Manipulation in the Enrollment of Research Participants

Hastings Center Report

Volumn 43, Issue 2, 2013, Pages 38-47

  Mandava, Amulya ^a   Millum, Joseph ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DECEPTION; DECISION MAKING; ETHICS; HUMAN; INFORMED CONSENT; METHODOLOGY; PATIENT SELECTION; PERCEPTION; PERSONAL AUTONOMY; PERSONNEL; PERSUASIVE COMMUNICATION; PSYCHOLOGICAL ASPECT; RESEARCH ETHICS; RESEARCH SUBJECT; SOCIAL PSYCHOLOGY; STANDARD;

CHOICE BEHAVIOR; DECEPTION; DECISION MAKING; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; PATIENT SELECTION; PERSONAL AUTONOMY; PERSUASIVE COMMUNICATION; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; SOCIAL PERCEPTION; SOCIAL VALUES;

EID: 84875013958     PISSN: 00930334     EISSN: 1552146X     Source Type: Journal    
DOI: 10.1002/hast.144     Document Type: Article

References (25)

1. N.S. Sung et al., "Central Challenges Facing the National Clinical Research Enterprise," Journal of the American Medical Association 289 (2003): 1278-87; D. Orentlicher, "Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research," Hastings Center Report 35, no. 5 (2005): 20-28.
2. L. Stunkel and C. Grady, "More Than the Money: A Review of the Literature Examining Healthy Volunteer Motivations," Contemporary Clinical Trials 32 (2011): 342-52.
3. For an analysis of the concept of coercion applied to the context of clinical research, see A. Wertheimer and F.G. Miller, "Payment for Research Participation: A Coercive Offer?" Journal of Medical Ethics 34 (2008): 389-92. For analysis of undue inducement, see Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva, Switzerland: CIOMS, 2002), Guidelines 4, 6, and 7; and E.J. Emanuel, "Ending Concerns about Undue Inducement," Journal of Law, Medicine and Ethics 32 (2004): 100-105.
4. The term "persuasion" gets used to describe all sorts of attempts to motivate others, including acts that are clearly manipulative or coercive. Here, we follow the usage of Ruth Faden and Tom Beauchamp by defning persuasion narrowly as "restricted to influence by appeal to reason"; R.R. Faden and T.L. Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986), at 261.
5. A detailed analysis of what constitutes deception is outside of the scope of this paper. J.E. Mahon gives the following defnition: "to intentionally cause another person to have or continue to have a false belief that is truly believed to be false by the person intentionally causing the false belief by bringing about evidence on the basis of which the other person has or continues to have that false belief";J.E. Mahon, "A Def-nition of Deceiving," International Journal of Applied Philosophy 21 (2007): 181-94, at 189-90.
6. Adapted from R. Cialdini, Influence: The Psychology of Persuasion, rev. ed. (New York: Quill, 1993), at 32.
7. Note that one person's causing another to do something does not entail that the other did not engage in the action freely. For example, if I offer twenty dollars to Mudit to wash my car, my offer has caused him to wash my car when he would not have done so otherwise. Yet Mudit has still freely chosen to wash my car. This suggests if ethical analysis is to determine the effect of different types of cause on the validity of consent, it needs to distinguish between different ways in which one person can cause another to do something.
8. Whether a particular proposal constitutes a threat depends on the baseline from which we measure. A normative baseline will judge a proposal to be a threat only if carrying it out would make the victim worse off than she ought to be. A predictive baseline will judge a proposal to be a threat only if carrying it out would make the victim worse off than she would otherwise be in the normal course of events. See 5. Anderson, "Coercion," in The Stanford Encyclopedia of Philosophy, ed. E.N. Zalta, winter 2011, at http://plato.stanford.edu/archives/win2011/entries/coercion.
9. Since the publication of Nozick's classic analysis, philosophical discussion of coercion has focused on the type of coercion described here; R. Nozick, "Coercion," in Philosophy, Science, and Method: Essays in Honor of Ernest Nagel, ed. S. Morgenbesser, P. Suppes, and M. White (New York: St. Martin's Press, 1969), at 440-72. However, there are two other types of action that might also be described as coercive. First, there are cases in which one agent is physically controlled by another, so that his movements are not voluntary under any description. For example, if I were to push you into a man by the train tracks so that you knocked him onto the tracks, your knocking him onto the tracks would be involuntary on your part. Second, Harry Frankfurt describes coercion in terms of its psychological effect, so that the coercee is incapable of resisting the threat; H. Frankfurt, "Coercion and Moral Responsibility," in The Importance of What We Care About (New York: Cambridge University Press, 1988), 26-46.
10. There is some debate in the philosophical literature about whether there can be offers one cannot refuse, and whether such offers disrespect autonomy or qualify as coercive; D. Zimmerman, "Coercive Wage Offers," Philosophy and Public Affairs 10, no. 2 (1981): 121-45; O. O'Neill, "Which Are the Offers You Can't Refuse?" in Bounds of Justice (Cambridge, U.K.: Cambridge University Press, 2000), at 81-96; A. Wertheimer, Coercion (Princeton, N.J.: Princeton University Press, 1987), at 204-6. If there can be coercive offers, then they should simply be classifed as coercion for the purposes of our analysis. One could imagine, further, that there might be non-coercive offers that disrespect autonomy, for example, in cases where an offer is made with the intention that it be so tempting that the recipient will accept it against her better judgment. Such offers would, however, be best analyzed as a form of motivational manipulation.
11. Compare Joel Rudinow's account, according to which manipulation involves the "complex motivation of a person by means of deception or by playing on a supposed weakness." Our account builds on Rudi-now's means of manipulation ("deception or by playing on a supposed weakness") in its analysis of ethically problematic ways in which one person can play on another's weakness through motivational and circumstantial manipulation; J. Rudinow, "Manipulation," Ethics 88 (1978): 338-47, at 346.
