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NIH issues draft policy promoting single IRB of record for domestic research sites

December 4, 2014

On December 3, 2014, the National Institute of Health (NIH) issued a draft policy stating its expectation that all domestic sites of multi-site NIH-funded studies will use a single Institutional Review Board (IRB) of record. This is a significant change from the long-standing policy that a local IRB serve as the IRB of record on behalf of each research site.

The NIH’s primary rationale for its draft policy is to achieve quicker approval and commencement of research activities by reducing the administrative time to obtain multiple IRB reviews and approvals. The NIH notes that several extramural NIH programs already use a single IRB for multi-site studies and that there is no evidence that multiple IRB reviews enhance protections for human subjects.

Under the single IRB model, accountability for providing initial and continuing research protocol reviews would reside with the single IRB of record. All participating sites would be responsible for meeting other regulatory obligations, such as obtaining informed consent and reporting unanticipated problems and adverse events to the single IRB of record.

Exceptions would be allowed only if the designated single IRB is unable to meet the needs of a specific population or where a local IRB review is required by federal, state or tribal laws or regulations (for example, FDA-regulated research involving a device must have local IRB review).

The NIH is seeking comments on the draft policy, which may be submitted until January 29, 2015. The effective date of the resulting policy is “to be determined” by the NIH.

Various questions arising from the draft policy include:

  • How will local perspectives be communicated to the single IRB?
  • How will investigator competence and site suitability be confirmed and monitored?
  • How will special population concerns or needs be protected by the single IRB?
  • Do foreign sites also benefit from a single IRB system? 

Comments and further developments will be essential to answer these questions. To access the NIH announcement and draft policy, click here.

If you have any questions regarding this important development or if you wish to join a group to collaboratively develop comments, please contact one of our Health Care attorneys.