Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-11-25T17:00:17.274Z Has data issue: false hasContentIssue false
  • English
  • Français

Research Involving Humans: A Time for Change?

Published online by Cambridge University Press:  01 January 2021

Don Chalmers
Get access Rights & Permissions [Opens in a new window]

Extract

Amongst Professor Dickens’ extensive writings on medical law and medical jurisprudence are a host of distinguished contributions on the subject of the proper legal and ethical limits on human experimentation. As early as 1975, Professor Dickens was examining the legal aspects of human experimentation. A few years later he was promoting the responsibility of researchers to recognize and protect human rights in medical experimentation. In the last two decades, Professor Dickens has penned a rich flow of scholarly contributions on the legal and ethical rights and duties in medical experimentation and the need to do better as a research community. His articles have considered a broad range of issues in medical experimentation including the imperative of voluntary consent, the ethical unacceptability of co-ercion or inducement of research participants, embryonic research, epidemiological research and the protection of vulnerable research participants, particularly children.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 32 , Issue 4 , Winter 2004 , pp. 583 - 595
Copyright
Copyright © American Society of Law, Medicine and Ethics 2004

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

See generally Dickens, , “Legal Aspects of Human Experimentation,” Eugenics Bulletin 7 (1975): at 11; Dickens, , “What is a Medical Experiment?” Canadian Medical Association Journal 113 (1975): at 635.Google Scholar
See generally Dickens, , “Research on Human Subjects,” in Medical Ethics and Human Rights (London: Commonwealth Medical Association, 1994): at 42; Dickens, , Experimentation and the Protection of Human Rights (Geneva: Council for International Organisations of Medical Sciences, 1979): At 200; Dickens, , “Human Rights in Medical Experimentation,” Israel Yearbook on Human Rights 23, no. 9 (1979).Google Scholar
Dickens, , “Coercion and Inducement in Medical Experimentation,” in Medicine, Science and the Law: Informed Consent Symposia 1986 (Melbourne: Law Reform Commission of Victoria, 1987): at 48.Google Scholar
Dickens, , “Legal Approaches to Regulating Human Embryonic Research,” in Nicholas, J. M., ed., Moral Priorities in Medical Research: The Second Hannah Conference (Toronto: Hannah Institute for the History of Medicine, 1989): at 251.Google Scholar
Dickens, , “Issues in Preparing Ethical Guidelines for Epidemiological Studies,” Law, Medicine & Health Care 19 (1991): at 175.CrossRefGoogle Scholar
Dickens, , “Vulnerable Persons in Biomedical Research: 50 Years After the Nuremberg Code,” International Journal of Bioethics 10 (1999): at 13; Dickens, , “The Legal Challenge of Health Research Involving Children,” Health Law Journal 6 (1989): At 131; Dickens, , “Contractual Aspects of Human Medical Experimentation,” University of Toronto Law Journal 25 (Autumn 1975): at 406; Dickens, , “The Use of Children in Medical Experimentation,” Osgoode Hall Law Journal 13 (1975): at 166.Google Scholar
Dickens, , “Ethics Committees, Organ Transplantation and Public Policy,” Law, Medicine & Health Care 300 (1992); Dickens, , “Ethics Committees and Transplantation/Implantation Decisions,” Transplantation/Implantation Today 3 (1986): at 11.Google Scholar
Dickens, , “Codes of Conduct and Ethics Guidelines,” ed. by Breslow, , in Encyclopaedia of Public Health (New York and Detroit: Macmillan Reference USA, 2002): at 224; Dickens, , “Introduction to the Draft Revised Guidelines,” in Bankowski, Z. and Levine, R. J., eds., Ethics and Research on Human Subjects: International Guidelines (Geneva: Council for International Organisations of Medical Sciences, 1993): at 11.Google Scholar
