The ELSI Working Group

The ELSI Working Group

The National Institutes of Health/Department of Energy Joint Working Group on the Ethical, Legal and Social Implications of Human Genome Research

The Ethical, Legal and Social Implications (ELSI) Working Group was established by the Program Advisory Committee on the Human Genome in 1989 to explore and propose options for the development of the ELSI component of the Human Genome Project. From 1989 to 1997, the Working Group provided overall guidance to the National Human Genome Research Institute (NHGRI) and Department of Energy (DOE) ELSI programs, facilitated a number of early policy discussions, and participated in the development of a number of policy options and recommendations related to these issues.

The Working Group also formed two task forces aimed at analyzing and developing recommendations about 1) genetic information and health insurance and 2) genetic testing. The Task Force on Genetic Information and Insurance, whose final report (Genetic Information and Health Insurance Report of the Task Force on Genetic Information and Insurance) was published in 1994, was charged with examining genetic information and health insurance. The Task Force's recommendations have been utilized in a number of legislative proposals related to health care reform. The Task Force on Genetic Testing was created to review genetic testing in the United States and make recommendations to ensure the development of safe and effective genetic tests. The Task Force released its final report (Promoting Safe and Effective Genetic Testing in the United States) in September, 1997.

In April 1996, the NHGRI and DOE advisory councils appointed an evaluation committee to consider the Working Group's role in the overall ELSI programs of the National Institutes of Health (NIH) and DOE. The evaluation committee's final report (Report on The Joint NIH/DOE Committee to Evaluate the Ethical, Legal, and Social Implications Program of the Human Genome Project), issued December 12, 1996, recommended dividing the Working Group's responsibilities among different committees and at various levels within the government. Specifically, they recommended the formation of three ELSI committees: an ELSI Research Program Advisory Committee to provide expert advice and oversight for the ELSI Research programs at NIH and DOE, a trans-NIH body to coordinate ELSI activities at other NIH institutes conducting genetics research, and a genetics and public policy advisory committee in the Secretary of the Department of Health and Human Services (DHHS) Office.

At its February 1997 meeting, the National Advisory Council for Human Genome Research (NACHGR) endorsed all three recommendations and specifically directed ELSI staff to prepare a plan for implementing the first recommendation. This plan, which was presented to and endorsed by NACHGR in May 1997, established an ELSI Research, Planning and Evaluation Group (ERPEG). This group is responsible for providing expert advice to the DOE and NHGRI, ELSI grant programs and for assisting in the development of a strategic plan for future ELSI Research Program activities.

The second and third recommendations were forwarded to the director of NIH and the Secretary of Health and Human Services for further consideration, and in July 1997, the NIH director established the Trans-NIH Ethical, Legal and Social Implications (ELSI) Coordinating Committee. This committee is charged with providing NIH-wide coordination of information and activities related to bioethical issues - not only issues related to genetics, but also emerging and continuing issues such as xenotransplantation and research involving the cognitively impaired.