Medical research is conducted by doctors as medical professionals with inspirational ideas and high ethical standards to gain knowledge for the future of medicine. Therefore, doctors must properly understand the three principles of ethics, i.e., respect for persons, beneficence, and justice, and appropriately practice them in the clinical research field. The Japan Clinical Research Act was established to restore the public confidence in clinical research that has been lost due to repeated research misconduct. Rather than being pessimistic towards the legal regulation of research, we should initiate a discussion regarding a framework to effectively utilize the evidence obtained in clinical research conducted under the law that could lead to innovative medical development. Amid changes in the global environment surrounding clinical research, we must continue generating evidence from our country, Japan, where medical resources are extremely limited, via high-quality clinical research with ethical validity and scientific rationality.
Keywords: Clinical trials act; Ethical guidelines for medical research; Informed consent; Research ethics.