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Federal Wide Assurance

As a condition of research funding, a number of US funding bodies require the University and the PI to demonstrate Federal Wide Assurance (FWA) compliance when the research involves:
a) intervening or interacting with human subjects; and/or
b) obtaining individually identifiable private information about human subjects.

Compliance entails:

1. Formal FWA registration of the University with the US Office for Human Research Protections within the US Department of Health and Human Services (HHS). By registering, the University signs up to the FWA Terms of Assurance which govern the ethical review of projects requiring FWA compliance, as set out below. The University’s registration details are listed at the bottom of this page.

2. Registration by the University of a designated Institutional Review Board which must undertake (a) formal ethical review and approval and (b) continuing review of the ethical conduct of all projects which require FWA compliance, in accordance with:

• the University’s Code of practice and principles for good ethical governance and its stated principles protecting the rights and welfare of human subjects
• the requirements set out in the HHS Protection of Human Subjects regulations at 45 CFR part 46 (the ‘Common Rule’).

The Institutional Review Board registered under the University’s Federal Wide Assurance is the Health Sciences Research Governance Committee. Operational procedures for the Institutional Review Board, including the procedures for ethical review and approval, are set out in the documents below:

• Institutional Review Board procedures (PDF , 375kb)‌
• Checklist for indicating Common Rule compliance (MS Word , 26kb)
• Procedure for continuing review of the ethical conduct of projects requiring FWA (PDF , 472kb)‌

It is the PI’s responsibility to initiate the Institutional Review Board ethical review and approval process in order to meet the funder’s deadlines. To avoid subsequent delays, PIs are strongly encouraged to contact the Research Integrity Officer in the Policy, Integrity and Performance Team as soon as possible (details below), for informal guidance and support prior to submitting their ethical review application.

In the case of collaborative projects and/or projects involving subcontracting of research activity, PIs should seek clarification on FWA requirements from Research Grants and Contracts in the first instance (details below).

University of York FWA registration details:

Institution number: IORG0008279
FWA Assurance number: FWA00022439
IRB identification: IRB00009924 University of York IRB #1

For queries relating to FWA:
Jen Mayne, Research Ethics Policy Officer

For queries relating to funder requirements:
research-grants@york.ac.uk