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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:

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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

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