Ethical requirements in the clinical drug trial: Indian perspective

Advances in Biomedical Science and Technology and their application in medicine are provoking anxiety among the public and society with new ethical dilemmas. Society is concerned about what it fears would be abused in scientific investigation and biomedical technology. Biomedical research (BMR) involving human participants (HPs) raises many unique and complex ethical, legal, social, and political issues. Research scholars in medical education need sound knowledge and a clear perspective in their relevant field. The academic curriculum hardly includes such experiences and skills, neither taught nor shared. Mastery and proficiency on the topic shall assist researchers in dealing with research misconduct issues challenging legal and ethical aspects in their experiments, studies, and publication. There are national and international guidelines, regulations, and acts to curb any unhealthy BMR, including clinical drug trials (CDTs). All research involving HPs should be conducted per three basic ethical principles: respect for the person, beneficence and justice. The present guidelines are directed at applying these principles to research involving HPs. The scholars need to remember those defined ethical and legal issues, failing which legal intervention will come into force. In this regard, relevant ethical and legal issues for carrying out BMR-like CDT will be focused.
Keywords: Indian Council of Medical Research; Central Licensing Authority; Indian Medical Council Regulations.