RD88 - Annual Report of the Human Research Review Committee on Human Research Projects

Executive Summary:
Section 51.5-14.01 of the Code of Virginia requires the Department of Rehabilitative Services’ (DRS) Human Research Review Committee (HRRC) to submit to the Governor, the General Assembly, and the DRS Commissioner, at least annually, a report on the human research projects reviewed and approved by the Committee; including any significant deviations from the research applications as approved by the Committee. This report presents State Fiscal Year 2004 activities of the DRS HRRC.

The HRRC has internal oversight responsibilities for ensuring protection of the rights and welfare of DRS consumers who volunteer to participate in research conducted or authorized by DRS or any of its partner organizations covered by the Code. The DRS Commissioner established the Committee in August 2000 to review and approve all research to be conducted or authorized by DRS or the Woodrow Wilson Rehabilitation Center (WWRC), as well as the Centers for Independent Living (CILs) and Virginia Employment Services Organizations (ESOs) that partner with DRS in the delivery of services to persons with disabilities. Elizabeth E. Smith, DRS Policy and Planning Director, is the Committee’s Chair and this is the Committee’s fourth annual report. The composition of the Committee is governed by 22 VAC 30-40-60 and a list of Committee members is provided at Appendix A. There was one resignation from the Committee during SFY 2004 and one continuing ESO vacancy. Efforts are ongoing to find a suitable ESO representative and a community-at-large member. As of June 30, 2004, the Committee had seven members and one alternate medical consultant.

The regulation gives DRS partner organizations the options to: 1) establish their own research review committee; 2) work with other institutions to establish a single committee; or 3) use the DRS established committee. As of this report, there are 103 organizations under the DRS umbrella (WWRC, one university based rehabilitation research and training center, 16 CILs, and 85 ESOs [*1]).

To carry out its oversight responsibilities, the Committee follows procedures as specified by 22 VAC 30-40-10 et seq. for the review and approval of applications for all proposed research involving human participants when such research is not federally funded or sponsored. The regulatory body for federally funded or sponsored human research is the Department of Health and Human Services. To supplement regulatory requirements, the Committee has a procedures manual which standardizes Committee practices and activities, describes study participant complaint procedures, specifies the responsibilities of investigators, and provides templates for: 1) investigator application, 2) voluntary informed consent, and 3) investigator periodic progress reports.

The Committee meets monthly, or as needed, to fulfill its responsibilities and must meet at least once annually. A quorum of the Committee consists of a majority of its members including at least one member whose primary concerns are in nonscientific areas. The Committee’s responsibilities begin when a research proposal is submitted to the Chair for review and approval. Elements of the Committee’s review include consideration of potential benefits and risks and the methodology of the research, the degree of risk for non-therapeutic research, the protection of the rights and welfare of participants, voluntary informed consent, competency of the research investigators, equitable selection criteria for research participants, and whether appropriate studies in nonhuman systems have been conducted prior to the involvement of human participants. All research applications are reviewed within 45 days of submission of a complete application. Research investigators are notified in writing of the Committee’s decision to approve or disapprove the proposed research activity, or of modifications required to secure approval.
[*1] The actual number of ESOs that have Federal Identification Numbers (FINs) is greater than the number of ESOs reported here because several ESOs have administrative authority for a network of other ESOs and speaks for all members of the network. As an example, Frontier Health is composed of several branches (Developmental Services, Independence Unlimited, Opportunities Unlimited-Bristol, and Opportunities Unlimited-Kingsport) and the same administrative authority covers all branches of Frontier Health.