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.

A yellow light for male circumcision

In the past few years, a series of randomized controlled trials indicated that male circumcision reduced the risk of men acquiring HIV from women during hetrosexual intercourse. This finding seemed to confirm two decades of less rigorously controlled studies, and has turned out to be a rare success in the world of HIV prevention research, a world still reeling from failed HIV vaccine, diaphragm and microbicide trials. Male circumcision has always been a contested practice, so findings of the randomized controlled trials on male circumcision predictably sparked a great deal of debate. Some critics have argued that the findings were untrustworthy for a variety of reasons: because the trials were stopped prematurely or because not all possible confounders had been controlled for. Some of these criticisms were motivated by sincere concerns about scientific standards, but many times it seemed that criticisms of the trials were driven by a priori ethical views about the irrationality and harmfulness of male circumcision as such. In the meantime, emerging news items about male circumcision and HIV prevention are invariably accompanied by verbal battles among pro- and anti-circumcisionists in their comments sections.

The world has moved on. Or, at least, the biomedical research establishment in developed countries -- and in some developing ones -- seem to have moved on. The methods and findings from the randomized controlled trials are no longer the main event. The focus now is on how to implement male circumcision as an HIV prevention strategy in high HIV-prevalence countries with low-circumcision rates, mainly in sub-Saharan Africa. And the wallets are starting to open. To use a traffic metaphor, the strategy is getting a 'yellow light': proceed, but with caution. Caution for surgical risks in resource-poor clinics. Caution for diversion of scarce resources from other important health needs to circumcision initiatives. Caution for risky sex behavioral change among the recently circumcised. And a variety of other vexing and challenging hurdles. But there is the overwhelming sense of rolling up one's sleeves, that this is a fight worth fighting.

In the interests of full disclosure, my colleagues and I published a 'proceed with caution' piece about HIV and male circumcision last year in the Journal of Medical Ethics. But that piece does not have the same sort of authority or significance as last week's commentary article in Journal of the American Medical Association or the perspective piece in the New England Journal of Medicine: these are prestigious journals with a large and influential readership, and these are some well-known authors. Initiatives to promote male circumcision seem to have gotten the official yellow light, and join the increasingly crowded and messy world of HIV prevention.

Governing unto death in Zimbabwe

If you were ever wondering if politics is a 'social determinant of health', well, just take a hard look at Zimbabwe. A few decades ago, the country was the breadbasket of the sub-Saharan region, and it is now heavily dependent on food aid and imports, with an economy crippled by massive debt and astronomical levels of inflation. In fact, its chief export in the coming months, besides Zimbabweans, could be infectious disease. This week, the Zimbabwean health minister, David Parirenyatwa, has declared the nation’s recent cholera outbreak a national emergency, and has asked for outside help in bringing the epidemic under control. But to bring the epidemic under control, you would need more than just oral rehydration therapy and truckloads of antibiotics. You would need a functional health care system. But that would require a government actually devoted to the welfare of its own people, rather than lining the pockets of some of its own people, and blaming foreign powers (while also asking them for stuff) whenever things go wrong. So what to do?

The Kenyan Prime Minister Raila Odinga -- in a rare display of backbone by an African leader -- has called for the isolation and ousting of Zimbabwean president Robert Mugabe. In the grander scheme of things, this could be as effective a public health intervention as any. Epidemiologist John Snow is said to have removed the handle on the water pump on Broad Street in London in 1854, once he discovered that contaminated water from the pump was responsible for the city's deadly cholera epidemic. The outbreak dissipated soon afterward. In Zimbabwe, Mugabe is the pump handle.

UPDATE: I was premature in calling President Mugabe the 'pump handle.' Today in a news conference he declared that there is no cholera epidemic in Zimbabwe. So it would be better to characterize him as a public health version of Jesus Christ the Savior, healing sick populations with his miraculous powers.