Thursday, March 22, 2012

Research ethics as a sideshow

There seems to be a new approach to the publication of research studies that have been conducted in a questionable way from an ethical point of view, or are otherwise regarded as 'ethically hot.' Call it the pre-emptive strike approach: you still publish the paper, but you also simultaneously publish editorials that criticize the researcher's ethics. A way of having your cake and eating it too. The researchers and their scientific readership are happy, because they get to look at the data; the ethics people are happy-ish, because at least the problems with the study have been raised. I am reminded of the male circumcision and HIV studies in 2007, where an article was first rejected by the Lancet, and then subsequently published in PLoS Medicine with accompanying ethical commentary.

This time around, it is a tuberculosis treatment study. In the most current issue of the International Journal of Tuberculosis and Lung Disease, Aung et. al. describe how their operational research compared two treatment regimes, in order to evaluate the value of extending the intensive phase of anti-TB treatment for one month. The researchers did not ask participants for informed consent, arguing that: (1) neither of the treatment arms were likely to cause harm (2) the participants were be unlikely to be capable of making a rational choice to decide to participate (3) asking them to participate might lead to selection bias. The study was approved by the Bangladesh Medical Council Ethics Review Committee, and published by the International Journal of Tuberculosis and Lung Disease in full knowledge that informed consent was not sought. And published along with two (not one, but two) editorials that reject all three of the justifications given for not obtaining consent from participants.

So it goes. Another possibility would have been not to publish the article; a possible option now is to retract it. But I doubt this will happen. It seems that if an article looks sufficiently important, as long as the research was approved by an ethics committee (even if they admittedly dropped the ball), then it is acceptable to publish, as long as there is an accompanying ethics sideshow.

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