The U.S. Food and Drug Administration (FDA) has released a guidance allowing for an Institutional Review Board (IRB) to waive informed consent requirements for clinical investigations that include adequate protections for human subjects and present a minimal risk. The guidance, which takes effect immediately, outlines the following criteria as grounds to waive informed consent:
- The investigation involves no more than “minimal risk” to subjects;
- The waiver or alteration of informed consent will not adversely affect the rights and welfare of the subjects;
- The investigation could not practicably be carried out without the waiver or alteration;
- Subjects will be provided additional pertinent information after participation whenever appropriate;
Updates to the Common Rule – the Federal Policy for the Protection of Human Subjects – issued earlier this year, which will take effect in January of 2018, include the additional criterion “if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.” While this criterion is not currently specified in the FDA guidance, the agency is considering adding this criterion to harmonize its regulations to those included in the Common Rule in future updates to any waiver provision.
This guidance was issued to take effect immediately while the FDA plans future revisions to its human subjects protection regulations. The new FDA policy is intended to facilitate the collection of real-world data for low risk research, including observational and retrospective studies.