June 21, 2016
Final NIH Policy on the Use of a Single Institutional Review Board for Multi- Site Research in the Federal Register (Effective May 25, 2017)
Additional information will be posted on the NIH Office of Science Policy IRB website.
Decemeber 16, 2016
Extension of Efective Date of NIH Policy on the use of a Single Institutional Review Board for Multisite Research
Federal Register Notice of Extension of Effective Date
September 8, 2015
Notice of Proposed Rulemaking in the Federal Register (NPRM)
Federal Policy for the Protection of Human Subjects
U.S. Department of Health and Human Services, Office for Human Research Protections
- 45 CFR 46, Protection of Human Subjects
- 45 CFR 46.114, Cooperative Research
- Guidance on Engagement of Institutions in Human Subjects Research
- Guidance on Extension of an FWA To Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement
- File a New Federalwide Assurance (FWA)
- Update or Renew a Federalwide Assurance (FWA)
- Terms of the Federalwide Assurance for the Protection of Human Subjects (FWA)
- Assurance Process - FAQs
- See What are the key features of the Federalwide Assurance (FWA)? for information on listing institutional review boards (IRBs) on the FWA and written agreement requirements for reliance on an IRB of another institution or organization.
- Requests for Information and Comments on IRB Accountability
- Use of Centralized Institutional Review Board (IRB) (April 30, 2010)
- Individual Investigator Agreement
- Institutional Review Board (IRB) Authorization Agreement
- Draft Transfer Document: Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution
Food and Drug Administration
- 21 CFR 56, Institutional Review Boards
- 21 CFR 56.114, Cooperative Research
- Non-local IRB Review - Information Sheet
- Using a Centralized IRB Review Process in Multicenter Trials
- Cooperative Research - Information Sheet
- Considerations When Transferring Clinical Investigation Oversight to Another IRB
Association for the Accreditation of Human Research Protection Programs (AAHRPP)
- AAHRPP Accreditation Procedures & Standards
- IRB Evaluation Checklist (MS Word) for determining whether an IRB meets the accreditation standards
- Tip Sheet 24, Relying on an External IRB
Related Links
- Alternative IRB Models--2005 Workshop Summary Report and 2006 National Conference Report (Association of American Medical Colleges)
- National Cancer Institute Central IRB Initiative
- U.S. Department of Veterans Affairs (VA) Central Institutional Review Board
- Clinical Trials Transformation Initiative (CTTI) Use of Central IRBs for Multiple Center Clinical Trials
NIH Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) IRB Experience (National Institute of Neurological Disorders and Stroke)
Content last reviewed on January 11, 2017