Ethical issues in secondary uses of human biological materials from mass disasters

Journal of Law, Medicine and Ethics

Volumn 34, Issue 2, 2006, Pages 352-365

  Knoppers, Bartha Maria ^a,b   Saginur, Madelaine ^b   Cash, Howard ^c  

^a Department of Law and Medicine ^*

^b UNIVERSITÉ DE MONTRÉAL   (Canada)

^c GeneCodes Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; CANADA; CHILD; CONFERENCE PAPER; DISASTER; DNA FINGERPRINTING; ETHICS; EUROPE; GENETIC PRIVACY; GENETICS; HEALTH CARE FACILITY; HUMAN; INFORMED CONSENT; INTERNATIONAL COOPERATION; LEGAL ASPECT; NUCLEIC ACID DATABASE; UNITED STATES;

ADULT; BIOLOGICAL SPECIMEN BANKS; CANADA; CHILD; DATABASES, NUCLEIC ACID; DISASTERS; DNA FINGERPRINTING; EUROPE; GENETIC PRIVACY; GENETIC RESEARCH; HUMANS; INFORMED CONSENT; INTERNATIONAL COOPERATION; UNITED STATES;

EID: 33745310483     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2006.00040.x     Document Type: Conference Paper

References (133)

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3. A. Lawler Terrorism: Massive DNA Identification Effort Gets Underway Science 294, no. 5541 ( 2001 at 278. Laboratories to whom identification work was contracted out following September 11, 2001: Bode Technology Group, Myriad Genetics, Orchid/CellMark, Celera Corporation.
4. S. Edwards DNA Hunt Abandoned for 9/11 Victims Ottawa Citizen, February 24, 2005, at A13.
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6. A. Marshall How to ID the Bodies Time Magazine 165 ( 2005 20 21, at 20; See also "Tsunami Zone," supra note 1.
7. See in particular, K. Staley The Police National DNA Database: Balancing Crime Detection, Human Rights and Privacy January 2005, at 47, at http://www.genewatch.org/HumanGen/Publica-tions/Reports/NationalDNADatabase.pdf ( last visited February 7, 2006 We believe the following existing practices raise serious concerns:...using the [forensic UK National DNA Database] for genetic research without consent note 1, 39.9.
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11. The Genetic Privacy Act, at http://www.ornl.gov/sci/techresources/ Human_Genome/resource/privacy/privacy3.html ( last visited February 10, 2006.
12. Sections A and B of Part I build on B. M. Knoppers and C. Sallée Ethical Aspects of Genome Research and Banking in C. W. Sensen, ed., Handbook of Genome Research: Genomics, Proteomics, Metabolomics, Bioinformatics, Ethical and Legal Issues, volume 2 ( Boschstarfe: Wiley-VCH, 2005).
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17. HUGO DNA Sampling, supra note 15, rec. 2.
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19. CIOMS, supra note 16, commentary under guideline 4.
20. CIOMS, supra note 16, Guideline 18.
21. CIOMS, supra note 16, Guideline 8.
22. UNESCO Genetic Data, supra note 17, article 16.
23. UNESCO Genetic Data, supra note 17, article 16(b).
24. UNESCO Genetic Data, supra note 17, article 16(a).
25. See, e.g., HUGO DNA Sampling, supra note 15, rec. 3 UNESCO Genetic Data, supra note 17, article 16.
26. CIOMS, supra note 16, commentary on guideline 4.
27. CIOMS, supra note 16, commentary on guideline 4; see also for genetic databases, WHO Genetic Databases, supra note 14, rec. 6.
28. CIOMS, supra note 16, guideline 4, and commentaries.
29. UNESCO Genetic Data, supra note 17, article 16.
30. UNESCO Genetic Data, supra note 17, article 17.
31. UNESCO Genetic Data, supra note 17, article 14(e).
32. WHO Genetic Databases, supra note 14, rec. 4.2 and 7.
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35. Council of Europe (Steering Committee on Bioethics) ( 2002 Proposal for an Instrument on the Use of Archived Human Biological Materials in Biomedical Research, Strasbourg, October 17, 2002, at http://www.coe.int/T/E/Legal_affairs/ Legal_co-operation/Bioethics/Activities/Biomedical_research/CDBI-INF(2002)5E. pdf ( last visited February 20, 2006.
