Notice Number: NOT-OD-19-110
Release Date: May 17, 2019
National Institutes of Health (NIH)
The purpose of this notice is to provide guidance to the extramural research community regarding where to post clinical trial informed consent forms, as required by Section 46.116(h) of the Revised Common Rule (Subpart A of 45 CFR 46).
For clinical trials conducted by or supported by a Federal department or agency, the Revised Common Rule requires the posting of an IRB-approved consent form on a public federal website designated for posting such consent forms. Recipients of NIH funding subject to the Revised Common Rule and conducting a clinical trial as defined in 45CFR46.102(b) must submit an IRB-approved consent form in accordance with Section 46.116(h).
Submit an IRB-approved English-language informed consent form to ClinicalTrials.gov. Documents that are uploaded to ClinicalTrials.gov should be uploaded in accordance with the instructions at https://prsinfo.clinicaltrials.gov/. ClinicalTrials.gov does not currently support upload of non-English documents. Or:
Submit an IRB-approved informed consent form to Regulations.gov following the instructions in the paragraph below. NIH recipients submitting informed consent forms to Regulations.gov should maintain a copy of their Regulations.gov receipt and tracking number.
Institutions submitting documents to either ClinicalTrials.gov or Regulations.gov must protect participant privacy in accordance with applicable federal, state, and local laws and regulations (e.g., the HIPAA Privacy Rule, Certificates of Confidentiality) and any applicable terms of their NIH award.
Please direct all inquiries to:
Office of Policy for Extramural Research Administration