FDA regulations and the Common Rule share the same definition for “minimal risk,” but while the Common Rule allows a waiver of informed consent for minimal risk research if specific criteria are met current FDA regulations do not. FDA indicates that waiver of informed consent for certain FDA-regulated minimal risk clinical investigations will facilitate investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, or address unmet medical needs. FDA intends to revise its informed consent regulations in response the 21st Century Cures Act. Learn what the FDA is requiring, via recent Guidance in order for minimal risk research to be conducted with an alteration or waiver of informed consent. Be sure you are prepared for the new opportunities this policy change will open to your research teams.
Describe existing regulatory exceptions to informed consent.
Define minimal risk as it pertains to waiver or alteration of informed consent by the IRB.
List the four criteria the IRB must document in order to grant an alteration or waiver of informed consent.