3 December 2014

NIH Proposes New IRB Guidelines

The NIH has announced new policy guidelines proposing the use of a single institutional review board (IRB) to review applications for multi-site clinical studies. According to NIH Director Francis S. Collins, MD, PhD, this change will “reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”

A number of NIH institutes and centers have been supporting the use of a single IRB in multi-site studies, and their experiences have shown the benefits and feasibility of the single IRB review model. Examples include the National Cancer Institute’s (NCI) Central Institutional Review Board, which has been in place for the review of NCI-sponsored clinical trials since 1999. The National Institute of Neurological Disorders and Stroke has also incorporated the use of a single IRB for its Network for Excellence in Neuroscience Clinical Trials’ (NeuroNEXT) and its stroke research network, NIH StrokeNET.

As part of this ongoing effort, the NIH has released an RFA to explore 1) the principles and characteristics for central Institutional Review Boards (IRBs); and 2) consent and participant preferences for research using clinical records and data.

TGC Research is hosting an invitation-only round table to explore the opportunities this presents for our research partners.

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Posted by Melanie Daniels

Mel has spent 15 years working alongside some of the most successful clinical research investigators in the world. She understands the pressures that are placed on highly productive academic investigators, and she is always finding new ways to help increase their productivity while respecting the demands of their existing research portfolio.