The FederalWide Assurance

Introduction

All organizations "engaged in" federally funded human subjects research must have an OHRP-approved Federalwide Assurance (FWA). The FWA is an agreement between the organization and OHRP in which the organization commits itself to certain standards of conduct in research involving human subjects. Before Yale will agree to allow an organization to rely on one of Yale's IRBs, the organization must have obtained an OHRP-approved FWA on file with OHRP. An organization must not submit (or update) its FWA to OHRP before the organization and Yale have signed an IRB Authorization Agreement (IAA).

An organization will need to obtain an OHRP-approved FWA if any of the following apply:

• The organization (through its employee or agents), in the course of non-exempt research activities a) obtains data through intervention or interaction with a living human being or b) obtains identifiable private information about a living human being.
• The organization received a direct federal award to conduct human subjects research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.
• The organization plans to conduct aspects of the research at Yale University (regardless of how the research is funded). Engagement of Institutions in Research

If the organization already has an OHRP-approved FWA, continue on to Human Subjects Protection Policies.

Preparing the FWA Application

The organization must prepare a DRAFT copy of the FWA, have it signed by the organization's Signatory Official (SO), and submit the signed draft FWA to Yale with the organization's application to become a Yale RA. DO NOT SUBMIT THE FWA TO OHRP AT THIS POINT.

Step1 - Go to the OHRP website and select the Assurances section, or follow this link: OHRP Assurances or visit the OHRP Spanish web page.

Step 2 - Select either a Domestic or International Assurance.
Use the Domestic FWA Filing if your organization operates within the U.S. Use the International FWA Filing if your organization operates outside of the U.S.

Step 3 – Review the FWA Terms of Assurance, FWA form, and FWA instructions located on the OHRP website Assurances section.
Follow the FWA instructions to complete a draft of the FWA form. This draft form must be submitted to Yale for review as part of the RA Application. Do not submit the FWA form to OHRP.

Step 4 - Review the information listed below to complete FWA Sections 3-7.
This information clarifies certain aspects of the FWA as they relate to Yale University and its RAs.

a. FWA Section 3, Statement of Principles
Organizations that wish to be guided by the ethical principles contained in the Belmont Report should place a "check" next to t he Belmont Report. Organizations that wish to be guided by ethical principles in a document other than the Belmont Report should contact the cognizant Yale IRB .

b. FWA Section 4, Applicability
Contact the cognizant Yale IRB to discuss this section.

c. FWA Section 5, Designation of Institutional Review Boards
Contact the cognizant Yale IRB to discuss which Yale IRB(s) should be designated. The FWA form asks for the IRB Registration Number and the name of the IRB as it is registered with OHRP. For each IRB that will be designated, this information must be listed on the FWA exactly as it appears below:

• Yale University Faculty of Arts and Science IRB, known as the Human Subjects Committee (behavioral and social sciences)
  DHHS IRB Registration Number: IRB00000594
  Name of IRB As Registered with DHHS: Yale U IRB #1
• Yale University School of Medicine IRB, known as the Human Investigation Committee I (HIC I) (normally biomedical studies)
  DHHS IRB Registration Number: IRB00000595
  Name of IRB As Registered with DHHS: Yale U IRB #2
• Yale University School of Nursing, known as the Human Subjects Research Review Committee (HSRRC) (normally nursing studies)
  DHHS IRB Registration Number: IRB00000596
  Name of IRB As Registered with DHHS: Yale U IRB #3
• Yale University School of Medicine IRB, known as HIC II, (normally biomedical studies)
  DHHS IRB Registration Number: IRB00000730
  Name of IRB As Registered with DHHS: Yale U IRB #4B

Even though the Yale IRBs will be listed on the DRAFT FWA form, Yale must have entered into a signed IAA before a Yale IRB will review the research protocol.

d. FWA Section 6, Human Protections Administrator
The Human Protections Administrator (HPA) does not have to hold any specific rolJanuary 3, 2006n administrator capable, both in experience and available resources, of overseeing and managing the day-to-day operations of the organization's human subjects protection program.

e. FWA Section 7, Signatory Official
The Signatory Official (SO) must be a senior level official who has the authority to commit the organization to the Terms of the FWA. The SO takes ultimate responsibility for the integrity of the organization's research involving human subjects, its human subjects protection program, and compliance with applicable federal regulations and state and local laws.

Step 5 – Prepare the FWA Application
The organization must prepare a DRAFT copy of the FWA and have it signed by the organization's Signatory Official (SO). The organization must submit the signed draft FWA to Yale with the organization's application to become a Yale RA.

DO NOT SUBMIT THE FWA TO OHRP AT THIS POINT. Yale will review the FWA form and the other RA application materials. The organization should submit the FWA to OHRP for approval only after Yale has approved the RA application and signed the IAA.

Continue on to Human Subject Protection Policies