Against the inalienable right to withdraw from research

Bioethics

Volumn 22, Issue 7, 2008, Pages 370-378

  Chwang, Eric ^a  

^a UNIVERSITY OF COLORADO   (United States)

Author keywords

Alienable; Ethics; Inalienable; Research; Rights; Subject; Withdraw

Indexed keywords

ARTICLE; CLINICAL TRIAL; ETHICS; HUMAN; HUMAN RIGHTS; MORALITY; PATERNALISM; PERSONAL AUTONOMY; PSYCHOLOGICAL ASPECT; REFUSAL TO PARTICIPATE; RESEARCH SUBJECT;

CLINICAL TRIALS AS TOPIC; HUMAN RIGHTS; HUMANS; MORAL OBLIGATIONS; PATERNALISM; PERSONAL AUTONOMY; REFUSAL TO PARTICIPATE; RESEARCH SUBJECTS;

EID: 49549123852     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2008.00666.x     Document Type: Article

References (31)

1. For the purposes of this paper I take alienating a right to be synonymous with waiving that right. The reason I did not make use of this synonymy in the above definition is that 'a right is alienable just in case its holder is allowed to alienate it' is less cognitively helpful than the definition given in the text.
2. S.J.L. Edwards. Research Participation and the Right to Withdraw. Bioethics 2005 19 : 112 130
3. M.A. Spillman R.M. Sade. Clinical Trials of Xenotransplantation: Waiver of the Right to Withdraw from a Clinical Trial Should Be Required. J Law Med Ethics 2007 35 : 265 272.
4. Judith Jarvis Thomson argues that the distinction between moral and legal rights rests on a confusion, that 'moral right' and 'legal right' do not name distinct species of rights. (See Judith Jarvis Thomson. 1990. The Realm of Rights. Cambridge, MA: Harvard University Press: chapter 2, section 5.) My point here can be stated in a way consistent with her thesis: I intend to argue that the right to withdraw from research is alienable, not that we should implement legal policy to allow such alienation.
5. The Nuremberg Code's clause on subject withdrawal is:During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him impossible.(Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law, No. 10, Vol. 2. 1949. Nuremberg Code. Washington, DC: US Government Printing Office: 181-182.) This is an exception to the general consensus of the inalienable right to withdraw, but not one friendly to my argument, for if I am right then it is sometimes permissible for a subject to waive the right to withdraw even when he has reached the physical or mental state where continuation seems to him impossible.
6. World Medical Association (WMA). 2004. Declaration of Helsinki, Ethical Principles for Medical Research involving Human Subjects. Tokyo, Japan. Available at: http://www.wma.net/e/policy/b3.htm [Accessed 18 Mar 2008].
7. Council of Europe. 1997. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo, Spain. Available at: http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm [Accessed 18 Mar 2008].
8. Code of Federal Regulations. 2005. Title 45, Public Welfare, Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks, Part 46 Protection of Human Subjects. Bethesda, MD. Available at: http://ohsr.od.nih.gov/guidelines/45cfr46.html#46.116 [Accessed 18 Mar 2008].
9. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization. 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland. Available at: http://www.cioms.ch/frame_guidelines_nov_2002.htm [Accessed 17 Apr 2007].
10. A. Herxheimer. The Rights of the Patient in Clinical Research. Lancet 1988 12 : 1128 1130.
11. One very important issue which I will not consider is whether, even granting that the moral right to withdraw is sometimes alienable, it might be too costly or open to abuse to figure out when exactly subjects should be allowed to waive it. I suspect that many of the costs of figuring out when subjects are competent enough to decide to waive their right to withdraw will be borne by the research team itself, on a par with how a clinical care team is responsible for determining when their patients are competent to consent to medical treatment. However, there will surely be extra burdens on oversight committees and the legislative system to accommodate this moral right. The important point is that these sorts of questions fall under the heading of whether we should allow the legal waiver of the right to withdraw, not whether it is in fact morally permissible to allow subjects to waive that right.
12. Of course, this is not to say that (a) whether rights are alienable depends on considerations of cost. Rather, it is to say merely that (b) the reason it is important to examine whether rights are alienable is that the wrong answer may be costly. And, of course, neither (a) nor (b) above presupposes that rights are grounded in cost or utility, though the affirmative answer to (a) claims that whether rights are alienable is grounded in costs or utility.
13. Stuart Brown, Jr. Inalienable Rights. Philos Rev 1955 64 : 192 211
14. For a recent defense of the choice theory of rights, see Hillel Steiner. 1994. An Essay on Rights. Oxford: Blackwell Publishers.
15. I say 'typically' to postpone discussion of possible exceptions, such as slavery contracts, which I will address shortly. At the moment, my concern is merely a general presumption in favor of alienability.
16. This second reason may be just a restatement of the first, but if so the restatement still looks at the issue from a different-enough angle to be worth articulating and distinguishing.
17. Note that this dilemma does not take a stand on the contentious issue of whether considerations of autonomy are distinct from and should trump consequentialist concerns. The dilemma still arises even if autonomy is merely one among many goods to be thrown into the consequentialist hopper, for in that case there is still no good reason to throw only first-order autonomy into the hopper, excluding second-order autonomy.
18. Note that I need not take a stand on whether rights are grounded in respect for autonomy, as opposed to grounded in consequentialist concerns. That is because either way rights should be presumed to be alienable: inalienable rights can infringe on autonomy and also lead to worse consequences.
19. A. Wertheimer. 1996. Exploitation. Princeton, NJ: Princeton University Press.
20. K. Marx. 1993. Capital: A Critique of Political Economy, vol. 3
21. See, for example, Mohrlag v. Draper. 219 Neb. 630, 633 (Neb. 1985).
22. I. Kant. 1997. Groundwork of the Metaphysics of Morals. Cambridge Texts in the History of Philosophy. Edited by M. Gregor. Introduction by C.M. Korsgaard. Cambridge: Cambridge University Press.
23. J.S. Mill. 1989. 'On Liberty' and Other Writings. Edited by S. Collini. Cambridge: Cambridge University Press: 102-103.
24. R. Hardin. The Utilitarian Logic of Liberalism. Ethics 1986 97 : 47 74.
25. A. Kuflik. The Utilitarian Logic of Inalienable Rights. Ethics 1986 97 : 75 87.
26. Another potential disanalogy is that the right to $50 is trivial, in the sense that agents are not missing out on much if they fail to get it. Thus, perhaps Hardin's reasoning is intended to apply only to significant rights. However, this worry can be accommodated easily enough: just change the monetary amount in question from $50 to whatever amount is sufficient to generate a significant right.
27. Carl Elliott. 2008. Guinea-Pigging. The New Yorker 7 January : 36 41.
28. K.B. Dreenan. Patient Recruitment: the Costly and Growing Bottleneck in Drug Development. Drug Discov Today 2002 7 : 167 170
29. J. Sullivan. Subject Recruitment and Retention: Barriers to Success: Study Findings Identify Various Factors Affecting Subject Enrollment in Today's Clinical Trial World. Applied Clinical Trials 2004 4 : 50 54.
30. J.P. Bentley P.G. Thacker. The Influence of Risk and Monetary Payment on the Research Participation Decision Making Process. J Med Ethics 2004 30 : 293 298
31. E.J. Emanuel. Undue Inducement: Nonsense on Stilts? Am J Bioeth 2005 5 : 9 13.