References for Commisioned Paper by Donald Chalmers (Research Involving Human Participants V2)

International Reports
Legislation
Books and Articles
Parliament Debate
National Health and Medical Research Council and AHEC Reports
Australian Reports
Court Decisions

International Reports

  • President's Commission Report. (1983) The Study of Ethical Problems in Medicine and Biomedical and Behavioural Research: Deciding to Forego Life Sustaining Treatment Washington.
  • The Belmont Report. (1979) Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Department of Health, Education and Welfare, pub. No. (OS) 78-0012 U.S. Government Printing Office Washington.
  • Council of Europe. (1996) Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine Strasbourg (164).
  • CPMP/ICH. (1995) Code of Good Pharmaceutical Practice/ International Conference on Harmonisation Note for Guidance on Good Clinical Practiceñ135/95. See also ISO 14155 Clinical Investigation of Medical Devices.
  • CIOMS. (1993) Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects Geneva Switzerland.
  • Canadian Code. (1997) Code of Ethical Conduct for Research Involving Humans, which is a tri-partite effort by the Medical Research Council, Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council of Canada.
  • Royal College of Physicians. (1996) Guidelines on the Practice of Ethics Committees in Medical Research Involving Humans London.
  • Health Research Council of New Zealand. (1997) Ministry of Health Review of the Ethical Review Structure in New Zealand Health Department New Zealand.
  • Nuffield Council on Bioethics. (1999) The Ethics of Clinical Research in Developing Countries United Kingdom.
  • National Bioethics Advisory Commission. (1997) Cloning Human Beings: Report and Recommendations of the National Bioethics Advisory Commission Washington.

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Legislation

  • Poisons Act. 1966 New South Wales (see also the Poisons Act in ACT 1933; WA 1964; Tas 1971 and Vic Drugs Poisons and Controlled Substances Act 1991; Qld Health Act 1937; NT Poisons and Dangerous Drugs Act 1983).
  • Status of Children Act. 1978. (Qld) (and Artificial Conception Act 1984 (NSW); Status of Children Act 1974 (Vic); Family Relationships Act 1975 (SA); Status of Children Act 1974 (Tas); Artificial Conception Act 1985 (WA); Artificial Conception Act 1985 (ACT); Status of Children Act 1978 (NT); Family Law Act 1975 (Cth.).
  • Freedom of Information Act. 1982 Commonwealth Parliament Australia.
  • Human Tissue Act. 1983 ss. 6ñ9 NSW (see also Transplantation and Anatomy Act 1978 ss. 6ñ10 ACT; Human Tissue Transplant Act, ss. 6ñ10 NT; Transplantation and Anatomy Act 1979 ss. 8ñ12 Qld.; Transplantation and Anatomy Act 1983 s.7ñ10, SA; Human Tissue Act 1985 ss. 5ñ9 Tas; Human Tissue Act 1982 ss. 5ñ12 Vic.; Human Tissue and Transplantation Act 1982 ss. 6ñ9 WA).
  • Reproductive Technology Act. 1988 No 10 Parliament South Australia.
  • National Health and Medical Research Council Act. 1992 No 225 of 1992 Commonwealth Parliament Australia.
  • Code of Federal Regulations. (1992) 21 Food and Drugs Part 56.
  • Therapeutic Goods Act. 1993 Commonwealth Parliament Australia.
  • Infertility Treatment Act. 1995 Victoria Parliament Australia.
  • Human Reproductive Technology Act. 1993 Parliament Western Australian.

