Legal enforcement of xenotransplantation public health safeguards

Journal of Law, Medicine and Ethics

Volumn 32, Issue 1, 2004, Pages 117-123

  Florencio, Patrik S ^a,b,c   Ramanathan, Erik D ^d,e,f,g  

^a Ropes and Gray   (United States)

^b McGill Law School ^*

^c MCGILL UNIVERSITY   (Canada)

^d ELI LILLY AND COMPANY   (United States)

^e Proskauer Rose LLP   (United States)

^f HARVARD LAW SCHOOL   (United States)

^g JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BODY FLUID; CONTRACT; HUMAN; INFORMED CONSENT; LAW; LAW ENFORCEMENT; LEGAL ASPECT; NONHUMAN; PUBLIC HEALTH; RECIPIENT; REVIEW; SAFETY; SOCIETY; TISSUE; XENOTRANSPLANTATION; BIOMEDICAL AND BEHAVIORAL RESEARCH; HEALTH CARE AND PUBLIC HEALTH; INFECTION CONTROL; LEGAL APPROACH; XENOGRAFT;

BIOMEDICAL AND BEHAVIORAL RESEARCH; HEALTH CARE AND PUBLIC HEALTH; LEGAL APPROACH;

CONTRACTS; HUMANS; INFECTION CONTROL; INFORMED CONSENT; PUBLIC HEALTH; TRANSPLANTATION, HETEROLOGOUS;

EID: 2942657644     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2004.tb00456.x     Document Type: Review

References (81)

