Updated Processes to Accommodate New FDA Guidance on Waivers of Consent

August 4th, 2017

Schulman IRB has updated submission and review processes to accommodate FDA’s new guidance document IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.

Intended for immediate implementation, this guidance explains that FDA “does not intend to object to an IRB waiving or altering informed consent requirements for certain minimal risk clinical investigations.” In response, Schulman has updated submission forms and standard operating procedures to accommodate waivers of informed consent for FDA-regulated minimal risks research meeting the criteria below:

  1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3[k] and 102[(i)]) to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The clinical investigation could not practicably be carried out without the waiver or alteration; and
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The 21st Century Cures Act amended the Federal Food, Drug, and Cosmetic Act to provide authority for FDA to permit an exception from informed consent requirements for research that is no more than minimal risk. Until the FDA issues revised regulations, this latest guidance document provides guidance to sponsors, investigators, and IRBs on enforcement of FDA regulations governing informed consent requirements and the ability waive elements of consent for minimal risk research.

Many FDA and OHRP regulations are aligned, though a few still remain different (see Comparison of FDA and HHS Human Subject Protection Regulations for a summary of differences). One of those differences is the criteria for waiving informed consent. Through this new guidance, FDA moves a step closer to being aligned with OHRP’s regulations (aka the Common Rule).

If you have any questions regarding this information, please contact your Study Manager or call 513-761-4100.