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Books and Articles

  • Annas G. (1984) Ethics Committees in Neo-Natal: Substantive Protection of Procedural Diversion? Am J Pub Health 74; 843.
  • Beauchamp T. and Childress J. (1994) The Principles of Biomedical Ethics (4ed ) Oxford UP.
  • Beecher H. (1966) Ethics and Clinical Research New Eng J of Med 274:1354.
  • Beecher H (1968) Ethical Problems Created by the Hopelessly Unconscious Patient New Eng J of Med 278:1425.
  • Bennett B. (1997)Law and Medicine, LBC.
  • Brazier M. (1990) Liability of Ethics Committees and their Members Professional Negligence 186.
  • Breen K. (1997) Ethics Laws and Medical Practice Allen and Unwin Melbourne.
  • Brody H. (1981) Ethical Decisions in Medicine 2d ed Little, Brown and Co.
  • Bulletin of Medical Ethics. (1999a) Medical Research has its Downsides Bulletin of Medical Ethics, November 152: 7 (citing reports in The Times, 2 October 1999; The Guardian 8 November 1999; and 1999 Brit Med J 319274).
  • Bulletin of Medical Ethics. (1999b) Helsinki Declaration Revising Continues Bulletin of Medical Ethics 146:3.
  • Capron M.A. (1985) Legal Perspectives on Institutional Ethics Committees Journal of College and University Law 11:7.
  • Chalmers D. and Pettit P. (1998) Towards a Consensual Culture in the Ethical Review of Research Med J of Austt 168:79.
  • Clarke C. (1998) Should There Be an Accredited Ethics Committee System of Centralised Review of Multi-Centre Clinical Research Med J of Austt
    • 169:283 (and Henman M. et al. Med J of Austt
    • 169:283ñ4; E. OíBrien E. (1998) et al. Med J of Austt
    • 169: 284ñ5; S. Gandevia S. et al. Med J of Austt
    • 169:285.
  • Cohen M.(1998) Should There Be an Accredited Ethics Committee System for Centralised Review of Multi-Centre Clinical Research? Med J. of Aust 168:528.
  • Darvall L. (1993) Autonomy and Protectionism: Striking a Balance in Human Subject Research Policy and Regulation Law in Context 11:82.
  • Editorial. (1976) 7 Med J of Austt 7:179ñ80.
  • Engelhardt H. T. (1986) The Foundations of Bioethics Oxford UP.
  • Fletcher J. (1973) Realities of Patient Consent to Medical Research Hastings Center Studies 1:1.
  • Freckelton I. and Petersen K. (1999) Controversies in Health Law Federation Press Sydney.
  • Freedman B. and Glass K. (1990) Weiss v Solomon: A Case Study in Institutional Responsibility for Clinical Research Law, Medicine and Health Care 18:395.
  • Furrow B. et al. (1995) Health Law West Law Publishing.
  • Giesen D. (1995) Civil Liability of Physicians for New Methods of Treatment and Experimentation: A Comparative Examination
  • Med LR 3:22.
  • Gillespie R. (1988) Research and Human Subjects: an Historical Overview Conference Proceedings: Can Ethics Be Done by Committee? Monash University Centre for Bioethics Australia.
  • Healy D. (1999) Clinical Trials and Legal Jeopardy Bulletin of Medical Ethics 153:13ñ18.
  • Jonas H. (1969) Philosophical Reflections on Experimenting with Human Subjects (1969) Daedalus 98.
  • Kelly F. and Boyages S. (1999) Pilot Programme to Reform the Ethics Committee System in NSW Med J of Austt 171:52.
  • Kirby M. (1983) IVF - The Scope and Limitation of Law Conference on Bio-ethics and the Law of Human Conception IVF 29ñ30 September London UK.
  • The Lancet. (1999) 353:400ñ3 (Cited in Bulletin of Medical Ethics 148:5).
  • Laufer S. (1990) The Regulation of Medical/Scientific Research Practices Involving Experimentation on Human Beings Law in Context 8:78.
  • Levine R. (1986) Ethics and Regulation of Clinical Research Urban and Schwarzenburg Baltimore.
  • Mant D. (1999) Can Randomised Trials Inform Clinical Decisions About Individual Patients? The Lancet 353:743ñ746.
  • McNeill P. (1993) The Ethics and Politics of Human Experimentation Cambridge UP.
  • Magnusson R. (2000) The Use of Human Tissue in Medical Research: Legal Issues for Human Research Ethics Committees J of Law and Medicine 7:390.
  • Merritt A. (1987) The Tort Liability of Hospital Ethics Committees Southern Cal LR 60:1239.
  • NCBHR. (1995) Protecting and Promoting the Human Research Subject: A Review of the Function of Research Ethics Boards in Canadian Faculties of Medicine NCBHR CommuniquÈ 6:1ñ33.
  • Nelson D. and Weiss R. (1999)Hasty Decisions in the Race to a Cure? Washington Pos Sunday Nov 21 p A1.
  • Neuberger J. (1992) Ethics and Health Care: The Role of Research Ethics in the UK Kings Fund Institute Research Report 13 London.
  • Pellegrino E. and Thomasa D. (1996) Christian Virtues in Medical Practice Georgetown UP.
  • Rawbone R. (2000) Observation from Six Years Experience of a Health and Safety Research Ethics Committee Bulletin of Medical Ethics 155:13.
  • Scott R. (1984) Experimenting with Life: Must Law-Makers Experiment Too? 5th International Conference on Forensic Science, Sydney Australia.
  • Skene L. (1998) Law and Medical Practice Butterworths Melbourne.