1. U.S. Food and Drug Administration, PHS Guideline on Infectious Disease Issues in Xenotransplantation, at 〈http://www.fda.gov/cber/gdlns/ xenophs0101.htm〉 (last visited January 21, 2004).
2. L.E. Chapman et al., "Xenotransplantation and Xenogeneic Infections," N. Engl. J. Med. 333 (1995): 1498-1501; F.A. Murphy, "The Public Health Risk of Animal Organ and Tissue Transplantation Into Humans," Science 273 (1996): 746-47; J.S. Allan, "Xenotransplantation at a Crossroads: Prevention Versus Progress," Nature Medicine 2 (1996): 18-21; J.A. Fishman, "Infection and Xenotransplantation: Developing Strategies to Minimize Risk," Annals of the New York Academy of Sciences 862 (1998): 52-65; R.A. Weiss, "Xenografts and Retroviruses," Science 285 (1999): 1221-22; J.S. Allen, 'Understanding Xenotransplantation Risks from Nonhuman Primate Retroviruses," Current Topics in Microbiology and Immunology 278 (2003): 101-123.
3. L.E. Chapman et al., "Xenotransplantation and Xenogeneic Infections," N. Engl. J. Med. 333 (1995): 1498-1501; F.A. Murphy, "The Public Health Risk of Animal Organ and Tissue Transplantation Into Humans," Science 273 (1996): 746-47; J.S. Allan, "Xenotransplantation at a Crossroads: Prevention Versus Progress," Nature Medicine 2 (1996): 18-21; J.A. Fishman, "Infection and Xenotransplantation: Developing Strategies to Minimize Risk," Annals of the New York Academy of Sciences 862 (1998): 52-65; R.A. Weiss, "Xenografts and Retroviruses," Science 285 (1999): 1221-22; J.S. Allen, 'Understanding Xenotransplantation Risks from Nonhuman Primate Retroviruses," Current Topics in Microbiology and Immunology 278 (2003): 101-123.
4. L.E. Chapman et al., "Xenotransplantation and Xenogeneic Infections," N. Engl. J. Med. 333 (1995): 1498-1501; F.A. Murphy, "The Public Health Risk of Animal Organ and Tissue Transplantation Into Humans," Science 273 (1996): 746-47; J.S. Allan, "Xenotransplantation at a Crossroads: Prevention Versus Progress," Nature Medicine 2 (1996): 18-21; J.A. Fishman, "Infection and Xenotransplantation: Developing Strategies to Minimize Risk," Annals of the New York Academy of Sciences 862 (1998): 52-65; R.A. Weiss, "Xenografts and Retroviruses," Science 285 (1999): 1221-22; J.S. Allen, 'Understanding Xenotransplantation Risks from Nonhuman Primate Retroviruses," Current Topics in Microbiology and Immunology 278 (2003): 101-123.
5. L.E. Chapman et al., "Xenotransplantation and Xenogeneic Infections," N. Engl. J. Med. 333 (1995): 1498-1501; F.A. Murphy, "The Public Health Risk of Animal Organ and Tissue Transplantation Into Humans," Science 273 (1996): 746-47; J.S. Allan, "Xenotransplantation at a Crossroads: Prevention Versus Progress," Nature Medicine 2 (1996): 18-21; J.A. Fishman, "Infection and Xenotransplantation: Developing Strategies to Minimize Risk," Annals of the New York Academy of Sciences 862 (1998): 52-65; R.A. Weiss, "Xenografts and Retroviruses," Science 285 (1999): 1221-22; J.S. Allen, 'Understanding Xenotransplantation Risks from Nonhuman Primate Retroviruses," Current Topics in Microbiology and Immunology 278 (2003): 101-123.
6. L.E. Chapman et al., "Xenotransplantation and Xenogeneic Infections," N. Engl. J. Med. 333 (1995): 1498-1501; F.A. Murphy, "The Public Health Risk of Animal Organ and Tissue Transplantation Into Humans," Science 273 (1996): 746-47; J.S. Allan, "Xenotransplantation at a Crossroads: Prevention Versus Progress," Nature Medicine 2 (1996): 18-21; J.A. Fishman, "Infection and Xenotransplantation: Developing Strategies to Minimize Risk," Annals of the New York Academy of Sciences 862 (1998): 52-65; R.A. Weiss, "Xenografts and Retroviruses," Science 285 (1999): 1221-22; J.S. Allen, 'Understanding Xenotransplantation Risks from Nonhuman Primate Retroviruses," Current Topics in Microbiology and Immunology 278 (2003): 101-123.
