Commentary: Reconstruing Genetic Research as Research

Journal of Law, Medicine and Ethics

Volumn 26, Issue 1, 1998, Pages 48-54

  Lysaught, M Therese ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; BENEFICENCE; BIOMEDICAL AND BEHAVIORAL RESEARCH; ETHICS; GENE THERAPY; GENETIC DISORDER; GENETICS; GENETICS AND REPRODUCTION; GOVERNMENT; GOVERNMENT REGULATION; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; LEGAL APPROACH; MEDICAL ETHICS; NATIONAL INSTITUTES OF HEALTH; PATIENT ADVOCACY; RECOMBINANT DNA ADVISORY COMMITTEE; RESEARCH SUBJECT; RISK ASSESSMENT; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; GENETICS AND REPRODUCTION; LEGAL APPROACH; NATIONAL INSTITUTES OF HEALTH; RECOMBINANT DNA ADVISORY COMMITTEE;

ADVISORY COMMITTEES; BENEFICENCE; CONSENT FORMS; ETHICAL REVIEW; ETHICS, MEDICAL; FEDERAL GOVERNMENT; GENE THERAPY; GENETIC DISEASES, INBORN; GENETIC RESEARCH; GOVERNMENT REGULATION; HEALTH POLICY; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; NATIONAL INSTITUTES OF HEALTH (U.S.); PATIENT ADVOCACY; RESEARCH SUBJECTS; RISK ASSESSMENT; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES;

EID: 0032008878     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.1998.tb01905.x     Document Type: Article

References (31)

