Friday, December 19, 2008

Resuscitating undue inducement

There seems to be such a thing as ethical habit and routine. It goes something like this: someone finds a certain aspect of moral life that perhaps went unnoticed before, and under the light of new attention, it blossoms into an explicit moral concern. One thinks: yes, that is something we ought to care (more) about. This rediscovered concern then gets put into public circulation, and it passes through many hands. It gets standard definitions. It gets slipped into regulations and policies, and repeated. A lot. At a certain point, it becomes something you feel you have to take into account, in certain contexts, even if you are not quite sure what it means anymore.

The notion of 'undue inducement' in international research seems to have gone this route. Researchers commonly induce participants to join their studies by offering them something attractive, something that makes the burdens of research worth their while: the image of themselves as benefitting society perhaps, a key chain, maybe a T-shirt, or cold hard cash. However, the argument goes, what looks like a minor inducement in Chicago may be a whopping big inducement in Kampala, given the socio-economic differences between the two cities. Would the participant in Kampala be free to choose to be in the study, or would he or she automatically agree to join, in order to get whatever was on offer? In that case, aren't the researchers taking unfair advantage of -- i.e. exploiting -- global inequalities to get the poor into their studies? Thus the concern about undue inducements was born. And the concept, which has its legitimate uses, has become a knee-jerk reaction in no time. I have personally experienced discussions in ethics committees where members, in all seriousness, debate about whether $5 in some far-flung land will unravel somebody's agency, and that giving $2 would be better. (I have also heard investigators in central African countries murmuring that 'ethical concerns' about undue inducement are just a con: it is all about saving research money.)

There have initiatives to counteract the fall of 'undue inducement' into ethical habit. Emanuel reasonably proposed that if a study does not pose any great risk, then size does not really matter: give any inducement you want, you won't be making (poor) people act against their better judgment, which is the underlying issue. A researcher who offers a Mercedes to a poor farmer in Zimbabwe if he would join a highly risky phase I tolerance study is unethically manipulative; a researcher who offers a Mercedes to a poor farmer in Zimbabwe to take a simple household survey is just stupid (or a kind of Robin Hood). What makes inducement 'undue' is whether it motivates people take dangerous risks. Being worried about inducements that actually benefit people seems a bit strange.

In this month's issue of Developing World Bioethics, Angela Ballantyne tries to discern what is living and what is dead in regard to undue inducement. The conclusion of the argument is that (a) there is little empirical support for claims that payments distort research participants' assessments of risk in research and (b) that if research sponsors in the developed world are worried about exploitation, they should offer more benefits to research participants (and their communities), not less. It deserves to be read in full, and read widely. Hopefully the paper will help the concept of undue inducement awake from its slumber.

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Blogger Jim Sabin said...

Hi Stuart -

Thank you for this posting and for the link to the excellent Ballantyne article. This is one of the issues I'll be looking into when I'm in India next month. I think your argument is spot on.



9:21 AM  
Anonymous Anonymous said...

Cool, thanks for the heads-up. Just a off-the-cuff response to your post (not the article, which I have not read yet): isn't there a difference between the kind of benefits a sponsor might provide to a community and the kind of benefits a sponsor might provide to an individual to entice enrollment?

This is not to say undue inducement is not a risk in both scenarios, but that there does seem something ethically distinct about a scenario in which a sponsor agrees to build a clinic or provide mosquito nets and one in which the sponsor offers an individual potential subject $75 to participate.


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