Reliance Basics
OHRP Guidance: Assurance Process
HHS human subject protection regulations and policies require that any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to OHRP. The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP. FWAs also are approved by the Office for Human Research Protections (OHRP) for
An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by HHS. Through the assurance of compliance, an institution commits to HHS that it will comply with the requirements set forth in the regulations for the protection of human subjects at 45 CFR part 46. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.
All institutions engaged in human subjects research that is not exempt from the regulations, and is conducted or supported by any HHS agency must be covered by an Office for Human Research Protections-approved assurance of compliance.The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP.
An institution may extend its FWA to cover a collaborating individual investigator under certain conditions using the sample Individual Investigator Agreement or a comparable agreement developed by the institution.
The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance
FWAs also are approved by OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.
There is a single version of the FWA and the Terms of Assurance for domestic (U.S.) institutions and international (non-U.S.) institutions.
Employees and agents of the institution holding an approved FWA are covered whenever they are involved in the conduct of research covered by the FWA. Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.
An institution holding an OHRP-approved FWA (hereafter referred to as the assured institution) may extend the applicability of its FWA to cover two types of collaborating individual investigators: collaborating independent investigators and collaborating institutional investigators.
1. A collaborating independent investigator is:
- not otherwise an employee or agent of the assured institution;
- conducting collaborative research activities outside the facilities of the assured institution
; and - not acting as an employee of any institution with respect to his or her involvement in the research being conducted by the assured institution.
2. A collaborating institutional investigator is:
- not otherwise an employee or agent of the assured institution;
- conducting collaborative research activities outside the facilities of the assured institution;
- acting as an employee or agent of an institution that does not hold an OHRP-approved FWA with respect to his or her involvement in the research being conducted by the assured institution; and employed by, or acting as an agent of, an institution that does not hold an OHRP-approved FWA and does not routinely conduct human subjects research.
The extension of an assured institution’s FWA to cover a collaborating individual investigator should be documented using an Individual Investigator Agreement (IIA) or another similar agreement developed by the institution holding the FWA. (See OHRP’s guidance on the use of the IIA and the link to the sample IIA document).
If HHS-conducted or -supported human subjects research activities routinely occur at a non-assured institution, the institution should obtain an OHRP-approved FWA, and the IIA (or similar agreements) should not be used. Also, if the non-assured institution is the primary awardee for an HHS-supported award providing support for non-exempt human subjects research, the institution must obtain its own OHRP-approved FWA. If an institution is uncertain about the need for its own FWA, it should consult with OHRP.
NOTE: All previous types of sample agreements to cover an independent investigator [i.e., Agreement for Independent Investigators (AII), Non-Institutional Investigator Agreement (NIA), and Unaffiliated Investigator Agreement (UIA)] have been replaced by the sample Individual Investigator Agreement (IIA). Previously executed AIIs, NIAs, and UIAs may remain in effect until all applicable research that has already been initiated is completed or until the previous agreement has been replaced by a new Individual Investigator Agreement modeled on the OHRP sample IIA, or by a comparable written agreement developed by an assured institution.
The FWA Signatory Official should be a high-level institutional official who has the authority to represent the institution named in the Federalwide Assurance (FWA), as well as all the institutional components listed in the FWA.
Please contact the GU IRB office at 202-687-1506 to discuss the conditions under which an Authorization Agreement may be an option for your project.
Information about Georgetown University’s FWA can be found on FWA Information