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McGill.CA / Clinical Trials Research Group

Publications

Recent publications (1998-present)

Published works (before 1998)

Recent publications (1998-present)

Ethics of clinical trials - general

Fergusson, D., Glass, K.C., Waring, D., Shapiro, S., Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo-controlled trials. BMJ 2004; 328: 432-4.

Glass, K.C. and Carnevale, F., Learning from the experience of others: Ethical issues surrounding the use of clinical data for teaching and other professional activities. Annals RCPSC 2002; 35(8): 571-573.

Weijer, C. and Glass, K.C., The ethics of placebo-controlled trials (letter to the editor). New England Journal of Medicine 2002; 346(5): 382.

Glass, K.C. and Lemmens, T.M., Research Involving Humans. In: Canadian Health Law and Policy (2nd ed.) T. Caulfield and J. Downie (eds.) Toronto: Butterworths, 2002.

Glass, K.C. and Waring, D. Effective patient care need not conflict with good trial design. American Journal of Bioethics 2002; 2(2): 25-6.

Campbell, A. and Glass, K C. The Legal Status of Clinical and Ethics Policies, Codes and Guidelines in Medical Practice and Research. McGill Law Journal 2001; 46(2): 473-89.

Shapiro, S.H., Weijer, C., Freedman, B. Reporting the Study Populations of Clinical Trials: Clear transmission or static on the line? Journal of Clinical Epidemiology 2000; 53(10): 973-9.

Lemmens, T. and Freedman, B. Ethics Review for Sale? Conflict of Interest and Commercial Research Ethics Review. Milbank Quarterly 2000; 78(4): 547-84, iii-iv.

Szebik, I. Giving Medicine a Fair Trial: Blanket enthusiasm for trials won't help. BMJ 2000; 321(7275): 1530-1.

Glass, K.C. Research Involving Humans. In Canadian Health Law and Policy, Caulfield, T. and Downie, J. (eds). Toronto: Carswell, 1999.

Lemmens, T. In the Name of National Security: Lessons from the Final Report of the Advisory Committee on Human Radiation Experiments. European Journal of Health Law 1999; 6: 7-23.

Lemmens, T. and Elliott, C. Guinea Pigs on the Payroll: The Ethics of Paying Healthy Subjects. Accountability in Research 1999; 7(1): 3-21.

Herrera, C. Two arguments for "covert methods" in social research. British Journal of Sociology Spring, 1999.

Lemmens, T. and Singer, P.A. Conflict of Interest in Research, Education and Patient Care. Canadian Medical Association Journal 1998; 159(8): 960-965.

Weijer, C. Research methods and policies. Encyclopedia of Applied Ethics. New York: Academic Press, 1998, pp. 835-60.

Weijer, C., Freedman, B., Shapiro, S., Fuks, A., Skrutkowska, M., Sigurionsdauter, M. Measuring the interpretation of clinical trial eligibility criteria: survey of 365 clinical trial investigators. Clinical and Investigative Medicine 1998; 21: 17-26.

Fuks, A., Weijer, C., Freedman, B., Shapiro, S., Skrutkowska, M., Riaz, A. A study in contrasts: eligibility criteria in a 20-year sample of NSABP and POG clinical trials. Journal of Clinical Epidemiology 1998; 51(2): 69-79.

Turner, L. The Greening of Bioethics: Corporate funding of bioethics research. Cambridge Quarterly of Healthcare Ethics 1998; 326-8.

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The analysis of research risk

Lemmens, T. and Miller, P. Balancing Ethical Issues in Psychiatric Research. Psychiatric Times 2000; 17(6): 63-67.

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Clinical Equipoise

Shapiro, S.H. and Glass, K.C. Why Sackett's analysis of randomized controlled trials (RTCs) fails, but needn't (editorial). CMAJ 2000; 163(7): 834-5.

Weijer, C., Shapiro, S.H., Glass, K. Clinical equipoise, and not the uncertainty principle, is the moral underpinning of the randomized controlled trial. BMJ 2000; 321: 756-758.

Fergusson, D. and Hebert, P.C., Uncertainty and equipoise. CMAJ 2000; 163(7): 807.

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Genetics

Szebik, I. Masked ball: ethics, laws and financial contradictions in Hungarian health care. Science and Engineering Ethics 2003; 9: 109-124.

Szebik, I. Moral dilemmas of gene transfer techniques. In Society and Genetic Information Sandor, J. (ed.), Budapest: Central European University Press, 2003.

Knoppers, B.M., Avard, D., Cardinale, G., Glass, K.C. Children and incompetent adults in genetic research: consent and safeguards. Nature Review: Genetics 2002; 3: 221-5.

