Saturday, February 25, 2012

Research ethics committees in developing countries: something old, something new

February has been a rough month for bioethics in the USA. Alleged conflicts of interest at the American Journal of Bioethics -- the top ranked bioethics journal -- has lead to a kind of feeding frenzy of accusation, distain and soul-searching in regard to the whole idea of bioethics and how it is practiced in it's most powerful home. Is bioethics a lousy kind of philosophy? Does it just consist in rationalizing the newest biotechnology that comes along, and running intellectual roughshod over whatever traditional values (often religious) might be threatened by that technology? Is that why bioethicists are lured to agencies and institutions that are part of one might call the military-industrial-university-biotech-pharma complex? Is bioethics losing ability to speak truth to power, because they are part of (or eating hors d'oeuvres with) the 1%?

Perhaps on another occasion there will be room for reflection about whether all this should be a cautionary tale for bioethics in other countries in the world, how much of it is true, and how much of it is overblown to serve the interests of other agendas. For my part, I have been lying low, staying away from bioethics news, and looking at what other journals have been putting out. A recent research ethics article in the Journal of Medical Ethics caught my eye, called 'Ethical Approval in Developing Countries is not an Option' (Online First, requiring subscription, goddammit).

What struck me initially was the obviousness of the title: how is that news? It is like having an article called 'Eating people: some arguments against'. And in a certain way, the point of the article is obvious: when there is an appropriate body in developing countries to review human subjects research conducted by anyone (local or from abroad), then it should be reviewed. The authors cite a published article about research conducted in Nepal, which did not have local Nepalese research ethics committee approval. It doesn't sound like a very risky study, but that is not the point. Nepal has an ethics committee that could have reviewed it, and it was not even submitted.

What makes the article publication-worthy are the underlying issues. Central among them is who should have ensured that the study was submitted to local review. Ethics committees are not detective agencies, who scour the community to find out who is doing research on what. Researchers have to volunteer this information; they also have to know that there is a committee to submit their research to. In many developing countries, this is not straightforward: in some settings, research ethics committees may not exist; where they exist, they may only review certain kinds of (biomedical) studies; and even if they do exist and they could review a certain study, getting information about them and their procedures can be unreasonably taxing for scientists. Compounding the problems, some committees may be dysfunctional and intolerably slow, undermining motivations to bother looking for them.

Perhaps if a study is conducted by a developed world institution, their own research ethics committee should ensure that scientists make good faith efforts to get their research reviewed where it will be conducted, or help them get it reviewed. Or journals should not publish articles in which researchers failed to get their research reviewed where it really is human subjects research, and there really is an adequate body that can appropriately assess its ethics. The authors rightly point out that if researchers from Nepal were to do a research study in the UK or USA, but only sought ethics approval for it in Nepal, and published it, this would be considered scandalous -- but when developed world institutions do the same in the developing world, there is far less concern, even when committee members do not know much more about Nepal than Everest expeditions.

So it is not news that local ethics committee review in developing world ought to be reviewed; the news is how this requirement continues to fall through the gaps.

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