Globalization of Clinical Trials- A Review of Underlying Ethical and Scientific Considerations Involving Human Subjects in India

Abstract

The conduct of clinical research involving the participation of human beings embroils a variety of ethical issues like dignity, liberty, autonomy, privacy and bodily integrity. The ethical conduct of a clinical trial just not only includes a signature on the informed consent form by the concerned participant but protecting the dignity, rights, interests, and safety of research subjects must continue throughout the duration of the study. Pharmaceutical industries are legally and ethically bound to protect human participants involved in clinical research. This article reviews and describes the scientific and ethical aspects of clinical trials and necessary regulatory mechanism to protect the rights, dignity, and privacy of human subjects: the institutional review board, the Ethical committee, the sponsor, the informed consent process and the investigator in developing countries like India. This article also reviews some of the important issues like informed consent, payment for participation in a clinical trial, and defining standard of care in critically ill patients.