FDA Gives Industry Green Light on IRB Waivers for Minimal Risk Studies

FDA Logo

A new guidance from the U.S. Food and Drug Administration (FDA) assures sponsors, investigators, and institutional review boards (IRBs) the agency “does not intend” to object to an IRB waiving informed consent requirements for certain minimal risk clinical investigations.

To remove this obstacle, however, the IRB must be in the position to demonstrate:

  • The clinical investigation involves no more than minimal risk to trial subjects as defined by 21 CFR 50.3(k) or 56.102(i) in the Code of Federal Regulations.
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects.
  • The clinical investigation could not practicably be carried out without the waiver or alteration.
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

In addition, FDA says it does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters consent requirements meeting roughly the same criteria as for an IRB waiving some informed consent requirements. FDA acknowledges industry has often asked for guidance on situations spelling out when a waiver of obtaining informed consent matched the criteria.

In the guidance, the agency implies it might have acted sooner if it had statutory authority to permit such a waiver. An amendment to the Federal Food, Drug, and Cosmetic Act has since granted FDA such authority.

Author: Michael Causey