Streamlining IRB Review of Multi-Site Clinical Research Studies

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 examp...
Source: NIH Extramural Nexus - Category: Research Authors: Tags: Rock Talk clinical research Grants policy human subjects IRB Source Type: funding