Research protections in India: a case of unethical ethics?

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.

NIH pulls clinical trials research out of India: but why?

Last month, the National Institutes of Health (NIH) postponed, delayed or scraped nearly 40 clinical trials in India, and it is still not completely clear why. What is clear that it has something to do with the local, Indian regulations governing the conduct of clinical trials, what is called the Drugs and Cosmetics Act. But what about the Act is making the NIH withdraw or suspend its activities is not receiving a clear answer, and creating a vacuum for speculation to enter. Industry experts are talking about an 'unstable regulatory environment' in India, which could mean anything: contradictory policies, bureaucratic cul-de-sacs, or just obstacles to (potential lucrative) drug development. Maybe the Act requires a regulatory structure that the Indian government is not prepared to adequately bankroll: it is always easier to create shiny new regulations than to establish institutions capable of effectively implementing them. Ethics committee chaos can grind research to a halt. Or maybe it has to do with provisions in the Act regarding compensation for research-related harm, that could drive up research costs, precisely in a country that has attracted biomedical research due to its low overhead, ease of recruitment, drug-naive populations, and so on.

India has been a hotbed of concern about global health research ethics for some time. Typically the concerns are about conducting responsible research there among the vulnerable, impoverished sick. But this time it is about the ethics of pulling up stakes and halting research in such circumstances, including (one supposes) research with current or potential benefits for patients. To tap down adverse speculation, you need transparency. Without that, there is nothing to do but watch the rumors freely breed and spread.