Academic researchers rely on Institutional Review Boards (IRBs) to get work done. IRB requirements are a central pillar of research program operations. Studies run by universities must meet these requirements, including informed consent, risk minimization, equitable participant selection, and privacy protections, in order to receive Institutional Review Board approval.
When IRB applications stall, it’s because research teams miss documentation details or structure incentives in ways that raise compliance concerns.
This is your hands-on guide to requirements for IRB approval. You’ll learn how to structure your protocols, prepare comprehensive documentation, and properly handle research incentives so you can avoid approval delays.
For a general overview of what IRBs are and how they work, explore our complete guide to Institutional Review Boards.
Checklist: Core IRB approval requirements at a glance
Before an IRB approves your research program, it must confirm your study meets all of the following criteria. These requirements come from federal regulations: 45 CFR 46.111 for Health and Human Services (HHS)-funded research, and 21 CFR 56.111 for Food and Drug Administration (FDA)-regulated studies.
Use this checklist to ensure your study meets basic IRC requirements.
Risks are minimized. Your study design shouldn't expose participants to unnecessary risk. Use procedures already being used for diagnosis or treatment whenever possible.
Risks are reasonable relative to benefits. Any potential knowledge your research team gains and any direct benefits participants receive must justify the risks involved. IRBs can't count participant payments as a benefit in this calculation.
Participant selection is equitable. Research teams can’t target vulnerable groups just because they're easier to recruit. Selection criteria must make sense for your research goals.
Informed consent is obtained and documented. Panelists or their legal representatives must understand what they're agreeing to when they participate in a study, per 45 CFR 46.116 requirements.
There's a plan to monitor participant safety. For studies with ongoing risk, you need adequate provisions to track data and protect participants throughout the study duration.
Privacy and confidentiality are protected. Your protocol must include safeguards for how you'll collect, store, and handle identifiable participant information.
Vulnerable populations get extra protections. Research involving children, prisoners, pregnant people, or individuals with impaired decision-making capacity triggers additional requirements under Subparts B, C, and D of 45 CFR 46.
If you miss any of these factors, your application will likely be sent back for revisions.
Step 1: Meet IRB requirements for research design
Let’s say your research team wants to investigate the effects of musical podcasts on children, or test a new sleep apnea machine before it hits the market. Before you start an application, your research design needs to satisfy the core requirements IRBs evaluate. Building compliance into your methodology from the start is crucial.
Federal regulations require that your study design minimizes risks to participants by using procedures consistent with sound research methods. For biomedical research, that means leveraging procedures participants would already undergo for diagnosis or treatment whenever possible. For behavioral research, it means choosing the least intrusive data collection methods that still answer your research questions.
Your protocol should also pre-plan how you'll handle data. IRBs want to see specific provisions for protecting participant privacy and maintaining confidentiality before you collect a single data point.
Step 1 IRB requirements:
You've reviewed all seven approval criteria above and designed your study to meet them
Your methodology uses the least risky procedures that still answer your research questions
Data storage, access controls, and confidentiality measures are documented in your protocol
If your study involves vulnerable populations, you've identified which subpart applies
Step 2: Required documents for IRB submission
Your IRB expects a complete protocol package. Missing elements are one of the most common reasons applications are sent back.
According to the UAB IRB Submission Guidebook, a standard application includes:
Protocol document: Background, objectives, research questions, methodology, and timeline
Informed consent materials: Written in plain language with all required elements under 45 CFR 46.116
Recruitment plan and materials: How, where, and by whom participants will be contacted, including ads, flyers, and interview scripts
Incentive structure: What you're offering, how much, and when participants receive it — compensation can't be so high that it constitutes "undue inducement”
Data handling procedures: Storage, access, retention, and destruction plans
HIPAA authorization: Required when collecting identifiable health information
Step 2 IRB requirements:
Protocol describes methods in chronological order, from recruitment through study completion
All documents include consistent procedure, timeline, and incentive details
All recruitment materials are included and match consent form language
Personnel have completed required human subjects training
Step 3: IRB pre-review requirements
Once you submit your application, an IRB staff member conducts a preliminary review to make sure your application is complete before it goes to board members.
At this stage, the reviewer checks whether you've included all required documents, answered all applicable questions, and provided enough detail for the board to evaluate your study. If something's missing or unclear, you'll get a request for additional information.
Step 3 IRB requirements:
All required forms are uploaded and complete
Document details are consistent across your protocol, consent form, and application
Personnel training certifications are current and documented
Any applicable ancillary approvals (radiation safety, biosafety, etc.) are in place
Step 4: What IRBs evaluate during review
This is where your application goes before the board. Reviewers check whether your study meets the criteria in 45 CFR 46.111 (for federally-funded research) or 21 CFR 56.111 (for FDA-regulated studies). There are three types of reviews IRBs conduct depending on your program design.
Step 4 IRB review requirements:
| Review type | Risk level | What qualifies | Timeline |
|---|---|---|---|
| Exempt | Minimal | Benign behavioral interventions, educational testing, surveys with non-identifiable responses, secondary research on existing data | Fastest (days to weeks) |
| Expedited | Minimal | Studies that don't qualify for exemption but pose no more than minimal risk: voice recordings, non-invasive specimen collection, research on group behavior | Moderate (2-4 weeks typical) |
| Full board | More than minimal | Clinical trials, studies involving vulnerable populations with elevated risk, any research not fitting exempt or expedited categories | Longest (requires scheduled convened meeting) |
Knowing which category your study falls into helps you set realistic timeline expectations and prepare the right documentation.
