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Examples of Full Proposals

Proposals using the "full proposal" form.

Experiments in Virtual Reality (Crawford, Twedt, et al)

The full research proposal submission, Experiments in Virtual Reality , consists of four components: (1) the completed full proposal form , (2) the proposal consent form , (3) a debriefing form to be used with subjects after their participation in the study, and (4) recruiting materials which announce the study and solicit participants.

Mindsets Matter: An interdisciplinary approach for increasing female involvement and acheivement in STEM: Renewal (Burnette, Hoyt, Lawson et al)

The full research proposal submission, Mindsets Matter , consists of two components: (1) the full proposal form , which also includes information needed by the IRB for the renewal of the proposal, and (2) additional materials , which include the consent form, instruments to be used in the research, and other materials.

"Unique" Proposals That do not Fit the Full Proposal Form

Examples of approved unique full proposals from past years follow. Note that some of these proposals may not include all of the information currently required by the IRB.

Example of Unique Faculty Psychology Proposal .

Example of Unique Student Geography Proposal .

In some cases, a professor may want to submit a proposal that incorporates various components of separate student surveys or interviews. An example of such a classroom proposal can be downloaded HERE .

JacqueLENS PhD

How to Write an IRB Proposal

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• IRB Proposal Creation Guidelines
• Campus Resources & Services

Guidelines detailing obligatory and optional documentation to be included in proposals submitted to Colgate’s Institutional Review Board, as well as example proposals.

All proposals submitted for either expedited or full review must contain four primary sections:

• Purpose of investigation and procedures
• Anticipated risk and potential benefits to participants
• Steps taken to protect the participants
• Manner of obtaining participants

Details regarding what should be included in each of the four sections are shared below.

Additional documents may also be required in an appendix, depending on the nature of the proposal.

In general, this section should briefly outline what the researcher plans on doing and why. This section should begin with a brief background literature review (complete with citations) centered on the research question at hand.

The background portion of this section should be followed by a full description of what the anticipated participants will be asked to do during the course of the study. For example, if in-depth interviews will be employed, the researcher must address where the interviews will take place, along with whether or not the interviews will be recorded.

Any non-standardized material used in a given study (e.g., questionnaires, interview protocols, vignettes, etc.) should be included with the proposal in an appendix, and referenced in this section.

The IRB is composed of Colgate faculty and staff from a broad range of backgrounds. Thus, your proposal should be written for a general audience, and not rely on terminology specific to any particular field of study. If the purpose and/or procedures are unclear, your proposal will be returned with a request for clarification.

This section must address all reasonable risks. These include physical, emotional, legal, and potential threats to one’s reputation.

If the researcher has deemed that the risks within their study are no greater than risks associated with everyday living, then the researcher should discuss why that is the case.

Typically, there are no benefits to participants in Colgate-sponsored research. Benefits are typically present only in medical research in which participation provides tangible benefits (e.g., experimental medical procedures) that would otherwise be unavailable. Promotion of science, personal insight, participation credit, and payment are not considered benefits in this context.

This section should contain a full account for how the researcher plans on maintaining participant confidentiality or anonymity.

Specificity of Terms

Please be sure to use the terms confidential and anonymous carefully, and according to the following definitions:

• Confidential : This means that only certain authorized people will have access to the data and that appropriate measures will be taken to ensure that a given participant’s data will never be available and identifiable to others. This might entail discussion of how the data will be stored, ways in which personally identifiable information will be removed from the original surveys, notes, and computer files, and whether names will be replaced with code numbers. If names will be replaced with code numbers, please detail how the list of numbers and names will be stored. If data are recorded in audio or video format, then the researcher must specify what will happen to those recordings once the study is complete.
• Anonymous : There is a high threshold for being able to claim that data will be anonymous. In order for data to be truly anonymous, there must be no viable mechanism by which the identity of the respondent could be connected to the data. Thus, even if investigators with a warrant sought the identity of the respondents, they would be unable to make the connection between names and data. Interview data is almost never anonymous, since the interviewer is likely to recall who said what. Lab-based data might be anonymous, but only if all identifiable information is removed and the order of completion is randomized. Anonymity would be violated if data were stored by order of completion, and the order of completion was recorded on the original sign-up sheet. 

Please note that either confidential or anonymous are acceptable forms of protecting the privacy of potential participants, therefore, if anonymity cannot be guaranteed, promising confidentiality will suffice.

It is important that the researcher specifically explains to the IRB just how confidentiality or anonymity will be maintained in this section. Any study involving surveys, in-depth interviews, or experimental manipulation (broadly construed) that do not explicitly state how either confidentiality or anonymity will be maintained will be returned to the researcher for clarification.

If you have any questions about maintaining either confidentiality or anonymity, please seek advice from your faculty supervisor, or the chair of Colgate’s IRB at [email protected] .

This section should also clearly state how participants will be reminded that their participation will be completely voluntary.

Finally, should your study require a debriefing statement, the debriefing statement should be included in the appendix, and referenced in this section.

This section should briefly outline how the experimenter plans on acquiring participants.

If participants will be recruited from Colgate (e.g., PSYC 150), this section should describe how they will be approached. If data collection is to involve actual class time, the researcher should note that the faculty have specific preferences for how they would like to be approached about the use of class time for data collection.

If you have any questions regarding data collection during class time, please contact the chair of Colgate’s IRB at [email protected] .

Certificate of Informed Consent

Download consent form template

It is important that researchers retain a copy for their records and provide a copy to every participant for their records. It is therefore necessary to provide a place for both the experimenter and the potential participant to sign the Certificate of Informed Consent. If this form represents the only record of a participant’s identity, then the IRB may, at its discretion, waive some or all of the sections listed on the template provided. 

The Certificate of Informed Consent should be written in clear, simple language at the 5th grade level. It should be written in the second person (e.g., “you,” “your”) and not the first person (e.g., “I”). In accordance with federal regulations, the CIC should address specific concerns, outlined as follows:

A brief paragraph clearly and succinctly explaining what the participant will do and/or experience during the research project. It is permissible to omit certain details if necessary for methodological purposes (e.g., the hypothesis of the study). However, information that might reasonably make a potential participant choose to opt out of a study may not be withheld. This section must also include the expected duration of participation in this study.

This typically refers to participation credit, direct payment, or participation in a raffle of some sort. Raffles should reveal the expected odds of winning and the value of the prize. If a study is completely voluntary (i.e., no compensation), then this portion should simply state that there is no compensation.

Participant Debriefing Form

A debriefing form is typically read aloud to the participant once he or she has completed the study. The form itself should explain to the participant the full aim of the study he or she has just completed.

If the proposed study involves some degree of deception, or manipulation of behavior that could lead to moderate (or greater) levels of physical and/or psychological distress, a debriefing form (signed by both the participant and the experimenter) must accompany the proposal as a part of the appendix. If a proposed study does not contain either of the above, a debriefing form is not required, but may be included at the researcher’s discretion (but does not need to be signed by the participant).  

Example Proposals

Examples for expedited review.

• Example experiment-based proposal
• Example external survey proposal
• Example internal survey proposal
• Example interview proposal  

Examples proposals for full review

• Full review proposal example 1
• Full review proposal example 2
• Example full-review proposal involving children

Information for Researchers Planning Audio or Video Recordings

Some research may include audio or video recordings taken of participants. If this applies to your research then please note the following:

• The informed consent needs to inform participants that there will be such recordings.
• After the study is complete, participants must be given an audio/video release form to be signed by participants indicating whether or not they provide permission for the recordings to be used by a) researchers working on the study and/or b) future participants, depending on the intentions of the researchers. Samples of such audio/video release forms appear below.
• Sample release for recordings used only by researchers
• Sample release for recordings used by researchers and future participants

Information for Researchers Planning to Conduct Research in Daycare or Schools

If you plan to conduct research within K-12 schools, please fill out and submit the form below (unsigned) with your proposal. Then, once you receive IRB approval for your study, you should submit this form (signed) to the IRB Chair as a modification request.

Approval to Conduct Research in Schools

• Whitepapers
• Ethics in Clinical Research
• FDA & ICH
• Regulatory Compliance

Drafting a Research Plan for IRB Review and Research Conduct: Information That Must Be Included in a Clinical Trial Protocol

A clinical trial is an interventional clinical study, in which participants are recruited for the administration of a specific intervention (use of a study drug, a procedure with a medical device, an educational intervention, etc.). Planning for a clinical research trial includes the development of a clinical protocol document. There are several reasons to have a clear and well-written protocol:

• So that the research plan is clearly defined to everyone who will participate in conducting the study, and all processes and procedures are clearly and completely described to avoid variation in procedures and the introduction of assessment bias into the study conduct
• So that oversight committees and agencies (Institutional Review Boards (IRBs)/Research Ethics Committees, scientific review committees, radiation safety or other committees, and regulatory agencies such as the Food and Drug Administration (FDA)) can review the research proposal in enough detail to ensure that it meets regulatory requirements to grant approval for the research conduct
• So that the endpoints, study design, data collection parameters, and the data analysis plan are prospectively defined prior to the research being conducted, and bias cannot be introduced by changing the design or analysis plan during the study (for this reason, many journals now require public posting of the full research protocol along with the publication of study results).

There are many ways to outline and describe the necessary components of the research protocol and plan, and there are many protocol templates that are available to serve as guidelines for protocol development. In this paper, we are addressing these requirements from the perspective of the IRB. Federal regulations dictate specific criteria against which the IRB must review all protocol submissions , to make an independent determination regarding whether the prospective research plan can be approved. If the protocol (or other documents such as the IRB submission form and consent documents that accompany the protocol in the submission) does not provide adequate or complete information for the IRB to make a determination that all criteria have been met, the IRB cannot approve the research plan. This document is intended to assist investigators and research teams by providing a list of the necessary information that they can use as a writing guide, or use as a checklist against the protocol and submission document package, to ensure that all the necessary information is included prior to submitting the protocol and plan for review by an IRB.

TABLE 1 lists the criteria for the approval of research (paraphrased here from the full regulatory language in 21 CFR 56.111 ) by an IRB, and describes the information that is necessary for the clinical protocol (or elsewhere in the research plan submitted for review), for the IRB to be able to make determinations regarding whether a research plan can be approved.

TABLE 2 describes additional components or documents that may need to be included, based on specifics of the study product or the study plan.

In addition, all protocol documents should:

• Be final documents. Draft protocols or other study documents should not be submitted for IRB review as the IRB must review final and complete study plans. If edits or changes are made after IRB review, the amended protocol must be resubmitted for approval of the changes.
• Include page numbers and/or section or outline numbering so that the location of content can be identified
• Include a table of contents
• Include some kind of version control notation (either a version number or version date) so that revisions of the documents can be clearly tracked.

