Posting an Informed Consent Form for
Federally Supported Clinical Trials
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)
·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:
·for studies that use only non-English consent forms, the copy of the IRB-approved translated consent form may be uploaded to:
§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)]
·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
·only one consent form is required to be uploaded even if there are multiple consent forms for different populations / phases in the research