Clinical trials, consent, and context: the Indian experience

Abstract

This thesis shows how the perceptions of practitioners and other stakeholders in clinical research in India differ from how informed consent appears in the academic literature and the regulatory framework. My empirical research findings hint at apathy towards the purpose and process of informed consent. I argue that this apathy raises doubts as to the impact of prescriptive work on informed consent in clinical research.

I reach the above conclusion in three broad parts. First, I outline the conceptual framework of informed consent (what makes consent ethically and legally valid) and show how this conceptual framework appears in practice in India and what problems have arisen with regard to the way informed consent is dealt within this contemporary context. Second, I show how informed consent has been legally translated by courts in India and the limits of law in dealing with informed consent in clinical research. Third, I lay out the findings of an empirical research that I conducted in India (between April 2016-October 2016) that reflect stakeholder perspectives on informed consent.

The empirical findings are analysed using the contrasting method where stakeholder perspectives are juxtaposed with how informed consent appears in the academic literature and law. What emerges from my data is a picture that presents a situation where the process of informed consent is oftentimes followed neither as an ethical compulsion nor strictly as a legal obligation. It is not uncommon that researchers consider the process of consent as a mere procedural necessity, thereby performing the action without affording much consideration to either law or ethics. This often leads to apathy towards the ‘larger cause’ (or end goal) of informed consent which, I suggest, is a major reason for the misalignment between ethics, law and the practice of informed consent. To mitigate this misalignment I suggest some non-traditional tools of behaviour regulation alongside the traditional ones.