Revision of the Ethical Guidelines

On March 10, 2023, we held the 6th Academia Clinical Development Seminar online, inviting Dr. Kyoko Yoshioka from Health Policy Bureau, Ministry of Health, Labor and Welfare.
She has been responsible for the development and revision of the "Ethical Guidelines for Medical and Biological Research Involving Human Subjects" ("Ethical Guidelines"). Based on her extensive experience, she gave a lecture on the outline of the review of the Ethical Guidelines in the seminar.

She explained that the Ethical Guidelines were revised in line with the revised Act on the Protection of Personal Information (APPI), which went into effect in April 2022, and are now undergoing further revision in line with the scheduled partial enforcement of the Act on the Arrangement of Related Laws for the Formation of a Digital Society (April 2023).

Specifically, she said that in the discussion on "how the guideline should be based on the revised APPI (2021)," the provisions for common nationwide rules regarding local governments are being considered.
In addition, the following issues are being discussed in relation to "how informed consent should be": (1) informed consent procedures for the use of pseudonymized personal information, (2) requirements regarding social importance when existing specimens and information are utilized by an institution, and (3) how the rules for simplification should be, she said.

In this seminar, she gave a lecture on the review of the revised Ethical Guidelines, which was followed by a lively Q&A session and was a great success.

The next seminar will be held in end of May 2023, with Mr. Jun Yamadera from Eyes, JAPAN.
We look forward to seeing you at the next seminar.