More on benchmarks of fairness: Response to ballantyne

Bioethics

Volumn 26, Issue 1, 2012, Pages 49-56

  Phillips, Trisha ^a  

^a MISSISSIPPI STATE UNIVERSITY   (United States)

Author keywords

Benefit assesment; Exploitation; Fairness; International research; Research ethics; Risk assessment; Social justice

Indexed keywords

ARTICLE; BIOETHICS; DEVELOPING COUNTRY; ETHICS; HUMAN; INTERNATIONAL COOPERATION; MEDICAL RESEARCH; SOCIAL JUSTICE; SOCIAL WELFARE;

BIOETHICAL ISSUES; BIOMEDICAL RESEARCH; DEVELOPING COUNTRIES; HUMANS; INTERNATIONALITY; SOCIAL JUSTICE; SOCIAL WELFARE;

EID: 83655196803     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2010.01822.x     Document Type: Article

References (31)

1. A. Ballantyne.HIV International Clinical Research: Exploitation and Risk. Bioethics 2005; 19(5-6): 476-491.
2. A. Ballantyne. Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducement? Dev World Bioeth 2008: 1-14
3. D.L. Helman et al. Analysing the Short-Term Effect of Placebo Therapy in Pulmonary Arterial Hypertension: Potential Implications for the Design of Future Clinical Trials. Chest 2007; 132(3): 764-772
4. A. Schulz-Baldes, E. Vayena & N. Biller-Andorno. Sharing Benefitsin International Health Research. EMBO Reports 2007; 8(1): 8-13.
5. In some of these cases the ex ante expectation of benefit was only potential (for example, when participants are motivated by therapeutic benefit); in other cases it was certain (for example, when participants are motivated by material benefit such payment for participation).
6. F. Miller & H. Brody. What Makes Placebo-controlled Trials Unethical? Am J Bioeth 2002; 2: 3-9
7. M. Angell. The Ethics of Clinical Research in the Third World. N Engl J Med 1997; 337: 847-849
8. P. Lurie & S. Wolfe. Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. N Engl J Med 1997; 337: 853-856
9. R. Bayer. The Debate Over Maternal-Fetal HIV Transmission Prevention Trials in Africa, Asia and the Caribbean: Racists Exploitation or Exploitation of Racism. Am J Public Health 199888: 567-570
10. T. Phillips. Exploitation in Payments to Research Subjects. Bioethics (forthcoming)
11. Participants of the 2001 Conference on Ethical Aspects of Research in Developing Countries [hereafter Emanuel et al.]. Moral Standards for Research in Developing Countries: From 'Reasonable Availability' to 'Fair Benefits.'Hastings Cent Rep Ballantyne2004; 34(3): 17-27
12. D.B. Resnik. Exploitation in Biomedical Research. Theor Med 2003; 24: 233-259
13. A. Wertheimer. 1996. Exploitation. Princeton: Princeton University Press.
14. For the purpose of this paper, the terms 'researcher' and 'research team' will refer to all parties who contribute to the administration of a clinical trial (this includes coordinators, investigators, other clinical research staff, for profit and not-for-profit sponsoring institutions at local, regional, national, and international levels.)
15. The World Medical Association (WMA) proposed the reasonably available standard in 2000, which was then criticized by many commentators. In 2004 the WMA revised and relaxed the requirement. Emanuel et al. proposed the fair benefits account which was later endorsed and augmented by Gbadegesin and Wendler and then criticized by Ballantyne. Emanuel et al. and Gbadegesin and Wendler have yet to respond to Ballantyne's concerns. For more see: World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. (Adopeted in 1964 and amended in 1975, 1983, 1989, 1996, 2000, 2002, 2004 and 2008) (accessed on 8 June ); Emanuel et al.2009
16. S. Gbadesin & D. Wendler. Protecting communities in Health Research from Exploitation. Bioethics 2006; 20(5): 248-253
17. A. Ballantyne. 'Fair Benefits' Accounts of Exploitation Require a Normative Principle of Fairness: Response to Gbadegesin and Wendler, and Emanuel et al. >Bioethics 2008; 22(4): 239-244.
18. There is at least one more adequacy criterion: the ability to nullify advantages of bargaining position. This condition is a byproduct of Ballantyne's critique of Emanuel et al.'s fair benefits account. The fair risk account satisfies this condition, but applying this condition to the fair risk account would not illuminate a strength or a weakness of the account, so in the interest of space this condition will not be discussed in this article. For more on this condition, see: Ballantyne
19. For an example of a paper that critizies the practialtiy of the reasonably available standard, see: R. Crouch & J. Arras. AZT Trials and Tribulations. Hastings Cent Rep1998; 28: 26-34.
20. Presumably risk will be considered when calculating the risk/benefit assessment for the social value of the research, but not when calculating fairness in the distribution of benefits and burdens to individual subjects or host communities.
