The death of babies in Indian clinical trials

About a week ago, the London Times Online broke a story about the deaths of 49 infants in clinical trials conducted at the All India Institute of Medical Sciences (AIIMS). Worse, the sad information was not volunteered by researchers or regulatory agencies; it was dug up by a non-governmental organization operating under India's freedom of information act. Accusations of 'using infants as guinea pigs' and unfairly targetting the vulnerable poor swiftly followed. Calls for official investigations. Editorial and commentaries. Spirited defences of the study from the research institution. In short: all the trapping of a research ethics scandal.

With these sorts of things, it is generally wise to wait for the smoke to clear, at least for those of us with the luxury of time. Those scandalized by or merely interested in such cases typically do not have the research protocol in hand, nor background information about how the protocols were followed (or not) in actual practice. In the case of the studies at AIIMS, it is not clear from media reports what the research questions of the clinical trial were or which drugs were given to the babies. Nevertheless, there are some recurring pieces of information that are worth noting:

• The infants in the trials were less than a year old.


• The infants had pre-existing medical conditions, i.e. were suffering from sepsis or respiratory failure (and were placed on ventilators).


• The parents of the infants were generally poor and illiterate.

The AIIMS defends the trials by claiming that none of the infants died from the administration of trial drugs, and that all of the studies were approved by a competent and independent ethics committee. This is good to know, if true. But the more important ethical questions are: do these studies stand to benefit children in general? Could the children in the trial benefit from participation in some way or was it purely 'non-therapeutic' research? What was the scientific justification of recruiting this particularly vulnerable population? Were the parents of these children, dependent on AIIMS for low-cost care, really in a position to give informed consent for their children to participate in research? On the surface, the studies sound like an ethical hot potato, but only time will tell just how hot they are.