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Parliament Debate

  • Commonwealth of Australia Parliamentary Debates: Senate Volume S154 36th Parliament, 1st Session 5th period 1991.

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National Health and Medical Research Council and AHEC Reports

  • NHMRC. (1984) Supplementary Note on Embryo Flushing AGPS Canberra Australia.
  • NHMRC. (1985) Report on Workshops on the Constitution and Functions of Institutional Ethics Committees in Australia 1984ñ85 NHMRC. AGPS Canberra Australia.
  • Statement on Human Experimentationt. (1992) NHMRC Canberra Australia.
  • AHEC. (1992) CTN Guidelines for Institutional Ethics Committees Canberra Australia (see also Clinical Trials of Drugs in Australia DEB 1 The Clinical Trial Notification (CTN) Scheme; Guidelines for Good Clinical Research Practice Therapeutic Goods Administration; Australian Guidelines: Clinical Trials Exemption (CTX) Scheme for Drugs DBE 5).
  • AHEC. (1993a) Report of the 1993 Workshops for Institutional Ethics Committees: Consultation with Researchers and Forum on HRECs
  • NHMRC Canberra Australia.
  • NHMRC. (1993b) Report of the 1993 Survey of Institutional Ethic Committees NHMRC AGPS Canberra Australia.
  • NHMRC. (1994) Annual Report 1993 AGPS Canberra.
  • Bienenstock J. (1993) Report of an External Review of the National Health and Medical Research Council AGPS Canberra Australia.
  • NHMRC. (1994) Report on Compensation, Insurance and Indemnity Arrangements for Institutional Ethics Committees, AGPS Canberra Australia.
  • AHEC. (1996) Ethical Guidelines on Assisted Reproductive Technology AGPS Canberra Australia.
  • NHMRC. (1997) Annual Report 1996 AGPS Canberra.
  • NHMRC. (1998) Annual Report 1997 AGPS Canberra.
  • AHEC. (1998) Report on the Scientific, Ethical and Legal Considerations Relevant to Human Cloning Commonwealth Minister for Health and Aged Care NHMRC Canberra Australia.
  • NHMRC. (1999) Annual Report 1998 AGPS Canberra.
  • NHMRC. (2000) Annual Report 1999 AGPS Canberra.
  • NHMRC. (2000) Guidelines under Section 95 of the Privacy Act 1998 Canberra Australia.
  • National Statement on Ethical Conduct in Research Involving Humans. (1999) Commonwealth of Australia AGPS Canberra (www/nhmrc.gov.au/ethics/statemen.htm).