21. Mikhail Valdman thinks that information about background injustices can not only confuse issues of micro and macro allocation, but it can confuse obligations to avoid exploitation with obligations to aid. In a recent article on exploitation and injustice, Mikhail Valdman suggests that a micro-level principle of fairness should be 'anti-historical,' meaning that it should disregard the 'origins, causes, or history' of a party's starting position in a transaction. He argues that the presences of a background injustice is neither a necessary nor a sufficient condition for micro-level exploitation, in fact, it does not even contribute to the wrongness of exploitation. The history of a party's starting position is, however, relevant when determining obligations to aid. 'When a person's troubles stem entirely from his own fecklessness, it is natural to think that he has a weaker claim to the aid of others than if his troubles had stemmed from injustice or from forces beyond his control.' Because historical information is irrelevant to questions of exploitation, but relevant to questions of aid, including background considerations runs the risk of 'conflating the wrongness of ignoring the desperate with the wrongness of exploiting them.'M. Valdman. Exploitation and Injustice. Soc Theory Pract 2008; 34(4): 556.
22. According to P29 of the version of the Declaration of Helsinki, 'The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or not treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.' See WMA2000
23. P. Lurie & S. Wolfe. Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. N Engl J Med 1997; 337: 853-856
24. N. Kass. 2008. Just Research in an Unjust World: Can Harm Reduction Be an Acceptable Tool for Public Health Prevention Research? In Global Bioethics: Issues of Conscience for the Twenty-First Century. R. Green, A. Donovan & S.A. Jauss, ed. Oxford: Clarendon Press89-115.
25. Nancy Kass introduces such advocacy as a necessary but not sufficient criterion for morally acceptable research
26. Such a trial can be morally acceptable, but not all harm prevention trial designs will be acceptable. For a list of other necessary criteria see Kass
27. J. Rawls. 1971. A Theory of Justice. Oxford: Oxford University Press.
28. Equality of gain requires price discrimination based on need. If A is selling the same product to both B and C, but A knows that B's desire for the product is much greater than C's, then A must charge B a higher price for the same product. If A charges B and C the same price, and A's utility gain is equal to C's utility gain, then A's utility gain will be less than, and therefore not equal to, B's utility gain.
29. In David Resnik proposed an account of exploitation in which fairness is based on equality of gain. According to Resnik, a criterion that requires nothing more than treating people equally is so intuitively appealing that 'Many different theorists, with the possible exception of libertarians, would view inequitable transactions or relationships as unjust.' Appealing as it may be, however, equality of gain as a criterion of fairness in micro-level transactions is problematic for the reasons Wertheimer notes, and Resnik neither acknowledges nor defends against these objections. For more, see: Resnik 2003
30. One could argue that applying equality of holdings in the context of international research would result in a requirement that looks very much like the reasonably available standard. If the cooperative venture between a sponsor and a host community produces an effective therapeutic intervention, then equality would obtain if both parties received the finish product. But this formulation of equality would have the same problems as the reasonably available standard and is therefore not a promising candidate for fairness in international research.
31. Wertheimer proposes a similar requirement when he considers and then rejects axiomatic bargaining theory as a principle of fairness. As a candidate principle of micro-level fairness, axiomatic bargaining theory would hold a fair distribution to be whatever rational self-interest-maximizing bargainers would accept. According to Wertheimer, axiomatic bargaining theory can serve as a principle of fairness only if it can do two things: (1) provide a determinate answer to the problem of dividing the burdens and benefits associated with a transaction; and (2) supply a reason to regard this answer as fair. For reasons he explains more fully in his book, Wertheimer declares that the answer to both questions is 'no,' so he dismisses the candidate principle. For more see: Wertheimer