part 200.340 Termination and  NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support . 

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the  Research Performance Progress Report (RPPR)  annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting .

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout . NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online:  https://www.era.nih.gov/need-help  (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email:  [email protected]  (preferred method of contact) Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email:  [email protected]

Brian Remortel, M.P.H. National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 240-292-4816 Email: [email protected]  

Geraldina Dominguez, Ph.D. National Cancer Institute (NCI) Telephone: 301-920-6044  Email: [email protected]  

Sonia Lee, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-594-4783 Email: [email protected]  

Christopher Gordon, Ph.D. National Institute of Mental Health (NIMH) Telephone: 301-443-1613 Email: [email protected]  

Kendall Bryant, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA) Telephone: 301-402-0332 Email: [email protected]  

David Chang, Ph.D. Office of AIDS Research (OAR) Telephone: 301-827-4221 Email:  [email protected]  

Dr Michelle Mulder Ph.D. South African Medical Research Council Telephone: +27 21 938 0937 Email: [email protected]  

Raul Rojas, Ph.D. Center for Scientific Review (CSR) Telephone: 301-435-0492 Email:  [email protected]  

Annie Grimes National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 301-761-7315 Email: [email protected]  

Dawn Mitchum National Cancer Institute (NCI) Telephone: 240-276-5699 Email: [email protected]   Margaret Young Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-642-4552 Email: [email protected]  

Rita Sisco National Institute of Mental Health (NIMH) Telephone: 301-443-2805 Email: [email protected]   

Judy Fox National Institute on Alcohol Abuse and Alcoholism (NIAAA) Telephone: 301-443-4704 Email: [email protected]    

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.