Society's Choices Social and Ethical Decision Making in Biomedicine (1995) / Chapter Skim
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The Ethical, Legal, and Social Implications Program of the National Center for Human Genome Research: A Missed Opportunity?
The Ethical, Legal, and Social Implications Program of the National Center for Human Genome Research: A Missed Opportunity?
Pages 432-457
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From page 432... ...
and the Department of Energy (DOE) was initiated in fiscal year 1988 as a line item in the federal budget to map and sequence the entire complement of genetic information in the human genome.
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From page 433... ...
It is the ability to characterize and profile the genetic information of individuals that has led to speculation and concern about the use and potential abuse of such information in terms of discrimination, stigmatization, and potential medical harm. Although these concerns are not new they were previously raised in concert with early genetic diagnostic capabilities such as sickle cell carrier screening and the use of prenatal diagnosis for selective abortion- the debate about the human genome initiative brought many of these issues to the surface once again because of the scale and magnitude of the mapping effort.
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From page 434... ...
But in both the short term and the long run, the significance of the ELSI component will be greatly diminished if the concerns that generated it, and its work and results, are seen by scieni~s~cs and clinicians as politically necessary but basically irrelevant appendages to the "real work" of the Genome Project tSwazey, 1992~. Those who have worked closely with Watson on the creation of the National Center for Human Genome Research and its ELSI program claim that he truly believes in the need for such analyses and that the policy issues which will arise out of genome research are too important to be left to scientists alone (Cook-Deegan, personal communication, May 1993~.
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From page 435... ...
The hearing focused on the implications of human genetics, particularly gene therapy. Splicing Life emphasized the distinction between genetically altering somatic cells, which would not lead to inherited changes, and altering germ cells (sperm, egg cells, and their precursors)
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From page 436... ...
But the ethics of genetic research arose early on in the short history of the Biomedical Ethics Advisory Committees (Cook-Deegan, 1994; Hanna et al., 1993~. In 1989 the Advisory Committee was pursuing its congressional mandate to report on ethical issues related to "human genetic engineering." LeRoy Walters of the Kennedy Institute of Ethics testified before the committee as chairman of the NIH subcommittee that oversaw gene therapy.
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From page 437... ...
At the same hearing, Watson had featured his plans for the ELSI program of the National Center for Human Genome Research in his opening statement before the subcommittee. Eventually, the ELSI program would be the recipient of 3 percent of the genome budget and, today, 5 percent of the NIH share.
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From page 438... ...
Two members of the advisory committee were to play key roles in the development of the ELSI program, Nancy Wexler, President of the Hereditary Disease Foundation and on the faculty of neurology and psychiatry at Columbia University, and Victor McKusick, a medical geneticist at Johns Hopkins University and keeper of Mendelian Inheritance in Man, the largest database in the world of genetic disorders. When NCHGR was approved and funded by Congress in 1990, the advisory committee and NIH and DOE staff had already developed a fiveyear scientific plan (NCHGR, Annual Report 1990~.
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From page 439... ...
In terms of policymaking, the group developed the following objectives: . clarify the ethical, legal, and social consequences of mapping and sequencing the human genome through a program of targeted research; · develop policy options at professional, institutional, governmental, and societal levels to ensure that genetic information is used to maximize the benefit to individuals and society;
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From page 440... ...
Nevertheless, the development of a laundry list for topics to be addressed by future grantees is an expansive, if inefficient, method for setting priorities. Three sets of issues were identified as particularly important considerations: privacy of genetic information, safety and efficacy of new genetic testing options, and fairness in the use of genetic information.
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From page 441... ...
. · stigmatization · ostracism · labelling · individual psychological responses Privacy and confidentiality · ownership and control of genetic information · consent issues The impact of the Human Genome Project on genetic counseling prenatal testing pre-symptomatic testing carrier status testing testing when there is no therapeutic remedy counseling and testing for polygenic disorders population screening versus testing Reproductive decisions influenced by genetic information · effect of genetic information on options available · use of genetic information in the decision-making process Issues raised by the introduction of genetics into mainstream medical practice · qualifications and continuing education of all appropriate medical and allied health personnel · standards and quality control · education of patients · education of the general public Uses and misuses of genetics in the past and the relevance to the present · the eugenics movement in the United States and abroad · problems arising from screening for sickle-cell trait and other recent examples · the misuse of behavioral genetics to advance eugenics or prejudicial stereotypes Commercialization of the products of the Human Genome Project · intellectual property rights · property rights · impact on scientific collaboration and candor · accessibility of data and materials Conceptual and philosophical implications of the Human Genome Project · the concept of human responsibility · the issue of free will versus determinism · the concept of genetic disease .
