Posting Clinical Trial Informed Consent Forms

Learn more about the new requirement that clinical trials post informed consent documents to a public federal government website


Purpose

The purpose of this requirement is to be more transparent about the consent forms being used and, over time, improve the quality of consent forms.


Policy Implementation

Sections 46.102(b) and 46.116(h) of the Revised Common Rule requires clinical trials post one IRB-approved version of a consent form that has been used to enroll participants on a public federal website designated for posting such consent forms. The form must be posted after recruitment closes, and no later than 60 days after the last study visit. 


For additional guidance, refer to the OHRP FAQs on Informed Consent