On 24 July 2017, the U.S. Food and Drug Administration (FDA) issued guidance (IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects) that it will not object if an IRB approves a waiver or alteration of consent for a no more than minimal risk clinical investigation. The IRB must determine and document that:
- The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3[k] or 56.102[i]) to subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
This guidance is an effort to harmonize FDA and U.S. Department of Health and Human Services (HHS) regulations for human subjects research, and facilitate minimal risk research. However, the FDA is harmonizing with the current Common Rule waiver and alteration criteria, not the revised Final Rule criteria that includes a fifth criterion about identifiable private information and identifiable biospecimens (the revised Common Rule will be effective 19 January 2018).
The CITI Program has updated all affected modules to be current with the FDA guidance.