" Revision of Clinical Trials Act and ethical guidelines"

On March 11, 2022, we held the 7th Academia Clinical Development Seminar online, inviting Dr. Kyoko Yoshioka from Research and Development Division, Health Policy Bureau, Ministry of Health, Labor and Welfare.

Dr. Yoshioka has been responsible for the development and revision of the "Ethical Guidelines for Medical and Biological Research Involving Human Subjects" (hereinafter called "Ethical Guidelines"). Based on her extensive experience, she gave a lecture on the outline of the review of the Clinical Trials Act and the Ethical Guidelines in the seminar.

First of all, she explained the revision of Clinical Trials Act.
The Clinical Trials Act is to be revised within five years of its enactment in light of its operational status.
In January 2021, the Clinical Research Committee of the Health and Science Council was begin to discuss the issues, and in December 2021, the "Interim report on the revision of the Clinical Trials Act after five years from enforcement" was published, and in the report, the following five issues were consequently summarized: (1) global consistency of the clinical research implementation system, (2) clarification of applicability to the Clinical Trials Act, (3) streamlining of procedures, (4) ensuring transparency, and (5) ensuring the quality of research, she said.

Second of all, she explained the "Revision of Ethical Guidelines in accordance with the revision of the Act on the Protection of Personal Information (APPI).
Regarding the revision of APPI, she explained that the 2020 amendment included: 1) elaboration of procedures for obtaining informed consent, 2) establishment of pseudonymously processed information, 3) handling of provision of personally referable information to third parties, and 4) enhancing the provision of information on cross-border transfer, she said.
Then, in the 2021 amendment, she said, the personal information protection system was reviewed through the public and private sectors, and the overall jurisdiction and content were centralized.
In addition, in order to unify regulations in the medical and academic fields, public hospitals and universities would in principle be subject to the same discipline as private companies and universities, thereby eliminating any imbalance in discipline, she said.
She further stated that with regard to the exemptions for academic research, the new rules provide for exceptions for each obligation, rather than the uniform exemptions previously in place, and that overall, it must be noted that even academic research is subject to the application of the APPI.

Finally, she explained the revision of the Ethical Guidelines in light of the revised regulations of the APPI.
She said that "The Joint Conference on the Handling of Personal Information in Medical and Biological Research" discussed the Ethical Guidelines, and the revised Ethical Guidelines will go into effect on April 1, 2022.

She also explained the following major revisions.
1) Revision of definitions of terms
2) Revision of the scope of application of the Ethical Guidelines
3) Clarification of the subjects of personal information control
4) Revision of procedures for obtaining informed consent (IC), etc.
5) Revision of Chapter 9 of the current Ethical Guidelines
The key points of the revision are, in particular, that the definitions of terms have been changed significantly and that the IC procedures have been simplified, and that it will be necessary to revise internal regulations, etc., and develop an ethics committee system that can handle the APPI, she said.

In this seminar, Dr. Yoshioka gave us useful and valuable lecture on revision of Clinical Trials Act and Ethical Guidelines and the seminar ended successfully with a large number of participants and a lively question and answer session.

The next seminar will be held on Friday, May 27, 2022, with Dr. Yasuo Kitaoka from Co-Creation Bureau, Osaka University under the theme of "Entrepreneurship Development in Academia".
We look forward to seeing you at the next meeting.