How to write an IRB application (or research ethics application)
By Mubarak MutesasiraUpdated 11 min read
Short answer:
To write an IRB application, describe your study so a non-specialist board can judge its risks: who takes part and how they are recruited, exactly what they do, what could harm them and how you reduce it, how you get informed consent, and how you store and protect data. Use your institution's form, attach every recruitment and consent document, and submit before any data collection.
This guide is for students and researchers preparing a first submission to an Institutional Review Board (IRB), a UK Research Ethics Committee (REC) or an Australian HREC. It is part of our series on how to write a research proposal. It explains what boards look for. It is not legal advice: your IRB office and your institution's policies decide what applies to your study.
What is an IRB application?
An Institutional Review Board (IRB) is a committee that reviews research involving human participants to protect their rights and welfare. An IRB application is the set of forms and documents you submit so the board can decide whether your study can go ahead. Outside the US, the same job is done by research ethics committees, with different names and rules.
| Country or region | Body | Main rules and guidance |
|---|---|---|
| United States | Institutional Review Board (IRB) | Common Rule, 45 CFR 46, overseen by HHS OHRP [1] [2]; FDA rules for FDA-regulated studies |
| United Kingdom | Research Ethics Committee (REC); Health Research Authority for NHS studies | HRA guidance and IRAS [3] [4] |
| Australia | Human Research Ethics Committee (HREC) | National Statement on Ethical Conduct in Human Research [5] |
| International (medical research) | Research ethics committees | World Medical Association Declaration of Helsinki, revised 2024 [6] |
All of these rest on the same principles, stated in the US Belmont Report as respect for persons, beneficence and justice. [7] In practice, that means consent, minimizing harm, and choosing participants fairly.
Do you need IRB review at all?
You need IRB review when your project is research and it involves human subjects, as your institution defines them. Under the Common Rule, research means a systematic investigation designed to contribute to generalizable knowledge, and a human subject is a living person about whom you obtain information through interaction or intervention, or identifiable private information. [1]
Do not make this call alone. Most institutions require you to submit even when you think the study is exempt, so the IRB office can make the determination. The HHS Office for Human Research Protections publishes decision charts that show the logic, [2] and the UK HRA has an online tool for deciding whether a study needs NHS REC review. [4]
What are the levels of IRB review?
US IRBs review at three levels, set by risk. Minimal risk means the probability and size of harm or discomfort are no greater than those met in daily life or during routine physical or psychological tests (45 CFR 46.102(j)). [1]
| Level | When it applies | Who reviews | Typical examples |
|---|---|---|---|
| Exempt | Fits one of the categories in 45 CFR 46.104(d) | IRB office or a designated reviewer | Anonymous online survey of adults; normal classroom practices; secondary use of de-identified data |
| Expedited | Minimal risk and on the expedited categories list (46.110) | One or more experienced board members | Interviews about non-sensitive topics with identifiers; small blood draws from healthy adults |
| Full board | More than minimal risk, or not eligible for the other two | Convened IRB meeting | Clinical interventions; research with prisoners; sensitive topics with identifiable data |
Exempt does not mean "no rules": many institutions still require a consent script.
What does an ethics board ask?
Under the Common Rule, an IRB can approve research only if it finds, among other criteria, that risks are minimized and reasonable in relation to benefits, participants are selected fairly, informed consent is sought and documented, data is monitored where needed, and privacy and confidentiality are protected (45 CFR 46.111). [1] Every section of your application should help the board make those findings.
Study summary in plain language
Write the purpose and procedures as you would explain them to a friend outside your field. Boards include non-scientist members. Avoid jargon and acronyms, and keep it under 300 words.
Participants and recruitment
State who, how many, the inclusion and exclusion criteria, and exactly how you will contact them. Attach every recruitment email, poster and social media post. If you recruit your own students, employees or patients, explain how you will avoid pressure, for example by having a third party do the recruiting.
Procedures
List what participants do, in order, with the time each step takes. Attach every instrument: surveys, interview guides, tasks, debrief sheets. A board cannot approve questions it has not seen.
