Ethical Considerations in Clinical Research: A Comprehensive Review
Venkataramana Kandi, Sabitha Vadakedath
Abstract
Clinical studies involve research that is carried out in human beings and has direct implications on the health of people who participate in it as study subjects. Moreover, clinical trials are performed on healthy and diseased human subjects, wherein the safety and efficacy of a novel drug/device are tested. Therefore, the study design and the subject recruitment assumes increased significance. In this review we attempt to comprehensively discuss the importance of ethics in clinical research and specific ethical considerations concerning the evaluation of medical products, epidemiological studies, human genetics, and genomic research, transplantation studies, reproductive procedures/interventions, research among geriatric and pediatric populations and research involving the development of vaccines and diagnostic devices.