7. L.E. Chapman et al., "Xenotransplantation and Xenogeneic Infections," N. Engl. J. Med. 333 (1995): 1498-1501; F.A. Murphy, "The Public Health Risk of Animal Organ and Tissue Transplantation Into Humans," Science 273 (1996): 746-47; J.S. Allan, "Xenotransplantation at a Crossroads: Prevention Versus Progress," Nature Medicine 2 (1996): 18-21; J.A. Fishman, "Infection and Xenotransplantation: Developing Strategies to Minimize Risk," Annals of the New York Academy of Sciences 862 (1998): 52-65; R.A. Weiss, "Xenografts and Retroviruses," Science 285 (1999): 1221-22; J.S. Allen, 'Understanding Xenotransplantation Risks from Nonhuman Primate Retroviruses," Current Topics in Microbiology and Immunology 278 (2003): 101-123.
8. Id. See also, D. Butler, "Last Chance to Stop and Think on Risks of Xenotransplantation," Nature 391 (1998): 320-24; L.E. Chapman and F.T. Bloom, "Clinical Xenotransplantation," JAMA 285 (2001): 2304-06. The public health risks associated with Xenotransplantation are also reviewed in P.S. Florencio and E.D. Ramanathan, "Are Xenotransplantation Safeguards Legally Viable?," Berkeley Technology Law Journal 16: Suppl. (2001): 937-77.
9. Id. See also, D. Butler, "Last Chance to Stop and Think on Risks of Xenotransplantation," Nature 391 (1998): 320-24; L.E. Chapman and F.T. Bloom, "Clinical Xenotransplantation," JAMA 285 (2001): 2304-06. The public health risks associated with Xenotransplantation are also reviewed in P.S. Florencio and E.D. Ramanathan, "Are Xenotransplantation Safeguards Legally Viable?," Berkeley Technology Law Journal 16: Suppl. (2001): 937-77.
10. Id. See also, D. Butler, "Last Chance to Stop and Think on Risks of Xenotransplantation," Nature 391 (1998): 320-24; L.E. Chapman and F.T. Bloom, "Clinical Xenotransplantation," JAMA 285 (2001): 2304-06. The public health risks associated with Xenotransplantation are also reviewed in P.S. Florencio and E.D. Ramanathan, "Are Xenotransplantation Safeguards Legally Viable?," Berkeley Technology Law Journal 16: Suppl. (2001): 937-77.
11. S.S. Morse and A. Schluederberg, "Emerging Viruses: The Evolution of Viruses and Viral Diseases," Journal of Infectious Diseases 264 (1990): 1-7; A. Gibbons, "Where are New Diseases Born?," Science 261 (1993): 68-70.
12. S.S. Morse and A. Schluederberg, "Emerging Viruses: The Evolution of Viruses and Viral Diseases," Journal of Infectious Diseases 264 (1990): 1-7; A. Gibbons, "Where are New Diseases Born?," Science 261 (1993): 68-70.
13. J.K. Taubenberger et al., "Initial Genetic Characterization of the 1918 'Spanish' Influenza Virus," Science 275 (1997): 1793-96.
14. G.M. Baer and N. Tordo, "Rabies Virus," in R.G. Webster, A. Granoff, eds., Encyclopedia of Virology (San Diego: Academic Press, 1994): 1180-85.
15. A. Nikiforuk, The Fourth Horseman: A Short History of Plagues, Scourges and Emerging Viruses (Toronto: Penguin Books, 1996): at 27.
16. G.P. Holmes et al., "Lassa Fever in the United States: Investigation of a New Case and Guidelines for Management," N. Engl. J. Med. 323 (1990): 1120-23; V. Suresh, "The Enigmatic Haemorrhagic Fevers," Journal of the Royal Society of Medicine 90 (1997): 622-24.
17. G.P. Holmes et al., "Lassa Fever in the United States: Investigation of a New Case and Guidelines for Management," N. Engl. J. Med. 323 (1990): 1120-23; V. Suresh, "The Enigmatic Haemorrhagic Fevers," Journal of the Royal Society of Medicine 90 (1997): 622-24.
