In October the Food and Drug Administration (FDA) offered a final guidance document about how its regulations will align with next January’s changes to the Common Rule. Both the FDA and the Common Rule oversee the treatment of human subjects in research; the FDA’s jurisdiction is over treatments that could be approved as commercial products, while the Common Rule is concerned with research either funded or conducted by the Federal government. The requirements of the two sets of rules overlap for the most part, but in a few areas the rules differ, and the coming changes to the Common Rule will widen some of the gaps. This guidance focuses on three areas: requirements for the informed consent document; expedited review for minimal risk studies; and the need for continuing review of research involving human subjects.
The Common Rule’s 2018 Requirements introduce a number of changes to informed consent (which an appendix to the FDA guidance document helpfully summarizes), and the FDA appears willing to support those changes as much as possible. As the guidance states it, the Common Rule revisions to informed consent are “not inconsistent” with existing FDA requirements. The guidance anticipates that researchers and institutions will use Common Rule-compliant templates for FDA studies.
Review of Minimal Risk Research
Before the 2018 Requirements, the FDA and the Common Rule had the same requirements for allowing expedited IRB review of minimal risk research. Both sets of rules allowed for the expedited review of research if (1) the required procedures of the research appeared on a list of straightforward practices, and (2) an IRB reviewer agreed that the study presented only minimal risk to human subjects. The Common Rule requirements have now flipped the decision in (2): an IRB reviewer must find that the research is not minimal risk rather than determine that it is. In a sense, it moves from an opt-in decision to an opt-out decision. This could hasten the approvals for these studies under the Common Rule, but it creates a new distinction from the comparable FDA process (though the language of the guidance document suggests the FDA could soon introduce a similar shift).
The new rules for continuing review may present the most dramatic difference between the Common Rule and FDA versions of the rules. The 2018 Requirements will allow some research to avoid annual renewals, and as part of that will recognize in some cases a new “limited IRB review.” The FDA has no means to recognize limited IRB review, nor has it removed any requirements for continuing review of human subjects research.
Other Areas for Clarification
The FDA appears open to hearing other concerns from researchers even though it was published as a final document. The guidance encourages observers to chime in on any additional problem areas between FDA regulations and the revised Common Rule.