RD195 - Annual Report on the Human Research Projects Reviewed and Approved by the State Board of Social Services


Executive Summary:
Section 63.2-218 of the Code of Virginia authorizes the Department of Social Services to establish regulations regarding human subjects research, to form a human research committee, and annually report on human research activities. The purpose of this report is to provide the General Assembly with a summary of the activities of the Department of Social Services' human research committee, also referred to as the Institutional Review Board, for the period of July 1, 2005 through June 30, 2006. The Institutional Review Board is charged with reviewing, approving, and monitoring research conducted or authorized by the Department of Social Services, local departments of social services, contractors, and Department-licensed facilities.

The State Board of Social Services' human research regulation was published in the "Virginia Register of Regulations" in August 1993. In May 2005, the Department of Social Services reconstituted its human research committee by creating an Institutional Review Board, and in January 2006, it registered as a domestic Institutional Review Board with the U.S. Department of Health and Human Services, Office for Human Research Protections (IRB # 00005238, Virginia Department of Social Services IRB #1).

Research involving Department of Social Services clients generally involves no risk of physical harm, because it is not clinical research but rather observational studies of human behavior. The potential risks for Department of Social Services studies most often involve issues of clients' privacy and, to a lesser extent, psychological harm (for example, from surveys that include sensitive questions). The Institutional Review Board was established to protect clients' privacy and, more generally, to minimize the risks of the research activities to Department of Social Services clients and, specifically, to their welfare.

In state fiscal year 2006, the Institutional Review Board reviewed four (4) proposed research studies. Three studies were approved and one exempted from the Institutional Review Board review process. This total excludes two studies reviewed and approved in August 2005 and reported in last year's Calendar Year 2005 Annual Report.