Introduction- ARCHIVE

CHAPTER SECTIONS

ARCHIVED PAGE

Archived on September 26, 2025. Go to the latest version.

The Logistics of Using a Single IRB


Section 1

Introduction- ARCHIVE

Contributors

The main goal of using a single institutional review board (IRB), or sIRB, for multisite research is to streamline the review process by eliminating duplicative reviews at the clinical trial sites. There has been a dramatic increase in the use of an sIRB review model in response to the 2016 NIH policy requiring sIRB review for NIH-funded multisite research (NIH 2016) and the requirement for sIRB review of cooperative research set forth in the revised Common Rule (Office of Human Research Protections 2017).

Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction- ARCHIVE
  2. Process for Setting Up an sIRB – ARCHIVE
  3. Responsibilities of Relying Institutions – ARCHIVE
  4. Working With an sIRB During the Conduct of Research – ARCHIVE

REFERENCES

back to top

NIH. (2016). Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. NOT-OD-16-094. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html

Office of Human Research Protections. (2017). Federal Policy for the Protection of Human Subjects. Final rule. Fed Regist. 82(12):7149-274. PMID: 28106360.

back to top

ACKNOWLEDGMENTS

Megan K. Singleton, JD, MBE, CIP, reviewed previous versions of this chapter.

back to top

back to top


Version History

Published January 18, 2024

current section :

Introduction- ARCHIVE

  1. Introduction- ARCHIVE
  2. Process for Setting Up an sIRB – ARCHIVE
  3. Responsibilities of Relying Institutions – ARCHIVE
  4. Working With an sIRB During the Conduct of Research – ARCHIVE

Citation:

O’Rourke P. The Logistics of Using a Single IRB: Introduction- ARCHIVE. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/the-logistics-of-using-a-single-irb/the-logistics-of-using-a-single-irb-introduction/. Updated October 2, 2025. DOI: 10.28929/236.