Ethical guidelines for clinical studies: Overview

Clinical research is guided by ethical principles promulgated in several statements, principally the Nuremberg Code, the Helsinki Declaration of the World Medical Association etc. In Japan, clinical research of medical products, principally trial of new pharmaceutical products is regulated by GCP (good clinical practice). Other types of clinical research are regulated by some ethical guidelines for clinical researches. The result is a regulatory position that is a complex combination of legislation and ethical guidelines. In the Ethical Guideline for Clinical Studies revised in 2008, clinical research is classified into intervention research and observational research. When researchers plan clinical research, they must determine the type of clinical research and appropriate ethical guideline for the type of clinical research. Advances in health informatics and genetic research have produced a new and very rich body of raw material for clinical research in the form of gene banks and genome-wide association study etc. The use of human tissue and medical information in the course of clinical research raises issues under the ethical regulations for research with human subjects.