Indian Journal of Medical Ethics

CASE STUDY RESPONSES

The study served no purpose

V Raman Kutty

DOI: https://doi.org/10.20529/IJME.2007.029


It is perhaps unfair to subject a study done in the early 1970s to the ethical standards of a later period, and thereby judge it harshly. As has been pointed out, ethics is an evolving concept and in the early 1970s, our understanding of what is ethical and just was deficient. It could even be argued that by designing a perfect “experiment” in the field, with a classical randomised blocks design, the study was well-equipped to clear all doubt on the question of the value of nutritional supplements for children. And, as the protagonists said, they had ensured that any child who was seriously sick was immediately helped. After all, the study did deliver the result that nutritional supplementation is almost as good as nutrition plus health intervention.

Larger questions, however, remain. Nutritional supplementation and health interventions are not options you pick from a cafeteria of approaches to battle malnutrition and its attendant consequences. They are the right of every child and they cannot be wilfully denied. To that extent, even the idea of conducting a study on them could be offensive to one’s sense of ethics. Could it be said, for instance, on the basis of the study, that health interventions are not necessary? One could hardly agree with this point of view. What, then, was the point of the study? It could be argued that the researchers did not do any additional harm in a situation where supplements or health care were anyway absent. Even if that were the case, it is doubtful whether the study gained any additional information than would have been possible with a comparison of just three of the groups studied—nutritional supplement alone, health intervention alone, and both together.

One more crucial question remains. Would the investigators have thought of a similar design, even in the 1960s, in any community in the US or among white children? Even the most sympathetic reviewer can only honestly say “no”. What we are faced with, then, is the question of the ethics of taking advantage of ignorance and underdevelopment in a community to serve so-called “scientific” pursuits. Unfortunately, this attitude persists, as is evident in the large number of clinical trials flowing to India.