[Ethics in clinical research: for participant protection and higher-quality research].

Abstract

Ethics in clinical research are indispensable for participant protection and ensuring research quality, and constitute essential knowledge for all healthcare professionals involved in clinical practice. Learning from historical case studies of unethical research, such as the Nazi human experiments and the Tuskegee Syphilis Study has led to progressive development of ethical guidelines like the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report-which presents the three core principles of respect for persons, beneficence, and justice. In Japan, incidents including the Diovan case prompted the enactment of the Clinical Research Act. The 8 requirements set forth by the U.S. National Institutes of Health (social/scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for subjects) serve as a key framework for modern research practice. In Japan, regulations such as the Pharmaceuticals and Medical Devices Act/Good Clinical Practice, the Clinical Research Act, and associated guidelines have been established, and require compliance tailored to the specific type of research. The practice of clinical research adhering to ethical principles forms the foundation for the advancement of medicine built on trust.