News Release

Wednesday, December 3, 2014

NIH takes step to speed the initiation of clinical research by ensuring use of single IRB

The National Institutes of Health issued a draft policy today to promote the use of single institutional review boards or IRBs, in multi-site clinical research studies. IRBs play a critical role in assuring the ethical conduct of clinical research, and studies must be reviewed and approved by an IRB before they can begin. When the regulations for protection of human subjects were first published, most clinical research was conducted at a single institution. Since then, the research landscape has evolved, and many studies are carried out at multiple sites and within large networks. Studies that go beyond a single site are often able to recruit more individuals from diverse populations. These multi-site studies can often generate important results in less time. However, working through IRB review at each site can add delay without increasing the protections for the research participants in the study.

The draft NIH policy proposes that all NIH-funded, multi-site studies carried out in the United States, whether supported through grants, contracts, or the NIH intramural program, should use a single IRB. Exceptions to the policy would be allowed 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. Wider use of single IRB review in multi-site studies will help achieve greater efficiencies in the initiation of studies across NIH’s entire clinical research portfolio.

“Maintaining the highest ethical standards in the research we fund is of utmost importance,” said NIH Director Francis S. Collins, M.D., Ph.D. “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.”

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.

NIH is seeking public comments on the draft policy through a 60 day comment period closing Jan. 29, 2015.

Comments may be submitted by any of the following methods:

• Email: SingleIRBpolicy@mail.nih.gov
• Fax: 301-496-9839
• Mail/hand delivery/courier: Office of Clinical Research and Bioethics Policy, Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892.

For the full draft policy, visit http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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