Notice of Incidents of Non-Compliance with the "Ethical Guidelines for Medical Research Involving Human Subjects" and Measures to Prevent Recurrence

March 29, 2023

President of Kyushu University
Tatsuro Ishibashi

This is to inform you that the Faculty of Agriculture of Kyushu University (hereinafter referred to as "Graduate School of Agricultural Sciences") (hereinafter referred to as "the Graduate School of Agricultural Science") and a multicenter research institute, it has come to our attention that a case of non-compliance with the "Ethical Guidelines for Medical Research Involving Human Subjects" (hereinafter referred to as "the Guidelines for Medical Research"), as stipulated by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labor and Welfare, has occurred. The research was conducted jointly with a research partner. Although this incident will not cause any disadvantage or danger to research subjects, we would like to express our deepest apologies and report on the outline of the incident and measures taken to prevent its recurrence.

Medical research using samples of human origin conducted at the Faculty of Agriculture in FY2020 was conducted without the approval of the Ethics Review Committee and the permission of the head of the research institution, as stipulated in the Medical Research Guidelines.
In addition, the joint research institute from which the samples were provided did not meet the requirement of obtaining approval from the Ethics Review Committee as stipulated in the Medical Research Guidelines when the samples were provided.

Preventive Measures
In response to the fact that this incident occurred due to the faculty member's lack of awareness of the guidelines for medical research, it was made known at a major meeting of the Graduate School of Agricultural Science held in June 2021 that, in principle, research involving human subjects or research using samples of human origin constitutes "life science and medical research involving human subjects" and requires an ethical review. In November 2021, the National Institute for Health Sciences (NIH) was established. In November 2021, we held the "Seminar on Life Science and Medical Research Involving Human Subjects (FD)," which all faculty members of the Institute were required to attend, and recorded videos of the seminar were distributed to newly hired faculty members and graduate students so that they could attend the seminar individually and watch it at any time.
In addition, when starting a new research project, we informed the participants that a checklist and checkflow, including confirmation of whether or not ethical review is required, should be used to confirm the results.

In February 2023, we submitted a report to the Minister of Health, Labor and Welfare and the Minister of Education, Culture, Sports, Science and Technology regarding the results of the investigation and measures to prevent recurrence of this incident.
In order to prevent such an incident from occurring again in the future, we will make sure that all faculty members at this institute are thoroughly aware of the need to comply with relevant laws and regulations, and will establish a new checklist and checkflow confirmation system at the beginning of research to prevent recurrence of such an incident.

Thank you very much for your cooperation.