Section II:

VCU Human Research Protection Program

WPP #: II-3

Title 3:

VCU Assurance of Compliance (FWA)

Effective Date:

06-23-15

Revision History:

06-07-04; 04-28-06; 06-21-06; 1-18-14; 1-28-14

Policy Statement

VCU maintains an active Federalwide Assurance (FWA) with the Department of Health and Human Services (FWA00005287). As stated in the FWA, VCU applies the federal regulations (45 CFR 46) to all human subjects research, regardless of funding. All research is guided by the ethical principles of the Belmont Report and is subject to equivalent protections.

Description

VCU has filed an assurance of compliance, called a Federalwide Assurance, with the Office for Human Research Protections (OHRP) in the Department of Health and Human Services. A Federalwide Assurance (FWA) is a binding written agreement between VCU and DHHS. The FWA describes the responsibilities of the institution, the Signatory Official, the Institutional Review Boards, and the investigator. The University is required to enter into this agreement because it receives federal funding for research involving human subjects. The VCU Signatory Official for the FWA is the VCU Vice President for Research. This position oversees the VCU Human Research Protection Program with identified responsible offices.

VCU provides IRB review for human research conducted at the VCU Health System (VCUHS) under a DHHS IRB Authorization Agreement (a document signed by both VCU and VCUHS granting permission to VCUHS to rely upon the VCU IRB). Projects reviewed for the VCUHS receive the same IRB review as those conducted at VCU. In order to document this relationship, the Virginia Commonwealth University Health System has its own FWA: FWA00004325. Under this FWA, the VCUHS identifies the VCU IRB as their IRB of record.

All investigators at VCU are expected to conduct research in accordance with the provisions of the Federalwide Assurance. Primary responsibility for assuring that the rights and welfare of the individuals involved are protected rests with principal investigator conducting the research. Faculty members who assign or supervise research conducted by students have an obligation to consider carefully whether those students are qualified to safeguard adequately the rights and welfare of subjects.

References

None listed