Abstract

India is becoming a hub for clinical trials, and collaboration between developed countries and India in clinical trials has led to concerns regarding the potential exploitation of patients. This study, conducted by a doctorate student, surveyed Indian clinical research professionals about their perceptions regarding the ethical review process and the performance of Indian independent and institutional research ethics committees. The aim of the study was to identify ethical issues and challenges in clinical research in India. 137 clinical research professionals were located and invited via email and/or telephone to participate in the study. Snowball sampling method was used for data collection and a questionnaire with 35 questions exploring ethical issues and challenges was used. A total of 385 surveys were completed and used for analysis. The majority of the respondents were middle-aged, employed by sites and Contract Research Organisations, and had more than 10 years of experience as well as formal research ethics training. The study demonstrates that ethics committees in India have very limited resources. It also suggests that proper procedure, [End Page 81] requirements and financial conditions between applicants and ethics committees should be better defined.