Dickens, , “Governance Relations in Biomedical Research,” The Governance of Health Research Involving Human Subjects (Ottawa: Law Commission of Canada, 2000): 93; Dickens, , “The Role and Operation of Ethics Review Committees in Canadian Health Care and Research,” in Hoshino, K., ed., The Dignity of Life (Kyoto: Shi-bunkaku Publishers, 1999):at 67; Dickens, B. and Cook, R.J. “The FIGO study group on women’s sexual and reproductive rights,” International Journal of Gynaecology and Obstetrics 67 (1999): at 55; Dickens, , “Human Research Beyond the Medical Model: Legal and Ethical Issues,” Medicine and Law 16 (1997): at 687.Google Scholar
Dickens, , “The Challenge of Equivalent Protection,” in Ethical and Policy Issues in International research: Clinical Trials in Developing Countries, Volume II (Bethesda, Maryland: National Bioethics Advisory Commission 2001): A1.Google Scholar
In the gallery of works by Professor Dickens, there are equally distinguished collections of works devoted to mental health, organ transplantation, reproduction and sexual health law, informed consent, care of the terminally ill and law and genetics.Google Scholar
See National Bioethics Advisory Commission Report, Ethical and Policy issues in Research involving Human Participants Vols 1&II at <http://www.georgetown.edu/research/nrcbl/nbac/human/overvol2.html> (last visited on Sept. 9, 2004).+(last+visited+on+Sept.+9,+2004).>Google Scholar
Australian Law Reform Commission/Australian Health ethics Commission (ALRC/AHEC), “Essentially Yours: The Protection of Human Genetic Information in Australia” Report 96 (2003), Vols 1 & 2 at <http://www.austlii.edu.au/au/other/alrc/publications/reports/96/> (last visited on Sept. 9, 2004).+(last+visited+on+Sept.+9,+2004).>Google Scholar
National Health and Medical Research Council Act 1992, s8. However, these guidelines must be drawn up following a unique two stage public consultation process under s14.Google Scholar
Independent Review of the Role and Functioning of Institutional Ethics Committees Australia, Report of the Review of the Role and Functioning of Institutional Ethics, Committees AGPS Canberra (1996) (Chair D Chalmers): 1–104.Google Scholar
Australian Health Ethics Committee, National Statement on Ethical Conduct in Research Involving Humans Prepared by the Australian Health Ethics Committee under the relevant provisions of the National Health and Medical Research Council Act 1992 (Cth) and endorsed by the Australian Vice Chancellors’ Committee, the Australian Research Council and the Learned Academies in 1999. It is a national research code of practice governing social as well as biomedical research.Google Scholar
Ibid see Principles 16.1–16.23 and the section on Human Tissue (Principle 15).Google Scholar
Ibid Recommendation 5.2.1.Google Scholar
Ibid see Recommendations ibid. Recommendations 5.3.1; 5.4.1; 5.5.4; 5.7.3; 5.8.1 and 5.8.2; 6.1.3; 6.4.1; 6.5; 7.3.1 and 7.3.2.Google Scholar
See Dickens, B., “Governance Relations in Biomedical Research,” in Law Commission of Canada, The Governance of Health Research Involving Human Subjects, (Ottawa: Law Commission of Canada, 2000): at 93.Google Scholar
Ibid Recommendation 9.1.2.Google Scholar
Ibid Recommendation 6.2.1.Google Scholar
Ibid Recommendation 7.1.1 and 7.1.2.Google Scholar
National Statement on Ethical Conduct in Research Involving Humans Chapter 6 – Emergency, Intensive, Neo-natal and Terminal care; and, Impaired Capacity and Unconscious Patients.Google Scholar
For example, the Council of Europe, Convention on Biomedicine, the latest version of the Declaration of Helsinki, published by the World Medical Association, the Universal Declaration of the Genome and Human Rights, the Declaration of the Child, were referred to by the AHEC and noted in submissions to the consultation process.Google Scholar
