National policies to oversee inheritable genetic modifications research

Designing Our Descendants: The Promises and Perils of Genetic Modifications

Volumn 9780801881299, Issue , 2003, Pages 275-295

  Palmer, Julie Gage ^a   Cook Deegan, Robert ^b  

^a UNIVERSITY OF CHICAGO   (United States)

^b DUKE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 1942480283     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (76)

1. Robert M. Cook-Deegan, Do Research Moratoria Work?: A Review of Fetal Research, Gene Therapy, and Recombinant DNA Research (Washington, D. C.: National Bioethics Advisory Commission, 1997).
2. (Nicholas Wade, "Recombinant DNA: NIH Rules Broken in Insulin Gene Project", Science 197 [1977]: 1342-45.)
3. (Stephen S. Hall, Invisible Frontiers: The Race to Synthesize a Human Gene [New York: Atlantic Monthly Books, 1987]).
4. U. S. Patent Quarterly 39 USPQ2d 1225, 1248-1254 [S. D. Ind. 1995]
5. 119 F. 3d 1559 [Fed. Cir. 1997])
6. www.law.emory.edu/fedcircuit/july97/96-1175.html;
7. 119 F. 3d 1559;
8. 1997 U. W. App. LEXIS 18221;
9. 43 U. S. P. Q.2d [BNA] 1398.)
10. (Eliott Marshall, "Scientific Community: A Bitter Battle over Insulin Gene", Science 277 [August 22, 1997]: 1028-30).
11. Daniel J. Kevles, The Baltimore Case: A Trial of Politics, Science, and Character (New York: W. W. Norton, 1998).
12. "FDA Orders Tighter Watch over Safety in Gene Therapy Tests", Chicago Tribune, March 8, 2000, 3
13. "Advisory Panel on Gene Therapy Research Deadlocks", Chicago Tribune, March 10, 2000, 8.
14. FDA's proposed rule for publicly reporting adverse events for gene transfer and xenotransplantation research: www.fda.gov/cber/rules/frgene011801.htm (January 18, Federal Register).
15. The agreement between OBA (at NIH) and FDA to share adverse events data is: www.fda.gov/cber/regsopp/91102.htm.
16. And the FDA's generic adverse event program MedWatch is: www.fda.gov/medwatch/index.html.
17. LeRoy Walters and Julie Palmer, The Ethics of Human Gene Therapy (New York: Oxford University Press, 1997).
18. Medical Devices Amendments to the Food, Drug and Cosmetics Act, 21 U. S. C. § 360k (a).
19. Medtronic, Inc. v. Lohr, 518 U. S. 470, 1996.
20. Julie Gage Palmer, "Human Gene Therapy: Suggestions for Avoiding Liability", Gene Therapy for Neoplastic Diseases, Annals of the New York Academy of Sciences 716(1994):294-306.
21. Enright v. Eli Lilly & Company, 568 N. Y.2d 550 (N. Y. Feb. 19, 1991)
22. Sorrells v. Eli Lilly & Company, 737 F. Supp. 678, 679 (D. D. C. 1990)
23. J. G. Palmer, "Liability Considerations Presented by Human Gene Therapy", Human Gene Therapy 2(1991):235-42.
24. www4.od.nih.gov/oba/aboutrdagt.htm.
25. www4.od.nih.gov/oba/guidelines.pdf.
26. Sheldon Krimsky, Genetic Alchemy: The Social History of the Recombinant DNA Controversy (Cambridge, Mass.: MIT Press, 1982).
27. Maxine Singer and Dieter Soll, "Guidelines for Hybrid DNA Molecules", Science 181(September 21, 1973):1114.
28. Paul Berg et al., Summary Statement of the Asilomar Conference on Recombinant DNA Molecules, Proceedings of the National Academy of Sciences USA 72(June 1975a):1981-84;
29. "Summary Statement of the Asilomar Conference on Recombinant DNA Molecules", Science 72(June 6, 1975):991;
30. Paul Berg et al., "Potential Biohazards of Recombinant DNA Molecules", Proceedings of the National Academy of Sciences USA 71(July 1974a):2593-94
31. "Potential Biohazards of Recombinant DNA Molecules", Science 185(July 26, 1974):3034.
32. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Splicing Life (Washington, D. C.: U. S. Government Printing Office, 1982).
33. Walters and Palmer, The Ethics of Human Gene Therapy, 148-50.
34. National Science Board, Science and Engineering Indicators-2002, NSB 02-1 (Arlington, Va.: National Science Foundation, 2002).
35. LeRoy Walters and Julie Palmer, "Points to Consider", in The Ethics of Human Gene Therapy, 172. Also www4.od.nih.gov/oba/guidelines.pdf (NIH guidelines) and www4.od.nih.gov/oba/apndxm.htm ("Points to Consider").
36. George J. Annas and Michael A. Grodin, The Nuremberg Code in U. S. Courts: Ethics versus Expediency (New York: Oxford University Press, 1992), 201-22;
