CONSTITUTIONAL CHALLENGES AND SAFEGUARDS IN CLINICAL TRIALS

AUTHOR – SAMSON ALBERT S, STUDENT AT VINAYAKA MISSION’S LAW SCHOOL

BEST CITATION – SAMSON ALBERT S, CONSTITUTIONAL CHALLENGES AND SAFEGUARDS IN CLINICAL TRIALS, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (8) OF 2025, PG. 359-366, APIS – 3920 – 0001 & ISSN – 2583-2344.

Abstract

Clinical trials play a crucial role in advancing medical science, yet they also raise significant constitutional concerns regarding participants’ rights and protections. This paper explores the constitutional challenges and safeguards in clinical trials, focusing on two fundamental rights enshrined in the Indian Constitution: the Right to Life and Health (Article 21) and the Right to Equality (Article 14).

The Right to Life and Health guarantees every individual the highest attainable standard of health, which extends to ethical participation in clinical trials. However, concerns arise when trials compromise participants’ safety, lack proper informed consent, or fail to provide post-trial medical care. The Supreme Court of India has played a pivotal role in upholding ethical standards by delivering landmark judgments that emphasize the responsibility of pharmaceutical companies, research organizations, and the government to protect trial subjects. These rulings highlight the need for stringent guidelines, transparency, and accountability to prevent exploitation and ensure participant welfare.

Similarly, the Right to Equality underscores the need for fairness in the selection of trial participants. Discrimination in participant recruitment—whether based on socioeconomic status, gender, or other factors—raises ethical and legal concerns. Marginalized communities, often targeted for clinical trials due to their economic vulnerabilities, may face undue risks without sufficient safeguards. Ensuring equal access to trial benefits, including necessary medical care post-trial, is essential in maintaining justice and fairness in medical research. Addressing these concerns requires a robust regulatory framework that prevents biases in participant selection and mandates equitable distribution of benefits arising from clinical research.

By analyzing constitutional provisions, judicial precedents, and regulatory mechanisms, this paper aims to highlight the pressing ethical and legal challenges in clinical trials while suggesting measures to strengthen participant rights. A balanced approach—where scientific advancements align with fundamental rights—is crucial to maintaining the integrity of clinical trials and ensuring that medical research serves humanity without compromising ethical principles.

 Keywords:- Clinical trials, Indian Constitution, the Right to Life and Health (Article 21), the Right to Equality (Article 14), Discrimination, Marginalized communities, safeguard and humanity