Guidance on Posting Informed Consent Forms for Federally Supported Clinical Trials

Posting an Informed Consent Form for

Federally Supported Clinical Trials

Background

The Department of Health and Human Services (HHS) Regulation (“revised Common Rule”) requires a clinical trial conducted or supported by a Common Rule department or agency to post a copy of the approved consent form to a publicly available federal website within a specific timeframe.

On May 17, 2019, the National Institutes of Health (NIH) published guidance for this HHS requirement.  Other Common Rule departments and agencies plan to develop similar guidance – the intention is to aim for a common policy across HHS.

NIH Policy (NOT-OD-19-110)

§Scope: 

·funded Clinical Trials as defined in 45 CFR 46.102(b)

§Application of the requirement:

·a copy of an IRB-approved English-language consent form may be uploaded to:

–ClinicalTrials.gov, or

–Regulations.gov

·for studies that use only non-English consent forms, the copy of the IRB-approved translated consent form may be uploaded to:

–Regulations.gov

§Important note:  upload one blank copy of the approved consent form (to protect research participant privacy), and adhere to any applicable terms and conditions of the NIH award

HHS Regulation [45 CFR 46.116(h)]

§Scope:

·Clinical Trials [as defined in 45 CFR 46.102(b)] conducted or supported by a Common Rule department or agency

§Specifics of the requirement:

·trials initiated ≥ 1/21/19 must adhere to the 2018 HHS requirement

·trials initiated < 1/21/19 do not require consent forms to be posted

·uploading a consent form to Regulations.gov are for trials that are not already registered on ClinicalTrials.gov, or for trials that only use a translated consent form

·only one consent form is required to be uploaded even if there are multiple consent forms for different populations / phases in the research

§OHRP Timelines:

Additional guidance:

§NIH:  https://grants.nih.gov/policy/clinical-trials/informedconsent.htm

§OHRP:  https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html