Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in Japan

Tsunakuni Ikka; Misao Fujita; Taichi Hatta; Tetsu Isobe; Kenji Konomi; Tatsuo Onishi; Shoji Sanada; Yuichiro Sato; Shimon Tashiro; Morikuni Tobita

doi:10.1016/j.stemcr.2023.01.013

Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in Japan

Stem Cell Reports. 2023 Mar 14;18(3):613-617. doi: 10.1016/j.stemcr.2023.01.013. Epub 2023 Feb 23.

Authors

Tsunakuni Ikka¹, Misao Fujita², Taichi Hatta³, Tetsu Isobe⁴, Kenji Konomi⁵, Tatsuo Onishi⁶, Shoji Sanada⁷, Yuichiro Sato⁸, Shimon Tashiro⁹, Morikuni Tobita¹⁰

Affiliations

¹ Division of Bioethics & Healthcare Law, Institute for Cancer Control, National Cancer Center Japan, Chuo-ku, Tokyo 104-0045, Japan; Division of Bioethics, Center for Research Administration and Support, National Cancer Center Japan, Chuo-ku, Tokyo 104-0045, Japan. Electronic address: tikka@ncc.go.jp.
² Uehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application (CiRA), Kyoto University, Sakyo-ku, Kyoto 606-8507, Japan; Institute for the Advanced Study of Human Biology (WPI-ASHBi), KUIAS, Kyoto University, Sakyo-ku, Kyoto 606-8501, Japan. Electronic address: misao-fujita@cira.kyoto-u.ac.jp.
³ Graduate School of Public Health, Shizuoka Graduate University of Public Health, Aoi-ku, Shizuoka 420-0881, Japan.
⁴ Law School, Keio University, Minato-ku, Tokyo 108-8345, Japan.
⁵ Clinical and Translational Research Center, Keio University Hospital, Shinjuku-ku, Tokyo 160-0016, Japan.
⁶ MLIP Law Office, Minato-ku, Tokyo 105-0004, Japan.
⁷ Clinical and Translational Research Center, Kobe University Hospital, Kobe-city, Hyougo 650-0017, Japan.
⁸ Faculty of Education, Tokyo Gakugei University, Koganei-city, Tokyo 184-8501 Japan.
⁹ Department of Sociology, Graduate School of Arts and Letters, Tohoku University, Sendai, Miyagi 980-8567, Japan.
¹⁰ Medical Technology Innovation Center, Juntendo University, Bunkyo-ku, Tokyo 113-8421, Japan.

Abstract

We outlined five studies regarding the quality of the review by committees based on the Act on the Safety of Regenerative Medicine. The findings raise serious concerns about the independence, integrity, and quality of reviews of therapeutic plans by these committees with inappropriately close relationships to medical institutions and companies.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Japan
Regenerative Medicine*