18. J.F Levine, M.L. Wilson, and A. Spielman, "Mice as Reservoirs of the Lyme Disease Spirochete," American Journal of Tropical Medical Hygiene 34 (1985): 355-60; F.R. Matuschka et al., "Capacity of European Animals as Reservoir Hosts for the Lyme Disease Spirochete," Journal of Infectious Diseases 165 (1992): 479-83; J. Kaiser, "Of Mice and Moths - and Lyme Disease?," Science 279 (1998): 984-85.
19. J.F Levine, M.L. Wilson, and A. Spielman, "Mice as Reservoirs of the Lyme Disease Spirochete," American Journal of Tropical Medical Hygiene 34 (1985): 355-60; F.R. Matuschka et al., "Capacity of European Animals as Reservoir Hosts for the Lyme Disease Spirochete," Journal of Infectious Diseases 165 (1992): 479-83; J. Kaiser, "Of Mice and Moths - and Lyme Disease?," Science 279 (1998): 984-85.
20. J.F Levine, M.L. Wilson, and A. Spielman, "Mice as Reservoirs of the Lyme Disease Spirochete," American Journal of Tropical Medical Hygiene 34 (1985): 355-60; F.R. Matuschka et al., "Capacity of European Animals as Reservoir Hosts for the Lyme Disease Spirochete," Journal of Infectious Diseases 165 (1992): 479-83; J. Kaiser, "Of Mice and Moths - and Lyme Disease?," Science 279 (1998): 984-85.
21. G. Franchini and M.L. Bosch, "Genetic Relatedness of the Human Immunodeficiency Viruses Type 1 and 2 (HIV-1, HIV-2) and the Simian Immunodeficiency Virus (SIV)," Annals of the NY Academy of Sciences 554 (1989): 81-87; F. Gao et al., "Human Infection by Genetically Diverse SIVSM-related HIV-2 in West Africa," Nature 358 (1992): 495-99.
22. G. Franchini and M.L. Bosch, "Genetic Relatedness of the Human Immunodeficiency Viruses Type 1 and 2 (HIV-1, HIV-2) and the Simian Immunodeficiency Virus (SIV)," Annals of the NY Academy of Sciences 554 (1989): 81-87; F. Gao et al., "Human Infection by Genetically Diverse SIVSM-related HIV-2 in West Africa," Nature 358 (1992): 495-99.
23. M.B.A. Oldstone, Viruses, Plagues, and History (New York: Oxford University Press, 1998): at 46.
24. W.W. Stead, "The Origin and Erratic Global Spread of Tuberculosis: How the Past Explains the Present and is the Key to the Future," Clinical Chest Medicine 18, no. 1 (1997): 65-77.
25. B.J. Poiesz et al., "Detection of Type C Retrovirus Particles From Fresh and Cultured Lymphocytes of a Patient "with T-Cell Lymphoma," Proceedings of the National Academy of Sciences U.S.A. 77 (1980): 7415-19; I.J. Koralnik et al., "Phylogenetic Associations of Human and Simian T-Cell Leukemia/Lymphotropic Virus Type 1 Strains: Evidence For Interspecies Transmission," Journal of Virology 68 (1994): 2693-2707.
26. B.J. Poiesz et al., "Detection of Type C Retrovirus Particles From Fresh and Cultured Lymphocytes of a Patient "with T-Cell Lymphoma," Proceedings of the National Academy of Sciences U.S.A. 77 (1980): 7415-19; I.J. Koralnik et al., "Phylogenetic Associations of Human and Simian T-Cell Leukemia/Lymphotropic Virus Type 1 Strains: Evidence For Interspecies Transmission," Journal of Virology 68 (1994): 2693-2707.
27. Chapman, supra note 2, at 1499.
28. J.M. Hughes et al., "Hantavirus Pulmonary Syndrome: An Emerging Infectious Disease," Science 262 (1993): 850-51; S.S. Morse, Emerging Viruses (New York: Oxford University Press, 1993).
29. J.M. Hughes et al., "Hantavirus Pulmonary Syndrome: An Emerging Infectious Disease," Science 262 (1993): 850-51; S.S. Morse, Emerging Viruses (New York: Oxford University Press, 1993).
30. W.H. McNeill, Plagues and Peoples (New York: Anchor Press, 1976); C.A. Mims, "The Origin of Major Human Infections and the Crucial Role of Person-to-Person Spread," Epidemiology & Infection 106 (1991): 423-33.
