Ethical Challenges in Clinical Trials Involving Older Adults in India: A Bioethical and Public Health Perspective

<ns3:p>India’s aging population is growing rapidly, necessitating increased clinical research to address their healthcare needs. However, older adults remain underrepresented in clinical trials, leading to limited evidence-based treatment guidelines. Ethical complexities such as informed consent challenges, risk-benefit assessments, and participant selection make recruitment in geriatric trials particularly difficult. Cognitive impairments, sensory deficits, and socioeconomic barriers further hinder meaningful participation. Additionally, the absence of tailored ethical guidelines and inadequate oversight exacerbate these challenges. This paper explores key ethical concerns in conducting clinical trials among older adults in India, focusing on informed consent processes, the role of ethics committees, and the necessity for geriatric-specific risk assessment frameworks. We highlight issues of coercion, cultural influences on decision-making, and financial constraints affecting trial participation. Governance frameworks, including ethics committee capacity-building and improved insurance coverage for trial participants, are also discussed. To ensure ethical and inclusive research, we recommend strengthening regulatory oversight, integrating clinical trials within public health programs, and fostering community engagement to enhance trust in research. A systematic approach incorporating bioethics, public health priorities, and equitable participant selection is essential for ensuring that clinical trials among older adults uphold ethical principles while contributing to improved healthcare outcomes.</ns3:p>