AI assistance
Engine-resolved IRB pathway with citations to §46.x, §164.x, 21 CFR 50/56, and OHRP guidance. AI rationale paragraphs with citation guards that block fabricated CFR sections. Built for compliance.
Resolved pathway
This combination is generally eligible for expedited IRB review under 45 CFR 46.110 (Category 5: research involving materials collected solely for nonresearch purposes), with a HIPAA waiver of authorization required under 45 CFR 164.512(i). Your IRB has final authority.
Cited from registry · retrieved 2026-04-29 · engine v0.1.0
The pain
Most AI in research is ChatGPT pasted with a protocol. The output is fluent, the citations are confident, the §46.105(d)(7) it cites does not exist. AI in compliance has to start with a real citation registry, not a language model alone.
How it works
Tell the wizard your study type, subjects, jurisdiction, and data sensitivity. A pure-function engine resolves the pathway with conservative defaults — same inputs always produce the same output.
Every regulation cited in the engine output comes from a verified registry with sourceUrl and retrievedAt date. The LLM is constrained to cite from that set. Fabricated regulations are blocked.
Generate a 150–300 word justification paragraph for your IRB application. The model writes the prose; the citations come from the engine. PI edits before submission.
Anthropic via direct API with no-training, zero-retention contract. Your protocol text never enters a training set. SACHRP-aligned posture.
Cited regulations
SACHRP guidance on AI in HSR
Secretary's Advisory Committee on Human Research Protections guidance on the use of AI in human subjects research and IRB review.
SourceFAQ
No. The rationale generator runs every CFR-shaped citation in its output through the engine's citation registry. Anything not in the registry is flagged for human review before the output is shown.
No. We use Anthropic via direct API with a zero-retention, no-training contract. Your text isn't retained beyond the request and never enters training data.
The demo is a real, populated workspace. No signup, no email.