Background: The Drug Use-Results Surveys (DURSs) is complicated owing to the importance of post-marketing evidence. Consequently, some DURSs deviate from the scope of routine clinical practice. Furthermore, the results are used not only for reexamination and reevaluation by the regulatory authority, but also for academic papers and conference presentation. Therefore, the ethical consideration for patients is vital; however, no regulations for informed consent (IC) and ethical review (ER) are administered in Japan.

Methods: We conducted a questionnaire survey on IC and ER in the DURSs of 109 companies and 1274 hospitals in Japan.

Results: Overall, we collected information from 63 companies and 362 hospitals. Fifty-eight companies and 341 hospitals had conducted DURSs from 2016 to 2019. Among these, 60.3％ companies and 77.5％ hospitals took into consideration the requirements for IC. The need for ER was considered by 32.8％ companies and 73.1％ hospitals. There was a significant difference in the ratio of companies and hospitals that considered IC and ER (p＝0.017, p＜0.001). In addition, the perspectives were different. Hospitals were cautious with regards to the contents (p＜0.001) and ascribed significantly importance to IC and ER (p＝0.001, p＜0.001).

Conclusions: Many companies and hospitals considered the requirement of IC and ER in DURSs. However, the points of deliberation differed. Therefore, a unified regulation should be established.

The Japanese government developed a national-level whole genome sequencing project in December 2020, which is expected to promote precision medical care for cancer and rare disease patients. Since this is a nationwide project, there is a need for implementing patient and public involvement (PPI).

Considering the current COVID-19 pandemic, we conducted online PPI to formulate the contents of the project's informed consent form (ICF) for participation. This online PPI aimed at gaining insights from cancer patients and their family members regarding the ICF. A one-day seminar was conducted online in September 2021, which included three lectures related to the national project, followed by discussion among the attendees divided into two groups based on their age and types of cancer. We had eight attendees who were cancer patients and/or their family members. They discussed the ICF's contents based on the draft developed by the project's research team.

Online PPI has its merits and drawbacks. It allows for easier participation and is beneficial for patients who are unable to physically attend either because of their medical condition or geographical location. For the researcher also, it becomes easier to recruit a diverse variety of people who wish to join the PPI activities. In contrast, at times, participants find it difficult to use online devices. Moreover, the attendees may not feel comfortable with the online discussions owing to the lack of nonverbal expression and interactions when compared with personal interaction.

For promoting PPIs in the future, we recommend considering the following three crucial aspects： practicing online PPI in a variety of situations, constructing a framework that enables PPI quickly, and promoting diversity in the attendees participating in such PPI activities.

The Japanese research ethics guidelines titled, “Ethical Guidelines for Medical and Biological Research Involving Human Subjects” regulate for collective review. Research and medical institutions now employ internal ethical review systems to conduct reviews. At Kyoto University, the graduate school and faculty of medicine of the ethics committee office has utilized a central collective review system (central REC system) since the establishment of the previous guidelines. The present study details the current status of the central review system and its issues and their potential solutions, based on practical experience of the first author (Kitao) at Kyoto University ethics committee office before and after the implementation of the current guidelines.

The transition to the new research ethics guidelines eliminates the intervention of institutional authorities who are not directly involved in the review process, but further burdens principal investigators, who are now required to collect and submit the confirmation of institutional requirements of collaborating institutions.

The distinct features of the future review system, from the perspective of the Ethics Review Committee Secretariat, are described below.

（1）Changing the review procedure according to the type of research.

（2）Strengthening the research secretariat.

（3）Clarifying and distinguishing the roles of the head of the institution and the Ethical Review Committee.

In future, ethical review procedures should also be evaluated to ensure the true ethicality of clinical research, where researchers are not subject to arbitrary procedures and can focus on the safety and due respect of the research participants.