[Ethical issues].

Abstract

Key concepts which should be recognized to understand today's medical ethics required for information management regarding clinical research are privacy protection, use limitation, individual participation, and accountability. Special attention should be paid to concepts other than privacy protection, because they are fairly new to medical professionals. Furthermore, in laboratory medicine, we have real problems, for example, how to protect privacy concerning specimens gathered from patients. Therefore, there have been many kinds of rules or guidelines established recently. Although we tend to strictly follow these guidelines, it is not always clear which guidelines should be applied to certain cases, or they do not always exactly correspond to a specific case. The full understanding of the principles of medical ethics represented by these guidelines is essential. In this paper, a clinical research document reviewed by an ethical review board is shown as an example.