Risks and how you reduce them
A research risk is any harm a participant could experience because of the study: physical, psychological, social, legal, economic or a loss of privacy. For each risk, give its likelihood, its severity and what you will do about it.
| Risk | Example | How to reduce it |
|---|---|---|
| Psychological | Distress when discussing a bereavement | Allow skipping questions; pause or stop; give support contacts |
| Loss of privacy | A quote identifies a participant in a small community | Remove names, places and roles from quotes; aggregate small groups |
| Social or legal | Disclosure of illegal behavior | Do not collect identifiers; explain limits of confidentiality |
| Coercion | Students feel they must take part in their instructor's study | Third-party recruitment; data released only after grades are final |
| Data breach | Stolen laptop with recordings | Encrypted, institution-managed storage; delete recordings after transcription |
Informed consent
Informed consent is a process by which a person agrees to take part after receiving the information they need to decide, without pressure. The form is only the record of it. Under the revised Common Rule, consent forms must begin with a concise summary of the key information most likely to help a person decide (46.116(a)(5)(i)). [1] The basic elements include the purpose, procedures and duration, foreseeable risks, expected benefits, alternatives where relevant, how confidentiality is kept, who to contact, and a statement that participation is voluntary and can be stopped at any time without penalty (46.116(b)). [1]
Write the form at a reading level your participants can follow. Many IRBs ask for around an eighth-grade level; check yours.
If you want a waiver of consent or of a signed form (for example for an anonymous online survey), ask for it explicitly and give the reason. The rules for waivers are in 46.116(f) and 46.117(c). [1]
Confidentiality and data protection
Say what data you collect, where it is stored, who can access it, how long you keep it and how you will de-identify it. Name the storage system. In the UK and EU, your institution will also expect a lawful basis for processing personal data under data protection law; its data protection office can confirm the wording. Never promise "complete anonymity" for interviews you record.
Vulnerable participants
Children, prisoners, pregnant people in some study types, people with impaired decision-making capacity and people in dependent relationships need extra safeguards. In the US, Subparts B, C and D of 45 CFR 46 add rules for pregnant women and fetuses, prisoners, and children. [1] For children, plan for parental permission and the child's own assent.
Benefits, compensation and conflicts of interest
State direct benefits honestly: often there are none. Keep payments small enough not to pressure people into accepting risk. Declare any financial or personal interest.
How to write an IRB application in 8 steps
- Ask your IRB office which form and route apply, and complete any required human subjects training first.
- Finish the protocol before the forms. The application copies from your methods: design, sample, procedures, analysis. See the research proposal example for a methods section with an ethics paragraph.
- Draft the plain-language summary, under 300 words.
- Write the risk table with every risk, its likelihood and its mitigation.
- Write the consent form from your institution's template, key information first.
- Collect every attachment: recruitment materials, instruments, consent and assent forms, debrief, permission letters from sites, data management plan.
- Check consistency. The sample size, duration, payment and data retention period must match across every document.
- Get your supervisor's sign-off and submit before the meeting deadline. Do not recruit until you have written approval.
Why do IRB applications get sent back?
Most returned applications fail on missing detail or inconsistency, not on ethics. Boards commonly ask for changes when:
- Documents disagree: the protocol says 30 minutes, the consent form says 20.
- Instruments or recruitment materials are missing.
- The consent form is written in technical language or buries key information.
- Risks are listed as "none" for a study that asks about sensitive topics.
- Data storage is vague ("data will be kept securely").
- The recruiter has power over participants and no safeguard is described.
- Confidentiality is overpromised, such as "fully anonymous" recorded interviews.
IRB application checklist
Use this before you submit. It is a general list: your institution's checklist takes priority.
