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

David B. Resnik, Elise M. Smith, Min Shi

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)340-349
Number of pages10
JournalAccountability in Research
Volume25
Issue number6
DOIs
StatePublished - Aug 18 2018

Keywords

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

ASJC Scopus subject areas

  • Education
  • Library and Information Sciences

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