Paternalism and fairness in clinical research

Bioethics

Volumn 23, Issue 3, 2009, Pages 172-182

  Jansen, Lynn A ^a,b,d   Wall, Steven ^c  

^a St Vincent's Manhattan ^*  (United States)

^b NEW YORK MEDICAL COLLEGE   (United States)

^c BOWLING GREEN STATE UNIVERSITY   (United States)

^d ST VINCENT S HOSPITAL   (United States)

Author keywords

Basic liberty; Distributive fairness; Paternalism; Research ethics

Indexed keywords

ETHICS; HUMAN; MEDICAL RESEARCH; PATERNALISM; RESEARCH SUBJECT; REVIEW;

BIOMEDICAL RESEARCH; HUMANS; PATERNALISM; RESEARCH SUBJECTS;

EID: 58649097748     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2008.00651.x     Document Type: Review

References (48)

1. S.J.L. Edwards, S. Kirchin R. Huxtable. Research Ethics and Paternalism. J Med Ethics 2004 : 88 91
2. E. Garrard A. Dawson. What is the role of the research ethics committee? Paternalism, inducements and harm in research ethics. J Med Ethics 2005 : 419 423.
3. E.J. Pattullo. IRBs and the Freedom to take Risks. NEJM 307 1982 : 1156 1159.
4. Legal Theory 2005 11 : 259 284.
5. P. de Marneffe. Avoiding Paternalism. Philos Public Affs Winter, 2006 : 68 94.
6. th edition: New York: Oxford University Press: 442.
7. See R.J. Levine. The Role of Assessment of Risk Benefit Criteria in the Determination of Biomedical and Behavorial Research. The Belmont Report
8. C. Weijer. The Ethical Analysis of Risk. J Law Med Ethics 2000 28 : 344 361.
9. We assume here that when the state imposes federal restrictions on the practice of clinical research that is supported by public funds or takes place on a site supported by public funds that this constitutes interference with the liberty of researchers and potential research subjects. It is possible, however, to characterize these restrictions as (merely) paternalistic conditions on the receipt of public money or support. We will not explore this complication further.
10. G. Dworkin. 1972. Paternalism. The Monist 56 : 65 66
11. and J. Feinberg. 1986. Harm to Self. New York: Oxford University Press: 9-10.
12. J. Feinberg, Harm to Self, ibid: 12;
13. Beauchamp and Childress, Harm to Self, op. cit. note 4: 181.
14. For discussion of a range of cognitive deficiencies and biases that could affect decision-making in general see the essays collected in T. Gilovich, D. Griffin, and D. Kaheman, eds. 2002. Judgment Under Uncertainty: The Psychology of Intuitive Judgment. Cambridge: Cambridge University Press.
15. The example is taken from C. Taylor. 1985. Philosophy and the Human Sciences II. Cambridge: Cambridge University Press: 219.
16. See I. Berlin. 1969. Four Essays on Liberty. New York: Oxford University Press
17. R. Arneson. Freedom and Desire. Can J Philos 1985 15 : 425 448.
18. J. Rawls. 1993. Political Liberalism. New York: Columbia University Press: 291-292.
19. Rawls lists the following as basic liberties: 'freedom of thought and liberty of conscience; the political liberties [for example, the right to vote and to participate in politics] and freedom of association, as well as the rights and liberties specified by the liberty and integrity of the person; and finally, the rights and liberties covered by the rule of law.' Political Liberalism, Ibid: 291.
20. For Rawls, we must consider 'which liberties are essential social conditions for the adequate development and full exercise of the two powers of moral personality over a complete life.' Political Liberalism, Ibid: 293.
21. We do not, for example, need to defend the specific list of basic liberties that Rawls himself proposed.
22. R. Arneson. Paternalism, Utility and Fairness. Reprinted in Mills on Liberty: Critical Essays. ed. G. Dworkin 1997. Lanham, MD: Rowman and Littlefield.
23. Mills on Liberty: Critical Essays, Ibid: 86.