European Committee for Proprietary Medicinal Products/International Conference on Harmonization, Note for guidance on good clinical practice (CPMP/ICH/135/95): annotated with TGA comments (Canberra: Therapeutic Goods Administration, Department of Health and Aged Care, 2000). Available at: <www.tga.gov.au/docs/html/ich13595.htm> (last visited Sept. 2004).+(last+visited+Sept.+2004).>Google Scholar
CIOMS and WHO, International Ethical Guidelines for Biomedical Research Involving Human Subjects, (1993): 1–61.Google Scholar
U. S. Fed. Reg. Title 45 Part 46.Google Scholar
Royal College of Physicians, Guidelines and the Practice of Ethics Committees in Research Involving Humans (London: Royal College of Physicians, 1996).Google Scholar
Health Research Council of New Zealand, Ministry of Health Review and the Ethical Review Structure in New Zealand, (New Zealand: New Zealand Government Printer, 1997).Google Scholar
Canadian Code of Ethical Conduct in Research Involving Humans. Tri-Council Statement of the Medical Research Council, National Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council of Canada (1997). The National Statement adopted the Canadian term “collectivity,” included human genetics and followed the Canadian aim of a single national code, which was achieved in Australia.Google Scholar
See Chalmers, D. “Research Ethics in Australia” commissioned paper for National Bioethics Advisory Commission, USA at <http://www.georgetown.edu/research/nrcbl/nbac/human/over-vol2.pdf>..>Google Scholar
See National Statement, supra note 16, Principles 1.1, 1.2, 1.3 and 1.4 in particular.Google Scholar
See National Statement, supra note 16 Principle 2.2 at p15.Google Scholar
See National Statement, supra note 16, Principle 2.48 at p.21.Google Scholar
See Chalmers, D. and Pettit, P., “Towards a Consensual Culture in the Ethical Review of Research,” Medical Journal of Australia 168 (for the AHEC) (1998): 79–82.Google Scholar
SS 35 and 36 National Health and Medical Research Council Act 1992 (Cth).Google Scholar
Ibid SS 11–14Google Scholar
See National Statement, supra note 16.Google Scholar
See National Statement, supra note 16, Principles 1.1 – 1.21 and 2.1 – 2.48. On Human Genetics see Principles 16.1–16.23, and on Human Tissue Principles 15.1–15.8.Google Scholar
The concern about the regulatory gap over private institutions was a major concern raised with the Andrews’ Report discussed in Section 3 of this article.Google Scholar
The 2003 AHEC Annual Training Workshop held in Canberra drew an attendance of some 500 delegates who were mainly HREC members. A startling admission was made by many that they were unfamiliar with the contents of the National Statement.Google Scholar
National Bioethics Advisory Commission Report Ethical and Policy issues in Research involving Human Participants Vol. 1 (Bethesda, Maryland 2001): 1–139.Google Scholar
Ibid at Rec. 2.2 at 28Google Scholar
See Chalmers, D. and Pettit, P., supra note 36.Google Scholar
See Drahos, P. “Intellectual Property Law and Basic Science: Extinguishing Prometheus?” Law in Context 10 (1992): At 56. See also Merton, R., The Sociology of Science (Chicago: University of Chicago Press, 1973).Google Scholar
Sakaiya, T., Knowledge-Value Revolution (New York: Kodansha American, 1992).Google Scholar
See web site at <www.genomecanada.ca> (Last visited Sept. 10, 2004).+(Last+visited+Sept.+10,+2004).>Google Scholar
Commonwealth of Australia, Australian Biotechnology: A National Strategy (Canberra Australia: AGPS, 2000).Google Scholar
Nicol, D., Otlowski, M. and Chalmers, D., “Consent, Commercialisation and Benefit Sharing,” Journal of Law and Medicine 9 (2001): 80–94, at 80.Google Scholar
Heller, M. and Eisenberg, R., “Can Patents Deter Innovation? The Anti-Commons in Bio-Medical Research,” Science 280 (1998): 698–701, at 698.CrossRefGoogle Scholar
Nicol, D. and Nielsen, J., An Empirical Analysis of Issues Facing the Australian Industry (Tasmania: Centre for Law and Genetics, 2003): 1–276 at 36–38, 218–222; see also, Rabino, I., “How Human Geneticists in U.S. View Commercialization of the Human Genome Project,” Nature Genetics, 29 (2001) 15–16, at 15.Google Scholar
