RD325 - Annual Report on Human Subjects Research State Fiscal Year 2019 – June 10, 2019

Executive Summary:

The Code of Virginia § 51.5-132 directs the Department for Aging and Rehabilitative Services' (DARS) Human Research Review Committee (HRRC) to submit to the Governor, the General Assembly, and the OARS Commissioner, at least annually, a report on the human research projects reviewed and approved by the 1-IRRC, including any significant deviations from the research applications as approved by the Committee. The HRRC has internal oversight responsibilities for ensuring protection of the rights and welfare of OARS clients and employees who volunteer to participate in research conducted or authorized by OARS. The DARS Commissioner established the HRRC in August 2000 to review and approve research to be conducted or authorized by OARS, the Wilson Workforce and Rehabilitation Center (WWRC), and Centers for Independent Living and Employment Services Organizations that have a vendor relationship with DARS.

The HRRC also complies with federal requirements for the Protection of Human Subjects (45 CFR 46). The U.S. Department of Health and Human Services approved the HRRC Federal wide Assurance (FWA#00008936) beginning August 15, 2005. The FWA is currently effective through March 23, 2023.

The HRRC conducts three types of reviews: Exempt Review (regulatory oversight not required), Expedited Review (application reviewed and approved by one or more HRRC members) and Full Committee Review (a quorum of members in attendance). Two new applications were submitted, reviewed and approved during the State Fiscal Year 2019. The HRRC conducted six reviews to previously approved studies, and there were no (0) study closures.

To the best of the Committee's knowledge, all research involving human volunteers conducted or authorized by OARS or the WWRC during SFY 2019 was reviewed by the HRRC. The HRRC has no evidence suggesting that there were any significant deviations from study procedures as approved by the HRRC for the studies that were reviewed and approved by the DARS HRRC during SFY 2019.

Composition of the HRRC is governed by 22VAC30-40-60 and 45 CFR 46.107. As of June 10, 2019, the HRRC had seven members and one alternate.

This document is the HRRC's nineteenth Annual Report. I wish to express my appreciation to the members of the HRRC for their commitment to supporting this important endeavor.

/s/ Katheryn A. Hayfield