In lieu of an abstract, here is a brief excerpt of the content:The Environmental Genome Project and BioethicsRichard R. Sharp (bio) and J. Carl Barrett (bio)Eight years ago, the Kennedy Institute of Ethics Journal published a brief selection by Eric Juengst (1991) entitled “The Human Genome Project and Bioethics.” That essay introduced and described the Ethical, Legal, and Social Implications (ELSI) Program at the National Center for Human Genome Research. 1 Since that time, the ELSI program has grown to become (...) one of the largest and most well regarded bioethics programs in the country, sponsoring the work of hundreds of researchers and coordinating bioethics activities both nationally and internationally (Marshall 1996; Meslin, Thomson, and Boyer 1997). In 1991, however, Juengst, the first director of the ELSI program, had no way of anticipating these developments. Juengst’s goal in his essay was simply to highlight some of the moral and social issues that were emerging as focal points for the ELSI program. Looking back, the issues he outlined may seem vague and overly broad. At the time, however, the essay served an important purpose, to identify areas requiring additional study and thereby to serve as a guide to others interested in joining in these discussions.In many ways, Juengst’s article serves as an inspiration to those of us working on a new bioethics project. The National Institute of Environmental Health Sciences (NIEHS) recently launched a multi-year project aimed at better understanding genetic influences on environmentally associated diseases (Albers 1997; Brown and Hartwell 1998; Cannon 1997; Kaiser 1997). This project, known as the Environmental Genome Project (EGP), plans to identify and study a number of common genetic variants that may play an important role in determining how individuals respond to environmental exposures. NIEHS hopes that the information learned through the EGP will be instrumental in developing more effective disease-prevention strategies and intervention programs. Following the precedent developed in connection with the Human Genome Project, NIEHS also plans to address the moral and social implications of the EGP. Efforts in this regard include sponsoring workshops and conferences to address such issues, as well as supporting research on the ethical, legal, and social implications of the EGP. Through this work, NIEHS hopes to anticipate potential problems before [End Page 175] they arise and to develop policies that maximize the benefits of the research while avoiding potential misuses of the information learned.In exploring the social implications of the EGP, we at NIEHS are very fortunate to be able to draw upon the work being done by the ELSI program at the National Human Genome Research Institute (NHGRI), as well as the ever-expanding bioethics literature that has been sparked by the ELSI program. Still, there is much to be done and this is an exciting time for those of us involved with the EGP. Many of the ethical, legal, and social implications of the project are only beginning to become clearer, and several of these issues appear quite different from the sorts of concerns that have previously been discussed in connection with other types of genetic research.This essay highlights some of the ethical, legal, and social implications that are emerging as important focal points for the Environmental Genome Project. Like Juengst’s 1991 paper, the goal of this article is to provide an overview of current areas of interest and to encourage others to join us in thinking about these difficult issues.The Environmental Genome ProjectIndividuals differ greatly in their responses to chemicals, drugs, radiation, smoking, alcohol, and other environmental exposures. These differential responses are the result of complex interactions between many factors, including an individual’s genetic make-up, age, sex, nutritional status, and overall health. The EGP aims to better understand the genetic basis of differential responses to environmental exposures. The vast majority of diseases, many forms of cancer, for example, are the consequence of both environmental and genetic contributions (Perera 1997). Hence, understanding the relationships between genetic variation and response to environmental exposure is important for understanding the causes of human disease and is crucial for the development of effective disease-prevention strategies.The EGP and projects like it represent a new stage of genomic research. It is expected that the Human Genome Project will complete... (shrink)

: Some argue that human groups have a stake in the outcome of population-genomics research and that the decision to participate in such research should therefore be subject to group permission. It is not possible, however, to obtain prior group permission, because the actual human groups under study, human demes, are unidentifiable before research begins. Moreover, they lack moral standing. If identifiable social groups with moral standing are used as proxies for demes, group approval could be sought, but at the (...) expense of unfairly exposing these surrogates to risks from which prior group approval is powerless to protect them. Unless population genomics can proceed without targeting socially defined groups, or can find other ways of protecting them, it may fall to individuals to protect the interests of the groups they care about, and to scientists to warn their subjects of the need to do so. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Ethical, Legal, and Social Implications Research Program at the National Human Genome Research InstituteEric M. Meslin (bio), Elizabeth J. Thomson (bio), and Joy T. Boyer (bio)Organizers of the Human Genome Project (HGP) understood from the beginning that the scientific activities of mapping and sequencing the human genome would raise ethical, legal, and social issues that would require careful attention by scientists, health care professionals, government officials, and the (...) public. The establishment of the ELSI (ethical, legal, and social implications) programs at the National Human Genome Research Institute (NHGRI) and the Department of Energy (DOE) was thought to be vital to the success of the HGP in the United States. It also provided a novel approach to the simultaneous study of ethical, legal, and social issues and basic scientific issues. Eric Juengst, the first director of the ELSI program, described its origins in a previous issue of the Kennedy Institute of Ethics Journal (Juengst 1991). Now in its seventh year, the ELSI program has accomplished much. This article summarizes the evolution and goals of the ELSI program at NHGRI, outlines the program’s current research priorities with examples of activities within each priority area, and provides a look to the future, including the initiation of a strategic planning process.Evolution and Goals of the ELSI Research ProgramThe HGP’s “genomic” goals are unique: to map and sequence the entire human genome—some 3 billion base pairs that make up approximately 80–100,000 genes—and the genomes of related model organisms by the year 2005. This goal was particularly ambitious since, when it was proposed, the technologies for mapping and sequencing had yet to be developed. When the HGP was first established, its organizers also elaborated a set of ELSI goals, which they saw as vital to the success of the genome project. The original ELSI goals were: (1) to anticipate and address the implications of the HGP for individuals and society and (2) to examine the ELSI consequences of mapping and sequencing the human genome in order to stimulate public discussion. To meet these goals, the NHGRI created its ELSI research program in 1990. Along with mapping, sequencing, [End Page 291] and mammalian genetics, ELSI was one of four original branches in the NHGRI Division of Extramural Research that funded research in those areas. Although the individual “branches” no longer exist, the mechanisms for funding research remain much the same. While the overall goals of the program have not changed, the specific ways of achieving the goals have continued to evolve. The importance of the ELSI program lies not in the collection of a full set of data that will be valuable in and of itself, but in the value of using and interpreting this new set of information.Early on, the NHGRI described a set of somewhat more specific goals: (1) to develop a program to help understand the ethical, legal, and social implications of the human genome project and (2) to identify and define the major issues of concern and develop policy options to address them. These more specific goals have been largely met. As the most recent biennial NHGRI Progress Report notes, “a robust ELSI research and education program has been established, many of the most urgent ELSI issues have been identified, and many policy options to address these issues have been proposed” (NCHGR 1995, p. 21). Between 1990 and 1996, ELSI provided more than $32.5 million in funding through 128 research and education grants in more than 30 states and in Canada (Table 1). The ELSI research budget is unique in that when originally created, it was specifically tied to the amount of money provided for the overall NHGRI budget. The NHGRI originally devoted 3 percent of its extramural budget to fund ELSI projects, but in FY 1991, it increased the ELSI budget to 5 percent, a figure that remains today. Table 2 lists the expenditures for each fiscal year since 1990 and the cumulative expenditures to date. The ELSI research budget at NHGRI this year will be about $7 million. When other sources of funding—e.g., co-funding arrangements with other institutes and agencies and the funding of ELSI... (shrink)