Glass, K.C. Please lay them to rest (editorial). Western Journal of Medicine 2001; 175: 180.

Glass, K.C. and Kaufert, J. (eds.). Research involving aboriginal individuals and communities: Genetics as a focus. Ottawa: National Council on Ethics in Human Research, 2001.

Kaufert, J., Glass, K.C., Commanda, L. Ethics review of research impacting aboriginal and indigenous peoples: Establishing the historical context. In Research involving aboriginal individuals and communities: Genetics as a focus. Glass, K.C. and Kaufert, J. (eds.), Ottawa: National Council on Ethics in Human Research, 2001.

Deschenes, M., Cardinale, G., Knoppers, B.M. and Glass, K.C. Human Genetic Research, DNA Banking and Consent: a Question of 'Form'? Clinical Genetics 2001; 221-39.

Lemmens, T. Selective Justice, Genetic Discrimination and Insurance: Should We Single Out Genes in Our Laws? McGill Law Journal 2000; 45: 347-412.

Szebik, I., The genetic revolution and human rights-Human genetics (book review) BMJ 2000; 321: 1086.

Glass, K.C., Weijer, C., Cournoyer, D., Lemmens, T., Palmour, R.M. and Shapiro, S.H. Structuring the Review of Human Genetics Protocols Part III: Gene Therapy Studies. IRB: A Review of Human Subjects Research 1999; 21(2): 1-9.

Knoppers, B.M., Hirtle, M., Glass, K.C. Commercialization of Genetic Research and Public Policy. Science 1999; 286: 2277-2278.

Szebik, I. and Glass, K.C. Ethical Issues of Human Germ-cell Therapy: A Preparation for Public Discussion. Academic Medicine 2001; 26(1): 32-38.

Turner, L. The Media and the Ethics of Cloning. In The Norton Reader: An Anthology of Nonfiction Prose. Eds., Linda Peterson, John Brereton and Joan Hartman. New York and London: W.W. Norton & Co., 2000; 387-91.

Kimmelman, J. Risking Ethical Insolvency: A Survey of Trends in Criminal DNA Databanking in 50 States. Journal of Law, Medicine and Ethics 2000; 28(4): 209-23.

Kimmelman, J. Just a Needle Stick Away. The Nation 2000; 271: 17-21.

Kimmelman, J. The Promise and Perils of Criminal DNA Databanking. Nature Biotechnology 2000; 18(7): 695-6.

Szebik, I. Altering the Mitochondrial Genome: Is It Just a Technical Issue? Cambridge Quarterly of Healthcare Ethics Summer 1999; 8(3): 369-74.

Glass, K.C. and Lemmens, T.M. Conflict of Interest and Commercialization of Biomedical Research: What is the Role of Research Ethics Review? In T. Caulfield and B. Williams-Jones (eds.), The Commercialization of Genetic Research: Ethical, Legal and Policy Issues. New York: Plenum, 1999.

Glass, K.C., Weijer, C., Cournoyer, D., Lemmens, T., Palmour, R.M. and Shapiro, S.H. Structuring the Review of Human Genetics Protocols Part III: Gene Therapy Studies. IRB: A Review of Human Subjects Research 1999; 21(2).

Glass, K.C. Bioethical Implications of Science and Technology: Lessons From Genetics. In Bioethics and the Environment (translated into Spanish), Proceedings of a conference held at Universidad El Bosque. September 6-8, 1999, Bogota, Colombia.

Lemmens, T. Private Parties, Public Duties? The Shifting Role of Insurance in the Genetics Era. In A. Thompson and R. Chadwick (eds.), Genetic Information: Acquisition, Access, and Control. Plenum Press: New York, 1999: 31-39.

Campbell, A., Glass, K.C. and Charland, L. Describing Our Humanness: Can Genetic Science Alter What It Means To Be Human? Science and Engineering Ethics 1998; 4(4): 1-14.

Lemmens, T. Genetic Testing: A Profile. Unum Advisor Winter 1998: 1-3.

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Competence to consent

Charland, L. Is Mr. Spock Mentally Competent?: Competence to Consent and Emotion. With commentaries and replies. In Philosophy, Psychiatry and Psychology 1998; 5.1: 73-87.

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End of life

MacDonald, N., Boisvert, M., Dudgeon, D., Hagen, N. The Canadian Palliative Care Education Group. Journal of Palliative Care 2000; 16(3): 13-15.

MacDonald, N. Palliative Care Education: a global imperative. Cancer Treatment and Research 1999; 100: 185-201.