Step 5: Responding to IRB revision requests
After review, you'll receive a determination letter that gives an approval, conditional approval, request for additional information, deferral, or disapproval.
Most studies don't get approved on the first pass. Expect requests to clarify procedures, modify consent language, or add safeguards. Common feedback includes:
Requests for clarification on recruitment methods or participant eligibility
Modifications to the consent form for readability or completeness
Additional safeguards for participant protection
Updates to data handling or confidentiality provisions
When making revisions, use track changes so reviewers can see exactly what you modified. Provide both a tracked version and a clean version with changes accepted.
Step 5 IRB requirements:
All requested changes are addressed completely
Revised documents show changes clearly (track changes or redline)
Version dates are updated on consent forms
Response letter explains how you addressed each concern
Step 6: Post-approval IRB requirements
Once your study is approved, you'll receive an approval letter and stamped consent forms with an expiration date. You can then begin enrolling participants.
Step 6 IRB requirements:
Continuing review: For non-exempt studies, you'll need to renew approval at regular intervals (typically annually)
Amendment submissions: Any changes to your protocol, consent form, or study personnel must be approved before implementation
Adverse event reporting: Unanticipated problems involving risks to participants must be reported promptly
Your approval may also be conditional, requiring progress reports or data safety monitoring throughout the study.
IRB requirements for participant incentives
Incentives are critical to participant recruitment and retention. Studies show they motivate participation and improve panel retention rates. But IRBs scrutinize incentive plans carefully. Getting the structure wrong can stall approvals.
Here's what the regulations require when it comes to participant payouts.
What must consent forms say about incentives?
Your consent form needs to include a detailed account of payment terms: amount, schedule, delivery method, and conditions for partial or no payment. For example, explain what happens if a participant withdraws early.
Both OHRP and the FDA require that all information about payment, including method and timing, be presented to the IRB at initial review and included in consent documentation.
How much can you pay research participants?
Federal regulations require that researchers seek informed consent "under circumstances that minimize the possibility of coercion or undue influence" (45 CFR 46.116). This means incentive amounts can't be so high that they cloud a participant's judgment about the study's risks.
HHS defines undue influence as "an offer of an excessive or inappropriate reward or other overture in order to obtain compliance." The tricky part? There's no fixed dollar threshold. What's appropriate depends on the participant population, the study's risk level, and the time commitment involved.
Some researchers argue that IRBs are overly conservative on payment amounts. Largent & Lynch make the case that low incentives burden participants, hinder recruitment, and delay scientific progress. Rather than assuming payments are too high, they suggest IRBs should ask whether payments are high enough.
When should participants receive payment?
Both OHRP and the FDA recommend that incentives are paid out in stages as the study progresses rather than being contingent on completing the entire study. Holding payments until the end could unduly influence a participant's decision to exercise their right to withdraw.
A small completion bonus is acceptable, as long as it's not so large that it pressures participants to stay when they'd otherwise leave.
Can payment offset research risks?
IRBs evaluate whether risks are reasonable relative to anticipated benefits. But FDA guidance is clear: payment is a recruitment incentive, not a benefit. You can't use compensation to justify higher risk.
What are the privacy requirements for incentive payments?
Delivering incentives often requires collecting identifiable information like email addresses for digital gift cards, mailing addresses for physical cards, or Social Security numbers for payments over $2,000 in 2026 (which trigger IRS reporting requirements).
Your protocol should address how you'll collect, store, and protect this information separately from research data. If you're working with a HIPAA-covered entity, consider whether your payment method creates additional privacy obligations.
To meet IRB requirements for participant incentives, your application must address the following:
Payment amount, schedule, and method are documented in both the protocol and consent form
Consent form explains conditions for partial or no payment
Payment structure doesn't create undue influence given the participant population and risk level
Payments are prorated across the study rather than contingent on completion
Identifiable payment information is protected by privacy safeguards
If payments exceed $2,000 per participant annually, you have a plan for tax reporting
Each IRB sets its own policies, so confirm what's acceptable before submitting. Here are some example guidelines from the University of Oregon and UC Berkeley.
IRB incentive approval mistakes to avoid
Confusing language in consent forms. Forms must be written at an appropriate reading level for your target audience. Submit all recruitment materials: emails, website postings, flyers, advertisements, and verbal scripts.
Using incorrect terminology. Use the terms your IRB or state guidelines specify for incentives in recruitment materials.
Offering unjustified payment amounts. Justify incentive amounts relative to similar studies. Provide a clear rationale to strengthen your case.
Ignoring privacy in payment delivery. If using payment methods other than cash, detail how payment and personal information will be processed securely.
Collecting more data than necessary. Only collect the information required to deliver payment. Store it in password-protected systems separate from research data.
Choosing incentives that don't fit your population. A Target or Starbucks gift card works for many audiences. In-game currency for League of Legends? Probably not. Match the reward to your participants.
Get participant incentives right
Research teams that build compliance into their incentive structure from the start see faster approvals and smoother payouts. Structure payments to meet regulatory requirements, document everything clearly in your protocol and consent forms, and choose delivery methods that protect participant privacy.