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37. ESHG, supra note 35.
38. ESHG, supra note 35, rec. 9.
39. ESHG, supra note 35, rec. 14.
40. ESHG, supra note 35, rec. 12.
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49. Id., section. 53.
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53. Human Tissue Act, supra note 48, section 1.
54. Human Tissue Act, supra note 48, section 44.
55. The purposes listed in Schedule 1 are as follows : General: Anatomical examination; Determining the cause of death; Establishing after a person's death the efficacy of any drug or other treatment administered to him; Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person); Public display; Research in connection with disorders, or the functioning, of the human body; Transplantation. Deceased Persons: Clinical audit; Education or training relating to human health; Performance assessment; Public health monitoring; Quality assurance.
56. Art. L. 1122-1-1 Code de la santé publique (author's translation: Code of Public Health).
57. See also id., L. 1123-1.
58. Id., L. 1245-2.
59. Loi du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, modifiée par la loi relative à la protection des personnes physiques à l'égard des traitements de données à caractère personnel du 6 août 2004, art 54, available at http://www.legi-france.com/html/actualite/actualite_legislative/ decrets_appli-cation/2004-801.htm ( last visited February 8, 2006 Author's translation: Act of January 6th, 1978 regarding information technology, personal records, and liberties, as modified by the Act regarding the protection of persons with respect to the treatment of personal data of August 6th, 2004).
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61. Id., article 2.1.
62. Id., article 10.3(b).
63. Id., article 8.6.
64. Canadian Biotechnology Advisory Committee, Genetic Research and Privacy-Advisory Memorandum, Ottawa, February 2004, at http://cbac-cccb.ca/epic/ internet/incbac-cccb.nsf/vwapj/ge-netic_research_privacy.pdf/$FILE/ genetic_research_privacy.pdf ( last visited February 8, 2006).
65. Id.
66. Id.
67. Canadian Institutes of Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Ottawa, 2005, Element 2, at http://www.cihr-irsc.gc.ca/e/documents/pbp_sept2005_e.pdf ( last visited February 8, 2006).
68. Id., Element 3.
69. Id., Elements 3.31-3.3.5.
70. Id., Elements 3.3.6 and 3.3.7.
71. 45 CFR 46.101(b)(4).
72. L. Wolf and B. Lo Untapped Potential: IRB Guidance for the Ethical Research Use of Stored Biological Materials IRB Ethics and Human Research 26, no. 4 ( 2004 1 8.
73. 45 CFR 46.116 (d).
74. 45 CFR 46.102(f).
75. Genetic Privacy Act, supra note 12, section 131 (d) (1) and (2).
76. Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS), Guidance on Research Involving Coded Private Information or Biological Specimens, August 10, 2004, at http://www.hhs.gov/ohrp/ humansubjects/guidance/cdebiol.pdf ( last visited February 8, 2006 Note: Tissues may be used in conjunction with medical or dental records. For privacy protections afforded to these records, see Health Insurance Portability and Accountability Act of 1996, Public Law 104 191, 104th Congress, at http://aspe.hhs.gov/admnsimp/pl104191.htm ( last visited February 8, 2006).
77. Nationaler Ethikrat, Biobanks for Research-Opinion, March 17, 2004, at http://www.ethikrat.org/_english/publications/Opinion_Biobanks-for-research.pdf ( last visited February 8, 2006).
78. Id., regulatory proposal 2.
79. Id., regulatory proposal 3.
80. Id., regulatory proposal 3.
81. Id., regulatory proposal 4.
82. Id., regulatory proposals 5, 6, 9,12.
