FDA Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations: A Holdover until Rulemaking

July 31, 2017By James E. Valentine & Gugan Kaur

On July 25, 2017, FDA announced the availability of a guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” FDA issued this guidance for immediate implementation, without initially seeking prior comment, based on a determination that prior public participation was not feasible or appropriate because the guidance presents a less burdensome policy consistent with the public health.

This guidance addresses an amendment to the Federal Food, Drug, and Cosmetic Act (“FDC Act”) that provides FDA with the authority to permit an exception from informed consent for minimal risk clinical investigations when specific criteria are met. Title III, Section 3024 of the 21st Century Cures Act (“Cures Act”), enacted in December 2016, amends sections 520(g)(3) and 505(i)(4) of the FDC Act to alter the informed consent requirements for both drugs and medical devices such that a waiver of informed consent may now be granted for “proposed clinical testing [that] poses no more than minimal risk to . . . human beings and includes appropriate safeguards . . . .” (see our previous post here). Minimal risk is defined in FDA regulations as “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” (21 C.F.R. §§ 50.3(k), 56.102(i)).

This provision of the Cures Act is more aligned with how minimal risk is handled under the Federal Policy for the Protection of Human Subjects (“Common Rule”), which sets forth requirements for the protection of human subjects involved in research that is conducted or supported by the Department of Health and Human Services (“HHS”) and 15 other federal departments and agencies (see our previous post on the Final Common Rule).

Although FDA-regulated research is not subject to the Common Rule, efforts to harmonize human subject protections have led to this expression by FDA of its intent to promulgate revisions to its informed consent regulations by adding the Common Rule provisions for waivers of informed consent. Specifically, the guidance asserts that FDA intends to revise its regulations to add a waiver or alteration of informed consent for certain FDA-regulated minimal risk clinical investigations to the two existing exceptions from informed consent (i.e., in life-threatening situations and for emergency research).

However, until those regulations are promulgated, the guidance makes clear that FDA does not intend to object to an Institutional Review Board (“IRB”) approving a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth in 21 C.F.R. § 50.25, or waiving the requirements to obtain informed consent when the IRB finds and documents that:The clinical investigation involves no more than minimal risk to the subjects;

  1. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  2. The clinical investigation could not practicably be carried out without the waiver or alteration; and
  3. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Additionally, FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described above.

In the past, FDA has been criticized for utilizing guidance documents instead of promulgating regulations to regulate industry (see, e.g., our previous posts here and here). However, in this instance, FDA’s guidance may be appropriate as a stopgap to provide IRBs and sponsors comfort in operating under the new statutory framework. Indeed, the guidance explicitly states that FDA intends to withdraw the guidance after it promulgates regulations to permit a waiver or alteration of informed consent under appropriate human subject protection safeguards consistent with section 3024 of the Cures Act.