Background: Research ethics and integrity is an integral part of high-quality research, and education on this topic is widely provided to researchers in Japan. However, common Japanese educational programs appear to have the following issues: (a) learning contents not directly applicable to clinical research, (b) psychological gap between instructors and learners, (c) learners' passive participation, and (d) aiming solely for knowledge acquisition does not prepare learners to handle various situations and constantly changing research norms and responsibilities.

Methods: We developed a proactive learning program on research ethics and integrity designed for physicians and other healthcare professionals. The 60-minute program consists of a lecture and case discussions provided 13 times by incorporation into a 2- to 4-day clinical research program. At the end of the research program, the participants were asked to complete a questionnaire to evaluate the learning program on research ethics and integrity.

Results: Of the 178 healthcare providers who participated in the program, 156 completed the questionnaire (response rate: 87.6％, male: 73.1％, physicians: 84.6％). The majority of participants reported the program was useful (lecture 97.4％, case discussion 97.4％), and 91.0％ reported their intention to be an instructor and use the program in their institutions.

Conclusions: The proactive learning program on research ethics and integrity was shown to be feasible to facilitate learning of physicians and healthcare professionals.

Medical care in Japan, which has achieved one of the world's longest life expectancies, is highly regarded globally, but national medical expenses continue to increase yearly. In the past, physicians focused mainly on doing what is best for the patient without considering any budget impact. However, physicians are now required to take into consideration health economic evaluations as well. As a result, physicians now consider medications not only from the standpoint of individual patients (micro perspective), but also from that of the public/society (macro perspective). This has led to a situation in which these two perspectives on the allocation of medical resources are easily confused. The purpose of this paper is to describe the situation outlined above, taking into account the current state of medical practice as well as key concepts in research ethics and medical economics. First, in terms of medical practice, as seen in the “Minds Manual for Clinical Practice Guideline Development 2020,” the introduction of health economic evaluation has forced healthcare professionals to think from a macro perspective when considering patient treatment. Second, in terms of the distinction between research and treatment, an important topic in research ethics, medical researchers need to think from a macro perspective when planning and conducting research, because they are required to consider the social benefits of the research. Consequently, the social benefit sought in research and the clinical benefit to individual patients/subjects, as well as the macro and micro perspectives relating to the allocation of medical resources, are intertwined in the eyes of researchers, placing them in a situation where conceptual confusion can readily occur. Finally, in terms of medical economics, the efficiency of production (micro level perspective) and efficiency of allocation (macro level perspective) are easily confused in medical practice when considering the cost-effectiveness of treatment. In view of the above, this paper discusses the importance of recognizing, as a preliminary step to further discussions on the issue of allocation of limited healthcare resources, that the decision-making body at the macro level must be the government rather than individual medical personnel, and that the decision-making body at the micro level must be individual medical personnel (and individual patients) rather than the government.

Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems.

Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system.

In addition, although a clinical trial deviation report form (previous form) was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.

In recent years in Japan, ethical review applications for research that is not subject to regulation by administrative guidelines or laws (nonregulated research) have been submitted to institutional research ethics committees. Ethics committee offices' previous studies have revealed that the main reason for such applications was to satisfy paper submission requirements. Some academic societies require committee approval for all research involving human subjects. If this situation is not addressed, it could negatively impact the quality of ethics committee deliberations, and for research involving human subjects, it could adversely affect the subjects' safety and protection. Therefore, this research conducted a questionnaire survey among the editorial committees of academic societies and asked them about their responses regarding nonregulated research.

The results showed that 11 of the 14 surveyed societies require the approval of an ethics committee even for nonregulated research. Of these, only five societies stated that they have specified the scope of ethical considerations in their submission regulations. It became clear that information dissemination is possibly insufficient even in academic societies that have a specified scope. Institutional ethics committees are required to confirm the regulations of the academic society with which the applicant for ethical review is planning to publish their research results. Furthermore, the survey found that academic societies require authors to submit documentation stating that ethical review is not required at the time of submission or during the peer review process. For academic societies to accept the submitted certifying documents, institutional research ethics committees must define the types of nonregulated research that require their review, thereby accounting for the circumstances of the academic society and the importance of protecting research subjects.