Ethical Issues in Psychotropic Drug Trial

Lee, Hong Shick

Abstract

This paper covered a variety of issues that fall under the general rubric of ethical considerations in clinical psychopharmacologic research. The topics of ethical of subject selection and confidentiality, medication-free research. informed consent for those humans exposed to psychotropic drug research, and possible conflicts of interest in medical researcher/pharmaceutical sponsor were reviewed. Beginning with a brief section on the justifications for engaging in research, this review indentified the codflicts that inevitably arise between society's need for reliable and valid research and our obligation to protect subjects. Also author reviewed the patient consent issues, including the essential elements of informed consent, populations requiring surrogate consent, and confidentiality requirements. The paper continued with a discussion of responsible research practices, including the medication-free research, and conflicts of relationship between researcher and sponsor. In spite of a number of ethical dilemmas in clinical trials, the willingness of the scientist to confront the ambiguities of ethical questions in the pursuit of scientific knowledge reveals a basic truth, that is, the ethical characteristics of the scientist who undertakes such a task. Although it would be impossible to assure the general population that all researchers are ethical, it is incumbent on us to educate future researchers and provide practical guidelines for maintaining the primary ethical values of the individual who performs research with humans.