1. See L.R. Churchill et al., "Genetic Research as Therapy: Implications of 'Gene Therapy' for Informed Consent," Journal of Law, Medicine & Ethics, 26 (1998): 38-47.
2. See "Notice of Intent to Propose Amendments to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) Regarding Enhanced Mechanisms for NIH Oversight of Recombinant DNA Activities," 61 Fed. Reg. 35774 (July 8, 1996).
3. See S.H. Orkin and A.G. Motulsky, National Institutes of Health Ad Hoc Committee Report, Report and Recommendations of the Panel to Assess the N.I.H. Investment in Research on Gene Therapy, at 1 (Dec. 7, 1995) 〈http://www.nih.gov/od/ orda/panelrep.html〉.
4. See Comments of Dr. Lana Skirboll, Associate Director for Science Policy, Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, December 4-5, 1995" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/ docs.htm〉. See also I. Verma, Ad Hoc Review Committee, "Minutes of Meeting, March 8, 1995" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/docs.htm〉; FDA Week, 1, no. 13 (Sept. 8, 1995): 2; Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, September 12-13, 1994" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/ orda/docs.html〉; Letter from U.S. Senator Pryor to Dr. Harold Varmus, Director, National Institutes of Health (June 21, 1996) (on file with author); and Letter from U.S. Senators Mark Hatfield, Henry Waxman, David Pryor, and Ron Wyden to Dr. Harold Varmus, Director, National Institutes of Health (June 26, 1996) (on file with author).
5. See Comments of Dr. Lana Skirboll, Associate Director for Science Policy, Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, December 4- 5, 1995" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/ docs.htm〉. See also I. Verma, Ad Hoc Review Committee, "Minutes of Meeting, March 8, 1995" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/docs.htm〉; FDA Week, 1, no. 13 (Sept. 8, 1995): 2; Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, September 12-13, 1994" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/ orda/docs.html〉; Letter from U.S. Senator Pryor to Dr. Harold Varmus, Director, National Institutes of Health (June 21, 1996) (on file with author); and Letter from U.S. Senators Mark Hatfield, Henry Waxman, David Pryor, and Ron Wyden to Dr. Harold Varmus, Director, National Institutes of Health (June 26, 1996) (on file with author).
6. See Comments of Dr. Lana Skirboll, Associate Director for Science Policy, Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, December 4- 5, 1995" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/ docs.htm〉. See also I. Verma, Ad Hoc Review Committee, "Minutes of Meeting, March 8, 1995" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/docs.htm〉; FDA Week, 1, no. 13 (Sept. 8, 1995): 2; Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, September 12-13, 1994" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/ orda/docs.html〉; Letter from U.S. Senator Pryor to Dr. Harold Varmus, Director, National Institutes of Health (June 21, 1996) (on file with author); and Letter from U.S. Senators Mark Hatfield, Henry Waxman, David Pryor, and Ron Wyden to Dr. Harold Varmus, Director, National Institutes of Health (June 26, 1996) (on file with author).
7. See Comments of Dr. Lana Skirboll, Associate Director for Science Policy, Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, December 4- 5, 1995" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/ docs.htm〉. See also I. Verma, Ad Hoc Review Committee, "Minutes of Meeting, March 8, 1995" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/docs.htm〉; FDA Week, 1, no. 13 (Sept. 8, 1995): 2; Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, September 12-13, 1994" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/ orda/docs.html〉; Letter from U.S. Senator Pryor to Dr. Harold Varmus, Director, National Institutes of Health (June 21, 1996) (on file with author); and Letter from U.S. Senators Mark Hatfield, Henry Waxman, David Pryor, and Ron Wyden to Dr. Harold Varmus, Director, National Institutes of Health (June 26, 1996) (on file with author).
8. See "The N2-TIL Human Gene Transfer Clinical Protocol," Human Gene Therapy, 1 (1990): 73-92 (Steven A. Rosenberg, R. Michael Blaese, and W. French Anderson, principal investigators).
9. See Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, February 5, 1990," Human Gene Therapy, 1 (1990): at 368.
10. Id. at 366.
11. Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, December 3-4, 1992" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/ docs.htm〉.
12. Recombinant DNA Advisory Committee, National Institutes of Health, "Requests for Compassionate Use of Gene Therapy Memorandum from the Subcommittee to the RAC, January 13, 1993," Human Gene Therapy, 4 (1993): at 199.
13. B. Healy, "Remarks for the RAC Committee Meeting of January 14, 1993, Regarding Compassionate Use Exemption," Human Gene Therapy, 4 (1993): at 196, 197.
14. Recombinant DNA Advisory Committee Meeting, National Institutes of Health, "Recommendations of the RAC to the NIH Director, January 14, 1993," Human Gene Therapy, 4 (1993): at 203.
15. See Recombinant DNA Advisory Committee, supra note 8.
16. See Memorandum from the Members of the Recombinant DNA Advisory Committee to Harold Varmus, Director, National Institutes of Health, "Congressional Inquiry Regarding a Human Gene Transfer Protocol Entitled: A Phase I Study of Active Immunotherapy with Carcinoembryonic Antigen RNA-Pulsed Autologous Human Cultured Dendritic Cells in Patients with Metastatic Malignancies Expressing Carcinoembryonic Antigen" (Apr. 24, 1997) (on file with author).
17. These letters are part of the public record of materials for the June 1997 Recombinant DNA Advisory Committee (RAC) meeting. Copies of these documents should be available on request from the Office of Recombinant DNA, National Institutes of Health.
