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Self-Critical Federal Science? The Ethics Experiment within the U.S. Human Genome Project

  • Eric T. Juengst (a1)

Extract

On October 1, 1988, thirty-five years after co-discovering the structure of the DNA molecule, Dr. James Watson launched an unprecedented experiment in American science policy. In response to a reporter's question at a press conference, he unilaterally set aside 3 to 5 percent of the budget of the newly launched Human Genome Project to support studies of the ethical, legal, and social implications of new advances in human genetics. The Human Genome Project (HGP), by providing geneticists with the molecular maps of the human chromosomes that they use to identify specific human genes, will speed the proliferation of a class of DNA-based diagnostic and risk-assessment tests that already create professional ethical and health-policy challenges for clinicians. “The problems are with us now, independent of the genome program, but they will be associated with it,” Watson said. “We should devote real money to discussing these issues.” By 1994, the “ELSI program” (short for “Ethical, Legal, and Social Implications”) had spent almost $20 million in pursuit of its mission, and gained both praise and criticism for its accomplishments.

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1 Schmeck, Harold, “DNA Pioneer to Tackle Biggest Gene Project Ever,” New York Times, 10 4, 1988, pp. C1, C6.

2 Roberts, Leslie, “Genome Project Gets Underway at Last,” Science, vol. 243 (January 13, 1989), pp. 167–68.

3 National Research Council, Mapping and Sequencing the Human Genome (Washington, DC: National Academy Press, 1988).

4 Office of Technology Assessment, U.S. Congress, Mapping Our Genes: Genome Projects—How Big? How Fast? OTA-BA-373 (Washington, DC: U.S. Government Printing Office, 1988).

5 Murray, Tom, “Testimony,” OTA Report on the Human Genome Project Hearing, One Hundredth Congress, Second Session, Serial No. 100–123 (Washington, DC: U.S. Government Printing Office, 1988), pp. 5274.

6 The Department of Energy's interest in the Human Genome Project stems from its own research efforts to develop tools for measuring the biological effects of low levels of radiation in the environment. For a detailed political history of the DOE's involvement in the genesis of the Human Genome Project, see Cook-Deegan, Robert, The Gene Wars: Science, Politics, and the Human Genome (New York: W. W. Norton, 1994).

7 U.S. Department of Health and Human Services, U.S. Department of Energy, Understanding Our Genetic Inheritance: The U.S. Human Genome Project—The First Five Years, NIH Publication No. 90–1590 (Bethesda, MD: National Institutes of Health, 1989).

8 Larson, Edward J., “Half a Tithe for Ethics,” National Forum: Phi Kappa Phi Journal, Spring 1993, pp. 1517.

9 Juengst, Eric, “Human Genome Research and the Public Interest: Progress Notes on an American Science Policy Experiment,” American Journal of Human Genetics, vol. 54 (1994), pp. 121–28.

10 Personal communication, NIH Institute Directors' Briefing on the NCHGR, June 15, 1990.

11 Hubbard, Ruth and Wald, Elijah, Exploding the Gene Myth (Boston: Beacon Press, 1993), p. 159.

12 After the development of the first effective technique for recombining isolated pieces of DNA, discussion within molecular biology of the possible “biohazards” involved in performing this “genetic engineering” between species yielded a self-imposed moratorium on this research. In the wake of this moratorium, a wider public reaction occurred, leading eventually to the establishment of a public federal review process for all “recombinant DNA” research. For the history of this episode, see Krimsky, Sheldon, Genetic Alchemy: The Social History of the Recombinant DNA Controversy (Cambridge, MA: MIT Press, 1982).

13 Beckwith, Jonathan, personal communication, 02 11, 1990.

14 Cook-Deegan, , The Gene Wars (supra note 6).

15 Watson, James, “The Human Genome Project: Past, Present, and Future,” Science, vol. 248 (1990), pp. 4449.

16 Watson, James and Juengst, Eric, “Doing Science in the Real World: The Role of Ethics, Law, and the Social Sciences in the Human Genome Project,” in Annas, George and Elias, Sherman, eds., Gene Mapping: Using Law and Ethics as Guides (New York: Oxford University Press, 1992), pp. xvxviii.

17 Wilfond, Benjamin and Nolan, Kathleen, “National Policy Development for the Clinical Application of Genetic Diagnostic Technologies,” Journal of the American Medical Association, vol. 270 (1993), pp. 2948–54.

18 Annas, George and Elias, Sherman, “Social Policy Research Priorities for the Human Genome Project,” in Annas, and Elias, , eds., Gene Mapping, p. 275.

19 Collins, F. S., “Medical and Ethical Consequences of the Human Genome Project,” Journal of Clinical Ethics, vol. 2 (1991), pp. 260–67; Botkin, J. R., “Ethical Issues in Human Genetic Technology,” Pediatrician, vol. 17 (1990), pp. 100107.

