Tuesday, September 27, 2016

IRBSince our January 2016 blog post, What’s a Central IRB?, the National Institutes of Health (NIH) has released a final policy  published on Tuesday, June 21, 2016’s Federal Registrar regarding the use of a single institutional review board (sIRB) for all multi-site research projects.

This policy seeks to enhance and streamline the IRB review process so that research may be conducted in an effective and efficient manner. It hopes to eliminate duplicative reviews and reduce administrative burden without compromising human subjects protections.

The following provides the who, what, and when you need to know about this policy.

Who?

  • Non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States are expected to use a sIRB of record.
  • Exceptions to this policy will be made where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy. The NIH will determine whether to grant an exception for each request.

What?

  • Establishes the expectation that a sIRB of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States.

When?

  • Policy Effective date: May 25, 2017

To learn more, please visit:

Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research


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