The India Experience

This article featuring India constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream program funded by the Fogarty International Center for Advanced Study in the Health Sciences. Research ethics is a growing area of work and interest in India. Ethics review remains the weakest component in the mechanism of good clinical practice, and there is a severe dearth of professionals trained in ethics who can provide leadership. Although the Indian Good Clinical Practice Guidelines, the Indian Medical Council Act, and the Drugs and Cosmetics Act require that the Indian Council of Medical Research’s ethical guidelines be followed as a mandatory requirement for physicians who conduct research, there is a pervasive lack of awareness of basic requirements guiding the ethical conduct of research. There is a great need to strengthen India’s research ethics capacity and regulatory framework for research.