RD181 - Virginia Department for Aging and Rehabilitative Services Human Research Review Committee 2013 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 Woodrow Wilson 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 Federalwide Assurance (FWA#00008936) beginning August 15, 2005. The FWA is currently effective through July 16, 2017.

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 2013. One was approved by Expedited Review, and two were approved by Exempt Review. The HRRC also conducted five continuing/amended reviews to previously approved studies, and received three 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 2013 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 2013.

Composition of the HRRC is governed by 22 VAC 30-40-60 and 45 CFR 46.107. As of June 30, 2013, the HRRC had seven members and two alternates.

This document is the HRRC’s twelfth 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