Single IRB requirement intended to streamline multi-site clinical research

NIH national institutes of health logo single IRBBeginning September, 2017, the National Institutes of Health (NIH) will require that a single IRB (sIRB) of record be used in the ethical review for all NIH-funded non-exempt, multi-site human subjects research protocols in the United States (NOT-OD-16-094). The sIRB policy applies to all multi-site human subjects research regardless of the NIH funding mechanism (e.g., SBIR/STTR awards, grants, cooperative agreements, contracts or other mechanisms such as Cooperative Research and Development Agreements (CRADAs), and Interagency Agreements (IAA)).

The goal of this policy is to enhance and streamline the IRB review process, in the context of multi-site research, so that research can proceed as effectively and expeditiously as possible. In addition to streamlining some aspects of IRB reviews, the new sIRB policy presents an opportunity to harmonize the standards used in clinical research in the United States and streamline future administrative responsibilities.

The sIRB policy takes effect on September 25, 2017. This date is four months later than the effective date that appears in the sIRB policy document. NIH extended the effective date to allow additional time for successful implementation.

Finally, beginning in January 2020, the revised Common Rule will expand the studies to which this requirement will apply. The revised rule will require single IRB review for all multi-site studies conducted in the United States, rather than having each site’s IRB bear regulatory responsibilities. This had been a controversial provision of the NPRM, but became less so following the issuance of the NIH policy for research it funds.

Resources and guidance are available on the NIH Office of Science Policy website (http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review). But for now, the question remains on whether the requirement for sIRB review will be equally protective of subject interests and actually demonstrate to be more effectual.

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