31. W.H. McNeill, Plagues and Peoples (New York: Anchor Press, 1976); C.A. Mims, "The Origin of Major Human Infections and the Crucial Role of Person-to-Person Spread," Epidemiology & Infection 106 (1991): 423-33.
32. M.A. McClure et al., "Sequence Comparisons of Retroviral Proteins: Relative Rates of Change and General Phylogeny," Proceedings of the National Academy of Sciences U.S.A. 85 (1988): 2469-73.
33. C. Scholtissek, W. Rohde, V. von Hoyningen, et al., "On the Origin of the Human Influenza Virus Subtypes H2N2 and H3N3," Virology 87 (1978): 13-20.
34. U.S. Food and Drug Administration, PHS Guideline on Infectious Disease Issues in Xenotransplantation, at 〈http://www.fcla.gov/cber/gdlns/ xenophs0101.htm〉 (last visited January 21, 2004); Health Canada, Proposed Canadian Standard for Xenotransplantation, at 〈http://www.hc-sc.gc.ca/hpb- dgps/therapeut/zfiles/english/bgtd/xeno_std_e.html〉 (last visited January 21, 2004); United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA), Draft Report of the Infection Surveillance Steering Group of the UKXIKA, at 〈http://www.doh.gov.uk/pub/docs/doh/surveil.pdf〉 (last visited January 21, 2004).
35. U.S. Food and Drug Administration, PHS Guideline on Infectious Disease Issues in Xenotransplantation, at 〈http://www.fcla.gov/cber/gdlns/ xenophs0101.htm〉 (last visited January 21, 2004); Health Canada, Proposed Canadian Standard for Xenotransplantation, at 〈http://www.hc-sc.gc.ca/hpb- dgps/therapeut/zfiles/english/bgtd/xeno_std_e.html〉 (last visited January 21, 2004); United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA), Draft Report of the Infection Surveillance Steering Group of the UKXIKA, at 〈http://www.doh.gov.uk/pub/docs/doh/surveil.pdf〉 (last visited January 21, 2004).
36. U.S. Food and Drug Administration, PHS Guideline on Infectious Disease Issues in Xenotransplantation, at 〈http://www.fcla.gov/cber/gdlns/ xenophs0101.htm〉 (last visited January 21, 2004); Health Canada, Proposed Canadian Standard for Xenotransplantation, at 〈http://www.hc-sc.gc.ca/hpb- dgps/therapeut/zfiles/english/bgtd/xeno_std_e.html〉 (last visited January 21, 2004); United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA), Draft Report of the Infection Surveillance Steering Group of the UKXIKA, at 〈http://www.doh.gov.uk/pub/docs/doh/surveil.pdf〉 (last visited January 21, 2004).
37. D.R. Solomon, R.M. Ferguson and J.H. Helderman, "Xenotransplants: Proceed With Caution," Nature 392 (1998): 11; T.E. Starlz, et al., "Will Xenotransplantation Ever Be Feasible?," Journal of the American College of Surgeons 186 (1998): 383; D.H. Sachs et al., " Xenotransplantation - Caution, But No Moratorium," Nature Medicine 4 (1998): 372; X. Boch, "Spanish Researchers Reject Xeno Moratorium," Nature Medicine 5 (1999): 361; G. Vogel, "No Moratorium on Clinical Trials," Science 279 (1998): 648.
38. D.R. Solomon, R.M. Ferguson and J.H. Helderman, "Xenotransplants: Proceed With Caution," Nature 392 (1998): 11; T.E. Starlz, et al., "Will Xenotransplantation Ever Be Feasible?," Journal of the American College of Surgeons 186 (1998): 383; D.H. Sachs et al., " Xenotransplantation - Caution, But No Moratorium," Nature Medicine 4 (1998): 372; X. Boch, "Spanish Researchers Reject Xeno Moratorium," Nature Medicine 5 (1999): 361; G. Vogel, "No Moratorium on Clinical Trials," Science 279 (1998): 648.
