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July 31, 2021

Journal of Health and Life Sciences Law

An Overview of Single IRB Requirements: Where Did They Come From and Where are They Going?

  • July 31, 2021
  • Ryan Ballard , Indiana University’s Human Subjects Protection Program
  • Nichelle Cobb , Association for the Accreditation of Human Research Protection Programs

The National Institutes for Health and the Office for Human Research Protections recently issued policies and regulations that require the use of single or centralized institutional review board (IRB) review for most federally funded multi-site research. The purpose of the requirement is to increase efficiency in implementing research protocols. Critics of the policy argue that the agencies passed the requirement without any data indicating it will achieve the stated policy goals. Research institutions have been revising their policies, updating IT systems, rearranging staff, and expanding their workforce in order to comply with this new requirement. SMART IRB, both a national master reliance agreement and an online platform, has emerged as an innovative solution to facilitate single IRB compliance. Finally, now that use of single IRB (sIRB) review is required, federal agencies can start to evaluate the effectiveness of the policy, ensure that the effectiveness of review remains a priority, and that other agencies responsible for human research regulations, such as the Federal Drug Administration, provide a unified policy regarding single IRB review.

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