AI Protocol & Consent Generator
Draft compliant Institutional Review Board materials in minutes. Toggle the tabs below to draft a complete study protocol or compile a participant informed consent document.
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Consent Document Generated
Regulatory Background
Human subjects research under the Common Rule requires that informed consent be documented unless specific criteria for waiver of consent or waiver of documentation are met (45 CFR 46.116 and 46.117).
Our Consent Form Builder generates standard-reading level templates outlining key disclosures, voluntary participation clauses, data safety methods, and researcher contact blocks to ensure your document satisfies OHRP pre-requisites.
Dr. Raymond Holt
Dr. Holt is a research compliance consultant advising academic and clinical IRB submissions. He evaluates our generated templates against the Belmont principles and Common Rule subparts to ensure strict adherence to federal standards.