RD188 - Virginia Department for Aging and Rehabilitative Services Human Research Review Committee 2015 Annual Report


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 DARS Commissioner, at least annually, a report on the human research projects reviewed and approved by the HRRC, 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 DARS clients and employees who volunteer to participate in research conducted or authorized by DARS. The DARS Commissioner established the HRRC in August, 2000 to review and approve research to be conducted or authorized by DARS, 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 June 23, 2020.

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). Three new applications were reviewed during the State Fiscal Year 2015. One was approved by Expedited Review, one approved by Exempt Review and one is pending The HRRC also conducted five continuing/amended reviews to previously approved studies, and received no study closures.

To the best of the Committee’s knowledge, all research involving human volunteers conducted or authorized by DARS or the WWRC during SFY 2015 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 2015.

Composition of the HRRC is governed by 22 VAC 30-40-60 and 45 CFR 46.107. As of June 30, 2015, the HRRC had seven members and one alternate.

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

James A. Rothrock
Commissioner