# IRBGPT

> IRBGPT is a free AI-powered Institutional Review Board (IRB) protocol assistant.
> It reviews, drafts, and stress-tests human subjects research protocols against
> the Belmont Report, the Common Rule (45 CFR 46), HIPAA Privacy Rule (45 CFR 160 & 164),
> FDA regulations (21 CFR 50 & 56), HHS/OHRP guidance, FERPA, COPPA, and NIH policies.

IRBGPT is a custom GPT built on OpenAI's Builder platform. It is free, requires no
account on this site, and is maintained as a permanently free public resource by
Observable Compute Foundation, a South Dakota 501(c)(3) nonprofit (EIN 41-4747049).

## What it does

- Interactive exemption screener on this site (educational read on the likely review pathway)
- Interactive consent form quick-check on this site (45 CFR 46.116(b) required elements)
- Protocol audit against 45 CFR 46 requirements
- Exemption classification across all eight §46.104(d) categories, plus expedited (§46.110) and full board review
- Informed consent review against §46.116 required elements
- Vulnerable population screening (subparts B, C, D)
- Belmont risk–benefit analysis
- Draft and revision assistance for protocol sections

## Author

Built by Adam Stratmeyer, J.D., and maintained under Observable Compute Foundation.
He served on an IRB during law school, has a background in research science and law,
and has personally reviewed several hundred protocols.

## Important limitation

IRBGPT is an educational and drafting aid — not legal advice and not a replacement
for an institutional IRB office. All submissions must be reviewed and approved by
the researcher's institutional IRB.

## Organization

- Publisher: Observable Compute Foundation — https://observablecompute.org/
- Contact: contact@observablecompute.org
- Address: 58 Hillcrest Drive, Rapid City, SD 57701
- GitHub: https://github.com/Observable-Compute