24. The relevance of Arneson's argument for the practice of clinical research has gone largely unnoticed. We have found only one reference to it in the research ethics literature. This appears in F. Miller and A. Wertheimer. Facing Up to Paternalism. Hastings Cent Rep May-June 2007. Miller and Wertheimer mention Arneson's argument, but do not explore it.
25. NE Kass et al. Balancing Justice and Autonomy in Clinical Research With Healthy Volunteers. Clin Pharm Ther 4 2007 : 207.
26. E.J. Emanuel, D. Wendler C. Grady. What Makes Clinical Research Ethical? JAMA 2000 283 : 2701 2711.
27. For a critical survey of different accounts see J. Griffin, Well-being: Its Meaning, Measurement and Moral Importance.
28. C. Weijer, The Ethical Analysis of Risk, J Law Med Ethics 2000 28 : 344 361.
29. Arneson. J Law Med Ethics, op. cit. note 16: 86.
30. In Facing Up to Paternalism, J Law Med Ethics, op. cit. note 18, Miller and Wertheimer defend some restrictions on clinical research in terms of 'soft group paternalism.' We have no fundamental objection to this line of argument, although we concur with Feinberg's judgment that soft paternalism is not genuine paternalism since it is not aimed at protecting a person's good, but rather with making sure that his choices are truly his own. (Harm to Self:12) Be this as it may, our concern in this paper is to defend hard or, as we think of it, genuine, paternalistic restrictions.
31. See, for instance, F. Miller and A. Wertheimer, op. cit. note 18: 29-30.
32. See R. Dworkin. 2000. Sovereign Virtue Cambridge, Mass.: Harvard University Press;
33. E. Rakowski. 1991. Equal Justice. Oxford: Clarendon Press;
34. R. Arneson, Equality and Equal Opportunity for Welfare. Philos Stud 1989 56 : 77 93.
35. See, for example, D. Parfit's formulation of egalitarianism in Equality or Priority, Ratio. 10 December, 1997: 202-221.
36. Arneson, Ratio, op. cit. note 16: 96.
37. The example is for illustrative purposes only. No stand is being taken here on the morality of legalized gambling.
38. S. Joffe et al., Altruism among participants in cancer clinical trials. Proc Am Soc Clin Oncol 2003 22
39. For Kant's discussion of self-regarding duties - which are grounded in the requirement that we respect our own rational nature - see I. Kant. 1991. Metaphysics of Morals. trans. M.J. Gregor. Cambridge: Cambridge University Press.
40. For a discussion of Kant's ideas applied to the issue of altruism see J. Hampton. Selflessness and Loss of Self, reprinted 2007 in her The Intrinsic Worth of Persons: Contractarianism in Moral and Political Philosophy. Cambridge: Cambridge University Press.
41. Feinberg, The Intrinsic Worth of Persons: Contractarianism in Moral and Political Philosophy, op. cit. note 7: 59.
42. E.J. Emanuel, D. Wendler and C. Grady. The Intrinsic Worth of Persons: Contractarianism in Moral and Political Philosophy, op. cit. note 20: 2701-2711.
43. See, for example, see F. Miller and H. Brody. Clinical Equipoise and the Incoherence of Research Ethics. J Med Philos: 160.
44. See also Beauchamp and Childress, op. cit. note 4: 441.
45. This means that even if it were appropriate for funding agencies to reject the research, the investigators could claim that they have a liberty-right to pursue it, nonetheless.
46. S.V. Shiffrin, Paternalism, Unconscionability Doctrine, and Accommodation. Philos Public Aff 29 2000 : 237.
47. Philos Public Aff, Ibid.: 237.
48. It is sometimes claimed that legal paternalism is inherently insulting because it substitutes the judgment of governmental officials for the judgment of the individuals who are interfered with. But this cannot be right. As De Marneffe points out, governmental policies, whether paternalistic or not, commonly substitute the judgment of state officials for those who are subject to them. See P. de Marneffe, Philos Public Aff, op. cit. note 3: 77-78.