ELSI Planning and Evaluation History

ELSI Planning and Evaluation History

• What is ELSI?
• ELSI Planning and Evaluation

What is ELSI?

The planners of the Human Genome Project (HGP) recognized that the information gained from mapping and sequencing the human genome would have profound implications for individuals, families and society. While this information would have the potential to dramatically improve human health, they also realized that it would raise a number of complex ethical, legal and social issues. How should this new genetic information be interpreted and used? Who should have access to it? How can people be protected from the harm that might result from its improper disclosure or use?

The Ethical, Legal and Social Implications (ELSI) Research Program was established to address these issues and has become an integral part of the HGP. ELSI provides a new approach to scientific research by identifying, analyzing and addressing the ethical, legal and social implications of human genetics research at the same time that the basic science is being studied. In this way, problem areas can be identified and solutions developed before scientific information is integrated into health care practice.

The ELSI Research Program is essential to the success of the HGP in the United States and is supported with federal funds. The National Human Genome Research Institute (NHGRI) commits more than $18 million annually from its HGP budget to ELSI research, making it the largest supporter nationwide of research into the ethical, legal and social implications of genetic research. The United States Department of Energy (DOE) Office of Energy Research, which partners with NHGRI in the HGP, also reserves a portion of its funding for ELSI research and education.

ELSI Planning and Evaluation

The ELSI Working Group

At its January 1989 meeting, the Program Advisory Committee on the Human Genome established a working group on ethics to develop a plan for the ELSI component of the human genome program. This working group, later named the National Institutes of Health-Department of Energy Joint Working Group on Ethical, Legal and Social Implications of Human Genome Research, held its first meeting in September 1989.

In January, 1990, the ELSI Working Group issued its first report and defined the function and purpose of the ELSI program as follows:

• To anticipate and address the implications for individuals and society of mapping and sequencing the human genome.
• To examine the ethical, legal and social consequences of mapping and sequencing the human genome.
• To stimulate public discussion of the issues.
• To develop policy options that would assure that the information be used to benefit individuals and society.

The ELSI Working Group envisioned a program that would anticipate problems and identify possible solutions, and suggested a number of means to accomplish these goals. Specifically, it encouraged the research community to explore and gather data on a wide range of issues pertinent to the HGP that could be used to develop education programs, policy recommendations or possible legislative solutions. A number of focus areas were identified, including: fairness in the use of genetic information; the impact of knowledge of genetic variation on individuals; and privacy and confidentiality of genetic information.

In 1990, in response to the ELSI Working Group's report, the NHGRI established the ELSI Branch, later renamed the ELSI Research Program, in its Division of Extramural Research, and the DOE established an ELSI Program [ornl.gov] of its own in the Office of Energy Research (OER). Since the beginning, these two programs have collaborated closely, including the joint support of the ELSI Working Group, the development of complementary research priority areas, and the co-funding of ELSI activities of mutual interest.

n 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 discontinuing the original working group and dividing its 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, recommended the establishment of an ELSI Research advisory group focused specifically on the portfolio of ELSI Research Grants.

The ELSI Research Planning and Evaluation Group (ERPEG)

In July 1997, NHGRI's National Advisory Council for Human Genome Research(NACHGR) and DOE's Biological and Environmental Research Advisory Committee (BERAC) formally established the ELSI Research Planning and Evaluation Group (ERPEG). ERPEG's mission was to review and analyze the portfolio of ELSI research grants at both NHGRI and DOE, to participate in the development of the ELSI component of the new five-year plan for the HGP, and to prepare a report for submission to NACHGR and BERAC summarizing its findings and making recommendations.

After performing an initial analysis of the ELSI research grant portfolio, ERPEG developed five goals to guide ELSI research programs over the next five years. These goals were designed both to emphasize areas of research of ongoing importance and identify emerging issues requiring additional attention. The goals were seen by ERPEG as a work in progress that should be regularly updated and expanded. Following the publication of these goals - as part of the HGP five-year plan - in the October 1998 issue of Science, ERPEG continued its analysis of the ELSI portfolio.

In February 2000, ERPEG released its final report: Review and Analysis of the ELSI Research Programs at NIH and DOE." This document summarizes the findings of ERPEG's extended analysis and provides recommendations for strengthening the ELSI research programs at NHGRI and DOE. With publication of its final report in 2000, ERPEG concluded its mission.

The ELSI Research Advisors Group

ELSI research activities at NHGRI are now reviewed by the ELSI Research Advisors Group (ERA), established in 2000 as a working group of the National Advisory Council for Human Genome Research (NACHGR). The ERA was created to advise NHGRI on the progress and goals of the ELSI research program and to help identify emerging issues and implications of genomic research.

• ERA Mission, Administration, and Structure