Ethical Issues in Secondary Uses of Human Biological Materials from Mass Disasters

Australian Law Reform Commission (2003), ALRC 96: Essentially Yours: The Protection of Human Genetic Information in Australia, 42.1, Sydney, March 14, 2003, at <http://www.austlii.edu.au/au/other/alrc/publications/reports/96/> (last visited February 20, 2006); See also Ladika S. , “DNA Helps Identify Missing in the Tsunami Zone,” Science 307 (2005): 504; See also Cash H. D. Hoyle J. W. Sutton A. J. , “Development Under Extreme Conditions: Forensic Bioinformatics in the Wake of the World Trade Centre Disaster,” Pac Symp Biocomput 8 (2003): 638.

Altman L. , “Now, Doctors Must Identify the Dead among the Trade Center Rubble,” The New York Times, September 25, 2001; Chen D. , “Grim Scavenger Hunt for DNA Drags on for September 11 Families” The New York Times, February 9, 2002; Lawler A. , “Terrorism: Massive DNA Identification Effort Gets Underway,” Science 294 (2001): 278.

Lawler A. , “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.

Edwards S. , “DNA Hunt Abandoned for 9/11 Victims,” Ottawa Citizen, February 24, 2005, at A13.

Marshall A. , “How to ID the Bodies,” Time Magazine 165 (2005): 20–21, at 20; See also “Tsunami Zone,” supra note 1.

See in particular, Staley K. , “The Police National DNA Database: Balancing Crime Detection, Human Rights and Privacy,” January 2005, at 47, at <http://www.genewatch.org/HumanGen/Publications/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.”

Essentially Yours, supra note 1, 39.9.

FBI website, CODIS Homepage, at <http://www.fbi.gov/hq/lab/codis/index1.htm> (last visited February 7, 2006).

Royal Canadian Mounted Police, Safety and Security for Canadians, at <http://www.rcmp.ca/security/index_e.htm> (last visited February 7, 2006).

Knoppers B. M. and Saginur M. , “The Babel of Genetic Data Terminology,” Nature Biotechnology 8 (2005): 925–927; See also, for example, National Bioethics Advisory Committee, Research involving Human Biological Materials: Ethical Issues and Policy Guidance, August 1999, at 18, table 2.2. Available at <http://www.georgetown.edu/research/nrcbl/nbac/hbm.pdf> (last visited February 7, 2006).

The Genetic Privacy Act, at <http://www.ornl.gov/sci/techresources/Human_Genome/resource/privacy/privacy3.html> (last visited February 10, 2006).

Sections A and B of Part I build on Knoppers B. M. and Sallée C. , “Ethical Aspects of Genome Research and Banking,” in Sensen C. W. , ed., Handbook of Genome Research: Genomics, Proteomics, Metabolomics, Bioinformatics, Ethical and Legal Issues, volume 2 (Boschstarfe: Wiley-VCH, 2005).

World Health Organization (European Partnership on Patients' Rights and Citizens' Empowerment), Genetic Databases – Assessing the Benefits and the Impact on Human Rights and Patient Rights, Geneva, 2003, available at <http://www.law.ed.ac.uk/ahrb/publications/online/whofinalreport.rtf> (last visited February 7, 2006) Section 4.4, at 14.

Human Genome Organization, Statement on DNA Sampling: Control and Access, at <http://www.gene.ucl.ac.uk/hugo/sampling.html> (last visited February 7, 2006).

Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, November 2002, official CIOMS website, at <http://www.cioms.ch/frame_guidelines_nov_2002.htm> (last visited February 7, 2006).

United Nations Educational, Scientific and Cultural Organization (UNESCO), International Declaration on Human Genetic Data, Geneva, October 16, 2003, available at <http://portal.unesco.org/shs/en/file_download.php/6016a4bea4c293a23e913de638045ea9Declaration_en.pdf> (last visited February 7, 2006).

HUGO DNA Sampling, supra note 15, rec. 2.

CIOMS, supra note 16, guideline 4.

CIOMS, supra note 16, commentary under guideline 4.

CIOMS, supra note 16, guideline 18.

CIOMS, supra note 16, guideline 8.

UNESCO Genetic Data, supra note 17, article 16.

UNESCO Genetic Data, supra note 17, article 16(b).

UNESCO Genetic Data, supra note 17, article 16(a).

