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Informed Consent Posting Requirements

Per NIH Notice Number NOT-OD-19-050 regarding Common Rule implementation, the attachment of one IRB-approved version of a consent form that has been used to enroll participants on a public federal website (after recruitment closes and no later than 60 days after the last study visit) is required. This applies to studies initiated on or after January 21, 2019 and includes only those consent forms from clinical trials conducted or supported by a Common Rule department or agency (see list below) and meeting the NIH ‘Clinical Trial’ definition. The goal of this requirement is to increase transparency for federally funded clinical trials and simultaneously create a repository of sample consent forms that may be used as a reference for future research. It is the responsibility of the Principal Investigator to post consent forms as required.

Each document attached within the Protocol Registration and Results System (PRS) requires a cover sheet bearing the official study title, NCT number, and date of the document. Click here to access a generic cover sheet template which can be completed with study details prior to combining the cover sheet together with the informed consent document file using Adobe Acrobat. The combined file should be saved in the mandatory archivable PDF/A format. The PDF/A file can then be uploaded into the ClinicalTrials.gov Protocol Registration and Results System (PRS).

List of Common Rule Departments/Agencies

  1. Department of Homeland Security (DHS)
  2. Department of Agriculture (DOA)
  3. Department of Energy (DOE)
  4. National Aeronautics and Space Administration (NASA)
  5. Department of Commerce (National Institute of Standards and Technology [NIST])
  6. Social Security Administration (SSA)
  7. Agency for International Development (USAID)
  8. Department of Housing and Urban Development (HUD)
  9. Department of Justice (National Institute of Justice [NIJ])
  10. Department of Labor (DOL)
  11. Department of Defense (DOD)
  12. Department of Education (ED)
  13. Department of Veterans Affairs (VA)
  14. Environmental Protection Agency (Research and Development [EPA])
  15. Department of Health and Human Services (DHHS)
  16. National Science Foundation (NSF)
  17. Department of Transportation (DOT)
  18. Office of the Director of National Intelligence (ODNI)
    • National Counterterrorism Center (NCTC)
    • National Counterproliferation Center (NCPC)
    • National Counterintelligence and Security Center (NCSC)
    • Cyber Threat Information Integration Center (CTIIC)
    • Office of the Program Manager for the Information Sharing Environment
  19. Central Intelligence Agency (CIA)
  20. Consumer Product Safety Commission (CPSC)