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Australian Reports

  • Allars M. (1994) Report of the Inquiry into the Use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Disease (CJD) Commonwealth of Australia AGPS Canberra Australia.
  • Baume P. (1991) A Question of Balance: Report on the Future of Drug Evaluation in Australia Report to the Commonwealth Minister for Aged, Family and Health Services AGPS Canberra Australia.
  • Chalmers D. (1985) Interim and Final Report of the Committee to Investigate Artificial Conception and Related Matters Government Printer Tasmania Australia.
  • Chalmers D. (1996) Report of the Review of the Role and Functioning of Institutional Ethics Committees Report to the Commonwealth Minister for Health and Family Services AGPS Canberra Australia.
  • Cornwall J. (1984) Report of the Working Party on IVF and AID (and 1987 Select Committee of the SA Legislative Council, Report on Artificial Insemination by Donor, In Vitro Fertilisation and Embryo Transfer Procedures and Related Matters in South Australia)
  • Government Printer South Australia Australia.
  • Day R. (1993) Review of the Clinical Trials Notification (CTN) Scheme: Report to the National Manager of the Therapeutic Goods Administration, Therapeutic Goods Administration Canberra Australia.
  • Demack J. (1984) Report of the Special Committee Appointed by the Queensland Government to Enquire into the Laws Relating to AID, IVF and Related Matters Government Printer Queensland Australia.
  • Family Law Council of Australia. (1985) Creating Children: A Uniform Approach to the Law and Practice of Reproductive Technology in Australia Family Law Council AGPS Canberra Australia.
  • Finn P. (1990) Health Ethics: The NHMRC and the NBCC Report to the Federal Minister for Health Canberra 29 October 1990.
  • Michael C. (1984) Interim Report of the IVF Ethics Committee of W.A. and a final report in 1986; Report of the Committee Appointed by the Western Australian Government to Enquire into the Social, Legal and Ethical Issues Relating to In Vitro Fertilisation and Supervision
  • Government Printer Western Australia Australia.
  • Privacy Commissioner. (1996) The Privacy Implications of Genetic Testing AGPS Canberra Australia.
  • Senate Select Committee. (1986) Human Embryo Experimentation in Australia Commonwealth Parliament Australia.
  • TGA. (1990) Australian Code of Good Manufacturing Practice for Medicinal Products AGPS Canberra.
  • Waller L. (1982ñ1984) Interim Report of the Committee to Consider the Social Ethical and Legal Issues Arising from IVF; Report on Donor Gametes in IVF; Report on Disposition on Embryos Produced by IVF Government Printer Victoria Australia.
  • Wills P. (1999) Virtuous Cycle Report to Commonwealth Government AGPS Canberra July 1999 which reviewed the structure and financing of medical research in Australia.

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Court Decisions

  • Bennetts v Board of Fire Commissioners of New South Wales (1967) 87 WN (NSW) 307.
  • Bouvia v Glenchur (1986) No C 583828 Cal. S Ct. Los Angeles County 7 10.
  • Canterbury v Spence (1992) 464 F2d 772.
  • Davis v Rodman (1921) 146 Ark. 385, 227 SW 612.
  • Halushka v University of Saskatchewan (1965) 53 DLR(2d) 436.
  • In Re Quinlan (1976) 70 NJ 10; 355 A 2d 647 Certificate denied, 429 US 922.
  • Nyali Ltd. v the Attorney-General (1956) 1 QB at 16ñ17.
  • R v Ethical Committee of St Marys Hospital ex-parte Harriott (1988) 1 FLR 512.
  • Reibl v Hughes (1980) 114 DLR (3d)1.
  • Rogers v Whitaker (1992) 67 ALJR 47; (1992) 175 CLR 479.
  • Tobacco Institute of Australia Ltd v National Health and Medical Research Council and Others (1996) 142 ALR 1.
  • Weiss v Solomon (1989) 48 CCLT 280.
Cite this page: "References for Commisioned Paper by Donald Chalmers (Research Involving Human Participants V2)" Online Ethics Center for Engineering 7/25/2006 National Academy of Engineering Accessed: Wednesday, May 23, 2012 <www.onlineethics.org/Topics/RespResearch/ResResources/nbacindex/nbachindex/hchalmers/hchalref.aspx>