Abstract
When, if ever, should severely demented patients be included in “nontherapeutic” clinical trials? Do clinical researchers here face a moral dilemma of conflicting duties? Is it unjust to include patients in this category because they are unable to consent? Is it unjust to exclude them—thereby neglecting the needs of patients in the same category for their diseases to be studied?
The dilemma might be resolved if there were alternative indirect ways of getting consent from patients who are demented. However, I argue that the alternatives, advance statements or socalled “proxy” consent, are of little practical use.
The dilemma might be resolved if it were possible to substitute special safeguards to protect those who cannot consent from being harmed or wronged. The most recent Helsinki 2000 declaration and other recent guidelines attempt to supply the necessary safeguards. Does Helsinki 2000 mark an improvement over Helsinki 1964 on this matter? Are the current guidelines strict enough? Are they too strict?
I argue that the special safeguards in Helsinki 2000, if strictly interpreted and faithfully observed, ensure that no patients will be unjustly used. I suggest three reasons why it is unlikely, though, that they will be faithfully observed: (1) They are very restrictive on research; (2) obscure wordage make it easy to erode the requirements if one is so minded; (3) it is likely that some clinical researchers will be so minded because they will regard the requirements as excessively protective of subjects.
The firm stance to be found in Helsinki 1964 that “the interests of subjects must always prevail over the interests of science and society” continues to be repeated in more recent declarations and guidelines, but it is increasingly qualified. Should that stance be preserved? Also, should the pledge doctors have given “to act only in the patient’s interests when providing medical care” be modified to allow trade-offs between the individual patient’s interests and certain wider interests like the interests of medical science?
I forecast (ruefully) that the stance and the pledge are “at risk. “ In the future, the duty to protect subjects will instead be cited merely as one that should be balanced against other wider duties.
Socrates: “I enjoy talking to very old men, for they have gone before us, as it were, on a road that we too must probably tread, and it seems to me that we can find out from them what it is like and whether it is rough and difficult or broad and easy. You are now at an age when you are, as the poets say, about to cross the bar, and I would like to find out from you what you have to tell us. Is it a difficult time of life, or not?”
Cephalus: “If men are sensible and good-tempered, old age is easy enough to bear: if not, youth as well as old age is a burden.” (Plato’s Republic, Bk. 1)
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Notes and References
http://ohsr.od.nih.gov/nuremberg.php3; reprinted from Trials of War Criminals before the Nuremberg Military Tribunals (1949), under Control Council Law No.10, Vol.2, US Government Printing Office, Washington, DC, pp.181–182.
World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964.
It has been amended in 1975, 1983, 1989, 1996, and most recently, at the 52nd WMA Assembly, Edinburgh, Scotland, October 2000.
“In comparison with the average farm animal, a human being has a terrible end. Kept alive too long, by processes like the organ transplant which nature never intended, we can look forward to years of suffering and alienation, the only reward for which is death — a death which, as a rule, comes too late for anyone else to regret it. Well did the Greeks say that those whom the gods love die young. It is not only divine love but also human love that expires as the human frame declines. Increasingly many human beings end their lives unloved, unwanted and in pain.” Scruton, R. (1996) Animal Rights and Wrongs, Demos, London, p. 81.
Rosalind Hursthouse challenges the assumption that there can be no irresolvable dilemmas. However, she means by a dilemma simply any choice that is difficult, where there are good reasons for acting one way or the other, but, seemingly, no considerations that settle which way it is best to act. As she argues, there is no reason to assume that difficult choices, so defined, must all be resolvable that there must always be such a thing as the correct choice, what one has most reason to do or what those who have the virtues would do in the circumstances. Hursthouse, R. (1999) On Virtue Ethics Oxford University Press, Oxford, pp. 63ff.
Many duties are open-ended: duties of gratitude, of friendship, filial duties. These (as a rule) do not dictate specific actions. They allow us discretion over how and when we pursue them. Typically, although these duties compete, they do not give rise to conflict (i.e., incompatible requirements).
“Research into conditions which affect those who cannot consent needs to be done if treatments are to be developed. Some of that research will, of necessity, be non-therapeutic.” Foster, C. (2001) The Ethics of Medical Research on Humans, Cambridge University Press, Cambridge, p. 103.
http://www.rcpsych.ac.uk/publications/cr/cr82.htm; Royal College of Psychiatrists (2001) Guidelines for Researchers and for Ethics Committees on Psychiatric Research Involving Human Participants, Royal College of Psychiatrists, London, CR82, section 2.2.
Royal College of Paediatrics and Child Health (1999) Safeguarding Informed Parental Involvement in Clinical Research Involving Newborn Babies and Infants, Royal College of Paediatrics and Child Health, London, p. 2.