TABLE 1: Necessary Information for All Protocol Submissions

Criterion for approval of the research proposal:.

That risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Corresponding Information required in the Protocol/Research Plan:

• A clear and detailed list of all study procedures, including screening and follow-up procedures (often in tabular format, describing the procedures to be conducted at each study visit). “Procedures” includes (but is not limited to) study visits; interviews for the collection of safety or other data; vital sign measurements; surveys, questionnaires, or diary completion; study drug administration or other investigational study intervention; invasive and non-invasive procedures including blood draws, radiologic tests or other diagnostic testing.
• The protocol should very clearly define what visits, assessments and procedures would be occurring as part of standard care
• If participants need to leave the study early or suddenly, the protocol should include any specific testing or follow-up that may need to occur for safety purposes.

That risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

• the scientific knowledge expected to result from the research project
• the potential direct benefits to individual research participants in the study
• The protocol should also contain a clear and complete description of the study drugs/study intervention including (as appropriate) dosing information, storage information, and criteria for dose modification or dose adjustments.

That the selection of subjects is equitable.

• Eligibility criteria should be designed to make the study as inclusive as possible while excluding persons with factors or conditions that unacceptably increase the potential risks, or unreasonably confound the measurement of study endpoints
• Consider demographics, medical history and co-morbidities, concomitant medications, and whether the protocol must include testing for the presence or absence of conditions specified in the criteria
• It is not necessary to specify opposite factors in both lists, i.e., if inclusion criterion is age ≥ 18, the exclusion does not need to specify age < 18.

Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.

Informed consent will be appropriately documented or appropriately waived.

• While the protocol submission must include a written informed consent document, it should also describe the process of obtaining informed consent from participants; how they will be identified and contacted, who will approach them about the study, and how they will be given adequate opportunity to ask questions during the consent discussion
• The written informed consent document must provide all of the elements required by federal regulations
• If potential participants may be incapable of providing informed consent and consent must be provided by legally authorized representatives, the consent process must describe this and the consent form must have appropriate signature spaces
• While there are circumstances in which the regulations allow either a waiver of documentation of consent (no signature) or a waiver of obtaining consent for standard or for emergency research , if a waiver is requested the submission should describe how the proposed research meets the specific requirements for these waivers, and how participants’ rights and privacy will be protected if the waiver is granted.

When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.

• The protocol should include an adequate description of the safety and efficacy data points that will be collected, including how adverse events will be collected, recorded, graded, and assessed
• How will safety data be monitored on an ongoing basis to identify any unanticipated safety issues during the study? Who will review the data, and will the study include a Data Safety Monitoring Committee, Data Monitoring Committee, or Adjudication Committee?

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

• The protocol or associated documents should describe how the privacy of participants will be protected (including if appropriate how people will be approached about the study and given the opportunity to ask questions in a private setting), as well as how the data being collected will be anonymized or de-identified, stored, transferred and analyzed to maintain confidentiality.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

• Note that federal regulations have specific sections for additional precautions required in the research when research is conducted on children , pregnant persons , and prisoners . Inclusion or exclusion of these groups should be specified in the eligibility criteria.
• Consideration should also be given to whether the protocol should include specific steps for the protection of participants who may be unable to make consent decisions (temporarily or permanently).

TABLE 2: Additional Components to Include when Appropriate

Circumstance or condition:.

If the protocol is evaluating the safety and/or efficacy of a drug, biologic or medical device (even if the drug, biologic or medical device is already FDA approved).

Additional information or documents that must be provided:

The regulatory status of the drug/device must be provided to the IRB, either via

• a description in the protocol,
• the submission form, or
• a copy of a letter from the FDA.

For drugs or biologics , the documentation must include an (Investigational New Drug (IND) number or a regulatory-based rationale for why the product is considered IND-exempt (21 CFR 312.2).

For medical devices , the documentation must specify whether the device is used ‘on label’ (for exactly the same indication and circumstances for which is has already been FDA-cleared or approved) or is investigational. If the device is investigational, the documentation must include an Investigational Device Exemption (IDE), an NSR justification, or a regulatory-based rationale for why the device is considered IDE-exempt.

When the protocol is evaluating interventions for foods , herbal products , dietary and other supplements, vitamins , and cosmetics , a regulatory-based justification for why that agent is not considered a drug or biologic as used in the research must be provided. Remember that foods that are being researched for possible use as drug products (looking for evidence of action in diagnosing, treating or mitigating a disease or condition) are regulated as drugs.

The IRB must ensure that research is being conducted in compliance with FDA regulations, so submitting appropriate documents or explanations may prevent questions during the review process. If the IRB cannot confirm documentation, or if the IRB is not completely sure that the FDA would agree with the justification for why certain research would not need FDA oversight (i.e., would be IND- or IDE- exempt), the IRB must ask the researcher/sponsor to consult with FDA and obtain documentation that FDA agrees that their oversight is not indicated.

Some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant persons, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

When persons from vulnerable populations may be enrolled in the research the research plan must always specify this and consideration should also be given to whether the protocol should include specific steps for the protection of participants who may be unable to make consent decisions (temporarily or permanently).

Note that federal regulations have specific sections for additional precautions required in the research when research is conducted on children , pregnant persons , and prisoners .

The study includes the use of surveys, questionnaires or other instruments (quality of life assessments, etc.).

If the protocol includes the use of surveys, all survey questions must be submitted as part of the protocol, an attachment to the protocol, or a supplemental document. If standardized questionnaires or instruments are being used, these must also be submitted. The IRB is required to review all participant-facing materials, including participant diaries and participant recruitment materials [note: some IRBs, including WCG IRB, do not require submission of common, standard instruments such as the SF-36, but if there is any doubt about whether submission is required it is better to add it and avoid possible delays].

Study participants must provide written informed consent.

The informed consent document must be provided for review and must have all the elements required by regulations .

A waiver of informed consent documentation is being requested.

In addition to the regulatory-based justification for the waiver (see Table 1), a Participant Information Sheet must be included in the submission.

A waiver or alteration of HIPAA requirements is being requested.

A regulatory-based justification must be provided specifying how the research is eligible for the waiver or alteration.

For researchers new at conducting clinical research or writing protocols, developing a new clinical trial protocol that is complete and sufficient for the purposes for which it will be needed is often a larger and more time-consuming project that was initially expected. While IRBs are generally happy to provide information and to answer specific regulatory questions in advance of a protocol being submitted, most do not have the resources or capacity to provide one-on-one guidance to researchers who have protocols that need major revisions to meet the criteria for approval.

Researchers may find it best to work with an experienced medical writer or clinical research consultant; while the cost of these services can be significant, this may be the most cost-effective plan when balanced against the time saved by the researcher and the facilitation of the review and approval process when guided by someone who is familiar with clinical research regulations.

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Institutional Review Board

Policies, forms, templates, and samples.

These files may be useful to you if you are submitting a proposal to the IRB or developing written material for your project. Unless otherwise indicated, all files are Microsoft Word documents (.docx). Be aware that these form templates are provided as guidelines only, and you may need to include additional items depending on the nature of your study. Feel free to edit the text as needed, but take care to remove the brackets, quotation marks, and highlighting before you present it to participants.

IRB Checklist ·· Download here (PDF 39KB)

Sample IRB Proposal ·· Download here

Policy on Incentive Payments to Human Subjects – click here

Policy on Research Data Management  – click here

Research Data Management and Sharing Plan (RDMS) worksheet – click here

CONSENT FORMS

Consent form template for in-person data collection (experimental, surveys) ·· Download here

Consent form template for online surveys ·· Download here

Consent form addendum for video or audio recordings ·· Download here

Consent form template for parental consent (used when collecting data from minors) ·· Download here

Consent requirements when the research involves sensitive topics  – click here

DEBRIEFING FORMS

Debriefing form template ·· Download here

Debriefing form additions for research involving Bates participants where there is a chance the research may cause distress… Download here

Debriefing requirements when the research involves sensitive topics  – click here

As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.

The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.

ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.

Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).

eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).

Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.

Ethics & Compliance

• eResearch IRB NextGen Project
• Class Assignments & IRB Approval
• Operations Manual (OM)
• Authorization Agreement Process
• ORCR Policies and Procedures
• Self-Assessment Tools
• Resources and Web Links
• Single IRB-of-Record (sIRB) Process
• Certificate of Confidentiality Process
• HRPP Education Resources
• How to Register a Clinical Trial
• Maintaining and Updating ClinicalTrial.gov Records
• How to Report Clinical Trial Results
• Research Study Participation - FAQ
• International Research
• Coordinated Services & Practices (CSP)
• Collaborative Research: IRB-HSBS sIRB Process
• Data Security Guidelines
• Research Incentive Guidelines
• Routine fMRI Study Guidelines
• IRB-HSBS Website Directory and Guidance
• Waivers of Informed Consent Guidelines

IRB Review Process

• IRB Amendment Process
• Continuing Review Process
• Incident Reporting (AE/ORIO)
• IRB Repository Application
• IRB-HSBS Education
• Newsletter Archive

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• Human Subjects
• IRB Health Sciences and Behavioral Sciences (HSBS)

U-M HRPP Operations Manual References

IRB approval criteria: Part 3, Section III, C 6

Regulated/not regulated research: Part 4, Section V  

Exempt research policy: Part 4, Section VI

Using the U-M IRB System

IRB staff and board members have access to the IRB application and posted correspondence via the eResearch Regulatory Management (eRRM) system.  The system facilitates the IRB review process by:

• Providing regulatory checklists that guide IRB staff review
• Routing submissions to ancillary committees (e.g., COI-UMOR), as applicable
• Re-routing submissions to a different U-M IRB, if applicable

IRB-HSBS Turnaround Times

"Turnaround" is the estimated time it takes to complete the IRB review and determination process.

Full-board :  4 - 8 weeks

Expedited :  2 - 4 weeks

Exempt :  < 1 week

The U-M Institutional Review Boards (IRBs) fulfill their goals to protect human research participants and support the design and conduct of sound research by reviewing and approving IRB submissions for new applications, amendments, and continuing reviews.

All projects that meet the definition of research with human subjects ( 45 CFR 46.102 ) must be reviewed and approved by an IRB, or receive an exempt determination,  prior  to beginning the research.  The IRB staff initially screens submissions to determine the completeness and the appropriate type of review.  Submissions may be returned to the study team for changes before the review type is assigned.  The review type may be reassessed at any time during the review process.

