Clinical Trial Consent Form Posting Requirement

Single IRB Mandate 

Clinical Trial Consent Form Posting Requirement

The Final Rule (45 CFR 46.116(h)) includes consent form posting requirements for clinical trials conducted or supported by any Federal department or agency (not just NIH). For such studies, one IRB-approved version of a consent form that has been used to enroll participants must be posted on a public federal website designated for posting such consent forms.  Please see the Clinical Trials web page for more detailed information. ​

Single IRB Mandate

The single IRB (sIRB) mandate of the revised Common Rule is effective ​beginning January 20, 2020. The federal policy requires non-Exempt, federally-funded, cooperative research to rely on one IRB for study review and approval.  This applies to studies in which the same research protocol is being conducted at one or more domestic sites and that each site is under the control of a local participating investigator.  HRPP will be available for questions and guidance during this transitionary period. Visit Educational Workshops for upcoming training sessions and visit Single IRB (sIRB) Mandate for further guidance. ​

additional assistance

Need assistance with preparing a new IRB protocol or an amendment? Determining if a proposed project requires IRB review? Applying IRB-related policies or procedures?

Contact an appropriate HRPP team member to set up a time to discuss.

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Learn more about the *NEW* centralized submission, review, negotiation and approval process for Data Use Agreements here!

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Did you know about NIH's New Funding Opportunities for Basic Experimental Studies Involving Humans? Read more here.