MacDonald, N. Best Supportive Care. Cancer Prevention and Control 1998; 2(4): 191-2.

Gordon, M., Turner, L., Bourret, E. Addressing Ethical Issues in Geriatrics and Long-Term Care: Ethics Education at the Baycrest Centre for Geriatric Care. Medicine and Law 2000; 475-91.

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General publications

Szebik, I., Masked ball: Ethics, laws and financial contradictions in Hungarian health care. Science and Engineering Ethics 2003; 9: 109-24.

Campbell, A., A place for criminal law in the regulation of reproductive technologies. Health Law Journal (in press).

Campbell, A., Type 2 diabetes and children in aboriginal communities: The array of factors that shape health and access to health care. Health Law Journal (in press).

Campbell, A., Stretching the limits of "rights talk": Securing health care entitlements for children. Vermont Law Review (in press).

Campbell, A., Defining a policy rationale for the criminal regulation of reproductive technologies. Health Law Review 2002; 11: 26.

Szebik, I., Megjegyzesek az allasfoglalashoz Lege Artis Medicinae. Remarks to the Statement of the Hungarian Chamber of Physicians on Home Birth 2002; 12(5): 350-2 (In Hungarian).

Szebik, I., Ki marad a kamaraban? Toprenges az otthon szulesrol. (Who will remain a member of the Hungarian Chamber of Physicians? Reflecting on home births in Hungary.) Lege Artis Medicinae 2002; 12(3): 172-80 (In Hungarian).

Szebik, I., Eugenika a 19. es a 20. szazad fordulojan. (Eugenics at the turn of the 19th and 20th century.) Irodalmi es Tarsadalmi Havilap 2002; April: 68-74 (In Hungarian).

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Published works (before 1998)

Ethics of clinical trials - general

Lemmens, T. A Response to the Parliamentary Sub-Committee's Report and Recommendations on Compassionate Access to Experimental Drugs of the Parliamentary Subcommittee on HIV/AIDS. Canadian HIV/AIDS Policy and Law Newsletter 1997: 40-43.

Skrutkowska, M. and Weijer, C. Do patients with breast cancer participating in clinical trials get better nursing care? Oncology Nursing Forum 1997; 24(8): 1411-1416.

Lemmens, T. Compassionate Access to Experimental Drugs. Canadian HIV/AIDS Policy and Law Newsletter 1996; 3(1): 41-44.

Hegedus, K., Szebik, I., Modern medicine and death. International Journal of Bioethics 1996; Fall: 108-9.

Skrutkowska, M. The Road I Have Traveled in Research. Canadian Oncology Nursing Journal 1996; 6(2): 68-69.

Weijer, C., Freedman, B., Fuks, A., Robbins, J., Shapiro, S. and Skrutkowska, M. What difference does it make to be treated in a clinical trial? A pilot study. Clinical Investigative Medicine 1996; 10(3): 179-183.

Freedman, B. Unethical research. In: Reich, W.T. (ed.). The Encyclopedia of Bioethics. New York: Simon and Shuster MacMillan, 1995: 2258-2261.

Godard, B., Knoppers, B., Glass, K. et al. Ethical Issues Involved in Establishing a Registry for Familial Alzheimer's Disease. Alzheimer Disease and Associated Disorders 1994; 8(2): 79-93.
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Weijer, C. and Fuks, A. The Duty to exclude: excluding people at undue risk from research. Clinical and Investigative Medicine 1994; 17: 115-122.

Freedman, B. AIDS and the ethics of clinical trials: learning the right lessons. Controlled Clinical Trials 1992; 13: 1-5.
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Freedman, B. Financial arrangements of clinical trials: some ethical questions. Biopharmaceutical Report 1992; 1(1): 10-12.
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Freedman, B. A response to a purported ethical difficulty with randomized clinical trials involving cancer patients. Journal of Clinical Ethics 1992; 3: 231.

Freedman, B. Moral analysis and the use of Nazi experimental results. In: Caplan, A. (ed.). When Medicine Went Mad: Bioethics and the Holocaust. Totowa, NJ: Humana Press, 1992: 141-154.
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Freedman, B. Cohort specific consent: an honest approach to phase I clinical cancer studies. IRB: A Review of Human Subjects Research 1990; 12(1): 5-7.
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Freedman, B. and the McGill/Boston Research Group. Nonvalidated therapies and HIV disease. Hastings Center Report 1989; 19(3): 14-20.
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Freedman, B. Equipoise and the ethics of clinical research. New England Journal of Medicine 1987; 317: 141-145.
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Criteria for trial eligibility

Fuks, A., Weijer, C., Freedman, B., Shapiro, S., Skrutkowska, M. and Riaz, A. A Study in Contrasts: Eligibility in a Twenty-Year Sample of NSABP and POG Clinical Trials. Journal of Clinical Epidemiology 1997; 51(2): 69-79.
(No article available for downloading at this point)

Weijer, C. Evolving ethical issues in the selection of subjects for clinical research. Cambridge Quarterly of Healthcare Ethics 1996; 5(3): 334-345.
(No article available for downloading at this point)

Freedman, B. Multi-center trials and subject eligibility: should local IRBs play a role? IRB: a Review of Human Subjects Research 1994; 16(1-2): 1-6.

