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·Aug 15, 2026

Sample IRB Position Statement on AI in Protocol Drafting

A reference policy excerpt institutional review boards can adapt for internal guidance to PIs writing protocols with AI assistance.

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RedInk Research Team
Editorial reference template published by RedInkAI. Not a real practitioner contribution. Adapt to your context before use.
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Investigators may use AI tools during protocol preparation. The IRB requires disclosure when AI shaped any of the following: study design, eligibility criteria, recruitment language, informed consent text, or analysis plan.

Disclosure must include a verifiable cognitive audit (such as a RedInkAI attestation) demonstrating which AI suggestions were adopted, adopted with modification, or rejected. The IRB does not require submission of the audit at protocol intake. The PI must retain it and produce it on request during continuing review.

Studies involving vulnerable populations require explicit board review of AI consultation patterns where consent or recruitment language is concerned.

This is a template. Local IRBs should adapt the language to their institution's risk posture and align it with applicable federal regulations and accreditation standards before adopting.

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