39. D.R. Solomon, R.M. Ferguson and J.H. Helderman, "Xenotransplants: Proceed With Caution," Nature 392 (1998): 11; T.E. Starlz, et al., "Will Xenotransplantation Ever Be Feasible?," Journal of the American College of Surgeons 186 (1998): 383; D.H. Sachs et al., " Xenotransplantation - Caution, But No Moratorium," Nature Medicine 4 (1998): 372; X. Boch, "Spanish Researchers Reject Xeno Moratorium," Nature Medicine 5 (1999): 361; G. Vogel, "No Moratorium on Clinical Trials," Science 279 (1998): 648.
40. D.R. Solomon, R.M. Ferguson and J.H. Helderman, "Xenotransplants: Proceed With Caution," Nature 392 (1998): 11; T.E. Starlz, et al., "Will Xenotransplantation Ever Be Feasible?," Journal of the American College of Surgeons 186 (1998): 383; D.H. Sachs et al., " Xenotransplantation - Caution, But No Moratorium," Nature Medicine 4 (1998): 372; X. Boch, "Spanish Researchers Reject Xeno Moratorium," Nature Medicine 5 (1999): 361; G. Vogel, "No Moratorium on Clinical Trials," Science 279 (1998): 648.
41. D.R. Solomon, R.M. Ferguson and J.H. Helderman, "Xenotransplants: Proceed With Caution," Nature 392 (1998): 11; T.E. Starlz, et al., "Will Xenotransplantation Ever Be Feasible?," Journal of the American College of Surgeons 186 (1998): 383; D.H. Sachs et al., " Xenotransplantation - Caution, But No Moratorium," Nature Medicine 4 (1998): 372; X. Boch, "Spanish Researchers Reject Xeno Moratorium," Nature Medicine 5 (1999): 361; G. Vogel, "No Moratorium on Clinical Trials," Science 279 (1998): 648.
42. S.J. Gould, Rocks of Ages: Science and Religion in the Fullness of Life (New York: The Library of Contemporary Thought, 1999): at5-6.
43. P.S. Florencio and T. Caulfield, "Xenotransplantation and Public Health: Identifying the Legal Issues," Canadian Journal of Public Health 90 (1999): 282-84; T.A. Caulfield and G.B. Robertson, "Xenotransplantation: Consent, Public Health and Charter Issues," Medical Law International 5 (2001): 81-99.
44. P.S. Florencio and T. Caulfield, "Xenotransplantation and Public Health: Identifying the Legal Issues," Canadian Journal of Public Health 90 (1999): 282-84; T.A. Caulfield and G.B. Robertson, "Xenotransplantation: Consent, Public Health and Charter Issues," Medical Law International 5 (2001): 81-99.
45. A.S. Daar, "Ethics of Xenotransplantation: Animal Issues, Consent, and Likely Transformation of Transplant Ethics," World Journal of Surgery 21 (1997): 975-82; F. Bach et al., "Uncertainty in Xenotransplantation: Individual Benefit "Versus Collective Risk," Nature Medicine 4 (1998): 141-44; D.K.C. Cooper and R.P. Lanza, Xeno: The Promise of Transplanting Animal Organs into Humans (New York: Oxford University Press, 2000): at 218.
46. A.S. Daar, "Ethics of Xenotransplantation: Animal Issues, Consent, and Likely Transformation of Transplant Ethics," World Journal of Surgery 21 (1997): 975-82; F. Bach et al., "Uncertainty in Xenotransplantation: Individual Benefit "Versus Collective Risk," Nature Medicine 4 (1998): 141-44; D.K.C. Cooper and R.P. Lanza, Xeno: The Promise of Transplanting Animal Organs into Humans (New York: Oxford University Press, 2000): at 218.
47. A.S. Daar, "Ethics of Xenotransplantation: Animal Issues, Consent, and Likely Transformation of Transplant Ethics," World Journal of Surgery 21 (1997): 975-82; F. Bach et al., "Uncertainty in Xenotransplantation: Individual Benefit "Versus Collective Risk," Nature Medicine 4 (1998): 141-44; D.K.C. Cooper and R.P. Lanza, Xeno: The Promise of Transplanting Animal Organs into Humans (New York: Oxford University Press, 2000): at 218.
48. Supra note 1.
49. Ibid. Id.
50. Ibid. Id.
51. Ibid. Id.
52. Florencio and Ramanathan, supra note 3.
53. rd ed. (Scarborough: Carswell, 1996): at 110.
54. rd ed. (Scarborough: Carswell, 1996): at 110.
