COMPENSATION, VULNERABILITY, AND ETHICAL EROSION IN CLINICAL TRIALS IN INDIA

Abstract

The concept of compensation is generally regarded as an ethical principle in clinical trials as it protects the research participants who undertake the risks of biomedical research. In developing countries like India, where people have limited access to healthcare facilities and socio-economic disparities prevail, compensation may play an insignificant role for justice and more as an alternative of real and meaningful informed consent. Similar ethical gaps can be seen in the governance of clinical trials in India. This paper critically examines the functioning of compensatory frameworks in situations where economic, structural vulnerability and power imbalances prevail. By citing various international perspectives, this paper contends that while formula-based compensation is suitable and procedurally effective, it has the capacity to drift away from ethical attention from voluntarism and precaution towards post-injury remedy. In such circumstances, compensation may reinforce the structural challenges of informed consent rather than making them good. The paper further argues that compensation cannot be the sole base for ethical protection in clinical research but must be based on such principles that gives importance to informed consent, institutional accountability, and substantive justice for vulnerable populations which forms the core of any ethical clinical trial.