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Biological Chemistry

Reform Proposed For Clinical Trials

by Andrea Widener
December 8, 2014 | A version of this story appeared in Volume 92, Issue 49

Credit: Shutterstock
NIH’s proposal would affect clinical trials conducted at multiple sites.
A photograph of a woman scientist holding a tube containing a red fluid.
Credit: Shutterstock
NIH’s proposal would affect clinical trials conducted at multiple sites.

Multisite clinical trials should be able to use a single institutional review board (IRB) to ensure the ethics of the various groups’ clinical trials, NIH proposed last week. The draft policy aims to eliminate costly delays in starting multisite clinical trials, which currently require IRB approval from each site that participates. “By using single IRBs in multisite studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds,” NIH Director Francis S. Collins says. Multisite clinical trials have become more common because they allow researchers to recruit participants more quickly. However, getting approval from multiple sites has often delayed research without adding protection for participants, NIH says. Several NIH centers have already tried out single IRBs, including the National Cancer Institute and the National Institute of Neurological Disorders & Stroke. NIH included some exceptions in the proposed policy. The agency is seeking public comment on the draft policy through Jan. 29, 2015.


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