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From page 442... ...
27~. Beyond setting a research agenda, the NCHGR's ELSI program was assigned the broad goal of"developing the safeguards required as new genetic information is put to practical purposes" (NCHGR, Annual Report, 1990, p.
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From page 443... ...
They were all specialists in genetics and ethics, having written numerous publications on the topics they proposed to study. The titles of their grants were general and similar: "Legal and Ethical Issues Raised by the Genome Project," "Ethical and Legal Implications of Genetic Testing," "Ethical and Legal Issues in the Diffusion of Genetic Tests." Nearly $900,000 went to eight white, male principal investigators in aca
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From page 444... ...
The writings that have arisen from the grant funds appear in peer-rev~ewed journals and the TABLE 2 Representative Grants of the ELSI Program Ethical and Legal Issues in the Diffusion of Genetic Tests ($969,513) Ethical and Policy Issues in Cystic Fibrosis Screening ($695,696)
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From page 445... ...
Congressional Oversight The lack of a clear mechanism for ELSI input into the policy process has not gone unnoticed by Congress. The following exchange between Representative Bob Wise and NIH Director Bernadine Healy at a 1991 hearing illustrates the lack of Claris in the authoritative power of the ELSI program: MR.
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From page 446... ...
has established a clearly defined timetable, goal, or set of priorities for the ELSI programs." The report goes on further, saying, "The ELSI programs do not have the ability to present policy recommendations to the Nation, the Congress, or the executive branch in an effective manner. There is no existing policy process that will use the results of the ELSI research to make recommendations." The scientific and academic approach to addressing social issues has worked against developing timetables or expectations.
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From page 447... ...
. Less ambitious efforts have been through a lengthy information collecting process that has, in one case, resulted in a policy statement on the Americans with Disabilities Act, and in another a report issued in 1993 on insurance aspects of genetic information.
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From page 448... ...
At the urging of {ames Watson, who urged ELSI to stretch its self definition, the Working Group decided to go beyond its reconnaissance mission and seek funds for pilot projects to assess the impact of wide-scale population carrier screening for CF Juengst, personal communication, April 1993~. To analyze the implications for genome research, the ELSI Working Group convened a workshop in September 1990, inviting 12 experts from various sectors of genetic services to discuss the technical status of CF testing and to outline the policy issues facing the nation (NIH-DOE Workshop Report, 1990~.
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From page 449... ...
The OTA report on CF carrier screening was released in August 1992 citing several policy options to be considered by Congress, including professional and public education, discrimination, and clinical laboratory and medical device regulations. The OTA report concluded that CF carrier screening was quickly entering the realm of genetics practice and saw little need for congressional action other than through oversight and regulation.
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From page 450... ...
In January 1991, the Working Group formed the Task Force on Genetics and Insurance to gather information and prepare a report of policy options to prevent discriminatory use of genetic information by insurance companies and policy purchasers. The Task Force includes representatives from the insurance industry, corporate benefit plans, consumer and health voluntary groups, and scholars researching insurance issues (NIH-DOE, 1993~.
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From page 451... ...
have embarked on several initiatives related to genetic information and insurance. A CEO-level joint task force on genetic testing was formed to assess the public policy implications of the emerging technology.
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From page 452... ...
Statement on Americans with D'sabilides Act In April 1991 the ELSI Working Group convened experts from law, the humanities, genetics, and voluntary health organizations to discuss the Americans with Disabilities Act (ADA) to determine the effect of the law on individuals with identified disease or susceptibility genes.
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From page 453... ...
The ELSI program has the power to do what a broad-based commission cannot, fund the development of educational materials regarding clinical genetics and the human genome. Among its education support activities, for example, is support of a two-year project by the Council of State Governments to educate state government officials and legislators about genetic issues.
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From page 454... ...
The ELSI program, in its current configuration, runs the risk of being an overly academic, highly inbred mechanism for addressing issues of broad social impact. In order for it to be effective, it must diversify.
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From page 455... ...
uengst, E., Director, Ethical, Legal, and Social Implications Program, National Center for Human Genome Research, personal communication, April 1993. King, P., ELSI Working Group member, personal communication, May 1993.
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From page 456... ...
1992. Designing Genetic Information Policy: The Need for an Independent Policy Review of the Ethical, Legal, and Social Implications of the Human Genome Project.
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From page 457... ...
Watson to Head NIH Office of Human Genome Research. 26 September.
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