Yesterday, in the post below, I mentioned a controversy regarding a substantial withdrawal of research activities by the National Institutes of Health (NIH) in India. The controversy is gradually getting more media coverage, but little in the way of official explanation from the NIH. Here is one possible conjecture, however: the Indian regulations protecting human participants in research are problematic enough to necessitate halting NIH-funded biomedical research there, but the NIH is reluctant to pass official judgment on the regulations of another country with which it has collaborated fruitfully in the past. It is politically sensitive. This hunch can be supported to some extent by an editorial that came out yesterday in the BMJ
, which states that the Indian regulations have three main problems, and that these problems are causally responsible for the recent decline in research activity in India overall, and not just by the NIH.
According to the authors, the three main problems are: (1) the regulations do not state how injuries suffered by research participants, and to be compensated by research institutions, are to be determined as 'research-related'; (2) the regulations have an overly broad interpretation of what counts as a research related harm, including (for example) use of placebo in a placebo controlled trial; (3) the regulations state that ethics review committees and licensing authorities have to help determine whether and to what extent compensation for harm is warranted, but it is unclear they have the relevant skills and resources to do so.
On this reading, it looks like a case of 'unethical ethics.' Unethical ethics occurs when, even with the best intentions, actions or policies meant to promote certain values end up doing serious damage to other important values. In this case, the drive to promote the welfare of research participants has apparently been taken to a point where it becomes difficult to conduct health research at all, including research focusing on important public health problems in India. The BMJ authors end on an optimistic note: the Indian government has the power to restore balance between the interests of research participants and research institutions by reforming the regulations. Time will tell.
Labels: bioethics, clinical trials, India, NIH, Research ethics, research ethics committees