On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed consent regulation (21 CFR 50.25).
The 21st Century Cures Act, enacted on December 13, 2016, provides FDA with the authority to create an exception from its general informed consent requirements for minimal risk studies (defined as studies which entail probabilities and magnitudes of anticipated harm or discomfort “no greater in and of themselves than those ordinarily encountered in daily life” or during routine physical or psychological tests). Permitting changes to the regular informed consent obligations lowers the barrier to conducting studies which have little to no risk but may result in contribution to medical and scientific advances.
Accordingly, FDA has decided to revise its informed consent regulations to create exceptions from the general informed consent requirements for minimal risk studies. In the meantime, through this guidance document FDA is immediately implementing a policy to not object to IRB approvals of – and sponsors and investigators conducting studies under IRB approvals of – consent procedures that waive or alter the typical informed consent procedures when the following requirements are met:
- 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 investigation 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.
FDA noted that it plans to withdraw this guidance document once it issues regulations on the subject, which may alter the circumstances under which waiver or alteration of regular informed consent requirements are permissible.
Under the Common Rule, IRBs are already permitted to waive the requirements to obtain informed consent where the specific criteria in 45 CFR 46.116(d) are met. The waiver policy set forth in this guidance document adopts the waiver criteria contained in the Common Rule and now permits IRBs to grant the same waivers for FDA-regulated minimal risk research.