Types of IRB Review

The basic types of IRB Review are: Comprehensive , Exempt , and Not Regulated .  The type of IRB review and the associated review process (e.g., full board , expedited , limited IRB review , system-generated ) are determined by the:

• Level of risk to research participants
• Type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
• Sensitivity of the research questions or complexity of the research design
• Involvement of vulnerable populations as research participants
• Use of identifiable information or indentifiable biospecimens
• Applicability of one or more of the criteria for exempt or expedited review

Research Requiring Comprehensive IRB Review

The IRB may conduct either an  expedited or full board review for IRB-regulated research proposed in the  Interaction/Intervention or   Secondary Use   application types  to ensure:

• Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits
• The subject selection is equitable
• Privacy and confidentiality are protected
• Informed consent processes meet federal regulatory and U-M requirements 

Full Board Review

Federal regulations and institutional policy require a review by the IRB Full Board for applications where the research involves  more than minimal risk  to human subjects, does not meet the criteria for one of the categories of expedited review , or has been referred to the committee by an expedited reviewer or the Chair.  Regardless of risk level, IRB-HSBS may require full board review when the research involves: 

• Vulnerable populations, particularly prisoners
• Sensitive topics, including illegal behaviors which may require an NIH  Certificate of Confidentiality  (CoC) to protect subject data from compelled disclosure
• Research involving genetic/genomic analyses
• A complex research design requiring the expertise of multiple board members to evaluate

The IRB posts submission deadlines for upcoming IRB meeting dates. If an application is “board ready”, meaning that it contains all of the information and materials necessary for the full board to conduct its review, the application will be assigned to the next IRB meeting date (see Related Information to the right for schedule links), except where the agenda is already full or a reviewer with the necessary expertise is not available for that meeting. IRB staff assign submissions to a primary and secondary IRB reviewer for presentation at the full board meeting. Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination for the submission.

IRB Full Board Determinations 

Approved : the application is approved as submitted.  The approval date is the date of the IRB review.

Approved with Contingencies : the application is approved, contingent on submission of specified changes to the protocol, informed consent document(s) and/or other supporting materials.  Final approval status is granted when the IRB has reviewed and approved all requested changes. The date of the "approved with contingencies" determination is deemed the date of approval.

Action Deferred : the IRB needs additional information from the investigator before the IRB can make all of the determinations found at 45 CFR 46.111  necessary to approve the study. The principal investigator must submit the requested additional information before the IRB will consider the application for further review.

Disapproved :  the protocol does not provide adequate protection to human participants, and it is unlikely that it can be modified to provide such protection. The IRB notifies the principal investigator of the disapproval in writing, including a statement of the reasons for its decision, and provides the opportunity for the investigator to respond to the IRB in person or in writing.

Tabled :  the IRB full board did not have time to review the application at the convened board meeting. The application is placed on the agenda for the next convened meeting.

Expedited Review

Federal regulations ( 45 CFR 46.110 ) authorize the use of an expedited review process for:

• Minimal risk  human research that meets one or more of the OHRP  Expedited Review Categories   
• Minor  changes to research  previously approved by the full board

Applications qualifying for expedited review are assigned to an expediting reviewer, an experienced IRB member appointed to the role by the IRB Chair.  The expediting reviewer has the authority to make a determination or to refer a submission for full board review for multiple purposes (e.g., clarification, expertise), including in cases of disapproval.  Only the full board has the authority to disapprove a study.  Most studies that qualify for the expedited review process do not require annual Continuing Review .

IRB Expedited Review Determinations

In addition to the  Approved  and  Approved with Contingencies  determinations ( described above ) reviewer may issue a Changes Requested  determination, when substantial changes to the application and/or materials are required before the expediting reviewer can approve the study. 

Exempt Research Review

Per university policy, investigators must submit an IRB application for determination of exemption before research begins. Applications are routed for exempt review through the Interaction/Intervention application or the Secondary Use application types.  IRB-HSBS recommends using the Brief Protocol for Exempt Research Projects (download) to provide an overview of you exempt project or as a data entry guide when completing the IRB application.

Projects that meet the criteria for a  federal exemption category  (45 CFR 46.104) or for a  U-M exemption #5  may be granted a  determination of exemption  by the IRB, or where applicable, through the system-generated review process.  The review determination, whether conducted by the IRB or system-generated, is limited in scope to the information necessary to determine if the proposed exemption applies.  The IRB does not review informed consent documentation or recruitment materials for proposed exempt studies.  Exemptions may be granted by the IRB Chair, expedited reviewers, or (in most cases) qualified IRB staff members.

Projects receiving an exempt determination are not subject to the Continuing Review process .  Amendments are required only if the changes to the project would alter the exemption criteria.  An exempt determination does not lessen the researcher's ethical obligations to participants as articulated in the Belmont Report or to the codes of conduct for specific disciplines.

Limited IRB Review

The Common Rule provides a Limited IRB Review process, which is a required expedited review of recruitment and consent materials as well as plans to maintain participant privacy and data confidentiality for exempt 2 and 3 projects that collect or use sensitive and identifiable data .  An exempt determination is issued once the expediting reviewer confirms that these protections are acceptable.

Not Regulated Review

Not all research-related activities that involve people, their data, or their biospecimens are covered by the regulations governing human research. However, investigators may wish to submit a brief eResearch IRB application for a formal “not regulated” determination for funding or publication purposes; or, the investigator may be able to issue a system-generated determination letter without submission to the IRB.

Submission to the IRB is not required for the following activities:

• Case studies
• Class activities
• Journalism/documentary activities
• Oral history
• Quality assurance and quality improvement activities
• Research on organizations
• Research using deidentified data or biospecimens
• Research using publicly available data sets

Some categories require IRB review for the purpose of assessing compliance with HIPAA or other regulations. These include:

• Research involving existing information or biospecimens that have been coded before the researcher receives them, but identifiers exist
• Research involving deceased individuals only
• Pre-review of clinical data sets preparatory to research
• Standard public health surveillance or prevention activities

For a complete list of not regulated research activities, see the HRPP Operations Manual, Part 4 .

If you can answer "yes" to the following questions, you need to submit an IRB application in eResearch for IRB review:

1.  Is it research?

Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge   ~ Federal definition,  45 CFR 46.102 (l)

• Activities such as the  practice  of public health, medicine, counseling, or social work are not research. 
• Studies for internal management purposes (e.g., program evaluation, quality assurance, or quality improvement) are not research because the intent is not to provide generalizable knowledge but to apply findings only to the program or activity.

2.  Does the research involve human subjects?

Human subjects research is a project that involves a living individual about whom the investigator (whether student or professional) (i) obtains information or biospecimens through interaction/intervention with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses studies, analyzes, or generates identifiable private information or indentifable biospecimens.  ~  Federal definition  45 CFR 46.102 (e)(1) 

3.  Is the university engaged in the conduct of the research?​​

The university is "engaged" when the research is conducted by U-M faculty, staff, trainee, or other agent acting in connection to their university responsibilities.  See OHRP's Guidance on Engagement of Institutions for more information and examples.

• Direct awards from federal sponsors that meet criteria #1 and #2 are always reviewed by a U-M IRB, whether or not the university is engaged in the research.  
• If you answer "no" to any of these questions, you may have other obligations than IRB review.  See the U-M HRPP Operations Manual Part 4, Section V for more information about regulated/non-regulated research.

IRB Health Sciences and Behavioral Sciences Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

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Research Proposal Guidance

Does your research require irb approval.

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A project requires IRB review if it includes both research and human subjects. The IRB must make the final determination of whether or not a study requires review.

If you are wondering whether or not your research requires IRB oversight, the first question you should ask yourself is: Does your project involve human subjects? If your research does, then it requires IRB approval and you should continue reading this webpage. If it does not, then you do not need IRB approval.

Research That Involves Human Subjects

Below are a few examples of research that typically involve human subjects. This is not a comprehensive list and there are often exceptions to each research.

Generalizing Findings

Activities that obtain data about individuals, systematically performed with the intent to generalize findings.

Viewing Identifable Private Information

Identification of potential participants for a study or use of living individuals’ data for research purposes, whether or not the data will be recorded in an identifiable manner.

Survey, Interview, Observation

Collection of individuals’ data using surveys, interviews, or observation with the intent to generalize findings.

Audio or Videotaping

Taping individuals for study in situations not normally expected to be recorded or when individuals can be identified from recordings.

Research That Does Not Involve Human Subjects

Below are a few examples of research that typically does not involve human subjects. This is not a comprehensive list and there are often exceptions to each research.

Study or use of data that cannot be readily associated with the living individual about whom the information relates. There are some exceptions. Be sure to contact IRB for assistance.

Quality Improvement

Activities involving individuals intended solely for internal use, performed to improve services or develop new services or programs, (e.g., satisfaction surveys) without intent to generalize findings, even if results will be presented or published; audits (internal or external) performed as a part of organizational operations. There are some exceptions. Be sure to contact IRB for assistance.

Data Banking

Collection and storage of private information, if the data may be used in the future for research purposes, whether or not the data will be recorded in an identifiable manner.

Examples of Research & IRB Approval

Below are examples of research and whether or not they need IRB approval. Research that do need IRB approval also have levels of review.

Surveys, Questionnaires & Interviews with Adults

Not all survey, questionnaire, or interview research is minimal risk. For example, a survey or interview that asks questions about sensitive topics (childhood abuse, sexual functioning) likely to cause emotional stress or discomfort may require full IRB review. Some survey research may be classified as exempt from committee review if the information obtained is recorded in a way that the subject cannot be identified (either directly or through a code numbers or link); in other words, if the research data are anonymous.

A survey or interview study may also be considered exempt from committee review even when the data are not anonymous if the information being gathered could not reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.

The most common classification for survey, questionnaire, or interview research is expedited approval. If the study is not anonymous and contains information that, if known, could be damaging as described above, but it does not rise to the level of more than minimal risk, it may be given expedited approval. Although the proposal application gives the investigator the opportunity to indicate a classification, the IRB makes the final determination as to the classification of exempt or expedited.

Normal Educational Practices

Normal education practices are considered exempt from committee review, but must still be reviewed and approved by the IRB office. Some examples of this could be a students’

• Curriculum-related written work, test scores, grades, artwork and other work samples produced by children
• Curriculum-related oral and non-verbal communicative responses individually, such as in an interview, in small groups and with the whole class
• Responses (written, oral or behavioral) to curriculum-related activities
• Level of active participation in curriculum-related activities

Please note: A “normal educational setting” means preschool, elementary, secondary, and higher educational facilities, and after-school programs (if the project relates to tutoring, or homework help). In Special Education, normal educational practices correspond to the Individualized Educational Program (IEP), which is tailored to each student with an identified disability and may be implemented in diverse settings (school, home, work, community).

