Ethical and Legal Dimensions of Informed Consent for Survivors of Sexual Violence in Indian Clinical Trials

Abstract

A crucial ethical and legal prerequisite for clinical research is informed consent, which ensures the autonomy of participants and protection from coercion. However, where clinical trials involve survivors of sexual violence, the application of informed consent principles becomes deeply challenging. Survivors often experience significant psychological trauma, societal stigma, and structural inequalities that compromise their ability to provide free and fully informed consent. These issues are especially relevant in India, where cultural, legal, and institutional barriers further complicate the ethical conduct of clinical trials involving such vulnerable populations. This paper explores the complexities of truly informed consent in Indian clinical studies on sexual violence research and analyzes the effectiveness of national regulations, such as ‘the New Drugs and Clinical Trials Rules, 2019,’ and international guidelines, such as the ‘Declaration of Helsinki’ and the ‘Council for International Organizations of Medical Sciences’ (CIOMS) guidelines. The paper also examines judicial interpretations of informed consent in clinical research, highlighting landmark Indian cases and global best practices that can appraise policy reforms. By advocating trauma-informed consent procedures, strengthened legal regulations, and survivor-centric ethical standards, this study aims to achieve a more equitable framework for conducting clinical trials with survivors of sexual violence. It thus highlights the need for a balanced approach that maintains both the scientific validity of research and the dignity and rights of participants, ensuring that consent remains a genuine expression of autonomy and not a procedural formality.