New NIH IRB Guidelines Proposed

A draft policy from the US National Institutes of Health suggests that clinical studies performed at multiple sites should be reviewed by a single institutional review board.

Written byJef Akst

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FLICKR, SEATTLE MUNICIPAL ARCHIVESThe US National Institutes of Health (NIH) last week (December 3) issued a draft policy that suggests a single institutional review board (IRB) is sufficient to review applications for multi-site clinical studies.

The current regulations for the protection of human subjects requires review from the IRB of each involved institution, but according to an NIH statement, such rules were published when the majority of clinical studies took place at just one site. With multi-site trials becoming more and more common—allowing researchers to fill trials more quickly as well as recruit more diverse patient populations—the agency decided it was time for a revise. The new guidelines propose that all NIH-funded, multi-site studies carried out in the United States should use a single IRB, with occasional exceptions made “if local IRB review is necessary to meet the needs of specific populations or where it is required by federal, state, or tribal laws or regulations,” the press release read.

“Maintaining ...

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Meet the Author

Jef Akst
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Jef (an unusual nickname for Jennifer) got her master’s degree from Indiana University in April 2009 studying the mating behavior of seahorses. After four years of diving off the Gulf Coast of Tampa and performing behavioral experiments at the Tennessee Aquarium in Chattanooga, she left research to pursue a career in science writing. As The Scientist's managing editor, Jef edited features and oversaw the production of the TS Digest and quarterly print magazine. In 2022, her feature on uterus transplantation earned first place in the trade category of the Awards for Excellence in Health Care Journalism. She is a member of the National Association of Science Writers.
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