New Requirement to Post Clinical Trial Consent Forms

Wednesday, January 02, 2019

The following revision to the Federal Policy for the Protection of Human Subjects (also known as subpart A of 45 CFR part 46 or the “Common Rule”) requires the posting of clinical trials consent forms. This revision comes into effect on January 21, 2019 and impacts NIH award holders. 

(1) For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms.

(2) If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.

(3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

At this time, two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). Additional federal websites that would satisfy the revised Common Rule’s clinical trial consent form posting requirement might be identified in the future.

You can read more information about the revised Common Rule on the OHRP website (https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html).

Visit the ORS Compliance Requirements page for general information and guidance on registering clinical trials.