RD155 - Annual Report on the Human Research Projects Reviewed and Approved by the State Board of Social Services


Executive Summary:
The purpose of this report is to provide the General Assembly with a summary of the activities of the Virginia Department of Social Services' (VDSS) human research committee for calendar year 2005. Section 63.2-218 of the Code of Virginia directs the State Board of Social Services to establish regulations regarding human subjects research. The statute further provides that the human research committee will report to the Governor, General Assembly and Commissioner at least annually on research projects reviewed and approved. The Institutional Review Board (IRB) serves as the Department's human research committee, and is charged with reviewing, approving and monitoring research conducted or authorized by the Department, local departments of social services, contractors, and licensed facilities.

A key foundation for establishing human subjects research regulations is the National Research Act of 1974 (Public Law 93-348), which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In April 1979 the Commission produced a landmark document, known as the Belmont report, to provide guidance for protecting human subjects involved in research.

Research involving VDSS clients generally involves no risk of physical harm, because it is not clinical research but observational studies of human behavior. The potential risks for VDSS studies most often involve issues of clients' privacy and, to a lesser extent, psychological harm (for example, from surveys that include sensitive questions). The VDSS IRB has been established to protect clients' privacy and more generally to minimize the risks of research activities.

For calendar year 2005 to date, the VDSS IRB has reviewed two proposed research studies. Both studies were approved. In addition, a policy and procedures manual was developed for the IRB to delineate processes for conducting reviews of proposed research.