See, e.g., HUGO DNA Sampling, supra note 15, rec. 3; UNESCO Genetic Data, supra note 17, article 16.

CIOMS, supra note 16, commentary on guideline 4.

CIOMS, supra note 16, commentary on guideline 4; see also for genetic databases, WHO Genetic Databases, supra note 14, rec. 6.

CIOMS, supra note 16, guideline 4, and commentaries.

UNESCO Genetic Data, supra note 17, article 16.

UNESCO Genetic Data, supra note 17, article 17.

UNESCO Genetic Data, supra note 17, article 14(e).

WHO Genetic Databases, supra note 14, rec. 4.2 and 7.

Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, Oviedo, April 4, 1997 available at <http://conventions.coe.int/treaty/en/treaties/html/164.htm> (last visited February 7, 2006).

European Society of Human Genetics (2001), Data Storage and DNA Banking for Biomedical Research: Technical, Social and Ethical Issues, Birmingham, November 2001, official site of the ESHG, at <http://www.eshg.org/ESHGDNAbankingrec.pdf> (last visited February 7, 2006).

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_cooperation/Bioethics/Activities/Biomedical_research/CDBI-INF(2002)5E.pdf> (last visited February 20, 2006).

European Commission, 25 Recommendations on the Ethical, Legal and Social Implications of Genetic Testing, Brussels, 2004, available at <http://europa.eu.int/comm/research/conferences/2004/genetic/pdf/recommendations_en.pdf> (last visited February 8, 2006).

ESHG, supra note 35.

ESHG, supra note 35, rec. 9.

ESHG, supra note 35, rec. 14.

ESHG, supra note 35, rec. 12.

CE Proposal, supra note 36, article 14.

CE Proposal, supra note 36, article 16.

CE Proposal, supra note 36, article 15.1.

25 Recommendations, supra note 37, rec. 20.

ESHG, supra note 35, rec. 15.

Dickenson D. , “Human Tissue and Global Ethics,” Genomics, Society and Policy 1, no. 1 (2005): 41–53, available at <http://www.gspjournal.com/> (last visited February 20, 2006).

Human Tissue Act 2004: chapter 30, section 1, available at <http://www.opsi.gov.uk/acts/acts2004/20040030.htm> (last visited February 8, 2006).

Id., section 53.

Id., section. 53.

Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues, London, 1995, available at <http://www.nuffieldbioethics.org/fileLibrary/pdf/human_tissue.pdf> (last visited February 8, 2006).

Medical Research Council, Human Tissue and Biological Samples for Use in Research, 2001, at <http://www.mrc.ac.uk/pdf-tissue_guide_fin.pdf> (last visited February 8, 2006).

Human Tissue Act, supra note 48, section 1, schedule 5, paragraph 10; see also Parry B. , “The New Human Tissue Bill: Categorization and Definitional Issues and Their Implications,” Genomics, Society and Policy 1, no. 1 (2005): 74–85.

Human Tissue Act, supra note 48, section 1.

Human Tissue Act, supra note 48, section 44.

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.

Art. L. 1122-1-1 Code de la santé publique (author's translation: Code of Public Health).

See also id., L. 1123–1.

Id., L. 1245–2.

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.legifrance.com/html/actualite/actualite_legislative/decrets_application/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).

Medical Research Council, Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council (SSHRC), Tri-Council Policy Statement: Ethical Conduct for Research Involving Human, Ottawa, August 1998, available at <http://www.pre.ethics.gc.ca/english/pdf/TCPS%20June2003_E.pdf> (last visited February 8, 2006).

Id., article 2.1.

Id., article 10.3(b).

Id., article 8.6.

Canadian Biotechnology Advisory Committee, Genetic Research and Privacy – Advisory Memorandum, Ottawa, February 2004, at <http://cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwapj/genetic_research_privacy.pdf/$File/genetic_research_privacy.pdf> (last visited February 8, 2006).

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).

Id., Element 3.

Id., Elements 3.31 – 3.3.5.

Id., Elements 3.3.6 and 3.3.7.

45 CFR 46.101(b)(4).

Wolf L. and Lo B. , “Untapped Potential: IRB Guidance for the Ethical Research Use of Stored Biological Materials,” IRB Ethics and Human Research 26, no. 4 (2004): 1–8.