See generally Chalmers, D. and Nicol, D., “Commercialisation of Biotechnology: Public Trust and Research,” International Journal of Biotechnology 6 (2004): 116–133, at 116.CrossRefGoogle Scholar
Nicol, D., Otlowski, M. and Chalmers, D., supra note 50.Google Scholar
These include: UK Medical Research Council, Human Tissue and Biological Samples for Use in Research. Interim Operational and Ethical Guidelines Issues by the Medical Research Council (1999); Canadian Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans (1998); U.S.A. “Federal Policy for the Protection of Human Subjects” (45 CFR 46) and National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (1999).Google Scholar
For example, HUGO Statement on the Principled Conduct of Genetics Research (1996); HUGO Ethics Committee, Statement on DNA Sampling: Control and Access (1998); HUGO Ethics Committee Statement on Benefit Sharing (2000); HUGO Statement on Patenting of DNA Sequences (2000).Google Scholar
See National Statement, supra note 16, Principle 2.2.1.Google Scholar
See National Statement, supra note 16, Principle 2.2.1.Google Scholar
See National Statement, supra note 16, Principle 12.6.Google Scholar
See National Statement, supra note 16, Principle 12.5.Google Scholar
For example, the ARC Blood Service HREC requires disclosure of commercialization intentions as a condition of release of samples for research. These samples are almost invariably released in de-identified form.Google Scholar
The author is Chair of the National Australian Red Cross Blood Service Ethics Committee, which requires disclosure and has not received adverse comments from researchers nor reports of participant withdrawals.Google Scholar
United Kingdom Parliament, House of Lords Select Committee on Science and Technology 2000 Third Report: Science and Society, at <http://www.publications.parliament.uk/pa/ld199900/ldselect/ldsctech/38/3801.htm>..>Google Scholar
See Chalmers, D. and Nicol, D., “Commercialisation of Biotechnology: Public Trust and Research,” International Journal of Biotechnology 6 (2004): 116–133, at 116.Google Scholar
Ibid 50, paragraphs 13–14.Google Scholar
US Department of Health and Human Services, “Financial Relationships and Interests in Research Involving Human Subjects,” Bulletin of Medical Ethics 198 (2004): 9–11, at 9.Google Scholar
See Dickens, B., supra note 9, op cit.Google Scholar
Dickens, B., “Vulnerable Persons in Biomedical Research: 50 Years after the Nuremberg Code,” International Journal of Bioethics 10 (1999): at 13.Google Scholar
Rothman, D. Strangers at the Bedside (New York: Basic Books, 1991).Google Scholar
See Privacy (Private Sector) Amendment Act 2001 (Cth).Google Scholar
This ruling applies equally to all other committees of the NHMRC, Tobacco Industry Australia v. National Health and Medical Research Council (1996): 142 ALR 1 per Finn J.Google Scholar
SS 55–61 NHMRC Act 1992 (Cth). In fact, there have been few complaints and mainly about review of decisions on grants by the Research Committee.Google Scholar
For example, the Council of Europe Convention on Biomedicine, the latest version of the Declaration of Helsinki, published by the World Medical Association, the Universal Declaration of the Genome and Human Rights, the Declaration of the Child, were referred to by the AHEC and noted in submissions to the consultation process.Google Scholar
Promulgated by the General Conference of UNESCO at its 29th Session (November 11, 1997).Google Scholar
Gene Technology Act 2000(Cth).Google Scholar
Research involving Human Embryos Act 2002(Cth).Google Scholar
Established under state and territory Animal Welfare Acts.Google Scholar
Young, P., “Welcome to the Genome Era,” Australian Biotechnology News (July 4 2003): 8–8, at 8.Google Scholar
Science: Special Issue 291 (2001): 1177–1207; and Nature: Special issue 409 (2001): 745–964.Google Scholar
