[Ethical Guidelines for Clinical Trials in Medical Research Involving Human Subjects]

In Japan, investigator-initiated clinical phase IV trials must follow the Ethical Guidelines for Medical and Health Research Involving Human Subjects, issued in December 2014. In addition, researchers must follow the Helsinki Declaration. In these clinical trials, academia-industry collaborations involving funding and technical support are required to develop better evidence- based medicine. Nevertheless, instances of publications reporting biases or misconduct in the research process occur frequently, which may lead to other problems due to lack of transparency. To address this issue, an institutional framework must be developed and maintained in which investigators maintain a high level of ethical adherence to protect the welfare of research subjects while carrying out research scientifically and appropriately under a conflict of interest (COI) disclosure. All authors must be seriously committed to greater responsibility, accountability, and transparency in collaborating with the industry.