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Undue Fear of Inducements in Research in Developing Countries

Published online by Cambridge University Press:  01 April 2009

GARDAR ARNASON  and
ANTON VAN NIEKERK
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Extract

Prematurely born children who have underdeveloped lungs may suffer a potentially fatal condition called respiratory distress syndrome. A U.S. company developed a drug, called Surfaxin, to treat such poorly functioning lungs. A placebo-controlled study was planned in four Latin American countries (Mexico, Ecuador, Bolivia, and Peru). At the time, in 2001, four treatments were already on the market, although not available to the research populations used in the study. This case is usually discussed as part of the standard of care debate or offered as an example of exploitation. However, what concerns us in this case is rather the choice given to the parents of a prematurely born child under these circumstances: “You can give consent for your child's participation in this study. Half of the babies enrolled will receive sham air and are as likely to die as if they had not enrolled. The other half will receive an active treatment and are more likely to survive.” The parents can vastly increase their baby's chances of survival by participating in the study. Can the consent be voluntary? Do the parents have any meaningful choice?

Type
Special Section: Vulnerability Revisited
Information
Cambridge Quarterly of Healthcare Ethics , Volume 18 , Issue 2 , April 2009 , pp. 122 - 129
Copyright
Copyright © Cambridge University Press 2009

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References

1. This example is from Macklin R. Double Standards in Medical Research in Developing Countries. Cambridge, UK: Cambridge University Press; 2004:17–8.

2. See, for example, McCarthy M. US company's plan for trial in Latin America draws fire. The Lancet 2001;357:691; London AJ. Justice and the human development approach to international research. Hastings Center Report 2005;35(1):24–37, at p. 27; Denny CC & Grady C. Clinical research with economically disadvantaged populations. Journal of Medical Ethics 2007;33:382–5, at p. 384; and see note 1, Macklin 2004:17–8.

3. As a thought experiment, this example is not entirely realistic. It does try to create ideal circumstances that will show relevant characteristics while excluding irrelevant, complicating factors usually present in real life.

4. Schroeder S, Gefenas, E. Vulnerability: Too Vague and Too Broad? Cambridge Quarterly of Healthcare Ethics, this issue, 113–121.

5. The academic literature on undue inducement shows that many are in favor of allowing inducements or incentives, at least to some extent; see, for example, Emanuel EJ. Undue inducement: Nonsense on stilts? The American Journal of Bioethics 2005;5(5):9–13; Grant R, Sugarman J. Ethics in human subjects research: Do incentives matter? Journal of Medicine and Philosophy 2004;29(6):717–38; Wilkinson M, Moore A. Inducement in research. Bioethics 1997;11(5):373–89; Emanuel EJ, Currie XE, Herman A. Undue inducement in clinical research in developing countries: Is it a worry? Lancet 2005;366:336–40; Grady C. Money for research participation: Does it jeopardize informed consent? The American Journal of Bioethics 2001;1(2):40–4; Hyun I. Fair payment or undue inducement? Nature 2006;442:629–30; Wertheimer A, Miller FG. Payment for research participation: A coercive offer? Journal of Medical Ethics 2008;34:389–92; see note 2, Denny, Grady 2007.

6. This is a point of deductive inference. More formally, the argument is (1) if inducements for study S are ethically problematic, then it is not the case that study S is otherwise ethical [p→ ⌐q] and (2) study S is otherwise ethical [q]; therefore (3) it is not the case that inducements for study S are ethically problematic [⌐p]. We hope that this paper will substantiate the first premise of this argument.

7. Council for International Organizations of Medical Science and the World Health Organization (CIOMS and WHO). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Guideline 7. Geneva: CIOMS, 2002; available at http://www.cioms.ch/frame_guidelines_nov_2002.htm (last accessed 30 June 2008).

8. UNESCO. Universal Declaration on Bioethics and Human Rights. Article 15, paragraph 2. 19 October 2005; available at http://portal.unesco.org/en/ev.php-URL_ID=31058 (last accessed 30 June 2008).

9. Nuffield Council on Bioethics. The Ethics of Research Related to Healthcare in Developing Countries. 2002:79 (paragraph 6.27).

10. See note 9, Nuffield Council on Bioethics 2002:79 (paragraph 6.28).

11. See note 9, Nuffield Council on Bioethics 2002:71 (paragraph 6.2). See note 7, CIOMS and WHO 2002, commentary on guideline 7.

12. See note 9, Nuffield Council on Bioethics 2002:79 (paragraph 6.29).

13. See note 7, CIOMS and WHO 2002, commentary on guideline 7.

14. See note 5, Wilkinson, Moore 1997:376.

15. See note 5, Wilkinson, Moore 1997:377.

16. See note 5, Wilkinson, Moore 1997:377.

17. See note 5, Wilkinson, Moore 1997:377.

18. The possibility of harm is normally associated with taking risks, but is not an essential component thereof. If I (A.v.N.) buy my wife a present for her birthday and I do not want her to know what it is beforehand, but keep it in my cupboard, I run the risk that she will discover it. Her discovering it can, however, in no persuasive sense be regarded as harm to either her or myself.

19. The question of the nonexistence of reliable IRBs in some developing countries is a different matter, not being under discussion here.

20. The argument here is not that participating in research is just like work; the point is simply that we accept money, goods, and services in different areas of life that are aimed at influencing or changing our behavior without any relevant ethical concerns.

21. See note 9, Nuffield Council on Bioethics 2002:78 (paragraph 6.27).

22. Bentley JP, Thacker PG. The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics 2004;30:293–8.

23. The company did in fact redesign the study, but it was also relocated to the United States. See note 2, London 2005:27.