45 CFR 46.116 (d).

45 CFR 46.102(f).

Genetic Privacy Act, supra note 12, section 131 (d) (1) and (2).

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).

Ethikrat Nationaler , Biobanks for Research – Opinion, March 17, 2004, at <http://www.ethikrat.org/_english/publications/Opinion_Biobanks-for-research.pdf> (last visited February 8, 2006).

Id., regulatory proposal 2.

Id., regulatory proposal 3.

Id., regulatory proposal 3.

Id., regulatory proposal 4.

Id., regulatory proposals 5, 6, 9, 12.

Id., regulatory proposal 17.

Id., regulatory proposal 10.

The Oxford English Dictionary, 2d ed., s.v., “vulnerable.”

Dictionary.com, “vulnerable,” at <www.dictionary.com> (last visited February 8, 2006).

See, e.g., CIOMS, supra note 13, Introduction.

WHO Genetic Databases, supra note 14, rec. 13.

ESHG, supra note 35, rec. 13.

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.

25 Recommendations, supra note 37, rec. 24.

Genetic Privacy Act, supra note 12, sections 131, 133.

Human Tissue Act, supra note 48 section. 4, (a) to (e).

Code of Public Health, supra note 57, art. L. 1121–14.

Code of Public Health, supra note 57, art. L. 1232–1.

Code of Public Health, supra note 57, art. L. 1141–6.

Code of Public Health, supra note 57, art. L. 1241–6.

45 CFR 46.102(f).

OHRP Guidance, supra note 77.

Genetic Privacy Act, supra note 12, sections 101(a), 131(a)(3)(c).

Ethikrat Nationaler , supra note 78, at 9.2.

See, e.g., CIOMS, supra note 16, Introduction.

See CIOMS, supra note 16, Guideline 9; Council of Europe, Parliamentary Assembly, Draft Additional Protocol to the Convention on Human Rights and Biomedicine, on Biomedical Research, September 2003, article 19, and commentary, at <http://assembly.coe.int/Documents/WorkingDocs/doc03/EDOC9924.htm> (last visited February 8, 2006); WHO Genetic Databases, supra note 14, rec. 11.

Id., article 19, commentary, paragraph 106.

Id., article 19.

Id., article 19.

CIOMS, supra note 16, commentary on guideline 13.

Human Tissue Act, supra note 48, Part I, 1(d), and Schedule 1 Part 1,6.

Human Tissue Act, supra note 48, Part 1, 2.

Human Tissue Act, supra note 48, Part 1, 6.

Loi du 6 janvier, supra note 60, art 54. (Author's translation: Act of January 6th).

Code of Public Health, supra note 57, art. L. 1241–6.

Tri-Council Policy Statement, supra note 61, at 2.5.

Tri-Council Policy Statement, supra note 61, at 2.7.

Tri-Council Policy Statement, supra note 61, at 2.8.

CBAC Memorandum, supra note 65.

CIHR Privacy Best Practices, supra note 64, Element 3's “Link to Tri-Council Policy Statement (2003).”

45 CFR 46.404.

45 CFR 46.405.

45 CFR 46.406.

45 CFR 46.407.

45 CFR 46.108.

45 CFR 46.108 and 46.116.

Genetic Privacy Act, supra note 12, s.131(a)(3)(C) and consistent with 45 CFR 46.408 as such regulation is applicable.

Ethikrat Nationaler , supra note 74, 9.1.

CIOMS, supra note 16, Guideline 1.

Essentially Yours, supra note 1, at 15.5.

Fleischman A.R. and Wood E.B. , “Ethical Issues in Research Involving Victims of Terror,” Journal of Urban Health: Bulletin of the New York Academy of Medicine 315 (2002): 79; see also Lin Z. Owen A. B. Altman R. B. , “Genomic Research and Human Subject Privacy,” Science 305 (2004): 183.

Norris F. H. , “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, Galea S. , “Psychological Sequelae of the September 11 Terrorist Attacks in New York City,” The New England Journal of Medicine (2002): 346, no. 13, at 982.

Fleischman , supra note 102.

Rhodes R. , “Justice in Medicine and Public Health,” Cambridge Quarterly of Healthcare Ethics 13 (2005): 14.

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, Hirsch Charles Dr. , clearly and unequivocally stated this.

Fleischman , supra note 102.

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> (last visited February 20, 2006).