Reflections on Gadchiroli by Sadath A Sayeed, Harvard Medical School, Boston

IJMC

By Sadath A Sayeed,  Harvard Medical School, Boston

“In 1993, the Society for Education, Action, and Research in Community Health (SEARCH) began conducting what it termed a “field trial of home-based neonatal care” in rural India. The centrepiece of this clinical, intervention-oriented study was the training of village women to evaluate babies around the time of their birth, teaching and delivering essential medical care to those in need during the first month of life. The published results of this community trial were remarkable: incidence of neonatal morbidity and mortality was dramatically reduced in the intervention villages over a three-year time frame. Nevertheless, the work of SEARCH has been the subject of criticism in a textbook on international biomedical research published in 2007

Using a standard paradigm regarding the protection of human research subjects, it might seem a straightforward task to sound alarms about the Gadchiroli field trial. The main complaints appear to be as follows: 1) no trial was needed because antibiotics for bacterial sepsis in newborns are known to work; 2) even if a trial was needed in order to show that trained healthcare workers could effectively diagnose and treat babies with antibiotics, the Declaration of Helsinki was violated because adjacent control villages were not provided with the highest standard of care for the purposes of comparison. The ethical critique is captured by the following:

It is wrong for them to exploit the situation by conducting research that they could not get away with in affluent populations. And it is a strange sort of justice that excuses it on the grounds that villages in the control group are no worse off than many other villages in rural India”

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