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103. FDA Additions to DHHS Required Elements of Informed Consent (§50.25)

In addition to requirements in the Common Rule (see the informed consent sections in the policy manual), investigators conducting FDA-regulated research must adhere to the following:

  • Consent documents must note the possibility that the Food and Drug Administration may inspect study records.
  • Researchers conducting applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), must include the following FDA-required statement in consent documents:

"A description of this clinical trial will be available on http://clinicaltrials.gov/, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

  • FDA informed consent requirements shall not preempt any applicable Federal, State, and local laws requiring additional information to be disclosed for legally effective informed consent.
  • FDA regulations do not limit the authority of a physician to provide emergency medical care when provided as she/he is permitted under applicable federal, state, and local law.

NOTE: The Common Rule allows two categories of waivers for documentation of informed consent. The Category 1 waiver of documentation does not apply to FDA-regulated research because such research would not meet the criteria for the waiver (i.e., minimal risk research in which the only document linking participants to the research is the consent form) (for details, refer to the policy for consent waivers).

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