Collection Methods

The following list outlines the ways in which a researcher may collect the information for their research.

• Videotapes and photographs of curriculum-related classroom activities
• Audio tapes of teacher-student and student-student discourse related to the assignment
• Teacher’s non-participant observation of curriculum-related activity of individual children or groups of children, noting what will be observed and how it will be analyzed, or whether it will be used as anecdotal evidence in the study
• Teacher’s commentary on students’ curriculum-related written work, artwork and other artifacts produced by children
• Student journals and communication books related to the curriculum
• Student grades and test scores
• Teacher journals, notes and reflective comments on student responses and participation in curriculum-related activities
• Questionnaires or interviews with students, parents and family members, teachers and administrators
• Non-participant classroom observations by colleagues, with the class teacher’s permission, stating what will be observed and how it will be used (i.e. How data will be analyzed or whether it will be used as anecdotal evidence)

Research for University Courses

Research conducted solely for pedagogical purposes may be excluded from IRB review, under the following conditions:

• The instructor’s intention is to teach professional research methods such as interviewing, surveying, or experimental design
• The data are gathered solely for the purposes of teaching how to analyze them
• The results will remain in the classroom

These data can be presented at the end of the semester within the confines of the institution, for instance, at Scholars Day. However, if the results will be published (including on Digital Commons), presented at a larger conference off-campus, or generalized in some other way, it will be necessary to obtain IRB approval.

If a class project evolves into a research project that the student/instructor wishes to publish or generalize, then the research will need to undergo IRB review. This should occur as soon as it is known that the data will be used for research. If this is not determined until after the research is completed, the investigator should submit a protocol to the IRB requesting permission to use existing data.

Professors, students, and research assistants are asked to submit the In-Class Research Form prior to beginning their in-class research projects to verify whether the proposed activity will require an IRB approval process.

Pilot Studies

Pilot studies with human research volunteers, no matter how small, must obtain IRB approval. You can include the pilot study as a smaller section of the complete protocol, or you can get approval for the pilot study first, then come through the IRB again for a review of the full “parent” study. At this stage, you may have modified your research to take into account the results of the pilot study. (For example, you may decide to change the survey questions as a result of the pilot study, or change inclusion/exclusion criteria.)

Oral History

The researcher’s intention plays a large part in determining whether research is an oral history or not. If the intention is to interview informants who have a unique perspective on a particular historical event or way of life, and the researcher also intends to let the informant’s stories stand on their own as a “testimonial” or in an archive, with no further analysis, the research is most likely oral history.

However, if the surveys or interviews are conducted with the intention of comparing, contrasting, or establishing commonalities between different segments or among members of the same segment, it is safe to say your research will be regular survey/interview procedures, because you will be generalizing the results.

Historians explain a particular past; they do not create general explanations about all that has happened in the past, nor do they predict the future.

Moreover, oral history narrators are not anonymous individuals, selected as part of a random sample for the purposes of a survey. Interviewees are selected because of their personal relationship to the topic under investigation. An oral history interview provides one person’s unique perspective. A series of oral history interviews offers up a number of particular, individual perspectives on the topic, not information that may be generalized to all research volunteers in the event or time under investigation.

Oral history interviews are not analyzed in the same way that qualitative data is generally analyzed. No content analysis, discourse analysis, coding for themes or other qualitative analysis methods of data analysis are performed on the interviews. They stand alone as unique perspectives.

It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to “generalizable knowledge” that they are not subject to the requirements of 45 CFR part 46 and, therefore, can be excluded from IRB review.

Secondary Analysis of Existing Data

Research involving the secondary analysis of existing data must be reviewed by the IRB to ascertain whether or not it requires IRB oversight.

Such research will be considered exempt if one or more of the following are true:

• The sources of such data are publicly available
• The information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
• The dataset has been stripped of all identifying information and there is no way that the data could be linked back to the subjects from whom it was originally collected

Such research will qualify for an expedited or full-board review if:

• The source of the data is not publicly available data and/or contains private identifiable information about living individuals

Content Experts/Consultants/Key Informant

It may not be necessary to get IRB approval if interview questions are with experts about a particular policy, agency, program, technology, technique, or best practice. The questions are not about the interviewee themselves, but rather about the external topic. For instance, questions will not include demographic queries about age, education, income or other personal information.

IRB review will be required when a researcher is interviewing individuals about content, but there is a research question or hypothesis involved and when a researcher intends to analyze and generalize the results–that look for common themes in the collected data, try to universalize the interviewees’ experiences, or quantify the results in some way.

Examples That May Be Excluded From IRB Review

In all the following examples, the questions are focused on the facts about the program, policy, software, curriculum, procedures or project. The researcher will simply report the facts as they are related by the content experts. You may not need to submit a protocol or an informed consent form for IRB approval if one or more of the following are true. You are,

• Interviewing managers in a company about their billing procedures, or their use of a particular software program
• Interviewing or surveying teachers about what should be included in the development of a particular curriculum unit
• Asking a panel of nurses and doctors to review your antismoking program for teens for correct medical content
• Interviewing social agency directors about their client intake procedures

Additional Resources

The following decision flowcharts can help you determine whether your project requires IRB oversight.

Is an Activity Research Involving Human Subjects?

Is the Human Subjects Research Eligible for Exemption?

TC IRB Submission Document Templates & Samples

Researchers working with human subjects must submit their research plans and any research-related documents to Teachers College (TC) Institutional Review Board (IRB) for review and approval. Researchers may not begin recruitment or research until IRB has issued a final approval letter on the protocol. 

Submission Document Templates

TC IRB has designed templates for most documents required for IRB submission. The templates are located in MyTC/Resources/TC Mentor IRB (right hand side), or accessible through the Submitting a New Protocol  page. 

• IRB Application Template : required for all submissions, including  exempt existing data .
• Informed Consent Form Template : for adults competent to consent.
• Parental Permission Form Template : required if the research includes youth under the age of 18.
• Assent Form Template  - for participants under the age of 18.

Note : The Informed Consent, Parent Permission, and Assent Form templates are designed using a three-color-code-scheme: 

• BLUE text includes suggestions from TC IRB where researchers can freely edit  
• RED text is tailored for your study
• BLACK text is standard and should be kept in the final consent form copy

The templates are not designed as one-size-fits-all documents. Instead, they are intended to help guide researchers through the most common submission contexts. Researchers should read through the templates carefully and consider their population of interest when creating final versions of documents. 

Researchers are responsible for informing individuals of the research study activities, expectations, risks, and potential benefits of study participation.

Sample Application Documents

When writing human subject research materials, investigators often use an academic writing style for both the IRB submission and participant materials. For information on distinguishing your writing style between a general and academic audience, please visit our  Writing for an IRB Review page.

In addition to writing style, new researchers may struggle with knowing how to frame their research study within a TC IRB application. To assist researchers in the writing process, TC IRB has identified common types of studies frequently used among TC researchers and created sample applications with relevant explanations. Following these sample applications does not guarantee a protocol will be approved or that a researcher will have a flawless review process. It does, however, offer some suggestions on how to frame materials for a formal IRB review.

• Exempt Category 4 - Existing Data Sample Application : This research does not involve new recruitment of human participants, and falls under  Exempt Review . Researchers hoping to conduct this type of research must still submit an IRB protocol through TC Mentor IRB, however, many questions on the application related to participant recruitment and study activities should be marked “Not Applicable.” For more information on existing data studies, please visit our Exempt Existing Data Guide .
• Review of Public Data (Exempt Category 4)
• Review of Existing Data (Exempt Category 4)
• Anonymous Online Surveys
• Audio-Recorded In-Person Interviews and Focus Groups

Sample Consent Documents

Language used on consent, parent permission, and assent forms should be tailored to the population of interest, taking into account the participants’ reading level and familiarity with research procedures. In all of these documents, researchers should aim to clearly state the following:

• The study activities
• The duration of time the activities will take
• Explanation of risks and benefits
• Compensation and any limits to receiving it
• Protections and limits of confidentiality

The consent samples outline different types of research studies and the information researchers should provide participants. Following these samples does not guarantee a protocol will be approved or that a researcher will have a flawless review process. It does, however, offer some suggestions on how to write consent materials for participants.

• Online Survey Consent Sample Form : This consent form is for an online survey conducted with adults competent to consent. The following survey was part of an exempt study which posed minimal risk to participants. The sample demonstrates how to explain an online study to participants, as well as possible ways to obtain consent through digital platforms.
• Audio Recorded Individual Interview and Focus Group Sample Form : This study pertains to in-person data collection with recorded elements. Researchers hoping to conduct interviews or focus groups over digital platforms (e.g., Zoom) may also use this sample as a guide.

For information specifically related to working with youth, please review  The Assent Process with Minors  Guide and the  Obtaining Parent Permission Guide. TC IRB reviewers also provide their insights into the consenting process on  TC IRB’s Blog , and in the TC Reviewer Questions .

Sample Memo Documents

Throughout the IRB process, circumstances may call for a Primary Investigator (PI) to follow-up with an IRB reviewer. These follow up actions may be required through modification memos or responses to IRB revision feedback. When planning to submit a new modification or respond to request for revisions, PIs should submit a memo style document describing their specific scenario, revisions to their protocol and documents, and a list of files associated with the change. To assist in the writing process and timeliness, the IRB has provided sample memos for PIs to follow. These samples do not guarantee a protocol approval or take place of the PIs specific responses, but can be used as a model for writing a memo.

• Modification Memo Sample : This Modification Memo Sample can be used as a model for PIs when requesting modifications to an active protocol. This sample provides a format as well as examples of the adequate amount of information necessary for IRB administrators to review.
• Revision Memo Sample :  This Revision Memo Sample can be used as a model for PIs to respond to specific IRB administrator requested revisions. Following this format allows for both PIs and IRB administrators to effectively communicate protocol revisions and feedback.

Institutional Review Board

Address: Russell Hall, Room 13

* Phone: 212-678-4105 * Email:   [email protected]

Appointments are available by request . Make sure to have your IRB protocol number (e.g., 19-011) available.  If you are unable to access any of the downloadable resources, please contact  OASID via email [email protected] .

IRB Sample Applications

The following applications and guidance documents are meant to assist new researchers in completing their IRB applications. PI permission has been obtained and PIs had the option of retaining their names on the application or removing identifying information.

These sample applications are meant for training University researchers in completing a Montclair State University IRB application. For any other use please contact the  IRB office for permission.

