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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  2. For Patients
  3. Clinical Trials: What Patients Need to Know
  4. Informed Consent for Clinical Trials
  5. Minimal Risk
  1. Informed Consent for Clinical Trials

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

 
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