Berghmans, R. P. L. (1998) Advance directives for non-therapeutic dementic research: some ehtical and policy decisions, J. Med. Ethics 24, 32–37.
Ibid., p. 36.
Medical Ethics Today: Its Practice and Philosophy (1993) from the British Medical Association’s Ethics, Science, and Information Division, BMJ Publishing Group, London.
http://www.eortc.be/Services/Doc/clinical-EV-directive-04-April01.pdf/Services/Doc/clinical-EV-directive-04-April01.pdf.
http://www.lcd.gov.uk/menincap/ch.5/htm/menincap/ch.5/htm.
Consent, Rights and Choices in Health Care for Children and Young People (2001) British Medical Association, BMJ Books, London.
Snowdon, C., Garcia, J., and Elbourne, D. (1997) Making sense of randomisation: responses of parents of critically ill babies to random allocation of treatment in a clinical trial, Social Sci. Med. 45(9), 1337–1355.
http://www.rcpsych.ac.uk/publications/cr/cr82.htm; Royal College of Psychiatrists, Guidelines for Researchers and for Ethics Committees on Psychiatric Research Involving Human Participants, Royal College of Psychiatrists, London, CR82, 2001, section 3.4;
Alderson, P. (1999) Did children change, or the guidelines? Bull. Med. Ethics 150, 38–44.
Ibid, section 3.4.
Freeman, T. B., Vanter, D. E., Leaverton, P. E., et al. (1999) Use of placebo surgery in controlled trials of a cellular based therapy for Parkinson’s disease, N. Engl. J. Med. 341(13), p. 991.
The Donaldson Report: Stem Cell Research: Medical Progress with Responsibility, June 2000; http://www.doh.gov.uk/cegc/.
Royal College of Psychiatrists, Guidelines for Researchers, section 5.5.
Royal College of Psychiatrists, Guidelines for Researchers, section 5.5.
House of Commons Hansard Debates for 17 Nov 2000; http:// www.parliament.the-stationery-office.co.uk/pa/cmhansrd/ cm001117/debtext/01117–03.htm.
Ibid., Column 1184.
Ibid., Column 1184.
Ibid., Column 1197.
Allmark, P., Mason, S., Gill, B. G., and Megone, C. (2001) Is it in a neonate’ s best interest to enter a randomised controlled trial? J. Med. Ethics 27, 110–113.
Feinberg, J. (1984) The Moral Limits of the Criminal Law. Volume 1: Harm to Others, Oxford University Press, New York.
Allmark, P., et al., p. 112.
They confine their discussion to “so called, “therapeutic research”” in their view, presumably all research on human subjects is at least partly therapeutic.
http://www.frame-uk.demon.co.uk/legislat.htm.
O’ Neill, O. (1989) Constructions of Reason, Cambridge University Press, Cambridge.
O’ Neill, O. (1989) Constructions of Reason, Cambridge University Press, Cambridge. p. 138.
O’ Neill, O. (1989) Constructions of Reason, Cambridge University Press, Cambridge, p. 72.
Anscombe, E. (1981) Ethics, Religion and Politics, Blackwell, Oxford, Vol. 3, p. 138.
“The sharp distinction Kant draws between persons and things is not convincing. The intermediate possibilities often perplex us. Are infants and animals, the senile and the comatose, things or persons? . . . Despite his insistence that ethics is for finite rational beings, Kant fails to address the full implications of finitude.” (O’Neill, Constructions of Reason, p. 138, footnote 11).
Scruton, Animal Rights and Wrongs, pp. 47–48.
Warren, M. A. (1997) Moral Status, Oxford University Press, New York, p. 166.
Carruthers, P. (1992) The Animals Issue: Moral Theory in Practice, Cambridge University Press, Cambridge.
Ibid., pp. 113–114.
Warren, M. A., Moral Status, p. 174.
Ibid., p. 207.
Caruthers, P., The Animal Issue, p. 116.
Beauchamp, T. L. and Childress, J. F. (2001) Principles of Biomedical Ethics, 5th ed., Oxford University Press, New York.
Ibid., p. 214.
See pp. 56–57.
Singer, P. (1993) Practical Ethics, 2nd ed., Cambridge University Press, New York.
Singer, P. (1995) Rethinking Life and Death, Oxford University Press, Oxford, p. 1.
Beauchamp and Childress, Principles of Biomedial Ethics, p. 400.
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Jackson, J. (2003). Hazards of Decoupling Respect from Rights. In: Humber, J.M., Almeder, R.F. (eds) Care of the Aged. Biomedical Ethics Reviews. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-349-1_3
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