55. Ciarlariello v. Scbacter [1993] 2 S.C.R. 119 (Can.); Reibl v. Hughes [1980] 2 S.C.R. 880 (Can.); Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170 (Cal. 1957): Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).
56. th) 385 (Can.); Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990).
57. Daar, supra note 23; Bach et al., supra note 23; Cooper and Lanza, supra note 23.
58. Fitzpatrick v. Micheal, 9 A.2d 639 (Md. 1939); American Broadcasting Companies, Inc. v. Warner Wolf, 420 N.E.2d 363 (N.Y. 1981).
59. Warner Bros. Pictures Inc. v. Nelson [1937] 1 K.B. 209 (Can.); Emerald Resources Ltd. v. Sterling Oil Properties Management Ltd. [Alberta Ct. App. 1969] 3 D.L.R. (3d) 630, 647 (Can.), aff'd [1970] 15 D.L.R. (3d) 256 (Can.).
60. For additional reasoning on this point, see Florencio and Ramanathan, supra note 3, at 949-53.
61. Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (U.K.), 1982, c. 11, s. 7; U.S. Constitution, Amendment XIII; Universal Declaration of Human Rights, Art. III, U.N. Res. 217A(III) (1948).
62. Health Protection and Promotion Act, R.S.O. ch. 11-7, § 22(2) (1990) (Can.); Cal. Health and Safety Code § 120175 (West 2000).
63. Model State Emergency Health Powers Act (2001), available at 〈http://www.publichealthlaw.net/MSEHPA/MSKHPA2.pdf〉 (last visited July 24, 2002).
64. Id. at § 502(a).
65. Id. at § 301.
66. Florencio and Ramanathan, supra note 3.
67. J. Dunbar-Jacob et al., "Adherence in Chronic Disease," Annual Review of Nursing Research 18 (2000): 48-90.
68. K. Laederach-Hofmann et al., "Noncompliance in Organ Transplant Recipients: A Literature Review," General Hospital Psychiatry 22, no. 6 (2000): 412-24.
69. C.A. Ball and M. Barnes, "Public Health and Individual Rights: Tuberculosis Control and Detention Procedures in New York City," Yale Law & Policy Review 12, no. 1 (1994): 38-67.
70. 45 C.F.R. § 46.116(a)(8) (2001); 21 C.F.R. § 50.26(8) (2001).
71. Regarding the need for federal legislation, see Florencio and Ramanathan, supra note 3 at 953-63.
72. United States v. Estate of Romani, 523 U.S. 517 (1998).
73. Canadian Charter of Rights and Freedoms ch. 11, §§ 7-& 8; U.S. Constitution, Amendment IV (the "Search and Seizure Clause"); U.S. Constitution, Amendment XIV (the "Due Process Clause").
74. Canadian Charter of Rights and Freedoms, ch. 11, § 15; U.S. Constitution, Amendment XTV (the "Equal Protection Clause").
75. Florencio and Ramanathan, supra note 3, at 963-75.
76. Ibid. Id.
77. Ibid. Id.
78. Bach et al., supra note 23; M. Somerville, The Ethical Canary: Science, Society and the Human Spirit (Toronto: Penguin, 2000): at 104.
79. Bach et al., supra note 23; M. Somerville, The Ethical Canary: Science, Society and the Human Spirit (Toronto: Penguin, 2000): at 104.
80. In addition to the issue of how to assure that societal consent is informed, other issues needing further erudition include how to effectively disseminate information to the public (e.g., mailed information packages, televised debate); how to collect consent (e.g., referendum, online polls); quorum requirement - what percentage of a nation's citizenry must vote for the societal consent or refusal to be considered effective and binding (e.g., 15%; 30%; 50%); level of consent required (e.g., regular majority; two thirds majority); scope of the research to which consent is being provided (e.g., cell and tissue xenotransplantation, whole organ xenotransplantation); effect of societal refusal (i.e., particularly in countries already engaged in clinical trials of cell and tissue xenotransplantation).
81. D. Defoe, A Journal of the Plague Year (Oxford: Oxford University Press, 1990): at 35-36.