| Résumé : |
Informed consent is widely regarded as a cornerstone of ethical clinical research, ensuring that participants voluntarily take part in the trials with full awareness of the benefits and risks. However, in the Indian context, obtaining informed consent is particularly challenging due to cultural diversity, linguistic variations, and socio-economic disparities that often undermine patient autonomy. This paper critically examines informed consent practices in Indian clinical trials, highlighting the tension between universal bioethical norms and the lived realities faced by vulnerable populations. Further, drawing insights from international frameworks such as the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, as well as the Indian regulatory mechanisms, particularly the New Drugs and Clinical Trials Rules, 2019, and relevant judicial precedents, the paper highlights key gaps between policy and actual practice. It argues that informed consent in India often remains a procedural formality rather than an ethical process of true participant empowerment. To address these concerns, the paper proposes a Contextual Consent Model grounded in relational autonomy, culturally sensitive communication, and the involvement of independent witnesses. By aligning ethical principles with India's social realities, this model aims to advance clinical research in India while preserving the dignity and rights of all individuals involved in the study. The paper adopts a socio-legal methodology integrating doctrinal analysis with a public health ethics perspective. |
Informed consent in Indian clinical trials: Rethinking autonomy through a contextual consent model in Ethique et santé, n°1 (Mars 2026 Vol. 23) 
