How U.S. research institutions are responding to the single Institutional Review Board mandate

ABSTRACT

One of the most significant changes to the Common Rule is the requirement that institutions use a single Institutional Review Board (IRB) for cooperative research in the United States, unless more than one IRB is required by state, local, or tribal law, or a signatory federal agency decides an exception is warranted. We surveyed Human Research Protection Program (HRPP) officials at the top U.S. research institutions to understand their knowledge and opinion of the mandate, what steps their institutions are taking, and difficulties their institutions are facing. One-hundred seven institutions (56.9%) responded to the survey. While support for the single-IRB mandate was positive overall, most respondents acknowledged that their institution is likely to face some difficulties complying with it. Regulatory agencies can help institutions to comply with the mandate by providing guidance concerning such issues as exceptions to the mandate, local context review, oversight, and implementation of reliance agreements, and development of policies, procedures, and best practices.

KEYWORDS:

• Common rule
• human research regulation
• institutional review boards
• legal liability
• reliance agreements

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Conflict of interest

The authors have no competing interests.

Additional information

Funding

This research was supported by Intramural Program of the National Institute for Environmental Health Sciences (NIEHS), National Institute of Health (NIH). It does not represent the views of the NIEHS, NIH, or the U.S. government.