Single IRB Policy Will Streamline Multi-Site Clinical Research
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July 25, 2016
Last month, NIH issued a policy to promote effective Institutional Review Board (IRB) review of multi-site research proposals. This new policy establishes the expectation that a single IRB (sIRB) of record will be used in the ethical review for NIH-funded multi-site, non-exempt human subjects research protocols in the United States.
Prior to issuing this new policy, NIH carefully considered input from many different stakeholders in the clinical research process. Most of comments submitted after NIH published the draft sIRB policy were supportive of the NIH goal to streamline IRB review in multi-site clinical research. The public comments can be viewed on the NIH Office of Science Policy (OSP) website.
As this new sIRB policy will apply to all domestic NIH-funded clinical research involving more than one site, it will apply to many studies that will be funded by NIH Institutes and Centers, including NCCIH. In view of this broad impact, NIH is providing a long lead time before the policy takes effect on May 25, 2017, to give the research community ample time to prepare. In addition, guidance on implementation of the sIRB policy is currently available, to provide information such as how costs may be charged to NIH awards. Further information and resources, such as FAQs, will be posted to the NIH OSP website, as they are developed.
In addition to streamlining some aspects of IRB reviews, developing this new sIRB policy represents an opportunity for harmonizing standards and agreements used in multi-site clinical research in the United States. These efforts could further streamline future administrative tasks for the clinical research enterprise.
NCCIH will post updates about the new policy to the NCCIH Clinical Research Toolbox. If you have questions about the policy, please contact NIH atSingleIRBpolicy@mail.nih.gov.
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