Freedman, B. and Shapiro, S. Ethics and statistics in clinical research: towards a more comprehensive examination. Journal of Statistical Planning and Inference 1994; 42: 223-240.

Glass, K. Toward a duty to report clinical trials accurately: the Clinical Alert and beyond. The Journal of Law, Medicine and Ethics 1994; 22: 327-338.
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The analysis of research risk

Glass, K.C. and Speyer-Ofenberg, M. Incompetent Persons as Research Subjects and the Ethics of Minimal Risk. Cambridge Quarterly of Health Care Ethics 1996; 5(3): 362-372.
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Freedman, B., Fuks, A. and Weijer, C. In loco parentis: minimal risk as an ethical threshold for research upon children. Hastings Center Report 1993; 23(2): 13-19.

Freedman, B., Fuks, A. and Weijer, C. Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research. Clinical Research 1992; 40: 653-660. This article received an Honourable Mention for the 1992 Nellie Westerman prize.

Freedman, B. and Weijer, C. Demarcating research and treatment interventions: a case illustration. IRB: A Review of Human Subjects Research 1992; 14(4): 5-8.

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Monitoring ongoing clinical research

Weijer, C. The breast cancer research scandal: addressing the issues. Canadian Medical Association Journal 1995; 152: 1195-1197.

Weijer, C., Shapiro, S., Fuks, A., Glass, K. and Skrutkowska, M. Monitoring clinical research: an obligation unfulfilled. Canadian Medical Association Journal 1995; 152: 1973-1980.

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The ethics of placebos

Freedman, B., Weijer, C. and Glass, K.C. Placebo Orthodoxy in Clinical Research: Exposing the Myths. Part I: Empirical and Methodological Myths. Journal of Law, Medicine & Ethics 1996; 24: 243-251; reprinted in Monash Bioethics Review 1997; 16(4): 12-26.
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Freedman, B., Glass, K.C. and Weijer, C. Placebo Orthodoxy in Clinical Research: Exposing the Myths. Part II: Ethical, Legal and Regulatory Myths. Journal of Law, Medicine & Ethics 1996; 24: 252-259; reprinted in Monash Bioethics Review 1997; 17(3): 10-22.
(No article available for downloading at this point)

Freedman, B. Ethics and placebo-controlled thrombolytic trials: the future. Coronary Artery Disease 1991; 2: 849-852.

Weijer, C. and Elliott, C. Down with placebolatry. New Scientist 1996; 149(2019): 47.

Elliott, C. and Weijer, C. Cruel and unusual treatment. Saturday Night 1995; 110(10): 31-34.

Freedman, B. Placebo-controlled trials and the logic of clinical purpose. IRB: A Review of Human Subjects Research 1990; 12(6): 1-6.
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Community involvement in research design and conduct

Weijer, C. Our bodies, our science. The Sciences 1995; 35(3): 41-45.
(No article available for downloading at this point)

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Genetics

Lemmens, T. "What about your genes?" Ethical, Legal and Policy Dimensions of Genetics in the Workplace. Politics and the Life Sciences 1997; 16(1): 57-75.
(No article available for downloading at this point)

Glass, K.C., Weijer, C., Palmour, R.M., Lemmens, T.M. and Shapiro, S.H. Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies. IRB: A Review of Human Subjects Research 1997; 19(3,4): 1-11, 13.
(No article available for downloading at this point)

Glass, K.C. Challenging the Paradigm: Stored Tissue Samples and Access to Genetic Information. In DNA Sampling and Genetic Research: Ethical, Legal and Policy Aspects. Knoppers, B.M., Laberge, C., and Robertson, G. (eds). Hague: Kluewer Law International, 1997.
(No article available for downloading at this point)

Turner, L. A Sheep Named Dolly. Canadian Medical Association Journal 1997; 156(8): 1149-50.
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Glass, K.C., Weijer, C., Palmour, R.M., Shapiro, S., Lemmens, T.M. and Lebacqz, K. Structuring the Review of Human Genetics Protocols: Gene Localization and Identification Protocols. IRB: A Review of Human Subjects Research 1996; 18(4): 1-9.
(No article available for downloading at this point)

Lemmens, T. L'utilisation de l'information g茅n茅tique par les compagnies d'assurances. L'Actualit茅 M茅dicale 29 September 1993: 42-43.
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Freedman, B. and Goulet, M.C. New creations? (Commentary). Hastings Center Report 1991; 21(1): 32-35.

