Menu

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.

Dec 8, 2014
Jef Akst

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 the highest ethical standards in the research we fund is of utmost importance,” NIH Director Francis Collins said in the statement. “By using single IRBs in multi-site studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”

“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,” added Sally Rockey, the deputy director for extramural research at NIH, in a post on her Rock Talk blog.

The draft policy is open to public comments through January 29, 2015.

(Hat tip to GenomeWeb)

June 2019

Living with Bacteria

Can pathogens be converted to commensals?

Marketplace

Sponsored Product Updates

Gyros Protein Technologies introduces Gyrolab E. coli HCP Kit for automated impurity analysis of biotherapeutics
Gyros Protein Technologies introduces Gyrolab E. coli HCP Kit for automated impurity analysis of biotherapeutics
Ready-to-use immunoassay kit increases analytical output and productivity in bioprocess workflows. Kit developed as part of licensing and supply agreement with Cygnus Technologies
IDT launches ultra-high performance CRISPR Cas12a enzyme
IDT launches ultra-high performance CRISPR Cas12a enzyme
IDT’s new CRISPR Cas12a (Cpf1) Ultra enzyme can target new sites within the genome and with greater efficiency
Implen Launches New NanoPhotometer N120: The High Throughput Champion!
Implen Launches New NanoPhotometer N120: The High Throughput Champion!
Implen GmbH is excited to announce the release of the NanoPhotometer® N120, an absorbance based UV/VIS Multi Channel Spectrophotometer.
StemExpress Announces Release of New Frozen Leukopak® to Advance Research
StemExpress Announces Release of New Frozen Leukopak® to Advance Research
To continue to provide new products and services to further advance medical research around the world, today, StemExpress announced the release of their Frozen Leukopak®.