20 Watson, and Juengst, , “Doing Science in the Real World,” p. xvi.

21 Guyatt, George et al. , “The Role of Before-After Studies of Therapeutic Impact in the Evaluation of Diagnostic Technologies,” Journal of Chronic Disabilities, vol. 39 (1986), pp. 295304.

22 Maddox, John, “New Genetics Means No New Ethics,” Nature, vol. 364 (1993), p. 97.

23 NIH-DOE Working Group on Ethical, Legal, and Social Implications of Human Genome Research, Genetic Information and Health Insurance: Report of the Task Force on Genetic Information and Insurance (Bethesda, MD: National Center for Human Genome Research, 1993), p. 19.

24 Murray, Thomas, “Speaking Unsmooth Things about the Human Genome Project,” in Annas, and Elias, , eds., Gene Mapping, p. 247.

25 Juengst, Eric and Watson, James, “Human Genome Research and the Responsible Use of New Genetic Knowledge,” International Journal of Bioethics, vol. 2 (1991), pp. 99102.

26 Bulger, Ruth, Bobby, Elizabeth, and Fineberg, Harvey, eds., Society's Choices: Social and Ethical Decision-making in Biomedicine (Washington, DC: National Academy Press, 1995), p. 179.

27 Singer, Eleanor, “Public Attitudes towards Genetic Testing,” Population Research Policy Review, vol. 10 (1991), pp. 235–55.

28 Juengst, Eric, “Patterns of Reasoning in Medical Genetics: An Introduction,” Theoretical Medicine, vol. 10 (1989), pp. 101–7.

29 Holtzman, Neil A., Proceed with Caution: Predicting Genetic Risks in the Recombinant DNA Era (Baltimore: Johns Hopkins University Press, 1989).

30 Fox-Keller, Evelyn, “Genetics, Reductionism, and Normative Uses of Biological Information,” Southern California Law Review, vol. 65 (1991), pp. 285–91; Brock, Daniel, “The Human Genome Project and Human Identity,” Houston Law Review, vol. 29 (1992), pp. 1921; Kenen, R. H. and Schmidt, R. M., “Stigmatization of Carrier Status: Social Implications of Heterozygote Genetic Screening Programs,” American Journal of Public Health, vol. 49 (1978), pp. 116–20.

31 Nelkin, Dorothy and Tancredi, Laurence, Dangerous Diagnostics: The Social Power of Biological Information (New York: Basic Books, 1989).

32 Reilly, Philip, The Surgical Solution: A History of Involuntary Sterilization in the United States (Baltimore, MD: Johns Hopkins University Press, 1991).

33 Duster, Troy, Backdoor to Eugenics (New York: Routledge, 1990).

34 Capron, Alexander M. et al. , eds., Genetic Counseling: Facts, Values, and Norms (New York: Alan R. Liss, 1979).

35 Cf. Weir, Robert, “Why Fund ELSI Projects?” in Weir, Robert, Lawrence, Susan, and Fales, Evan, eds., Genes and Human Self-Knowledge (Iowa City: University of Iowa Press, 1994), pp. 189–95.

36 National Center for Human Genome Research, “Program Announcement: Ethical, Legal, and Social Implications of Human Genome Research,” NIH Guide to Contracts and Grants, vol. 19, no. 4 (1990), pp. 2326.

37 See Marshall, John, “Violence Research: NIH Told to Reconsider Crime Meeting,” Science, vol. 262 (1993), pp. 2324.

38 See, e.g., Hilgartner, Stephen, “The Human Genome Project,” in Peterson, James et al. , eds., Handbook on Science, Technology, and Society (Newbury Park, CA: Sage, 1992), pp. 132.

39 Nelkin, Dorothy, “Promotional Metaphors and Their Popular Appeal,” Public Understanding of Science, vol. 3 (1994), pp. 2531.

40 Kay, Lily, “Who Wrote the Book of Life? Information and the Transformation of Molecular Biology,” in Hagner, Michael and Rheinberger, Hans, eds., Experimentalsysteme in den Biologische-Medizinschen Wissenshaften: Objekt, Differenzen, Konjunkturen (Berlin: Academie Verlag, 1994).

41 Tauber, Alfred and Sarkar, Sahotra, “The Human Genome Initiative: Has Blind Reductionism Gone Too Far?Perspectives in Biology and Medicine, vol. 35 (1992), pp. 220–35.

42 Cf. Duster, , Backdoor to Eugenics, pp. 5863.

43 Engineers make up a large cohort of “genome scientists,” if not by professional affiliation then by personal inclination. The Human Genome Project, after all, describes itself as a “toolmaking” effort, and approaches its task accordingly.

44 Roberts, Leslie, “Taking Stock of the Genome Project,” Science, vol. 262 (1993), p. 22.

45 American Society for Human Genetics (ASHG), “Statement of the American Society for Human Genetics on Cystic Fibrosis Carrier Screening,” American Journal of Human Genetics, vol. 51 (1992), pp. 1443–44.

