IRB GPT is a free AI assistant for Institutional Review Boards, originally developed by Adam Stratemeyer and offered through the Observable Compute Foundation. The tool helps IRB members and researchers draft compliant protocols, assess risk classifications under the Common Rule (45 CFR 46), check Belmont Report alignment, and identify exempt vs. expedited review criteria — reducing review time and improving consistency across submissions.

Free AI Protocol Review Assistant for IRBs

IRB GPT helps Institutional Review Boards review research protocols efficiently and consistently. Built on early GPT-4 with compliance fine-tuning, it assists with exemption determinations, risk classification, consent form review, and Belmont Report alignment checks.

Developed by Adam Stratemeyer · Offered freely by the Observable Compute Foundation

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IRB GPT — Free Protocol Review Assistant for Institutional Review Boards, developed by Adam Stratemeyer

IRB GPT protocol checklist — AI-assisted IRB review for research compliance

What IRB GPT Does

Exempt / Expedited / Full Board classification guidance
Consent form language review against 45 CFR 46.116
Belmont Report principle alignment checks
Adverse event reporting checklist generation
Risk-benefit analysis framework for minimal risk studies
HIPAA research authorization language assistance

IRB Compliance Chat

Ask questions about your protocol or compliance requirements.

Example Prompts

Draft a low-risk survey protocol for exempt determination
Assess Belmont Report alignment in this consent form
Explain the difference between exempt and expedited review
Does this study qualify under 45 CFR 46.104(d)(2)?
Generate a risk-benefit analysis template for a minimal-risk study

Protocol Compliance Check

Upload your protocol PDF for an AI-powered compliance check.

Free to Use

IRB GPT is offered as a free public tool through the Observable Compute Foundation. Basic protocol queries, exemption guidance, and risk classification are available at no cost.

For institutions requiring unlimited protocol reviews, custom compliance frameworks, or priority compute: contact us through the Observable Compute Foundation.

IRB Compliance Reference Guide

Complete PDF covering Common Rule categories, Belmont principles, consent requirements, and audit checklists — formatted for IRB members and research coordinators.

About the Creator

Adam Stratemeyer originally developed IRB GPT to address a gap in IRB efficiency — review boards reviewing research protocols faced inconsistent guidance, slow turnaround, and limited access to plain-language interpretations of the Common Rule and Belmont principles. IRB GPT was built to close that gap by providing a free, AI-assisted reference tool accessible to any institution. The tool is now maintained and offered freely through the Observable Compute Foundation. Not a substitute for official IRB review or legal advice.