The term “junk DNA” was coined in an early article by Nowak, R., “Mining Treasures from ‘Junk DNA,’” Science 263 (1994): 608–610, at 608.CrossRefGoogle Scholar
Berjano, G., Pheasant, M., Makunin, I., Stephen, S., Kent, W.J., Mattick, J.S., and Haussler, D., “Ultraconserved Elements in the Human Genome,” Science Express (Published on line May 6 2004) at <http://www.sciencemag.org/sciencexpress/recent.shtml> (visited 10 Sept. 2004).+(visited+10+Sept.+2004).>Google Scholar
A bio-marker is a physiological response or a laboratory test that occurs in association with a pathological process that has possible diagnostic and/or prognostic utility.Google Scholar
With acknowledgement to Dr Tracey Edinburg of Eli Lilly Australia Pty Ltd for this information.Google Scholar
See National Statement, supra note 16, Principle 16.12–16.14. In these cases the HREC must take account of the nature of existing consents, the justification presented by the researcher for the waiver, proposals for privacy and the relationship of the project to an existing project.Google Scholar
ALRC/AHEC, supra note 13, 15–1 to 15–3.Google Scholar
Magnusson, R., “The Use of Human Tissue Samples in Medical Research: Legal Issues for Human Research Ethics Committees,” Journal of Law and Medicine 7 (2000): 390–403, at 390.Google Scholar
For example, this is the method adopted by the Australia Red Cross Blood Service.Google Scholar
National Statement on Ethical Conduct in Research Involving Humans, supra note 16, Principles 15.1–15.9 on Human Tissue (1999).Google Scholar
For a very good consideration of these issues see Knoppers, B., “Banking of Human Materials, Intellectual Property Rights and Ownership Issues: Emerging Trends in the Literature and International Policy Positions,” Parts I and II Law and Human Genome Review 5–6 (1996–1997): At 87 and 63 respectively.Google Scholar
See Privacy (Private Sector) Amendment Act 2001(Cth).Google Scholar
AHEC Scientific, Ethical and regulatory Considerations Relevant to Cloning of Human Beings Report to the Commonwealth Minister for Health and Aged Care 16 December 1998 (Chair D. Chalmers); Chalmers, D. and Nicol, D., “Embryonic Stem Cell Research: Ethical and Economic Values (Part 1)” Law and the Human Genome Review 18 (2003): 43–53, at 43.Google Scholar
See Nicol, D. Chalmers, D. and Gogarty, B., “Regulating Biomedical Advances: Embryonic stem cell technology,” Macquarie Law Journal 2 (2002): 31–59; Chalmers, D. and Nicol, D. Embryonic Stem Cell Research: Ethical and Economic Values (Part 1) Law and the Human Genome Review 18 (2003): 43–53, at 43; (Part II) in Law and the Human Genome Review 19 (2003): 91–108, at 91.Google Scholar
See House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: Scientific, Ethical and Legal Aspects of Human Cloning and the Stem Cell Research 2001 (Andrews’ Report), August 2001, Recommendation 15, at 235. This particular recommendation was not based on any survey or public consultation but based on the few submissions received, on stem cell research.Google Scholar
Commonwealth of Australia, House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research, AGPS (2001). See Nicol, D. Chalmers, D. and Gogarty, B., “Regulating Biomedical Advances: Embryonic Stem Cell Technology,” Macquarie Law Journal 2 (2002): 31–59.Google Scholar
Ibid at paragraph 12.80.Google Scholar
Andrews’ Report, supra note 93, at paragraphs 9.47 and 9.49.Google Scholar
Head of the United States National Human Genome Research Institute and Chair of the Human Genome Project and its successor the International Haplotype Mapping Project.Google Scholar
News release during the XIX International Congress of Genetics Melbourne (July 5–9, 2003).Google Scholar
ALRC/AHEC, supra note 13.Google Scholar
Ibid, Rec 5–1.Google Scholar
Ibid, Rec 7–1.Google Scholar
See Commonwealth Privacy Act 1988 (Cth) and Privacy Amendment (Private Sector) Act 2000 (Cth).Google Scholar
The Report Rec 8–1.Google Scholar
Ibid, Rec 15–1.Google Scholar
National Statement, supra note 16, at 2.Google Scholar