NOTE: Use of the content in these examples does not automatically confirm that your application will be approved. Each study and protocol is different and reviewed on a case-by-case basis under the guidance provided in the  IRB P&P Manual .

• Example 1: Interview/Focus Group: Sample Cayuse IRB Appliation
• Example 2: Online/Survey: Sample Cayuse IRB application
• Example 3: Online/Survey with compensation
• Example 4: School-Based research: Sample Cayuse IRB Application
• Example 5: Benign Behavioral Intervention: Sample Cayuse IRB Application
• Application Instructions: Exempt 1 Application Guidance – (existing classroom educational practices)

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The Three Types of IRB Review

IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.

Exempt Review

Studies that receive an exemption determination from IRB are exempt from the specific regulations and requirements in Title 45, Part 46 of the Code of Federal Regulations. Please note, however, that they are still considered human subject research.

If the proposed research involves no greater than minimal risk to participants and involves any of the following, it may qualify for exempt status in accordance with the revised Common Rule (effective January 21, 2019):

• Research, conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
• The identifiable private information or identifiable biospecimens are publicly available;
• Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
• The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA as “health care operations,” “research” or “public health”; or
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities and the information is subject to federal privacy standards and other requirements specified in the exemption [Refer to 45 CFR 46.104(d)(4) of the revised Common Rule]
• Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
• Taste and food quality evaluation and consumer acceptance studies.
• Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use. The exemption can only be used when there is broad consent from the subjects for the storage, maintenance, and secondary research use of their identifiable materials. [Refer to 45 CFR 46.104(d)(7), 46.111(a)(8), and 46.116(d) of the revised Common Rule.]
• Broad consent is obtained from the subjects for the secondary research use of their identifiable materials,
• Documentation or waiver of documentation of informed consent is obtained,
• An IRB conducts a limited review to make certain determinations relating to privacy and confidentiality protections and broad consent, and
• The investigator does not include returning individual research results to subjects as part of the study plan. [Refer to sections 45 CFR 46.104(d)(8), 111(a)(7) and 46.116(d) of the revised Common Rule]

Expedited Review

Studies that involve no more than minimal risk but which do not meet any of the above criteria for exempt status may be eligible for Expedited Review. According to the CFR, “ minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

If the proposed research presents no more than minimal risk, does not involve any vulnerable populations (i.e., children, prisoners, individuals with impaired decision-making capacity, and/or economically or educationally disadvantaged persons), and involves any of the following, it may qualify for Expedited Review.

• Collection of data from voice, video, digital, or image recordings made for research purposes.
• Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior), or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
• Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as for medical treatment or diagnosis).
• Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving X-rays or microwaves.
• Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (b) research on medical devices for which (i) an investigational device exemption application (21CFR 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
• Collection of blood samples by finger stick, heel stick, or venipuncture as follows: (a) from healthy, non-pregnant adults who weigh at least 110 pounds; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected.
• Prospective collection of biological specimens for research purposes by noninvasive means.
• Minor changes to research previously approved by the Lafayette IRB may also qualify for expedited review.

Full Review

If the proposed research does not qualify for Exempt or Expedited Review as defined above, it will be subject to a Full Review. In addition, if the proposed research involves any of the following, it will be subject to Full Review.

• Children under the age of 18
• Individuals with impaired decision-making capacity
• Economically or educationally disadvantaged persons
• Procedures that might cause physical harm.
• Procedures that might cause significant psychological/emotional distress.
• Collection of information about highly sensitive topics.
• Collection of information about illegal behavior.
• Collection of information that could seriously harm the participant legally, socially, financially etc. if other people could identify them.

Protocols requiring Full Review are vetted by the entire IRB and discussed at a convened meeting. Please see our Timing of the IRB Process web page for submission deadlines and meeting dates for Full Review protocols.

If you have questions about what type of review may be appropriate, contact the Chair of IRB at [email protected] prior to submitting a proposal. IRB, however, makes all final determinations of what level of review is required.

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Human Subjects & IRB

Accessibility disclaimer: To obtain information contained in document files on this page in an accessible format please contact the IU Human Research Protection Program (HRPP) at (317) 274-8289 or via email at irb@iu.edu

Forms & Templates

Kuali protocols form guides.

All IRB submissions must be created in Kuali Protocols.  The below Form Guides are meant as a tool for researchers to understand what information may need to be collected to complete the online IRB application in Kuali Protocols. The Form Guides are organized by Protocol Type and Submission Type.  Additional information on creating and submitting an IRB application in Kuali Protocols can be found in the Kuali Protocols instructional guides .

• Expedited/Full Board (Accessible 08/04/23)
• Exempt (Accessible 08/07/23)
• Request to Rely (Accessible 08/03/23)
• Not Human Subjects Research (Accessible 08/03/23)
• Humanitarian Use Device (HUD) (Accessible 08/02/23)
• Emergency Use (Accessible 08/02/23)
• Amendment (Accessible 05/21/21)
• Renewal (Accessible 08/16/22)
• Reportable Event (Accessible 08/03/23)
• Closeout (Accessible 08/16/22)

Informed Consent Templates

You are strongly encouraged to utilize sponsor-provided consent templates. If an informed consent template is not available for your study, the templates below can be used. For instructions and tips on writing informed consent documents, see IU HRPP Guidance on Informed Consent .

For use when the research primarily involves the study of specific diseases and conditions (mental or physical), treatment of diseases or conditions, or when the research is conducted in a patient treatment setting.

For use when the research focuses primarily on the understanding of social, behavioral, or educational processes, including research on human attitudes, beliefs, and behaviors as well as institutional and social function and processes.

• Study Information Sheet-Exempt Template (v01/19/21)  (Accessible 07/06/21)
• Assent Template (v10/01/23) (Accessible 10/04/23)

For use when treatment is being provided to a patient via an expanded access protocol.

• Non-English Informed Consent Documents

In order to promote readability of translated informed consent documents, the HRPP is no longer providing Spanish translations of the IU consent templates. If investigators anticipate enrolling subjects who do not speak English, the consent and other subject-facing documents should be translated as a whole, then submitted to the IRB for approval.

Translated short form consents are available below.  Please review the HRPP Policy on Informed Consent carefully prior to use of a short form consent.  Contact HRPP staff with any questions at [email protected] .

• Informed Consent Statement Short Form- Arabic (Accessible 09/26/22 )
• Informed Consent Statement Short Form- Burmese (Accessible 09/26/22 )
• Informed Consent Statement Short Form- Chinese (Accessible 09/26/22 )
• Informed Consent Statement Short Form- French (Accessible 08/05/24 )
• Informed Consent Statement Short Form- German (Accessible 09/26/22 )
• Informed Consent Statement Short Form- Haitian Creole (Accessible 08/05/24 )
• Informed Consent Statement Short Form- Hakha Chin (Accessible 09/26/22 )
• Informed Consent Statement Short Form- Russian  (Accessible 09/26/22)
• Informed Consent Statement Short Form- Spanish (Accessible 09/26/22 )
• Informed Consent Statement Short Form- Vietnamese  (Accessible 09/26/22)
• Interpreter Signature Page   (Accessible 09/26/22)

IRB Templates

• Protocol Template (v07/01/18) (Accessible 04/12/21)

NOTE: IU no longer requires a standalone HIPAA Authorization document.  Authorization language can be incorporated into the Informed Consent Statement.  See Informed Consent Document Template – Biomedical above for suggested language.

• HIPAA Authorization Template - Spanish (v01/21/19) (Accessible 07/18/19)
• HIPAA Authorization Template - Minors (v01/21/19) (Accessible 07/03/19)
• HIPAA Authorization Template - Minors - Spanish (v01/21/19) (Accessible 07/03/19)
• Case Study Consent/Authorization Template (v12/01/21) (Accessible 12/09/21)
• NIH sIRB–Communication Plan Template (v01/25/18) (Accessible 07/22/19)

Non-Affiliated Personnel Attestations

• Non-Affiliated Research Personnel Attestation (v01/21/19) (Accessible 07/22/19)
• Exempt Non-Affiliated Research Personnel Attestation (v11/5/19) (Accessible 07/16/21)
• Agreement to Extend FWA to Non-Affiliated Research Personnel (v07/01/2020)  (Accessible 07/16/21)

Additional Resources

Iu simon cancer center.

IU Simon Cancer Center (IUSCC) Scientific Review Committee (SRC) is required for prospective cancer-related research utilizing IUSCC patients or resources.

Note: Documentation of SRC approval is required at time of IRB submission unless an exception has been granted.

VA Research Documents

• VA Informed Consent Template (v08/01/21) (Accessible 08/13/21)
• For the VA HIPAA Authorization Form and the VA Investigational Drug Information Record form, search the US Department of Veterans Affairs forms . To ensure you are directed to the correct form, type the form number in the search field.

To obtain additional documents, contact the VA compliance office or search the US Department of Veterans Affairs forms .

The Indiana University Human Research Protection Program (HRPP) provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.

Indianapolis (Main):

• Phone: (317) 274-8289
• Email: [email protected]

Bloomington:

• Phone: (812) 856-4242
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Office of Research & Innovation

Irb forms / templates - office of research & innovation, irb forms & templates, new  read this first.

As of 21 January 2019, new Federal, DoD, and DON Human Research Protection Program (HRPP) policies are in effect. The policy updates will immediately and substantially change the manner in which human subjects research activities are submitted, reviewed, approved, and conducted at NPS. These changes are intended to address and recognize evolving technologies that have impacted modern research activities, to account for new kinds of research that have been developed, and to facilitate the conduct of minimal risk research.

For those faculty, staff, and students who have already had their IRB protocols approved, these new policy updates will not impact their research.  These changes will only impact new research that begins after the 21 January implementation date and long-term protocols (which exceed one calendar year) that will be transitioned to the new policy requirements.

Choose the relevant tab below for the forms appropriate for your protocol.

Note:  If you are having issues with any of the PDF documents below, please download the files and open with Acrobat Reader or Acrobat Pro.

• Post-21 Jan 2019 Protocols
• Pre-21 Jan 2019 Protocols

IRB Student Research Checklist

Students complete this checklist when writing their dissertation proposal, thesis proposal, or project plan. If student research involves any of the activities listed in the checklist a Human Subject Determination Request or IRB Initial Review Package must be completed and submitted to the IRB for review.

• IRB Student Research Checklist (updated 22 Jan 2019)

Human Subject Research Determination Request

Not sure if you are conducting human subjects research? Request a determination!