18. See Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, June 12-13, 1997" (visited Apr. 12, 1998) 〈http://www.nih.gov/od/orda/ docs.htm〉.
19. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
20. See T. Friedmann, "The Evolving Concept of Gene Therapy," Human Gene Therapy, 1 (1990): 177-78; J.C. Fletcher, "Evolution of Ethical Debate about Human Gene Therapy," Human Gene Therapy, 1 (1990): 57-61; T.H. Murray, "Human Gene Therapy, the Public, and Public Policy," Human Gene Therapy, 1 (1990): 50-51; L. Walters, "Human Gene Therapy: Ethics and Public Policy," Human Gene Therapy, 2 (1991): 115-17; and L. Walters and J.G. Palmer, The Ethics of Human Gene Therapy (New York: Oxford University Press, 1997): at 143-46.
21. See T. Friedmann, "The Evolving Concept of Gene Therapy," Human Gene Therapy, 1 (1990): 177-78; J.C. Fletcher, "Evolution of Ethical Debate about Human Gene Therapy," Human Gene Therapy, 1 (1990): 57-61; T.H. Murray, "Human Gene Therapy, the Public, and Public Policy," Human Gene Therapy, 1 (1990): 50-51; L. Walters, "Human Gene Therapy: Ethics and Public Policy," Human Gene Therapy, 2 (1991): 115-17; and L. Walters and J.G. Palmer, The Ethics of Human Gene Therapy (New York: Oxford University Press, 1997): at 143-46.
22. See T. Friedmann, "The Evolving Concept of Gene Therapy," Human Gene Therapy, 1 (1990): 177-78; J.C. Fletcher, "Evolution of Ethical Debate about Human Gene Therapy," Human Gene Therapy, 1 (1990): 57-61; T.H. Murray, "Human Gene Therapy, the Public, and Public Policy," Human Gene Therapy, 1 (1990): 50-51; L. Walters, "Human Gene Therapy: Ethics and Public Policy," Human Gene Therapy, 2 (1991): 115-17; and L. Walters and J.G. Palmer, The Ethics of Human Gene Therapy (New York: Oxford University Press, 1997): at 143-46.
23. See T. Friedmann, "The Evolving Concept of Gene Therapy," Human Gene Therapy, 1 (1990): 177-78; J.C. Fletcher, "Evolution of Ethical Debate about Human Gene Therapy," Human Gene Therapy, 1 (1990): 57-61; T.H. Murray, "Human Gene Therapy, the Public, and Public Policy," Human Gene Therapy, 1 (1990): 50-51; L. Walters, "Human Gene Therapy: Ethics and Public Policy," Human Gene Therapy, 2 (1991): 115-17; and L. Walters and J.G. Palmer, The Ethics of Human Gene Therapy (New York: Oxford University Press, 1997): at 143-46.
24. See T. Friedmann, "The Evolving Concept of Gene Therapy," Human Gene Therapy, 1 (1990): 177-78; J.C. Fletcher, "Evolution of Ethical Debate about Human Gene Therapy," Human Gene Therapy, 1 (1990): 57-61; T.H. Murray, "Human Gene Therapy, the Public, and Public Policy," Human Gene Therapy, 1 (1990): 50-51; L. Walters, "Human Gene Therapy: Ethics and Public Policy," Human Gene Therapy, 2 (1991): 115-17; and L. Walters and J.G. Palmer, The Ethics of Human Gene Therapy (New York: Oxford University Press, 1997): at 143-46.
25. See President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings (Washington, D.C.: The Commission, Nov. 1982).
26. See Friedmann, supra note 17, at 177-79; Fletcher, supra note 17, at 66; Murray, supra note 17, at 51; and R. Cook-Deegan, "Human Gene Therapy and Congress," Human Gene Therapy, 1 (1990): 163-70.
27. Office for Protection from Research Risks, U.S. Dept. of Health, Education and Welfare, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research (Washington, D.C.: OPRR Reports, ACHRE No. HHS-011795-A-2, Apr. 18, 1979).
28. 45 C.F.R. § 46 (1991).
29. See A.M. Capron, "The Impact of the Report, Splicing Life," Human Gene Therapy, 1 (1990): 69-71; see also Walters, supra note 17; and Walters and Palmer, supra note 17, at 147-52.
30. Vestiges of the original language remain in the NIH Guidelines, but only in a few short sections, specifically in Appendix M, the "Points to Consider," and Appendix D, "Major Actions Taken Under the NIH Guidelines." In Appendix M, use of the phrase gene therapy is limited to the discussion of the historical background of human gene transfer research (pp. 92-93) and as vestiges of the original guidelines in sections M-II, "Description of the Proposal," and M-IV, "Privacy and Confidentiality" (pp. 93-99). The terms patients and treatment are more problematic, but again are limited to sections M-II and M-IV and should be easy to revise. Appendix D, "Major Actions Taken Under the NIH Guidelines," presents a different and perhaps more intractable set of issues. Appendix D lists the various human gene transfer protocols approved by RAC, in addition to a number of recombinant DNA protocols. This section documents well the conceptual shifts regarding human gene transfer research that have occurred since 1989. For example, the early entries use only the term patient, the later entries use only the term subject, and the middle entries mix the terms. The appendix is consistent in referring to the protocols as experiments, but likewise vacillates between the phrases gene therapy experiment and gene transfer experiment. Early on, these phrases were used to differentiate between potentially therapeutic protocols and gene-marking protocols. Relatively quickly, the use of the phrase gene therapy essentially disappears; this reflects the March 1993 decision of RAC that the phrase gene transfer should be used for all unproven, phase I trials. See Recombinant DNA Advisory Committee, National Institutes of Health, "Minutes of Meeting, March 1-2, 1993" (visited Apr. 12, 1998) 〈http://www.nih.gov/ od/orda/docs.html〉. Thus, Appendix D provides an interesting window into the historical evolution of RAC's conceptualization of these issues. However, insofar as Appendix D contains the record, it is unclear how amenable it is to revision. The phrase gene therapy will be the most difficult to eliminate insofar as it used in the context of the recently instituted program "Gene Therapy Policy Conferences," created by Harold Varmus. This comprises the bulk of the uses of this phrase in the Guidelines.
31. E. Marshal, "Varmus Proposes to Scrap the RAC," Science, 272 (May 17, 1996): at 94 (emphasis added).