For many decades now the Department of Health and Human Services (HHS), and consequently NIH, has required institutional review board (IRB) review of research involving human subjects. When this regulation was instituted in 1975, most clinical research primarily took place at a single research institution. However, advances in science and technology facilitate greater connectivity between researchers, participants, and research centers and hospitals. Additionally, to get at a better understanding of human health, we support the use of multiple research sites to recruit individuals from diverse regions, and to increase participant numbers for better-powered research studies. Thus, as the clinical research landscape evolves, so should our policies to assure that NIH-funded research can more quickly generate research results without compromising protections for those who volunteer to participate in clinical studies.
Today, NIH released a draft policy proposing that all NIH-funded multi-site clinical studies carried out in the US should use a single IRB’s review, rather than working through the IRB approval process of each participating institution. A number of NIH institute and centers, such as the National Cancer Institute and the National Institute of Neurological Disorders and Stroke, already support the use of a single IRB review in several of their large clinical trial networks. Their experiences show the benefits and feasibility of the single IRB review model. For example, an analysis supported by NCI determined that having a single designated IRB decreases approval times for multi-site clinical protocol and is, in general, more cost effective than having each site reviewed by a different IRB. Several journal articles have described how the use of a single IRB review also minimizes institutional conflicts of interest, and leads to enhanced protections for research subjects. However, in some instances there may be reasons to request exemption from using a single IRB, for example, if one IRB cannot meet the needs of all applicable federal, tribal, and state laws. Therefore, exceptions to this policy may be made with appropriate justification.
I encourage you to read the NIH press release and review the full draft policy released in the NIH Guide today. We’re seeking your input on this proposed policy, and as described in the NIH Guide notice, your comment should be submitted to the NIH Office of Science Policy by January 29th for formal consideration.
I believe this proposed policy is a step forward to reducing burdens associated with NIH-funded clinical research and enhancing the efficiency of the process while still ensuring protections of all the volunteers who generously participate in human subjects research for the betterment of us all.