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The narrative, consent form, recruitment materials and data plan an IRB reviews, plus sheets that check each section and track amendments after approval.
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What you get
Pack of 6 files: 4 documents, 2 spreadsheets
IRB and Ethics Application TemplateRequirement Checklist: Recruitment Materials
| Requirement | Status |
|---|---|
| Names the research team and institution conducting the study | Ready |
| Distributed through a channel independent of the participant's own supervisor | Needs Revision |
The second row is the one a general read-through misses: the email reads fine until you ask who it's actually from.
An IRB application asks your institutional review board to approve a study involving people before you recruit anyone. It usually covers four things: a protocol explaining what you will do and why, a consent form, the recruitment materials people will see, and a plan for protecting their data. A good one lets reviewers check each approval criterion without guessing: which steps are research, how risks stay low, how people are invited without pressure, and who sees their data.
Reviewers read your documents side by side, so every detail of the study has to match across them.
In the US, IRB review is for research involving human subjects, and the federal Common Rule gives both terms legal definitions1. Research is a systematic investigation designed to develop or contribute to generalizable knowledge. A human subject is a living person you gather information from by interacting or intervening, or whose identifiable private information you use.
If both apply, your IRB office picks one of three review paths. The federal Office for Human Research Protections (OHRP) recommends that investigators not decide on their own that a study is exempt2.
Three review paths under the Common Rule
| Path | When it applies | Continuing review |
|---|---|---|
| Exempt | Work that fits one of eight federal exemption categories, such as many surveys and interviews | Not required |
| Expedited | No more than minimal risk and on a federal list, reviewed by the chair or designated members | Not required unless the IRB decides otherwise |
| Full board | Anything above minimal risk or not on that list, reviewed at a convened meeting | At least once a year3, until only data analysis remains |
FDA-regulated studies also follow 21 CFR 56.109, which keeps continuing review at least once a year.
Your IRB's rules come first
This guide follows the US Common Rule. FDA rules, HIPAA and your own IRB can add requirements, and outside the US an ethics committee applies national rules. Ask your IRB office early, and your privacy or legal office before you sign a data agreement with a partner.
Before approving a study, the board must find that it meets every criterion in 45 CFR 46.1114. Whatever form your institution uses, make sure your answers cover each one.
What the board must find, and where you answer it
| The board must find | Where you answer it |
|---|---|
| Risks are minimized | Procedures, and why each one is needed |
| Risks are reasonable for the benefits | Risks, benefits and the comparison between them |
| Selection is equitable | Eligibility and recruitment, with each exclusion explained |
| Consent is sought and documented | The consent form and process, or a waiver request |
| Data are monitored for safety | A monitoring plan, when the risks call for one |
| Privacy and confidentiality are protected | The data plan |
| Extra safeguards are in place | Protections for anyone open to coercion, such as children or prisoners |
Split every procedure into what happens only because of the study and what would happen anyway, such as routine care or records an employer already keeps. Boards weigh only the risks that may result from the research4 itself, so show them where that line falls.
Back a minimal-risk claim with a comparison, not a label. Minimal risk1 means harm or discomfort no more likely or serious than in daily life or routine physical or psychological tests. Attach the finished survey or interview guide, too, since a board can only judge questions it can read. A survey design template helps you finish one.
Recruitment is part of consent. OHRP says the consent process begins with the initial approach5, such as a flyer or an ad. Federal rules require consent to be sought under circumstances that minimize the possibility of coercion or undue influence6.
Take most care when the person asking has power over the person asked: a teacher, a doctor or a manager. OHRP notes that employees may fear a decision could affect performance evaluations or job advancement5, even if only in their perception. Students offered extra credit, it adds, must be told of a non-research option of comparable time and effort.
So have the research team send recruitment, not a supervisor, and don't tell managers or teachers who took part. In long or multi-session studies, OHRP recommends paying as people go rather than at the end, so waiting for payment doesn't keep anyone from withdrawing.
Before, from the office manager: "As part of the four-day pilot, you'll complete a short 10-question survey each week for 12 weeks."
