FDA says will not object to waiver of informed consent for minimal risk studies in new guidance

 
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In a new guidance, the US Food and Drug Administration (FDA) explains that it does not intend to object to the conduct of a minimal risk clinical study if the institutional review board has waived or altered the requirement for informed consent. While the Common Rule, a policy that applies to 17 federal agencies, allows waivers or alteration of informed consent for studies that carry no more than minimal risk, the FDA does not currently have such a provision. The 21st Century Cures Act gives the FDA authority to permit this exception, and the new guidance makes this intention clear until FDA regulations are updated to reflect the change.

 

Read the full guidance: IRB Waiver or Alteration of Informed Consent forClinical Investigations Involving No More Than Minimal Risk to HumanSubjects