46 Wilker, Nachama et al. , “DNA Data Banking and the Public Interest,” in Billings, Paul, ed., DNA on Trial: Genetic Identification and Criminal Justice (Plainview, NY: Cold Spring Harbor Laboratory Press, 1992), pp. 141–51.

47 National Institutes of Health-Department of Energy (NIH-DOE) Joint Working Group on Ethical, Legal, and Social Implications of Human Genome Research, “Genetic Discrimination and the Americans with Disabilities Act,” Human Genome News, vol. 3, no. 3 (1991), pp. 1213.

48 Weiss, Rick, “Gene Discrimination Barred in Workplace,” Washington Post, 04 7, 1995, p. A3.

49 NIH-DOE Joint Working Group, “Genetic Discrimination and the Americans with Disabilities Act,” p. 2.

50 Healy, Bernadine, “Testimony on the possible uses and misuses of genetic information,” Human Gene Therapy, vol. 3 (1992), pp. 5156.

51 Committee on Government Operations, House of Representatives, U.S. Congress, Designing Genetic Information Policy: The Need for an Independent Policy Review of the Ethical, Legal, and Social Implications of the Human Genome Project (Washington, DC: U.S. Government Printing Office, 1992).

52 It could have also pointed out that, in the eyes of the Federal Advisory Committee Act, the ELSI Working Group does not even exist between its meetings: strictly speaking, it is reconstituted for each meeting as a new “working group.”

53 Office of Technology Assessment, U.S. Congress, Biomedical Ethics in U.S. Public Policy—Background Paper, OTA-BP-BBS-105 (Washington, DC: U.S. Government Printing Office, 06 1993), p. 8.

54 Hanna, Kathi E., “The Ethical, Legal, and Social Implications Program of the National Center for Human Genome Research: A Missed Opportunity?” in Bulger, , Bobby, , and Fineberg, , eds., Society's Choices (supra note 26), pp. 432–58.

55 The same amount that went to one genome researcher, Eric Lander, that year alone—just to keep things in perspective!

56 Cf. Biesecker, Barbara et al. , “Genetic Counseling for Families with Inherited Susceptibility to Breast and Ovarian Cancer,” Journal of the American Medical Association, vol. 269 (1993), pp. 1970–74.

57 NIH-DOE Joint Working Group on the Ethical, Legal, and Social Implications of Human Genome Research, “Mission Statement,” 12 1, 1994.

58 NIH-DOE Joint Working Group on Ethical, Legal, and Social Issues, Five Year Planning Summary (Bethesda, MD: NIH, 04 15, 1993).

59 Cf. Levine, Robert, The Ethics and Regulation of Clinical Research (New York: Urban and Schwartzenberg, 1986).

60 Li, Fred et al. , “Recommendations on Predictive Testing for Germ-Line P53 Mutations among Cancer-Prone Individuals,” Journal of the National Cancer Institute, vol. 84 (1992), pp. 1156–60.

61 Office of Protection from Research Risk, Protecting Human Subjects: Institutional Review Board Guidebook (Bethesda, MD: OPRR, NIH, DHHS, 1993).

62 Alliance of Genetic Support Groups, Informed Consent: Participation in Genetic Research Studies (Chevy Chase, MD: Alliance of Genetic Support Groups, 1993).

63 Powers, Madison, “Publication-Related Risks to Privacy: Ethical Implications of Pedigree Studies,” IRB, vol. 15 (1993), pp. 711; International Committee of Medical Journal Editors, “Altering Data for Publication,” Statement to the Office of Protection from Research Risk, December 14, 1994.

64 Clayton, Ellen et al. , “Informed Consent for Genetic Research on Stored Tissue Samples,” Journal of the American Medical Association, vol. 274 (12 13, 1995), pp. 1786–92.

65 American College of Medical Genetics, “Statement on Storage and Use of Genetic Materials,” American Journal of Human Genetics, vol. 57 (1995), pp. 14991501.

66 Locke, Margaret, “Interrogating the Human Genome Diversity Project,” Social Science and Medicine, vol. 39 (1994), pp. 603–6.

67 Collins, Francis, “Statement on the Human Genome Diversity Project,” Senate Committee on Government Affairs, Hearings on the Human Genome Diversity Project, April 26, 1993.

68 For a history of the country's other efforts at national bioethical commissions, see Office of Technology Assessment, U.S. Congress, Biomedical Ethics in U.S. Public Policy (supra note 53), Appendix A.

69 The National Center for Human Genome Research has already been approached, for example, by representatives of the planned “Human Brain Project” at the National Institute of Mental Health about replicating an “ELSI” funding program within their efforts to compile and correlate all our knowledge of the brain.

Self-Critical Federal Science? The Ethics Experiment within the U.S. Human Genome Project

  • Eric T. Juengst (a1)

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