Bioethics and Protection of Personal Information in Experimental Studies

Kim, Ock Joo

Abstract

Experimental studies involve intervention and manipulation of study elements such as randomization of the participating groups. In general, experimental studies involving human are riskier than observational studies, demanding robust ethical vigilance and compliance among such stakeholders as investigators, sponsors, IRBs and health authorities. Social values of research should be counted as a primary ethical consideration in experimental research. It is unethical to put human subjects into uncertain and risky conditions if the study does not pursue valuable knowledge. Sound scientific design is prerequisite for good ethics. Risk-benefit ratio of the study must be carefully evaluated study. Not only risks from physical harms but also socio-economical and psychological harms from the study should be considered as risk of the study. Risks from the design of the study such as randomization and placebo must be carefully examined. Voluntary informed consent is essential in experimental studies involving human. Human subjects, before they decide to participate in the study, must be informed the followings: risks, benefits, experimental procedures, alternative treatment, compensation for injury, and participants' voluntariness and right to withdraw at anytime. Experimental studies are usually required written consent documentation and full institutional review board (IRB) review. Other elements of experimental research ethics includes special protection for high risk groups and various vulnerable groups, and protection of privacy and confidentiality.