The FDA recently issued new guidance that allows institutional review boards (IRBs) to waive or alter the FDA’s informed consent requirements for certain minimal risk clinical investigations without objection from the FDA.

The statutory basis for the guidance comes from amendments made by the 21st Century Cures Act from late in 2016 (P.L 144-255). This guidance, which took effect on July 25, 2017, is the first step for the FDA on this issue.  The FDA intends to implement subsequent regulations to permit IRB waiver or alterations of informed consent requirements for minimal risk clinical investigations.

The types of “minimal risk” clinical investigations for which the informed consent requirements may be waived or altered by the IRB, are those for which the IRB may determine “that 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.”

To waive informed consent for such minimal risk clinical studies, the IRB must determine that:

  • the clinical investigation involves no more than minimal risk to the subjects
  • the waiver or alteration will not adversely affect the rights and welfare of the subjects
  • the clinical investigations could not practicably be carried out without the waiver or alteration
  • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Thus, for example, if a sponsor desires to perform a new clinical investigation to support a drug application on existing data or biospecimens from a prior clinical investigation, but did not previously obtain appropriate informed consent from research subjects for the proposed clinical investigation, there is now a pathway to conduct the clinical investigation through an IRB waiver.

The Federal Policy for the Protection of Human Subjects (FPPHS) already permits IRB waiver or alteration for research involving minimal risk to research subjects.  The guidance now permits such IRB waivers or alterations for FDA regulated clinical investigations in the same manner as it does for studies subject to FPPHS.  If the research data at issue is maintained by an entity subject to HIPAA, a request for an IRB to waive HIPAA’s authorization requirements could also be made.