| Item | Done |
|---|---|
| Correct form and review route confirmed with the IRB office | ☐ |
| Human subjects training certificates for every team member | ☐ |
| Plain-language summary, under 300 words | ☐ |
| Inclusion and exclusion criteria, with sample size and its reason | ☐ |
| Recruitment materials attached (emails, posters, scripts) | ☐ |
| All instruments attached (surveys, interview guides, tasks) | ☐ |
| Risk table with mitigation for each risk | ☐ |
| Consent form with key information first; assent form if minors | ☐ |
| Waiver requests justified, if any | ☐ |
| Data storage, access, retention and de-identification described | ☐ |
| Site permission letters, if recruiting through an organization | ☐ |
| Conflicts of interest declared | ☐ |
| Numbers, durations and payments consistent across documents | ☐ |
| Supervisor or principal investigator sign-off | ☐ |
Draft an ethics application in AI for Research
Proposal Studio has an Ethics application tool. Describe your study (aim, design, who takes part, recruitment, what they do, what data you collect) or upload your protocol, choose the board (generic ethics committee, US IRB, UK Research Ethics Committee or Australian HREC) and the participant group (adults at low risk, children or vulnerable groups, patients or clinical data, online or secondary data). It drafts a plain-language summary, participants and recruitment, procedures, risks and mitigation, benefits, informed consent with a short draft consent statement, confidentiality and data protection, withdrawal and conflicts of interest. Anything you must confirm is marked in [square brackets], and it does not invent approvals or institution names. A draft costs 15 credits; the free plan has 45 credits a month.
Proposal Studio also writes a Data management plan (3 credits) in generic, NIH, NSF, Horizon Europe or UKRI format, which many boards ask for. If the study itself is still being planned, start with the research proposal generator; for a funded study, the grant proposal writer.
Limits: the draft follows general principles, not your institution's form or its current policies. Copy the content into your IRB's own system, and have your supervisor and the IRB office review it. It is a drafting aid, not a compliance check.
FAQ
What is an IRB application?
An IRB application is the set of forms and documents a researcher submits to an Institutional Review Board before starting research with human participants. It describes the study's aims, who will take part and how they are recruited, what participants will do, the risks and how they are reduced, the consent process and how data will be protected. The board approves, asks for changes, or declines.
How long does IRB approval take?
It depends on the review level and the institution. Exempt determinations and expedited reviews often take a few weeks; studies that need a convened full board meeting can take one to three months, especially if the board asks for revisions. Check your institution's published turnaround times and meeting deadlines, and build the time into your proposal timeline.
What is the difference between exempt, expedited and full board review?
Under the US Common Rule, exempt research is low-risk work that fits one of the categories in 45 CFR 46.104, such as some anonymous surveys. Expedited review is for minimal-risk research on an approved list of categories and is done by one or more experienced reviewers. Full board review is for anything above minimal risk, at a convened IRB meeting. Your IRB, not you, normally decides the level.
Do I need IRB approval for a student project or an anonymous survey?
Often yes, or at least an exemption decision from the IRB office. Many institutions require every project with human participants to be submitted, even class projects, so the office can decide whether it counts as research under their policy. Some class exercises not meant to produce generalizable knowledge are excluded. Ask your IRB office before collecting any data.
What is the UK equivalent of an IRB?
In the UK, studies are reviewed by a Research Ethics Committee (REC). Research involving NHS patients, staff or premises usually goes through the Health Research Authority, with applications made through IRAS and an NHS REC opinion where required. Other university research is reviewed by the university's own ethics committee. Australia uses Human Research Ethics Committees (HRECs).
Next steps
- Plan the whole study with how to write a research proposal.
- See an ethics section in context in the research proposal example.
- Format the proposal with research proposal APA format.
- Copy wordings by study type from the ethics approval statement template.
Sources
- Electronic Code of Federal Regulations. 45 CFR Part 46, Protection of Human Subjects (Common Rule), including 46.102, 46.104, 46.110, 46.111, 46.116, 46.117 and Subparts B to D. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
- U.S. Department of Health and Human Services, Office for Human Research Protections. Human Subject Regulations Decision Charts (2018 Requirements). https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html
- Health Research Authority. Research Ethics Committee review. https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/research-ethics-committee-review/
- Health Research Authority. Do I need NHS REC review? (decision tool). https://www.hra-decisiontools.org.uk/ethics/
- National Health and Medical Research Council. National Statement on Ethical Conduct in Human Research (2023). https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2023
- World Medical Association. (2025). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human participants. JAMA, 333(1), 71. https://doi.org/10.1001/jama.2024.21972 ; WMA page: https://www.wma.net/policies-post/wma-declaration-of-helsinki/
- U.S. Department of Health and Human Services. The Belmont Report (1979). https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html