• Determination Request Form  (updated 03 Oct 2023)

Initial Review Package (new research)

• Consolidated IRB Application (updated 28 Dec 2022)
• Scientific Review Form (updated 11 May 2021)
• Conflict of Interest Form (updated 22 Jan 2019)
• Standard Consent Form   (updated 27 Oct 2023)
• CITI Ethics Training Completion Report
• Recruitment script (if applicable, see Question 17 of IRB Application )
• All questionnaires, interview questions, or other materials to be used (if appropriate)
• Research proposal (student, SOW, funded)
• Organizational approval to conduct research from subjects command

Protocol Amendment Package (modify research)

• Revise your initial protocol submission by completing parts 1 and 3.
• Copy of any revised documents (consent form, data collection tools, recruitment script, etc.).
• CITI Ethics Training Include completion Report for any additional researchers

Research Protocol Check-In

• PI’s are required to complete a Research Protocol Check-in (RPC) and provide a status of the research at an interval determined by the IRB.  The check-in date is provided on the IRB approval letter. Complete by clicking this link:  Research Protocol Check-in

Continuing Review Package (extend approval period)

• Revise your initial protocol submission by completing parts 2 and 3.

Closing Research Protocol

• Final Report (previously known as End of Experiment Report)  (updated 22 NOV 2022)

Submit complete packages to the Human Research Protection Program Office through email at [email protected] or in hard copy in Halligan Hall Room 206.

• Determination Request Form (updated 26 Jan 2023)
• IRB Application  (updated 24 Mar 2017)
• Scientific Review Form  (updated 8 Mar 2017)
• Conflict of Interest Form
• Standard Consent  (updated 4 Feb 2019)
• Online Survey Consent  (updated 22 May 2018)
• CITI Ethics Training  Completion Report 
• Recruitment script (if appropriate, see Question 17 of  IRB Application )
• Amendment Form  (updated 28 Feb 2017)
• CITI Ethics Training  and updated Conflict of Interest Form for any additional researchers
• Continuing Review Form  (updated 28 Feb 2017)

Submit complete packages to the Human Research Protection Program Office through email at  [email protected]  or in hard copy in Halligan Hall Room 206.

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Contact the IRB

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Home » Institutional Review Board – Application Sample and Approval Guide

Institutional Review Board – Application Sample and Approval Guide

Table of Contents

Institutional Review Board (IRB)

Institutional Review Board (IRB) is a committee responsible for reviewing and approving research proposals involving human subjects. An IRB ensures that the proposed research meets ethical and legal standards to protect the rights and welfare of the participants.

Purpose of Institutional Review Board

Some specific purposes of an IRB include:

• Ensuring that the rights and welfare of human subjects are protected. This includes ensuring that participants are fully informed about the study and have given their informed consent to participate.
• Assessing the risks and benefits of the research study. An IRB must evaluate the potential risks to participants and ensure that the benefits of the research outweigh any potential harms.
• Reviewing the study design and methods. The IRB must ensure that the study is designed in a way that minimizes risks to participants and that the methods used to collect data are ethical.
• Monitoring ongoing studies . An IRB must ensure that studies are conducted in accordance with the approved protocol and that any changes to the study are reviewed and approved by the IRB.
• Ensuring compliance with regulatory requirements . An IRB must ensure that studies are conducted in compliance with applicable laws and regulations, such as the Common Rule and the Health Insurance Portability and Accountability Act (HIPAA).

Institutional Review Board Guidelines

Here are some general guidelines that IRBs follow:

• Informed Consent : Researchers must obtain informed consent from all participants. This means that the participants must be fully informed about the study, including its purpose, procedures, risks, and benefits, and they must be given the opportunity to ask questions and decide whether or not they want to participate.
• Risk Assessment: The IRB must assess the risks associated with the research and determine whether they are reasonable in relation to the potential benefits. The IRB must also consider ways to minimize risks and protect participants.
• Confidentiality : The IRB must ensure that the confidentiality of the participants is protected. This may involve using pseudonyms, removing identifying information, or limiting access to data.
• Privacy : The IRB must ensure that participants’ privacy is protected. This may involve conducting the research in a private setting or using measures to prevent unauthorized access to participants’ personal information.
• Conflict of Interest : The IRB must ensure that researchers do not have a conflict of interest that could bias the study results. Researchers must disclose any potential conflicts of interest to the IRB.
• Review and Monitoring : The IRB must review and monitor the study to ensure that it continues to meet ethical standards. The IRB has the authority to suspend or terminate a study if it determines that it is no longer ethical or safe.

How to Get IRB Approval

Here are the general steps to obtain IRB approval:

• Determine if your study requires IRB approval : IRB approval is required for any research study involving human subjects, which includes collecting data through interviews, surveys, or experiments.
• Complete required training: Many IRBs require that researchers complete training in the responsible conduct of research and human subjects protection.
• Develop the study protocol : The study protocol should describe the research question, methodology, recruitment and consent procedures, and data collection and analysis plans.
• Submit the IRB application : Once the study protocol is developed, submit the IRB application to your institution’s IRB. The application will include the study protocol, consent forms, and any other required documents.
• Respond to any requests for revisions : The IRB may request revisions to the study protocol or consent forms before granting approval.
• Receive IRB approval: Once the study protocol is approved, you may begin your research study.

Institutional Review Board Example

Here is an example of an IRB:

Let’s say that a researcher wants to conduct a study on the effects of a new medication on patients with depression. The study would involve giving the medication to a group of patients and monitoring their symptoms over a period of several months. Before the study can begin, the researcher must submit a detailed research protocol to the IRB.

The IRB will then review the protocol to ensure that the study meets certain ethical standards. For example, the IRB will want to make sure that:

• The risks to the participants are minimized and are reasonable in relation to the potential benefits of the study.
• The participants are fully informed about the nature of the study and have given their informed consent to participate.
• The confidentiality of the participants is protected.
• The study design is scientifically sound and will yield reliable results.

If the IRB determines that the study meets these and other ethical standards, it will issue a formal approval letter. The researcher can then begin the study, but must continue to follow the protocol and report any adverse events or other issues to the IRB. The IRB may also conduct periodic reviews of the study to ensure that it continues to meet ethical standards.

Institutional Review Board Proposal Sample

Here is a sample proposal for an Institutional Review Board (IRB) submission:

Title : Effects of Meditation on Stress Reduction in College Students

Introduction:

Stress is a common issue among college students, and it can have negative effects on academic performance and overall well-being. Meditation has been shown to be an effective tool for reducing stress and improving mental health. However, the effectiveness of meditation for stress reduction in college students has not been well-studied. This study aims to investigate the effects of a meditation intervention on stress reduction in college students.

Objectives:

The main objective of this study is to determine if a meditation intervention is effective in reducing stress levels in college students. Secondary objectives include assessing the feasibility and acceptability of the intervention and exploring potential moderators of the intervention’s effectiveness.

Participants will be recruited from a large university campus and randomly assigned to either a meditation intervention or a waitlist control group. The meditation intervention will consist of eight weekly 60-minute group meditation sessions led by a certified meditation instructor. The waitlist control group will receive the intervention after the study is completed.

Participants will complete self-report measures of stress, anxiety, and depression at baseline, post-intervention, and 1-month follow-up. Demographic information and previous experience with meditation will also be collected. Intervention participants will also complete measures of intervention satisfaction and adherence.

Data Analysis:

Descriptive statistics will be used to summarize demographic and baseline variables. Independent samples t-tests and chi-squared tests will be used to compare groups at baseline. Repeated-measures analysis of variance (ANOVA) will be used to compare changes in stress, anxiety, and depression between groups over time. Moderation analyses will also be conducted to examine potential moderators of intervention effectiveness.

Ethical Considerations:

Participants will provide informed consent prior to participating in the study. All data will be kept confidential and stored securely. The study has been approved by the university’s Institutional Review Board.

Conclusion:

This study will provide valuable information about the effectiveness of meditation for stress reduction in college students. If the intervention is found to be effective, it may have important implications for promoting mental health among this population.

Advantages of Institutional Review Board

Here are some advantages of IRBs:

• Ethical Review : IRBs ensure that research studies are conducted in an ethical manner and that the rights and welfare of human subjects are protected. This includes ensuring that informed consent is obtained, risks are minimized, and benefits outweigh potential harms.
• Compliance : IRBs help ensure that researchers comply with relevant laws and regulations governing human subjects research, such as the Common Rule, HIPAA, and FDA regulations.
• Expertise : IRBs are typically composed of individuals with diverse expertise, including scientists, ethicists, and community members. This expertise allows IRBs to provide valuable feedback to researchers and ensure that research studies are well-designed and scientifically sound.
• Transparency : IRBs provide transparency in the research process by reviewing study protocols, monitoring ongoing research activities, and ensuring that study results are reported accurately.
• Trust : IRBs help build trust between researchers and the public by ensuring that research studies are conducted in a responsible and ethical manner. This can enhance the credibility and reputation of researchers and institutions conducting the research.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Research at Brown

Does my project need irb review, decision chart | comprehensive comparison table | definitions  | public health surveillance.

Brown's IRB has assured federal regulatory agencies that the institution will review and approve all research that meets the federal definition of human subject research . Determining whether or not a project meets the federal definition of human subjects research is a two-step process. The investigator must first determine if the project meets the federal definition of research and, if so, then determine if the project includes human subjects. 

In addition to the information below, the Brown HRPP has provided self-assessment resources for students and researchers to use to determine if their project requires IRB review:

• The Self-determination tools and checklists are guides to assist Brown researchers in complying with federal regulations and institutional policy. 
• The NIH Decision Tool: Am I Doing Human Subjects Research? Developed by NIH to help you determine if your research involves human subjects, may be exempt from federal regulations, or is not considered human subjects research.
•   Is it Human Subjects Research? Is IRB Review Required?  educational video from HRPP's Learning Library .  

Decision Chart

A decision chart to help guide researchers in making a determination of whether they're conducting human subject research and need to submit an IRB Application.

Step 1: Is your Project Considered Research?

Federal regulation defines "research" as a systematic investigation, including research development, testing, and evaluation, that is designed to develop or contribute to generalizable knowledge.

Systematic Investigation ​

A "systematic investigation" is a detailed or careful examination that has or involves a prospectively identified approach to studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory based on a system, method, or plan. Systematic investigations include observational studies, interview or survey studies, group comparison studies, test development, and interventional research. Projects that are not systematic investigations include, for example, oral histories, journalism, and phenomenological activities. Program evaluation is seen as a gray area and requires further assessment of design and intent.