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Competence to consent

Charland, L. Is Mr. Spock Mentally Competent?: Competence to Consent and Emotion. With commentaries and replies. In Philosophy, Psychiatry and Psychology 1998; 5.1: 73-87.
(No article available for downloading at this point)

Glass, K.C. Refining definitions and creating instruments: two decades of assessing mental competence. International Journal Law & Psychiatry 1997; 20(1): 1-29.
(No article available for downloading at this point)

Charland, L. Reconciling Cognitive and Perceptual Theories of Emotion: A Representational Proposal. Philosophy of Science 1997; 64: 555-579.
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Glass, K.C. and Silberfeld, M. Ethical and Legal Issues: Determination of Competence. In Clinical Management and Diagnosis of Alzheimer's Disease. Gauthier, S. (ed.). London: Martin Dunitz, 1996 (2nd edition, 1999).
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Keyserlingk, E.W., Glass, K.C., Kogan, S. and Gauthier, S. Proposed guidelines for the participation of persons with dementia as research subjects. Perspectives in Biology and Medicine 1995; 32: 2.
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End of life

MacDonald, N. Palliative Care: An essential component of cancer control. Canadian Medical Association Journal (in press).
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MacDonald, N., Findlay, H.P., Bruera, E., Dudgeon, D. and Kramer, J. A Canadian Survey of Issues in Cancer Pain Management. Journal of Pain and Symptom Management 1997; 14(6): 332-342.
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MacDonald, N. Contributor to: Approaching Death: Improving Care at the End of Life. Cassel, C. and Field, M.J. (eds). Committee on Care at the End of Life, Division of Health Care Services, Institute of Medicine, National Academy of Sciences. Washington, DC: National Academy Press, 1997.
(No article available for downloading at this point)

Common Drugs and the Progress of Cancer, by J.H. Brown; response by Roy, D.J. and MacDonald, N. Canadian Medical Association Journal 1996; 154(1):16-17.
(No article available for downloading at this point)

Cohen, R., Mount, B. and MacDonald, N. Defining Quality of Life. (Invited Editorial). European Journal of Cancer 1996; 32A: 753-4.
(No article available for downloading at this point)

Hagen, N., Flynne, P. and MacDonald, N. Regulated analgesics and pain control. Canadian Medical Association Journal (Letter) 1996; 154(10): 1470-72.
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Lemmens, T. US Appeal Courts Rule in Favour of Assisted Suicide (case comment). Canadian HIV/AIDS Policy and Law Newsletter1996; 2(4): 1, 42- 43.
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Lemmens, T. Towards the right to be killed? Treatment refusal, assisted suicide and euthanasia in the United States and Canada. In G. Dunstan et al. (eds.). Euthanasia, Death, Dying and the Medical Duty; British Medical Bulletin 1996; 52(2): 341-353.
(No article available for downloading at this point)

Roy, D.J. and MacDonald, N. The Brandes-Friesen Case Reports: How Should We Interpret the News? Canadian Medical Association Journal 1995; 153(5): 569-571.
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MacDonald, N. A Proposed Matrix for Organisational Changes to Improve Quality of Life in Oncology. European Journal of Cancer 1995; 31A(Suppl. 6): S18-S21.
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Lemmens, T. Legalizing Euthanasia. Canadian HIV/AIDS Policy and Law Newsletter 1995; 2(1): 7-9.
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Lemmens, T. Euthanasia and the Good Life. Perspectives in Biology and Medicine 1995; 39(1): 15-27.
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Mount, B.M., Cohen, R., MacDonald, N., Bruera, E. and Dudgeon, D. Ethical issues in palliative care research revisited. Palliative Medicine 1995; 9:165-170.
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Moulin, D.E., Latimer, E.J., MacDonald, N. et al. Statement on Euthanasia and Physician-Assisted Suicide. Journal of Palliative Care 1994; 10(2): 80-81.
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Dossetor, J. and MacDonald, N. Ethics of Palliative Care in the Context of Limited Resources: An Essay on the Need for Attitudinal Change. Journal of Palliative Care 1994; 10(3): 39-42.
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