Proposed NIH policy calls for a single IRB to accelerate multi-centered trials and reduce redundancy
The National Institutes of Health (NIH) officially has backed a draft policy calling for a single IRB for multi-site reviews of NIH-supported clinical trials—a streamlined strategy it says will accelerate trials without compromising safety.
The proposed NIH policy, which has the support of the Association of Clinical Research Organizations (ACRO), would replace individual IRB reviews at each site, which can delay studies without increasing protections for trial participants, according to the NIH.
The draft covers NIH-funded, multi-site studies in the U.S., including those studies supported by grants, contracts or the NIH intramural program. Exceptions to the policy would be permitted if local IRB review is necessary to meet the needs of specific populations of patients or where federal, state or tribal regulations or laws are mandated.
By using a single IRB in multi-site studies, “we reduce duplication of effort, speed the initiation of important research and save time and taxpayer funds,” NIH director Francis Collins said in a statement.
ACRO, a long-time advocate of a central IRB to accelerate study start-up and improve efficiency of the trial process, acknowledged that the majority of studies involving its members fall under the FDA, which is not covered by the proposed NIH guidelines. John Lewis, ACRO senior vice president of policy and public affairs, said ACRO is encouraged and supportive of the NIH draft policy.
Also supporting the move toward a single IRB in multi-site studies is the National Cancer Institute’s Central Institutional Review Board, the National Institute of Neurological Disorders and Stroke’s Network for Excellence in Neuroscience Clinical Trial and its stroke research network.
Quintiles, the world’s largest CRO, also supports the policy, provided there are also accelerated protocol reviews and vigorous medical-ethical oversight of the study is maintained or enhanced.
“Some IRBs are very responsive without sacrificing their fiduciary responsibility to provide independent and rigorous oversight of clinical research,” said cardiologist Jeffrey Spaeder, M.D., Quintiles senior vice president and its chief medical and scientific officer. “However, there are other IRBs that introduce administrative delays in the review of protocols. These delays have had an increasing impact on clinical research timelines as the number of sites required for clinical studies increases, while, simultaneously, studies are becoming more complex and there are fewer sites capable of conducting these more sophisticated studies.”
Trial sites outside the U.S. may elect to comply with the single IRB protocol but would not be required to do so.
Public comments on the draft policy can be submitted via email to SingleIRBpolicy@mail.nih.gov. The 60-day comment period closes Jan. 29, 2015.