Trans NIAID Clinical Research Toolkit

Regulations, Guidances & Related Links

U.S. Department of Health and Human Services (HHS) 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)

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

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)

Clinical & Translational Science Awards (CTSA) Clinical Research Management Key Function Committee

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

Use of Central IRBs for Multiple Center Clinical Trials

• Considerations To Support Communication Between Institutions Inside and Outside IRBs When Responsibilities Are Being Assigned for Multicenter Clinical Trial Protocols (PDF)