Monday, September 06, 2010

Calling it a day on proceduralism in bioethics

It is unusual that an influential approach within our field is called ‘fundamentally wrong’ by its creator. Reidar Lie, a staff member of the US government’s NIH Department of Clinical Bioethics, and a leading expert on research ethics did just that in reference to the fair benefits approach that he substantially helped bring into being. In a recent commentary Lie conceded that there is ‘something fundamentally wrong’ with the approach.1 Lie proposed a procedural account of justice in international health research instead of a substantive approach. This approach reduces ethics in international health research to a market-like transaction, whereby what is fair is what is negotiated between international pharmaceutical multinationals and their – frequently impoverished, undereducated - local prospective trial participants. There is much talk about partnerships and collaboration among fair benefits proponents, but really market norms reign supreme. Fair benefits proponents amassed – to some extent meaningless – surveys of prospective trial participants’ wish lists in terms of what they would like to receive in return for their trial participation. These laundry lists are indicative of how desperate some trial participants really are (some asked for food and soap, for instance). However, unlike what the NIH staff wanted us to believe, these surveys never told us anything of significance with regard to what benefits, if any, should reasonably be made available to such trial participants.

What triggered Lie’s change of mind? His reaction was informed by an excellent paper in the US journal Hastings Center Report.2 Alex London and Kevin J.S. Zollman tried to put the fair benefits approach into action. Amongst their most significant findings was that the approach would likely result into a race to the bottom, whereby pharmaceutical companies would use their bargaining power to search across the globe for the cheapest possible deal to undertake their research. London and Zollman rightly concluded that the approach would produce results that would not even meet standards of fairness endorsed by its own proponents. Other aspects of the procedural approach to fair benefits have been sharply criticized by other bioethicists.3

It is time to move beyond this approach to fair benefits in international health research, and it is time to stop propagating it in developing countries under the guise of capacity building efforts. Alternative concepts aimed at addressing the normative problem at hand have been proposed. I am looking forward to how this debate will unfold.


1 RK Lie. 2010. The Fair Benefits Approach Revisited. Hastings Cent Rep 40(4):
2 AJ London, KJS Zollman. 2010. Research at the Auction Block. Hastings Cent Rep 40(4): 34-45.
3 RE Ashcroft. 2008. Fair Process and the Redundancy of Bioethics. Public Health Ethics 1: 3-9. U Schuklenk. 2010. For-Profit Clinical Trials in Developing Countries — Those Troublesome Patient Benefits. AJOB 10(6): 52-54.

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