Clinical Trials And Human Rights: Ethical Standards Under International Law
- IJLLR Journal
- Dec 13, 2025
- 2 min read
Pooja S, The Tamil Nadu Dr Ambedkar Law University
ABSTRACT
This article offers a critical examination of the ethical, legal, and regulatory dimensions of clinical research in India, assessed against internationally acknowledged instruments and codes such as the Nuremberg Code (1947), the Declaration of Helsinki (1964–2024), the Belmont Report (1979) and the CIOMS Guidelines. Clinical trials are central to medical progress and must be vigorously safeguarded to uphold participants’ autonomy, safety and dignity. While India has incorporated numerous global norms—among them the Drugs and Cosmetics Act, 1940; the Drugs and Cosmetics Rules, 1945; the Indian Good Clinical Practice (GCP) Guidelines; and the New Drugs and Clinical Trials Rules, 2019—persistent problems in enforcement, openness, compensation and protection of vulnerable populations remain.
This study identifies significant shortcomings in India’s regulatory supervision despite extensive regulatory texts, noting failures within the ethics committee ecosystem—such as deficient informed consent procedures, inadequate resourcing of Ethics Committees, insufficient compensation for trial-related harms, and systemic exploitation of socioeconomically marginalised groups. A comparative review with international frameworks, particularly the EU Clinical Trials Regulation, underscores the necessity for stronger enforcement tools and capacity- building in India. We advance the argument that robust governance of clinical research in India requires more than ethical exhortations; it necessitates enforceable statutory powers, institutional accountability, strengthened participant protections grounded in responsibility, and heightened participant-focused oversight. The paper urges clearer legislation, enhanced supervision, institutional capacity for system monitoring, and harmonisation with global research-ethics best practices so that scientific advancement does not trample human rights in the pursuit of progress in clinical trials.
Keywords: Clinical Trials in India. New Drugs and Clinical Trials Rules, 2019. Drugs and Cosmetics Act, 1940. ICMR Ethical Guidelines. Guidelines for Indian Good Clinical Practice (GCP). Informed Consent. Vulnerable Populations. CIOMS Guidelines. Belmont Report. Post-Trial Access. Governance of Biomedical Research. Human Rights in Clinical Trials. Comparative Regulatory Analysis.
