New Guidance on Informed Consent for Minimal Risk Clinical Trials


The 21st Century Cures Act (PL 114-255) gave the United States Food and Drug Administration (FDA) the authority to permit exceptions to Informed Consent for no more than minimal risk clinical trials that meet certain criteria. Currently, the regulations concerning human subject protections (21 CFR 50 and 21 CFR 56) only permit exceptions from Informed Consent requirements in life-threatening situations and emergency research. This change will bring FDA regulations more closely in line with recent revisions to the Common Rule (45 CFR 46). The FDA issued a final guidance concerning these changes, which will be effective immediately and until revisions to the human subjects’ protections regulations are completed.

The new guidance permits Institutional Review Boards (IRBs) to waive or alter some or all of the Informed Consent requirements set forth in 21 CFR 50.25, if the IRB finds and documents that the criteria listed below are met:

  • The clinical investigation involves no more than minimal risk to the subjects. Minimal risk is defined in 21 CFR 50.3(k) or 21 CFR 56.102(i) and is consistent with the definitions in the Common Rule. Minimal risk is defined as “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.”
  • The waiver or alteration may not adversely affect the rights and welfare of the subjects.
  • The clinical investigation could not practicably be conducted without the waiver or alteration.
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Note that trials exhibiting minimal risk to subjects still require IRB approval, and the governing IRB will make the determination as to whether the above criteria have been met. For medical devices, if sponsors, investigators, or IRBs have questions regarding the implementation of the guidance with regard to a specific clinical investigation, they are encouraged to contact the Clinical Trials Program in the Center for Devices and Radiological Health (CDRHClinicalEvidence@fda.hhs.gov).

For assistance in understanding the new regulation and how it will impact your business, contact ICON at www.iconplc.com/devices for more information.

Gordon MacFarlane, Ph.D., RAC
Senior Manager Regulatory Affairs