12. Faden and Beauchamp, A History and Theory of Informed Consent, at 236.
13. Cf. Patricia Greenspan, who identifies the wrong of manipulation as an "interference with self-governance"; P. Greenspan, "The Problem with Manipulation," American Philosophical Quarterly 40 (2003): 155-64, at 164. In contrast, Sarah Buss argues that the wrong of manipulation does not lie in its disrespect of autonomy. She cites the example of Johannes's seduction of Cordelia in Kierkegaard's The Seducer's Diary. Buss argues that Johannes's manipulative seduction is wrong, but not because he disrespects Cordelia's autonomy. In fact, Buss argues, Johannes's manipulation of Cordelia is carried out in an attempt to increase Cordelia's capacity for autonomous action, and therefore his manipulation ultimately respects her autonomy. Buss argues that Johannes's manipulation is wrong for reasons unrelated to autonomy: it prevents Cordelia from governing herself with an accurate understanding of her situation, it prevents her from relating to her manipulator as an equal, and it may be incompatible with her welfare. Johannes may well respect Cordelia's future autonomy in that his manipulation builds her capacity for future autonomous action. However, in manipulating Cordelia, Johannes disrespects her autonomy in the present by exerting illegitimate control over the choices that Cordelia would make now if she were in control of her situation. In fact, two of the wrongs of manipulation that Buss identifes as unrelated to autonomy-including the fact that Johannes's manipulation makes Cordelia unable to govern herself with an accurate understanding of her situation, and the inequality that Johannes's manipulation creates between them-are actually ways in which Johannes disrespects her present autonomy; S. Buss, "Valuing Autonomy and Respecting Persons: Manipulation, Seduction, and the Basis of Moral Constraints," Ethics 115 (2005): 195-235.
14. T.L. Beauchamp and J.F. Childress, Principles of Biomedical Ethics, 5th ed. (Oxford, U.K.: Oxford University Press, 2001), at 79-98.
15. Faden and Beauchamp, A History and Theory of Informed Consent, 258-59.
16. Faden and Beauchamp argue that coercion is always wholly controlling. However, threats may be more or less controlling depending on what is threatened and what the alternative options are. The harder (or less reasonable) it is to resist a threat, the more controlling it is.
17. S.I. Benn and W.L. Weinstein put it this way: "A plea of duress in criminal law works in the same way; the accused excuses himself by claiming that he was not free to obey the law, on account of some more immediate threat that he could not reasonably have been expected to disregard.... Corresponding to the standards presupposed by the plea of duress in contract..., there is here a kind of reasonable rate of exchange between the importance of a given law and what damage a man might reasonably be expected to risk or to suffer... rather than break that law"; S.I. Benn and W.L. Weinstein, "Being Free to Act, and Being a Free Man," Mind New Series 80, no. 318 (1971): 194-211, at 208-9. A complete account of the relationship between threats and consent or duress would require some analysis of "reasonable." However, as the following paragraphs should make clear, our argument about whether the control involved in manipulation is sufficient to render consent invalid does not require this level of precision.
18. Cases in which information is deliberately withheld or deception is attempted, but where the person giving consent nevertheless understands what he is consenting to (for example, from other sources), would still violate the disclosure requirement.
19. See D. Wendler, "Deception in Medical and Behavioral Research: Is It Ever Acceptable?" Milbank Quarterly 74 (1996): 87-114; M. Kemmelmeier, D. Davis, and W.C. Follette, "Seven Sins of Misdirection? Ethical Controversies Surrounding the Use of Deception in Research," in Handbook of Professional Ethics for Psychologists, ed. W.T. O'Donohue and K. Ferguson (Beverly Hills, Calif.: Sage, 2003).
20. A. Leach et al., "An Evaluation of the Informed Consent Procedure Used during a Trial of a Haemophilus infuenzae Type B Conjugate Vaccine Undertaken in The Gambia, West Africa," Social Science and Medicine 48 (1999): 139-48.
21. One could imagine a case in which the emotional stress from the peer pressure that the women experienced was so strong that it rendered them incapable of weighing the pros and cons of participation. Their consent would not then be valid. In this case, however, the consent would be invalidated because the capacity of the women to act autonomously would have been undermined, not because of the control exerted through manipulation.
22. Contrast this with a case where his options are not reasonable: Peter demands dinner at gunpoint. Here Peter's threat is controlling in a way that making use of John's strong desires not to cause a fuss in public or desert a friend would not be.
23. D. Ngare, "Malaria Drug Trial in Kenya," in Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-Poor Settings, ed. P. Marshall (Geneva, Switzerland: World Health Organization, Ethics and Health Unit, Division on Ethics Special Programme for Research and Training in Tropical Diseases, 2007), at 41.
24. N. Bryant, "Big Tobacco Takes Another Big Hit," BBC News, Nick Bryant's Australia, April 2011, at http://www.bbc.co.uk/blogs/thereporters/nickbryant/2011/04/big_tobacco_takes_another_big.html; S. Cohen, "Australia Passes 'Plain Package' Law for Cigarettes," National Public Radio News, November 2011, at http://www.npr.org/2011/11/11/142232709/australia-passes-plain-package-law-for-cigarettes.
25. P. Tindana, N. Kass, and P. Ak-weongo, "The Informed Consent Process in a Rural African Setting: A Case Study of the Kassena-Nankana District of Northern Ghana," IRB: Ethics and Human Research 28 (2006): 1-6.