Generalizable knowledge

Developing or contributing to "generalizable knowledge" means that the intent or purpose of the systematic investigation is to produce knowledge from which conclusions will be drawn that can be applied to populations outside of the specific study population. This usually includes one or more of the following concepts:

• knowledge that contributes to a theoretical framework of an established body of knowledge;
• the primary beneficiaries of the research are other researchers, scholars, and practitioners in the field of study;
• dissemination of the results is intended to inform the field of study (this alone does not make an activity constitute research “designed to contribute to generalizable knowledge”);
• the results are expected to be generalized to a larger population beyond the site of data collection;
• the results are intended to be replicated in other settings.

If your project is not considered research, you do not need to submit an IRB application. If your project does meet the definition of research, proceed to Step 2.

_______________________________________________________________________________________________________________________________________________________

Step 2: Does it involve human subjects?

The Federal Policy for the Protection of Human Subjects (Common Rule) defines a human subject as “…a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

Examples that do not meet the definition of Human Subjects:

• Analysis of data about people who are deceased
• Secondary analysis of anonymous data
• Interviews with “key informants” about topics other than themselves

Note that the definition of human subject focuses on what information is obtained about people or material that is acquired from people. If either of the following is true, your research activity involves human subjects:

If your project does not include human subjects, you do not need to submit an IRB application.

Comprehensive Comparison Table

A comprehensive comparison table to assist students and researchers with distinguishing whether a project qualifies as human subject research, quality assurance/quality improvement, program evaluation, a student project or scholarly & journalistic activities.

Definitions

Data about living individuals through intervention or interaction.

An intervention may be physical procedures (e.g. venipuncture) or manipulations of living individuals or the living individuals’ environments.

An interaction may be communication or interpersonal contact between the investigator (or research team) and the living individual. Examples include interviews, questionnaires, surveys, observations, manipulations of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), and administration of experimental drugs or devices.

Why “about whom” is key

Consider if the project focuses on the person or if the focus is on policies, practices or procedures about which the person is knowledgeable. Projects which collect information about policies, practices or procedures – even if the person who provided that information is identified – do not constitute human subject research.  Asking a person about someone else does not make that person a human subject.

Identifiable private information about living individuals

Identifiable means 1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator; or 2) the identity of the individual from whom the information was obtained is associated or may be readily associated with the information.

Private Information is information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g. medical record, employee or student records).

Examples of identifiable, private information include the subject’s name, address, phone number, social security number, medical record number, student or employee identification number, or in some cases, the combination of data such that they can identify a single individual through deductive reasoning. For example, data about employer, job title, age and gender may not individually identify a subject, but when combined, could in certain cases, identify a specific individual.

What is NOT considered identifiable, private information :  If the information cannot be linked to a living individual, or is considered public or is given with the expectation that it will be made public and that it will be linked to the individual (e.g. biography or news story), then it would not be considered private identifiable information. For example, use of a publicly available data set that does not contain identifiers or codes linked to individuals does not involve human subjects research. However, use of a publicly available data set that does contain identifiers or codes linked to individuals does involve human subject research.

If you obtain/purchase/are given specimens/cells/material/data that has already been collected by someone else for some other purpose, and the specimens/cells/material/data are not linked to any identifiers that would make it reasonably possible to identify an individual, the activity is not considered research with human subjects.

If your activity does not involve human subjects as defined in the regulations, your activity does not fall under the purview of the IRB. You do not need to submit an application.

If you have determined that your research does meet the federal definition for human subjects research, you will need to apply for IRB review and approval before you begin ( the IRB can not review projects retrospectively ).

Still unsure or require documentation that your project does not need IRB review?

If you are unsure if your project meets the definition of research, or if you require documentation that your project does not require IRB review, please contact the HRPP at (401) 863-3050 or [email protected] to discuss. If you are a student, we strongly encourage you to first work with your advisor / mentor to discuss whether the proposed project meets the definition of human subjects research before contacting the HRPP. 

If you have questions, please contact us at 401-863-3050 or [email protected] .

Explore Brown University

• Submitting to the IRB
• Types of Reviews

Exempt Review

Updates to Exempt Studies

Restrictions on exemptions.

OHRP Exempt Categories

Exempt human subjects research is a specific sub-set of “research involving human subjects” that does  not   require ongoing IRB oversight. Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. Studies that qualify for exemption must be submitted to the IRB for review before starting the research. Pursuant to NU policy, investigators do not make their own determination as to whether a research study qualifies for an exemption — the IRB issues exemption determinations. There is not a separate IRB application form for studies that could qualify for exemption – the appropriate protocol template for human subjects research should be filled out and submitted to the IRB in the eIRB+ system.

Although the HHS IRB regulations list eight exemption categories, NU has opted to implement six of those categories at this time (see the list below). Of the six exemption categories listed below, only exemption category 6 (for taste and food quality evaluation and consumer acceptance studies) applies to studies that are FDA-regulated.

The Belmont principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether or not to participate in research. For this reason, voluntary informed consent should be obtained from participants for any exempt research where the investigator will be collecting data through interaction with participants. For exempt research studies that will collect data through interaction with participants, the NU IRB expects that researchers provide participants with consent information that includes, at a minimum:

• An explanation that they are being asked to participate in a research study.
• The identity and affiliation of the researcher.
• A clear description of the study procedures and how data will be used in the future.
• A statement that participation in the research is voluntary.
• Contact information for questions and concerns about the research.

Studies that qualify for an exemption do not undergo continuing review. Additionally, modifications do not need to be submitted for exempt studies so long as the research remains minimal risk and stays within the boundaries of the exemption categories that the IRB found were applicable to the research.

It is a best practice recommendation to create a note-to-file in your research record to document the changes you make and your determination that these updates did not change the scope of the study or risk to participants.  You can download a template note-to-file template on the IRB Office’s  Study Support Resources and Templates  webpage.

If your proposed changes constitute any of the following, submit a track change version of the protocol you submitted to the IRB in a new IRB application using the “copy submission” function in eIRB+:

• add procedures that could affect risks to participants; or
• add procedures that do not fit within the exemption categories; or
• add new types of participants to your study that include vulnerable populations (e.g., adding children, individuals with cognitive impairments, prisoners, etc.)
• change of Principal Investigator

Examples of updates that would likely require IRB review:

• Removal of the consent process, or use of deception or incomplete disclosure.
• Significant changes to the recruitment procedures.
• Adding sensitive questions to a survey or interview process (e.g. questions regarding illegal activities; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation).
• Collection of new or additional identifiable information.
• Changes to the data storage plan which may affect confidentiality.
• Adding any new physiological measures that were not already determined to be exempt. 

Exempt studies may also be subject to the HIPAA Privacy Rule. For instance, a study involving medical record review to gather a dataset that would be eligible for Exemption Category 4 involves access to Protected Health Information (PHI) and should request a waiver of HIPAA authorization.

• Studies that are greater than minimal risk do not qualify for exemption.
• Exemptions  do not apply  to research with  prisoners , except for research aimed at involving a broader subject population that only incidentally includes prisoners.   [45 CFR 46.104(b)(2)].
• Exemption 2(iii) and Exemption 3  do not apply  to research with children.
• Exemptions  other than  Exemption Category 6  do not apply  to FDA-regulated research.

OHRP Exempt Categories 45 CFR 46.104 – (HRP-312)

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

• Evaluating the use of accepted or revised standardized tests
• Testing or comparing a curriculum or lesson
• A program evaluation of pharmacy continuing education

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

• The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects cannot be readily ascertained, directly or indirectly through identifiers linked to the subjects; OR
• Any disclosure of Human Subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
• The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects can be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review. (See “WORKSHEET: Limited IRB Review (HRP-319).”)
• Surveying teachers, nurses, or doctors about a technique or an outcome
• Interviewing managers about a management style or best practice
• Conducting a focus group about an experience or an opinion of a community program

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

• The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects cannot readily be ascertained, directly or indirectly, through identifiers linked to the subjects; OR
• Any disclosure of the Human Subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR

(i) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

(ii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

• Healthy adult subjects are asked to take part in two two-hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software.  The procedures are conducted during a single visit, and subjects are encouraged to take breaks when desired.

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

• The identifiable private information or identifiable biospecimens are publicly available; OR
• Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; OR
• The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164 (HIPAA), subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); OR
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Note: Exemption Category 4 only applies to the re-use of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study. The research materials typically will be publicly available materials, medical records, or existing repositories of clinical specimens. No contact between investigator and subject is allowed. If an investigator wants to collect information/specimens directly from research subjects, then another IRB review path will be required. Exemption Category 4(iii) only applies to the use of data (when HIPAA applies) and  not to biospecimens.

• A researcher is given two datasets that contain private, identifiable information. The researcher uses the identifiers to merge the two datasets but strips the resulting (merged) data of identifiers immediately after the merge and before conducting data analysis. The resulting data used for the analysis is completely de-identified with no link to identifiers.

Research and demonstration projects which are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine: public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the Dept. of Agriculture

Human Subjects Research Project Proposal

All principal investigators (PI) and student investigators (both undergraduate and graduate level) are required to be trained in Human Subjects Research before the beginning of their data collection. You still can apply to the IRB for approval without the completion of the course. However, your research project will be voided without the proof of proper training. Student researchers must consult with their PI to choose appropriate training module to take.

• To start, click on the following link:  https://about.citiprogram.org/en/homepage/
• Once you get to the above website, you must register (click on register tab at the top right corner). You must affiliate yourself with Briar Cliff University. The steps to register are user-friendly and easy to follow.
• When you get to the drop-down menu called “Roles in research, ” the student researcher must select either “Student researcher - Graduate level” or “Student researcher - Undergraduate level” and the PI must choose “Principal investigator.”
• Before finishing registration, you are directed to the site to choose the training module. These are divided into seven categories, from “Question 1” to “Question 7.” Both the PI and student investigator must choose at least one item (one training module) that is appropriate with your research project under “Question 1: Human Subjects Research.”
• The rest of the categories are not required at this time since IRB members are going over each of the modules under all categories to specify the assignment for BCU researchers. However, if the researchers (especially PI) have strong feelings to take additional training modules in different categories, you are free to take them.
• Principal investigators must consult your student researcher(s) for choosing the right training modules. The IRB will more specifically assign them soon.
• Once the training is finished, students/PI must email their link to the certificate or their scanned copies (a completion certificate only, not the one with your score) to Wendy Brame at [email protected] . Please specify whether you are a faculty or a student when you send your certificate.

Submit Your Research Project Proposal

Use the following form to submit your human subjects research project proposal to the Institutional Review Board at Briar Cliff University. As a deliberative body, the IRB will approve, approve with required modifications, or disapprove research protocols which are submitted.

For questions regarding an individual's rights as a participant or other questions regarding a particular research project, contact the Chair of the Briar Cliff IRB Committee .

