The FDA has introduced one of the first, if not the first, tangible consequences of the 21st Century Cures Act (Cures) for human research protection programs: a new guidance document, “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” The guidance expands the scope for researchers on FDA-governed studies to request changes to or waivers of informed consent requirements.
The new policy is another step toward better alignment between FDA and Common Rule regulations. This new guidance brings permissions to waive or alter some informed consent requirements for FDA-regulated research—which is primarily industry-funded—in line with the Common Rule, which governs federally-funded research. Harmonization between the two sets of regulations has been a goal of these two regulatory bodies for years, and the differing permissions for consent in minimal risk research posed one of the largest misalignments in approach. The Cures Act provided an opportunity to narrow the gap.
By applying existing criteria, the FDA has adopted guidelines familiar to any researcher, sponsor, or IRB that has worked with minimal risk research under the Common Rule. Under both regulatory frameworks, an IRB can authorize exclusion of or changes to some of the requirements of a study’s informed consent by finding the following:
- The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) 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.
We have identified at least two examples of FDA-regulated research that could fall under this new guidance:
- A post-approval observational study that searches electronic medical records for data on safety or efficacy, or
- A study that uses leftover clinical specimens to test an investigational assay that is considered an in vitro diagnostic device (for more information on this type of research, see the FDA’s previous discussion about in vitro diagnostic device studies).
In any situation, an IRB must agree that the waivers or changes to informed consent are appropriate. The requirement that the research presents no more than minimal risk to a subject ensures that this guideline cannot apply to trials involving as-yet unapproved study drugs.
The FDA and Common Rule use a shared definition of minimal risk:
Minimal risk means 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.
This shared definition contributes to easing the realignment process. Strictly speaking, this is not a formal change to FDA regulations. It is what the guidance calls a “less burdensome policy” that the FDA will follow until it updates regulations formally to conform with the Cures Act. In the interim, though, the FDA says that it “does not intend to object” to any decisions that conform to these new guidelines.
It is worth noting that this guidance relies on the pre-2018 Common Rule for its references, not the revision that came out on January 19. The new Common Rule will change the review of minimal risk research in a number of ways when it becomes effective January 19, 2018. To learn more about how the new Common Rule will impact your research, register for the upcoming Kinetiq webinar.
Since the FDA has incorporated language from the Common Rule, any IRB with Common Rule experience should have no difficulty implementing these new permissions.