After, from the research team: "Researchers at [University] invite you to a 3-minute weekly survey about the four-day pilot, for 12 weeks. It's your choice. Saying no won't affect your job, pay or reviews, and your manager won't know who took part."
The Common Rule requires consent to begin with a concise and focused presentation of the key information6 that helps someone decide whether to take part. Then cover the nine basic elements:
Write for your participants, not your field. A 2003 study in the New England Journal of Medicine checked the websites of 114 US medical schools. The template consent text their IRBs supplied7 averaged a grade level of 10.6. Boards that had set a readability standard missed their own target by 2.8 grades on average.
Cut anything that reads as a waiver of legal rights or a release from liability for negligence, which the rule forbids. Then treat the form as the start of a conversation: OHRP says a signed form alone is not an adequate consent process5.
List everything you will collect, including records a partner gives you, such as an employer's or a school's. Linked to a person, they need the same protection as anything you collect yourself. Then make each promise checkable, because "kept confidential" names no method, no people and no date.
From vague to checkable
| Topic | Vague | Specific |
|---|---|---|
| Coding | "Data will be kept confidential." | "Each participant gets a random code. Names and codes sit in a separate, encrypted key file." |
| Access | "Limited to the research team." | "Only the principal investigator and the study coordinator can open the key. Analysts see coded data only." |
| Retention | "As long as necessary." | "The key is deleted when data collection ends. Coded data are deleted 5 years after the study closes." |
Make the consent form and the plan agree. If the form promises to destroy the key when data collection ends, the plan must give that date. Keep signed consent forms at least 3 years after the research ends2, or longer if other rules, your institution or your funder require it.
A funder's data sharing plan can't promise more than your consent form allows. The research data management plan template checks that dataset by dataset.
Approval covers the study as written. To change anything, submit the change and wait for approval2 before you make it, unless it removes an apparent immediate hazard to participants. Minor changes may qualify for expedited review. Report unanticipated problems involving risks to participants or others promptly.
Check your approval letter for an expiration date. If approval lapses, research activities must stop2, except where continuing is in the best interests of people already enrolled, and then you must tell the IRB promptly. When the study is finished, close it as your institution requires.
Before you submit
If a grant funds the study, make the population, procedures and risks match your grant proposal. For a faster start, open the template at the top of this page in River. It drafts all four documents from your study design and grades each section against the checklist before you submit.
Use the files as they are, or open them in River. River starts by asking what your study actually does: who you would recruit and through what channel, and what you would collect. It also asks whether any other records, such as an employer's or a school's, would be linked. From that it drafts the narrative, consent form, recruitment materials and data plan, then grades each section in the Requirement Checklist before you submit.
After approval, it logs each amendment you describe in the Amendment Register and counts down to any continuing review date, marking it due soon 60 days ahead. Nothing goes to your IRB until you submit it, and the board makes every decision.
Download four Word documents and two CSV sheets with no signup, or open the template in River to draft with AI.
Write down who you'll recruit and how, what you'll collect and which existing records you'll link.
Fill in the four documents yourself or ask River to draft them, then grade every row in the Requirement Checklist.
Submit the way your IRB asks, then log each amendment and watch any continuing review date in the Amendment Register.
Application Narrative8 of 8 requirements Ready on first submission. Two shown here.
| Requirement | Status |
|---|---|
| Procedures separate research-only activity from data the firm already collects | Ready |
| Risk-benefit justification stated as a comparison, not an assertion | Ready |
Zero Needs Revision rows here. The narrative is not where this application loses time.
Consent Form9 of 10 requirements Ready. The tenth is the one a reviewer sends back.
| Requirement | Status |
|---|---|
| States that participation is voluntary with no penalty for withdrawing | Ready |
| Gives contact information for questions about the study and about participant rights | Needs Revision |
Names the department and the IRB, but gives no phone number or email for either.