83. Id., regulatory proposal 17.
84. Id., regulatory proposal 10.
85. The Oxford English Dictionary, 2d ed., s.v., "vulnerable. vulnerable at http://www.dictionary.com ( last visited February 8, 2006).
86. See, e.g., CIOMS, supra note 13, Introduction.
87. WHO Genetic Databases, supra note 14, rec. 13.
88. ESHG, supra note 35, rec. 13.
89. Id.
90. CE Proposal, supra, note 36, article 3.1,17. It must be noted that a final version is currently being drafted. Whether the regime governing post-mortem uses will be unchanged remains to be seen.
91. 25 Recommendations, supra note 37, rec. 24.
92. Genetic Privacy Act, supra note 12, sections 131,133.
93. Human Tissue Act, supra note 48 section. 4, (a) to (e).
94. Code of Public Health, supra note 57, art. L. 1121-14.
95. Code of Public Health, supra note 57, art. L. 1232-1.
96. Code of Public Health, supra note 57, art. L. 1141-6.
97. Code of Public Health, supra note 57, art. L. 1241-6.
98. 45 CFR 46.102(f).
99. OHRP Guidance, supra note 77.
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101. Id., article 19, commentary, paragraph 106.
102. Id., article 19.
103. Id., article 19.
104. CIOMS, supra note 16, commentary on guideline 13.
105. Human Tissue Act, supra note 48, Part I, 1(d), and Schedule 1 Part 1,6.
106. Human Tissue Act, supra note 48, Part 1, 2.
107. Human Tissue Act, supra note 48, Part 1, 6.
108. Loi du 6 janvier, supra note 60, art 54. (Author's translation: Act of January 6th).
109. Code of Public Health, supra note 57, art. L. 1241-6.
110. Tri-Council Policy Statement, supra note 61, at 2.5.
111. Tri-Council Policy Statement, supra note 61, at 2.7.
112. Tri-Council Policy Statement, supra note 61, at 2.8.
113. CBAC Memorandum, supra note 65.
114. CIHR Privacy Best Practices, supra note 64, Element 3's Link to Tri-Council Policy Statement ( 2003).
115. 45 CFR 46.404.
116. 45 CFR 46.405.
117. 45 CFR 46.406.
118. 45 CFR 46.407.
119. 45 CFR 46.108.
120. 45 CFR 46.108 and 46.116.
121. Genetic Privacy Act, supra note 12, s.131(a)(3)(C) and consistent with 45 CFR 46.408 as such regulation is applicable.
122. Nationaler Ethikrat, supra note 74, 9.1.
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124. Essentially Yours, supra note 1, at 15.5.
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126. Id.
127. Id.
128. F. H. Norris 50,000 Disaster Victims Speak: An Empirical Review of the Empirical Literature, 1981 2001 Part I of a Three-Part Series; Range, Magnitude and Duration of Effects, Prepared for the National Center for PTSD and the Center for Mental Health Services ( SAMHSA), September 2001, available at http://obssr.od.nih.gov/activities/911/disaster-impact.pdf ( last visited February 20, 2006); cited in Fleischman, id.; see also, S. Galea, et. al., "Psychological Sequelae of the September 11 Terrorist Attacks in New York City," The New England Journal of Medicine (2002): 346 no. 13, at 982.
129. Fleischman, supra note 102.
130. R. Rhodes Justice in Medicine and Public Health Cambridge Quarterly of Healthcare Ethics 13 ( 2005 14.
131. It must be noted that no research was done on the remains of the victims of the attack of September 11, 2001. In several public meetings, the New York City Chief Medical Examiner, Dr. Charles Hirsch, clearly and unequivocally stated this.
132. Fleischman, supra note 102.
133. United Nations Educational, Scientific and Cultural Organization, Universal Declaration on Bioethics and Human Rights, adopted by acclamation October 19,2005 by the 33rd session of the General Conference of UNESCO, article 18, (b) and (c), available at http://portal.unesco.org/shs/en/file_download. php/46133e1f4691e4c6e57566763d474a4dBioethicsDeclaration_EN.pdf ( ast visited February 20, 2006).