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FDA’s September 2022 NPRMs: What They Mean for Academia and Industry

On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed harmonization with the Health and Human Services (HHS) 2018 Common Rule (also referred to as the revised Common Rule). This blog highlights some of the major proposed changes and how they may impact the clinical research community.  

Consistent Human Subject Protection Requirements 

The proposal “Protection of Human Subjects and Institutional Review Boards” would revise 21 CFR Part 50 and harmonize the FDA regulations to match the 2018 revised Common Rule across several inconsistent areas, including informed consent and continuing review.  

Proposed changes to informed consent requirements include new basic elements similar to those included in the revised Common Rule. This includes a key information section at the beginning of the informed consent form (ICF) and required additional information about the future use (secondary use) of any personal information or biospecimens. Research sponsors would need to update existing ICF templates to ensure these elements are appropriately incorporated. 

The NPRM also proposes additional elements of consent, for use when appropriate, such as including information about whether biospecimens would be used for commercial profit and if the participant would gain anything from this profit. It also proposes adding information about if results will be returned to participants, under what conditions, and whether whole genome sequencing will occur. In addition to the harmonization goal, these additional elements help modernize the regulations with current scientific and participant expectations. 

The proposal also suggests eliminating continuing review once the study has progressed to involve only data analysis (including accessing identifiable data of follow-up care). Again, this is similar to what HHS regulations currently permit. 

These changes are just a few of the proposed updates allowing for more uniform review mechanisms. The changes could even lead institutional review boards (IRBs) to be able to relax their requirements to distinguish between studies governed by FDA regulations versus OHRP regulations. This, in turn, enables a streamlined review to one set of regulations (with a few exceptions, such as limited review and broad consent). 

Mandated Single IRB (sIRB) Review 

The second NPRM, “Institutional Review Boards; Cooperative Research,” is related to cooperative research, or research involving more than one institution (i.e., multisite research and trials). This proposal would require all U.S. sites involved in a multisite research protocol regulated by the FDA to use a single IRB (sIRB), harmonizing FDA regulations with the National Institutes of Health (NIH) and HHS requirements to utilize a single IRB in multisite cooperative research 

The FDA proposes some exceptions a bit different from those currently allowed by the NIH and HHS. For example, studies may be excepted from the sIRB requirement where a local IRB has specific expertise to carry out the review or when the study is conducted under tribal law or other laws prohibiting sIRB oversight. Also proposed are exceptions for research involving an investigational new drug application (IND), research that is investigational device exemption (IDE) exempt, and non-significant risk (NSR) device research. 

Many industry sponsors already request participating sites in multisite trials rely on the study’s central IRB as a way to reduce the administrative burden of managing multiple IRB requirements, processes, and timelines, citing FDA’s 2006 guidance on centralized IRB review. The proposed regulatory change would instead mandate relying on a single IRB, potentially changing the way sponsors and contract research organizations (CROs) design and conduct multisite research.

Many in the institutional site community have already updated policies to be in line with other sIRB mandates; this change would bring additional sites into the sIRB world and potentially require policy updates for many institutions and local IRBs.  

The FDA’s proposal does not designate who makes the decision of which IRB to use, rather just describing it must be agreed upon and identified in any FDA application.

This proposal also indicates all local and academic IRBs, both small and large, would still have responsibility for keeping track of the research conducted within their organizations. This is an important provision, as many organizations already include a ceded review mechanism for the human research protection program (HRPP) to verify non-IRB review items and to ensure local information is communicated to each single reviewing IRB.  

Change for the Better 

The past decade has brought some significant changes to IRB regulations, impacting a community and industry sometimes characterized as slow to adapt. Change is never easy, and evolving to meet these new requirements has created additional challenges for many institutions where so many research actions are intertwined with the IRB’s activities.  

However, it’s important to remember the foundation of these changes: modernizing requirements to better address the way research is currently conducted, reducing burdens, and adding efficiencies to help research progress more quickly and ultimately deliver better therapies for patients.

As stated in the HHS 2011 Advance Notice of Proposed Rulemaking (ANPRM), “Revisions to the current human subjects regulations are being considered because [the Office of Science and Technology Policy] and HHS believe these changes would strengthen protections for research subjects.” 

We are all partners in the protection of research subjects, no matter the type of organization. Local IRBs are vital to their organization’s oversight of research, with unique knowledge of their local communities, and must always have a voice in the process. sIRBs can help to streamline processes, but it’s ultimately a collaborative effort among all stakeholders to develop policies properly reflecting current research best practices and ensure proper subject protections. It is truly a partnership.

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