Recruitment Materials3 of 5 requirements Needs Revision, the section with the most rework almost every time.
| Requirement | Status |
|---|---|
| States plainly that declining has no effect on employment or pay | Needs Revision |
| Distributed through a channel independent of the participant's own supervisor | Needs Revision |
| Names the research team and institution conducting the study | Ready |
Both failing rows trace to one cause: the office manager, the person each employee reports to, is the one sending the email.
Data Management Plan3 of 6 requirements Needs Revision, the same count as Recruitment Materials.
| Requirement | Status |
|---|---|
| Names a specific de-identification method, not a confidentiality assertion | Needs Revision |
| States a retention period as a specific duration or triggering event | Needs Revision |
| Names specific storage and security safeguards | Ready |
"As long as necessary to complete the analysis" is the exact phrasing this checklist is built to catch.
Amendment RegisterThree amendments since approval, and the row that matters most today.
| Date | Type | What changed or is due | Days left |
|---|---|---|---|
| 2026-06-02 | Amendment | Removed a free-text field flagged as a re-identification risk | |
| 2026-09-18 | Amendment | Extended the comparison offices' survey window by two weeks | |
| 2027-01-20 | Continuing Review | Review due, computed from the one-year period the IRB set on 2026-01-20 | 18 |
18 days out, computed, not remembered. Federal guidance gives this row no grace period once it passes.
Most include a protocol, a consent form, recruitment materials, any surveys or interview guides, and a plan for protecting data. The protocol covers the study's aims, design, participants, procedures, risks and benefits. Your institution's form sets the exact sections and attachments, so open it before you write.
If it is research involving human subjects, it should get a decision from your IRB office. Research here means a systematic investigation meant to produce generalizable knowledge, and human subjects are living people you gather information from or whose identifiable private information you use. Even exempt studies get that decision, since the federal Office for Human Research Protections advises against researchers exempting themselves.
They are three levels of review, matched to risk and the kind of research. Exempt studies fit one of eight federal exemption categories and skip most federal requirements. Expedited studies carry no more than minimal risk, appear on a federal list and go to the chair or designated reviewers. Everything else goes to the full board at a convened meeting.
Up to a year for studies the full board reviews, since they need continuing review at least once a year until only data analysis remains. Under the revised Common Rule, exempt studies need none, and expedited studies need none unless the IRB decides otherwise. FDA-regulated studies under IRB review still need it at least once a year. Your approval letter says whether yours expires.
Answer each requested change point by point, the way you would answer journal reviewers: quote the request, then say what you changed and where. Make the change in every document it touches, so the protocol, consent form and recruitment materials still agree. A disapproval must come with written reasons and a chance to respond.
Yes. Download the four Word documents and two CSV sheets with no signup. They come filled in with a made-up workplace study, including the gaps its checklist catches, so you can see how each part works before you replace it. Edit with AI opens the same template in a free River workspace.
It opens the template in a free River workspace and asks what your study does: who you'd recruit and how, what you'd collect and which records you'd link. River drafts the narrative, consent form, recruitment materials and data plan, grades each section in the checklist and logs amendments after approval. You submit, and your IRB decides.
eCFR. “45 CFR 46.102 — Definitions for purposes of this policy.” ecfr.gov (opens in a new tab)
HHS. “Investigator Responsibilities FAQs.” hhs.gov (opens in a new tab)
eCFR. “45 CFR 46.109 — IRB review of research.” ecfr.gov (opens in a new tab)
eCFR. “45 CFR 46.111 — Criteria for IRB approval of research.” ecfr.gov (opens in a new tab)
HHS. “Informed Consent FAQs.” hhs.gov (opens in a new tab)
eCFR. “45 CFR 46.116 — General requirements for informed consent.” ecfr.gov (opens in a new tab)
The New England Journal of Medicine. “Readability standards for informed-consent forms as compared with actual readability.” pubmed.ncbi.nlm.nih.gov (opens in a new tab)
Written by
Co-founder & CEO, River
Chandler has spent the last six years working in AI, building tools for millions of users and Fortune 100 companies. In 2025, he co-founded River to build a new kind of operating system for AI agents.