IRBGPT
Institutional Review Board Protocol Assistant
A GPT-4-powered tool for reviewing, drafting, and stress-testing IRB protocols. Other people have built similar things. This one was put together by someone who's sat on an IRB and reviewed a few hundred protocols. Try to stump it.
Free
Always. No fees.
GPT-4
OpenAI Builder platform
7+
Regulatory frameworks
~300
Protocols reviewed (human baseline)
Research ethics shouldn't require a law degree.
IRB submissions are notoriously dense. IRBGPT is a GPT-4 custom GPT — built with the Builder platform, not custom code — configured with deep knowledge of the regulatory landscape. Plenty of people have had similar ideas. What matters is how well it actually works, and the regulatory coverage it brings.
It covers the Belmont Report principles, the Common Rule (45 CFR 46), HIPAA Privacy Rule (45 CFR 160 & 164), FDA regulations (21 CFR 50 & 56), HHS/OHRP guidelines, FERPA, COPPA, and NIH policies. It flags issues, explains why they matter, and drafts revision language — without automatically fixing things for you, because understanding the compliance concern is part of the point.
Protocol Audit
Paste your draft protocol and get a structured audit against 45 CFR 46 requirements. IRBGPT identifies missing elements, inconsistencies, and common rejection triggers before you submit.
Exemption Classification
Describes your research and IRBGPT analyzes which of the eight exemption categories under §46.104(d) may apply — or whether you need expedited or full board review.
Informed Consent Review
Consent documents must meet specific language requirements. IRBGPT checks for the required elements under §46.116 and flags anything that could compromise validity or confuse participants.
Vulnerable Population Screening
Research involving prisoners, pregnant individuals, children, or individuals with diminished autonomy triggers additional protections. IRBGPT flags applicable subparts (B, C, D) and special requirements.
Risk–Benefit Analysis
Walk through the Belmont Report's beneficence framework — articulating risks, mitigations, and the case that benefits to knowledge justify participant burden. Essential for full board submissions.
Draft & Revision Assistance
Not just critique — IRBGPT helps you write. Describe your study design and get draft language for protocol sections: study purpose, procedures, confidentiality plan, and participant rights.
Exemption Categories at a Glance
IRBGPT applies all eight exemption categories. Ask which applies to your study, or paste your protocol and let it decide.
Normal Educational Practices
Research in established educational settings involving normal curriculum or classroom management.
Educational Tests, Surveys, Interviews
Anonymous surveys, standardized tests, or structured interviews where disclosure presents minimal risk.
Benign Behavioral Interventions
Brief, non-deceptive, prospective interventions with adult subjects and limited disclosure risk.
Secondary Research — Identifiable Data
Use of previously collected identifiable private information when identifiers are not recorded.
Federal Demonstration Projects
Research on federal programs assessing public benefit or service programs.
Taste / Food Quality Studies
Consumer food acceptance and food quality studies not involving greater than minimal risk.
Storage or Maintenance
Storage or maintenance of identifiable private information for secondary research use.
Secondary Research — Broad Consent
Use of identifiable private information with documented broad consent from the subject.
IRBGPT analyzes all eight categories, plus expedited review (45 CFR 46.110) and full board criteria. Ask which applies to your protocol.
The Three Principles Behind Every IRB Decision
Every IRB protocol ultimately rests on these three principles. IRBGPT helps you articulate how your research honors each one.
Respect for Persons
Individuals must be treated as autonomous agents capable of making their own decisions. Those with diminished autonomy deserve additional protections. The vehicle: informed consent.
Beneficence
Do not harm. Maximize benefits and minimize harms. The research design must demonstrate that the scientific and social benefits justify the risks imposed on participants.
Justice
Fair distribution of research burdens and benefits. Vulnerable populations should not bear disproportionate risk for research that will primarily benefit others.
Not a Substitute for Your IRB Office
IRBGPT is an educational and drafting aid — not legal advice and not a replacement for your institution's IRB office or IRB coordinator. All submissions must be reviewed and approved by your institutional IRB. Use IRBGPT to prepare stronger submissions, not to bypass the process.
Useful, not genius.
IRBGPT is a custom GPT built using OpenAI's GPT Builder — the same tool anyone with a ChatGPT Plus subscription can use. No custom code, no fine-tuning (tried that once with an earlier project, overfit nightmare, completely unnecessary). Other people have built similar IRB tools with the same platform. This isn't a claim of invention.
What went into it was domain knowledge. Adam Stratmeyer, J.D. served on an IRB during law school, has a background in both research science and law, and has personally reviewed — and helped repair — several hundred protocols over the years. That experience shaped what the tool knows to look for and, just as importantly, how it explains problems rather than silently auto-correcting them.
It's been through multiple iterations, attracted a substantial user base, lost accounts, got rebuilt. Now it lives under Observable Compute Foundation as a permanently free resource. The domain irbgpt.com ranks at the top of search results for IRB protocol assistance — apparently because people keep finding it useful enough to share.
Who uses IRBGPT
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Graduate students and early-career researchers
Navigating their first IRB submission without institutional guidance.
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Faculty and principal investigators
Drafting and stress-testing protocols before formal submission.
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Independent and community researchers
Without access to institutional IRB support staff.
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IRB coordinators and compliance staff
As a second-pass check and drafting reference.
What it knows
IRBGPT is configured across the full stack of human subjects protection frameworks. Ask about any of these — or paste a protocol and let it figure out which apply.
The Common Rule — 45 CFR 46
Federal policy for protection of human subjects. All exemption categories, expedited review, full board criteria, and special subparts B, C, D.
The Belmont Report
Respect for persons, beneficence, justice. The ethical foundation every protocol ultimately has to satisfy.
HIPAA Privacy Rule — 45 CFR 160 & 164
Health information in research — authorizations, limited data sets, waiver criteria, covered entity requirements.
FDA Regulations — 21 CFR 50 & 56
Clinical investigations, informed consent requirements, and IRB oversight for FDA-regulated research.
HHS / OHRP Guidelines
Office for Human Research Protections guidance documents, compliance determinations, and assurance requirements.
FERPA & COPPA
Student educational records (FERPA) and children's online privacy (COPPA) — essential for school-based and youth research.
NIH Policies & Guidelines
NIH-specific human subjects requirements, inclusion policies, data sharing expectations, and grant application compliance.
Try to stump it.
If you've spent any time on an IRB, you've seen protocols that are breathtaking in their creative non-compliance. The ones where you wonder how the researcher got this far. The ones with vulnerable populations described as "low risk." The consent forms with more problems than sections.
Take all of that — combine the worst elements of every protocol you've ever reviewed — and run it through IRBGPT. Then share what you found. The tool has been put through its paces on intentionally flawed and deliberately ridiculous protocols, and it's held up well. But there's always something interesting lurking.
One thing it does correctly: it doesn't just automatically fix compliance violations. It explains why something is a concern. Part of the value of going through an IRB process was always the understanding that came from it — that shouldn't be lost just because an AI can now do a first pass in 30 seconds.
Sample output — protocol analysis