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The Role of Research Ethics Committees in Making Decisions About Risk

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Abstract

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role.

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Notes

  1. World Medical Association (1964).

  2. Athanassoulis and Ross (2010, p. 219).

  3. We are assuming in this paper that death, particularly unexpected death, is usually a kind of harm. We are aware that in some contexts this assumption is controversial and that there exists a long tradition of questioning whether death can constitute a harm because it leaves the dead person incapable of suffering. However, in the context of the topic of this paper we believe our assumption represents a widely accepted, and intuitively plausible, view.

  4. Moral hazard is a term borrowed from economic theory—it arises when someone is likely to take a risk because they are not the ones who will sustain losses that may result. An interesting history of the term and its use can be found in Rowell and Connelly (2012, pp. 1051–1075).

  5. The classic work in psychology on this topic has been done by Daniel Kahneman and Amos Tversky. See Kahneman and Tversky (1982).

  6. Slovi (2010, pp. 96–109).

  7. Sunstein (2002a, pp. 156–171) and Sunstein (2002b, pp. 33–49).

  8. A number of theories might support such a view of governments, from an Aristotelian conception of the state as a collection of individuals trying to lead eudaimon lives, to conceptions of the state as facilitators of economic activity.

  9. Garrard and Dawson (2005, p. 421).

  10. Garrard and Dawson (2005, p. 420).

  11. The Medicines for Human Use (Clinical Trials) Regulations (2004, p. 20).

  12. Edwards et al. (2004). For a more detailed discussion of the role of inducements see Grant and Sugarman (2004).

  13. Kahneman et al. (1982).

  14. Edwards et al. (2004).

  15. Garrard and Dawson (2005, p. 423).

  16. Ross and Athanassoulis (2010a, b), Athanassoulis and Ross (2010) and Ross and Athanassoulis (2012).

  17. Athanassoulis and Ross (2010, p. 149f).

  18. Ross and Athanassoulis (2012).

  19. Generally, but again not inevitably, taking a risk is easier to justify when doing so is the only option for achieving a good or avoiding a harm, and conversely if risk taking is one of many options it is a lot more difficult to justify the decision to do so.

  20. For more on these and other objective circumstances of risk see Athanassoulis and Ross (2010).

  21. Athanassoulis and Ross (2010).

  22. Angell et al. (2006).

  23. Rational choice theory is an economic theory designed to explain the choices/behaviour of persons in a market, the origins of which are sometimes accredited to Adam Smith’s An Inquiry into the Nature and Causes of the Wealth of Nations. Simply put, according to the ‘rational choice model’ a risk is well taken when the expected value multiplied by the probability of the desired outcome is higher than the (expected value X probability) of all other possible outcomes. In economics, expected values are often given in monetary terms. The important point for our purposes is that rational choice models rely on expected rather than realised values. This initially simple theory has been adjusted and developed over the years to try and accommodate anomalies that seem to arise when decisions are made under conditions of uncertainty. A good general summary of the evolution of rational choice thinking can be found in Kreps (1988).

  24. We use brackets to indicate the very narrow sense of ‘rational’ used in rational choice theory, also sometimes referred to as ‘instrumental rationality’.

  25. US Federal Policy for the Protection of Human Subjects, par 46.111(a)(2).

  26. World Health Organisation (2000).

  27. World Medical Association (2000).

  28. European Clinical Trials Directive (2001).

  29. European Forum for Good Clinical Practice (1997)

  30. World Medical Association (2013).

  31. European Clinical Trials Directive (2001).

  32. European Forum for Good Clinical Practice (1997).

  33. Rajczi (2004, pp. 338–348).

  34. Happich et al. (2009, pp. 88–95).

  35. Weijer (2000, p. 344).

  36. Weijer (2000, p.356).

  37. Rajczi (2004, p. 342).

  38. Ideal Observer theory is a well-established doctrine within normative ethics. Ideal observers or choosers are generally taken to be impartial (disinterested and dispassionate), rational (excellent deliberators) and to have ‘a good grasp of all the relevant non-moral facts’. The typical philosophical objections to such theories are that the standards they set are both unachievable—particularly impartiality (Friedman 1989; Young 1990, pp. 104–105)—and undesirable (Wolf 1982, 1992).

  39. For more on this see Ross and Athanassoulis (2012).

  40. For more on this see Ross and Athanassoulis (2012).

  41. Kerrison and Pollock (2005, p. 487).

  42. Ashcroft et al. (2005, p. 587).

  43. Annas (2011, p. 130). For more on all these ideas see Annas, Chapter 8.

  44. Aristotle (2013).

  45. For more on these Aristotelian ideas see Nussbaum (1986), Chapter 11.

  46. We are grateful to an anonymous reviewer for very helpful comments on an earlier version of this paper.

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Authors and Affiliations

  1. University of Cambridge, London, UK

    Allison Ross

  2. Keele University, Keele, UK

    Nafsika Athanassoulis

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  1. Allison Ross
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  2. Nafsika Athanassoulis
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Correspondence to Allison Ross.

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Allison Ross and Nafsika Athanassoulis are independent scholars.

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Ross, A., Athanassoulis, N. The Role of Research Ethics Committees in Making Decisions About Risk. HEC Forum 26, 203–224 (2014). https://doi.org/10.1007/s10730-014-9244-6

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