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Regulations, Guidances & Related Links

Notice of Proposed Rulemaking in the Federal Register (NPRM) September 8, 2015

Federal Policy for the Protection of Human Subjects

NB: The NPRM includes a proposed mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions.

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

IRB Knowledge of Local Research Context

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 (PDF)

Institutional Review Board (IRB) Authorization Agreement (PDF)

Draft Transfer Document: Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution (Word)

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 (PDF)

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)

Secretary’s Advisory Committee on Human Research Protections (SACHRP) October 19 - 20, 2010 Meeting Presentations

  • Refer to the sections Update on Federated IRB Model and CTSA Consortium Report.

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​)

The NeuroNEXT Central IRB Model (PDF)

NINDS' NeuroNEXT: The Central IRB Experience

NIH Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) CIRB Reliance Agreement Template (MS Word)​​

Last Updated November 03, 2015