Forms with attachments can sometimes take a little longer to submit, so please be patient and do not refresh your page after submitting your proposal.

• Find My GCO
• IACUC applications (Cayuse Animal Management System)
• IBC Applications (eMUA)
• IRB Applications (RASS-IRB) External
• Institutional Profile & DUNS
• Rates and budgets
• Report external interests (COI)
• Join List Servs
• Ask EHS External
• Research Development Services
• Cornell Data Services External
• Find Your Next Funding Opportunity
• Travel Registry External
• RASS (Formerly Form 10 and NFA) External
• International research activities External
• Register for Federal and Non-Federal Systems
• Disclose Foreign Collaborations and Support
• Web Financials (WebFin2) External
• PI Dashboard External
• Research metrics & executive dashboards
• Research Financials (formerly RA Dashboard) External
• Subawards in a Proposal
• Proposal Development, Review, and Submission
• Planning for Animals, Human Participants, r/sNA, Hazardous Materials, Radiation
• Budgets, Costs, and Rates
• Collaborate with Weill Cornell Medicine
• Award Negotiation and Finalization
• Travel and International Activities
• Project Finances
• Project Modifications
• Research Project Staffing
• Get Confidential Info, Data, Equipment, or Materials
• Managing Subawards
• Animals, Human Participants, r/sNA, Hazardous Materials, Radiation
• Project Closeout Financials
• Project Closeout
• End a Project Early
• Protecting an Invention, Creation, Discovery
• Entrepreneurial and Startup Company Resources
• Gateway to Partnership Program
• Engaging with Industry
• Responsible Conduct of Research (RCR)
• Export Controls
• Research with Human Participants
• Research Security
• Work with Live Vertebrate Animals
• Research Safety
• Regulated Biological Materials in Research
• Financial Management
• Conflicts of Interest
•   Search

IRB Policy: #13 Informed Consent, Enrollment, and Other Considerations for Research Involving Normal, Healthy Participants

This document sets forth the additional requirements for obtaining IRB approval for research involving normal, healthy participants, as well as special considerations concerning informed consent and enrollment of normal, healthy participants.

SOP 13: INFORMED CONSENT, ENROLLMENT, AND OTHER CONSIDERATIONS FORRESEARCH INVOLVING NORMAL, HEALTHY PARTICIPANTS

Human Subjects Office

August 2024 irb connection newsletter, tips for web-based survey research platforms, student pi training requirement: reminder to faculty advisors and student pis, assistance for new faculty and research scientists: research navigation tool, icts clinical lecture series: working with the irb, updates for the ui research community, in the news, irb educational resources.

The Human Subjects Office (HSO) has published a new educational tool focused on two of the web-based survey research platforms that are available to faculty, staff, and students at the University of Iowa. The publication provides tips on using Qualtrics and REDCap, including the different features available on the platforms, as well as tools for avoiding common issues, such as over-enrollment, multiple survey submissions, and bot activity.  

Topics addressed in the educational tool include:  

survey testing  

survey editing  

creating logic quotas and  

bot detection  

institutional policies related to survey-based research  

training and other support available   

The new educational tool is available on the HSO website: Survey Based Research Educational Tool    

Student PI Training Requirement: Reminder to Faculty Advisors and Student PIs  

Graduate and undergraduate student principal investigators (PIs) are required to view recorded trainings about the HawkIRB New Project form (Parts 1 and 2) prior to submitting an application in HawkIRB. While the training is required for student PIs, it is recommended for all new faculty, staff, residents, fellows, professional students, and HawkIRB Delegates who will be using the HawkIRB system.  

The student PI training policy was instituted to improve the quality of HawkIRB submissions and ensure efficiency of the IRB review process for all IRB applications. The training, available in the IRB ICON Course for Researchers , will assist student PIs in navigating the HawkIRB system and preparing thorough HawkIRB applications. Note to Faculty advisors and others who work with student PIs : Please make sure graduate and undergraduate student PIs know to complete this training.  

More information is available about the training requirement at Roles and Responsibilities / Role of the Student PI , and more detailed information in the September 2022 IRB Connection Newsletter article .   

Other educational resources are also available on the Human Subjects Office website :  

IRB Overview Recording – If you did not hear this in a research methods course, you can access it in the IRB ICON Course for Researchers .  

Do I Need IRB Approval – if you are uncertain whether your project is human subjects research requiring approval from the UI IRB ( Get Started / Do I need IRB Approval )  

Exempt Status – Most social/behavioral research qualifies for Exempt Status. You can read about this in the Exemption Tool (under Get Help / Educational Tools ) and learn about it in the Part 5 HawkIRB training in the IRB ICON Course for Researchers .  

HawkIRB Submissions – There is additional information about the IRB Review Process, HawkIRB System and New Project forms on the Submit to IRB web page.  

Assistance for New Faculty and Research Scientist s : Research Navigation Tool   

By emily shultz, cip  .

UI Research Administration units use a Research Navigation Tool to begin the onboarding process for new UI faculty and research scientists. This tool provides information about a wide range of UI programs that provide support for research. This tool collects information about the nature and type of research you conduct to help us better assist you with setting up your research program.  

Click here to use the Research Navigation Tool  

On a monthly basis, HSO staff sends an email with a link to the tool to all new faculty and research scientists. Based on research plans indicated in the Research Navigation Tool, representatives from the following units contact the researcher to provide guidance and support for transferring or initiating research activities:   

Office of the Vice President for Research (OVPR)  

Research Development Office (RDO)  

Division of Sponsored Programs (DSP) (work with the departmental grant administrator)

Human Subjects Office (HSO) and Institutional Review Board (IRB)  

Offices of Animal Resources (OAR) and the Institutional Care and Use Committee (IACUC)  

Environmental Health & Safety (EHS)  

University of Iowa Research Foundation (UIRF)  

Institute for Clinical and Translational Science (ICTS)  

Information Technology Systems (ITS)  

For researchers who work with human participants, the Human Subjects Office offers a one-on-one IRB orientation to provide guidance, resources and support. This session provides information about:   

The Human Research Protection Program (HRPP)  

The IRB review process and requirements for submission  

Other committees or entities that review and approve human subjects research applications  

Features of the eResearch application system (HawkIRB), including the delegate permission system  

Educational resources available for all human subjects researchers  

Contact the IRB Education & Outreach team to learn about other educational resources for faculty and research scientists.  

ICTS Clinical Lecture Series: Working WITH the IRB  

By kelly o’berry , bs, cip and deb o’connell-moore, mba  .

At the June Clinical Lecture Series hosted by the Institute for Clinical and Translational Science (ICTS), Kelly O’Berry and Deb O’Connell-Moore provided an overview of the working relationships between researchers and the Institutional Review Board (IRB) / Human Subjects Office (HSO).   

Novel Research Methods  

Researchers are encouraged to consult with colleagues in their college or department to see if others have received IRB approval for similar procedures, as their insights and experience could be helpful. Researchers can also consult with HSO staff and IRB Chairs about novel research methods. An advance consult can help the HawkIRB application go through the IRB review process more smoothly.  

Ask Questions  

HSO staff invite researchers to ask questions and seek guidance at any time, but especially prior to submission of forms in HawkIRB. HSO staff can be reached phone (319-541-0326), email ( [email protected] ) or at IRB Office Hours via Zoom .   

The ICTS Regulatory Core is also available to assist with their virtual walk-in hours for guidance and support .  

Request Clarification  

During the IRB review process, HSO staff typically communicate with researchers through HawkIRB Workflow. This satisfies a regulatory requirement to maintain records of communications between the IRB and the PI. Researchers are encouraged to ask for clarification about a Workflow question/request if they are unsure of how to best address the revision.   

To review a recording of this ICTS Clinical Lecture Series presentation, go to the IRB ICON Course for Researchers .  

Updates for the UI Research Community  

Changes Coming to ClinicalTrials.Gov Platform  

(link sends e-mai

• Dementia Risk Factors Identified in New Global Report Are All Preventable - Addressing Them Could Reduce Dementia Rates by 45% - The Conversation  
• Black employees more likely to experience depression after workplace mistreatment – Newswise  
• First NonInvasive Method to Continually Measure True Blood Pressure – Science Daily  
• Parents' eating behavior influences how their children respond to food – Science Daily  
• Blood Test Uses 'protein clock' to predict Risk of Alzheimer's and other diseases – Nature  

IRB Educational Resources   

Irb presentation : the roadmap to regulatory compliance: guidelines for clinicaltrials.gov registration & results reporting  .

This presentation will clarify the key aspects of ClinicalTrials.gov registration and results reporting, with an overview of guidelines and practical tips to avoid common errors that researchers encounter during this process. By the end of this presentation, participants will have a clear understanding of how to meet the Food and Drug Administration Amendments Act ( FDAAA 801 ) standards and ClinicalTrials.gov requirements, ensuring successful trial registration and reporting.  

Overview of the ClinicalTrials.gov database  

Which trials need registration & results reporting?  

How to Register a study, Report Results, and Update Records  

Common errors during registration, and results reporting, and how to avoid them  

Navigating the PRS Support System and Help content  

Overview of ClinicalTrials.gov PRS Beta website

Wednesday, September 18, 2024  

12:00 PM-1:00 PM  

Pre-register to receive the Zoom link  

IRB Efficiency Initiative Monthly Information Session

The Human Subjects Office invites the UI research community to attend monthly information sessions about the IRB Efficiency Initiative on the fourth Wednesday of the month from 12-1 pm, via Zoom. We will discuss the changes and demonstrate HawkIRB enhancements being implemented to streamline the IRB review process. The monthly sessions will cover upcoming enhancements and expected roll-out dates.   

Wednesday, September 25, 2024  

Office Hours  

Human Subjects Office staff host IRB Office Hours via Zoom to provide assistance with electronic IRB applications (in HawkIRB) and to discuss study proposals prior to submission.  All researchers are welcome to attend. No appointment is necessary.  

Fall Office hours will begin on September 4 th through December 19 th  

Wednesdays (2:00-4:00 PM) via Zoom    

Thursdays (10:00 AM-12:00 PM) via Zoom  

Recorded Training  

The IRB ICON Course for Researchers HawkIRB training sessions provide an orientation to the electronic IRB application and review system. These sessions are for anyone preparing to submit a HawkIRB application for the first time and for those who would like guidance about the proper completion of HawkIRB forms. Five recorded trainings are available 24/7.   

The recorded trainings are available on ICON at IRB ICON Course for Researchers .   

Note: HawkIRB training Parts 1 and 2 satisfy the Student PI Training Requirement.