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Informed Consent Posting Scope Clarification
On August 10, 2026, the Office for Human Research Protections (OHRP) published a new Frequently Asked Question document clarifying informed consent posting requirements for basic experimental studies involving human participants.
OHRP does NOT consider “basic experimental studies involving humans” or “BESH,” as described by the National Institutes of Health (NIH) in guide notice NOT-OD-26-032, to be subject to the informed consent form posting requirements under 45 CFR part 46.116(h).
OHRPs posting requirement applies to Federally Funded Clinical Trials.OHRP only considers studies evaluating outcomes that have the potential for direct effect on biomedical or behavioral health to meet the definition of a clinical trial at 45 CFR 46.102(b), and be subject to the requirement to post informed consent forms.
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