37. Leonard H. Glantz, "The Influence of the Nuremberg Code on U. S. Statutes and Regulations", in Annas and Grodin; and Michael A. Grodin, Historical Origins of the Nuremberg Code, in Annas and Grodin.
38. http://www.fda.gov/oc/ohrt/irbs/default.htm (accessed September 14, 2002).
39. Ruth Ellen Bulger, Elizabeth Meyer Bobby, and Harvey V. Fineberg, eds., Society's Choices: Social and Ethical Decision Making in Medicine, Institute of Medicine (Washington, D. C.: National Academy Press, 1995)
40. U. S. Congress, Office of Technology Assessment (Robyn Y. Nishimi, Project Director), Biomedical Ethics in U. S. Public Policy: Background Paper, OTA-BP-BBS-105 (Washington, D. C.: U. S. Government Printing Office, June 1993);
41. National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, U. S. Department of Health, Education, and Welfare, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, D. C.: U. S. Government Printing Office, 1978).
42. OPRR Report 95-02, "Exempt Research and Research That May Undergo Expedited Review" from Office of Protection from Research Risks, National Institutes of Health, May 5, 1995. grants.nih.gov/grants/oprr/humansubjects/guidance/hsdc95-02.htm;
43. 45 CFR 46, section 110.
44. Guidance for Industry, Guidance for Human Somatic Cell Therapy and Gene Therapy, which can be found at www.fda.gov/cber/guidelines.htm (accessed September 14, 2002).
45. www.fda.gov/cber/1tr/cytotrans07601.htm (accessed September 14, 2002).
46. Tissue Action Plan (updated November 8, 1999), available at www.fda.gov/cber/tissue/tissue.htm, 8 (accessed September 14, 2002).
47. D. A. Kessler et al., "Regulation of Somatic-Cell Therapy and Gene Therapy by the Food and Drug Administration", New England Journal of Medicine 329(October 14, 1993):1169-73.
48. Lori Andrews, "Is There a Right to Clone?: Constitutional Challenges to Bans on Human Cloning", Harvard Journal of Law and Technology 11(1998):643-81.
49. Kessler et al., "Regulation of Somatic-Cell Therapy and Gene Therapy by the Food and Drug Administration. "
50. "Investigators who have received authorization from FDA to initiate a human gene transfer protocol must report any serious adverse event immediately to the local Institutional Review Board, Institutional Biosafety Committee, Office for Human Research Protections (if applicable), and NIH OBA, followed by the submission of a written report filed with each group. Reports submitted to NIH OBA shall be sent to the Office of Biotechnology Activities, National Institutes of Health" (Appendix M-I-C-4, htttp://www.fda.gov/ohrms/dockets/ac/01/briefing/3794b3-11.pdf [accessed September 20, 2002];
51. FDA letter to gene transfer investigators, November 5, 1999, http://www.fda.gov/cber/1tr/gt110599.htm [accessed September 20, 2002]).
52. (DHHS, NIH, Office of Biotechnology Activities) "Actions under the NIH Guidelines", Federal Register 66, no. 223 [November 19, 2001]: 57970).
53. 111 Stat 1467, sec. 513.
54. La. Rev. Stat. Ann. §9:121-122 (2001);
55. Mass. Gen. Laws Ann. Ch. 112, §12 (2001);
56. Mich. Comp. Laws Ann. §333. 2685-.2692 (2001);
57. Minn. Stat. §145. 421-.422 (2001);
58. N. D. Cent. Code §14-02.2-02 (2002);
59. N. H. Rev. Stat. Ann. §168-B:15 (2002);
60. 18 Pa. C. S. §3216 (2002);
61. R. I. Gen. Laws §11-54-1 (2001).
62. Jane L. v. Bangerter, 61 F. 3d 1493, 1499-1502 (10th Cir. 1995)
63. Leavitt v. Jane L., 518 U. S. 137 (1996);
64. Lifchez v. Hartigan, 735 F. Supp. 1361, 1364-67 (N. D. Ill. 1990)
65. 914 F. 2d 260 (7th Cir. 1990);
66. Margaret S. v. Edwards, 794 F. 2d 994, 999 (5th Cir. 1986).
67. Mass. Gen. Laws Ann. Ch. 112, §12J (2001);
68. N. H. Rev. Stat. Ann. §168-B:15 (2001);
69. La. Rev. Stat. Ann. §9:121-122 (2001).
70. R. I. Gen. Laws §11-54-1 (2001);
71. Mich. Comp. Laws Ann. §333. 2685-.2692 (2001).
72. Mass. Gen. Laws Ann. Ch. 112, §12J (2001);
73. R. I. Gen. Laws §11-54-1 (2001).
74. N. H. Rev. Stat. Ann. §168-B:15 (2002).
75. R. I. Gen. Laws §23-16.4-2 (2001).
76. Jonathan Glover, What Sort of People Should There Be?: Genetic Engineering, Brain Control and Their Impact on the World (New York: Penguin Books, 1984).