by Julie Severson

NIH Proposes Changes to Human Gene Transfer Research

As any business leader will tell you, trimming the fat is a good thing. While most do not associate this type of thinking with the federal government, this is indeed what the National Institutes of Health (NIH) Office of Science Policy (OSP) recently accomplished in a published notice. In August, the agency proposed the removal of elements from the NIH Guidelines once thought to offer useful harmonization with the Food and Drug Administration’s (FDA) regulation of human gene transfer (HGT) studies, but are now commonly thought of as unhelpful and duplicative. This move is bold, for it acknowledges these components may actually hinder innovative research while adding little to participant and biological safety. It paves the way for more expedient research and growth in this area of scientific knowledge and medicine. We at Quorum are ready for these changes.

Changes Proposed in the NIH Notice

NIH proposes a handful of changes that lessen the administrative burden on researchers and increase the importance of Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs) in HGT research. For starters, the agency plans to remove the requirement that Principal Investigators (PIs) register their protocols with OSP prior to enrolling participants. Further, NIH proposes to remove the requirement that studies meeting particular criteria receive review by NIH’s Recombinant DNA Advisory Committee (RAC). (Historically, both IRBs and IBCs have been tasked with recommending that eligible studies receive this higher level of scrutiny.) Lastly, the notice proposes the removal of safety reporting requirements to OSP. An entire section of the NIH Guidelines—Appendix M—is slated for removal.

The Reasons for and the Effects of the Proposed Changes

NIH acknowledges the components slated for removal have become unnecessary over time. The notice calls out numerous safeguards that did not exist when NIH first drafted its guidelines overseeing research involving recombinant or synthetic nucleic acid molecules. For example, this area of research has advanced enough that the FDA has released a suite of guidance documents providing oversight and controls that are commensurate with the support provided for other areas of research. Additionally, NIH has discovered that RAC review is rarely warranted. Both IRBs and IBCs have proven effective at identifying participant and biological safety issues, particularly when their reviews include expertise from the field. Moreover, requiring safety reporting to OSP as well as IRBs, IBCs, and the FDA has proven unnecessarily redundant and administratively burdensome.

The formal implementation of the proposed changes will generate both specific and broad effects. First and foremost, it will remove the administrative redundancy and additional burdens (in time, effort, and cost) uniquely applied to this promising area of research. Registration, reporting, and RAC review requirements will make way for more efficient research and development streams. Secondly, the proposed changes will allow the RAC to focus on emerging biotechnologies research, a growing but still novel area that benefits from continued discussions regarding science, safety, and ethics. Lastly and more broadly, as NIH removes processes and minimizes OSP’s role overseeing HGT research, existing review bodies—namely, IRBs and IBCs—will become more central and important to the advancement of HGT research. In their place as primary thresholds on the path to study initiation, quality and efficiency of review become that much more valuable.

Quality, Efficiency, and Integration: the Quorum Way

NIH’s notice introduces opportune change at an opportune time. Earlier this year, Quorum launched a line of IBC services that provides not only quality and efficiency, but coordinated IRB and IBC review. We leverage our One-Touch Collaboration™ service philosophy, and promise clients that when they submit their studies for both IRB and IBC review they gain a far more streamlined experience than what’s available from any other company. Click here to learn more about IBC.

With the proposed elimination of registration, reporting, and RAC review, One-Touch Collaboration™ can make an even greater difference in study initiation. Researchers will no longer expend additional resources and wait a longer time to overcome OSP hurdles. IRB and IBC review quality and time emerge as the key variables, and Quorum is poised to deliver a better experience on your behalf.

Getting started is easy. You can request IBC services with your initial submission. Or, you can contact our IBC coordination team. Either way, our knowledgeable staff will tailor our processes to meet your administrative requirements and ensure your review needs are met. We’re looking forward to providing a seamless IRB and IBC experience for you!

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