ETHICAL ISSUES IN RANDOMIZED CONTROL TRIALS: A REVIEW

Abstract

Randomized Control Trials (RCTs) are scientific experiments that are used to investigate the effectiveness of various interventions in the field of Medicine and public health. As a result of complexity of the process, even the competent individuals are not able to understand the process of randomization with anticipated consequences associated with it. There is rise in trend of research and conduct of RCTs in developing countries; hence, there is a need to review all ethical issues confronted by the researchers during conduct of such trials. An Online literature search was carried out in April 2015 to May 2015 from Google Scholar, BioMed Central Ethics and PubMed using the key term “Trials”, “Randomized Control Trials”, “Ethical issues” and various synonymous terms from the titles of the articles. This resulted in 25 articles. Following, which these articles were scrolled down, and all articles with ethical issues encountered with different type of trials, were included. Avoiding the duplication of issues, 13 articles were finally selected for review. From the review narrates that ethical issues of patient autonomy, informed consent, therapeutic misconceptions, state of equipoise for individuals, clinicians and researchers, controversies between placebo and active control orthodoxies, design biases, role of gate keepers, benefit verses risk assessment and protection of vulnerable groups are the important ethical issues highlighted by various researchers. There can be issues related to some surgeries, early cessation of RCTs due to some apparent benefits and conduct of trials in third world countries. It is imperative that institutional review boards should consider all such issues during ethical assessment of such trials.

Keywords:Benefit verses risk assessment Institutional review board (IRB), Randomized Control Trials (RCTs), vulnerable groups.