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

自由診療で行われる再生医療の審査に関する課題を調査 今後の制度改正に期待. 京都大学プレスリリース. 2023-02-28.Questionable practices identified by an examination of therapeutic plan reviews performed by certified committees under the Act on the Safety of Regenerative Medicine. 京都大学プレスリリース. 2023-02-28.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

Research, Practice, and Innovative Therapy: On the Theoretical Model of Robert J. Levine

Asian Bioethics Review23229-23

Classes of Activities in Clinical Laboratories: Practice, Research, or Else?

Asian Bioethics Review13281-28

Handling incidental findings in neuroimaging research in Japan: current state of research facilities and attitudes of investigators and the general population.

[Background]To establish appropriate measures that deal with incidental findings (IFs), the neuroscience community needs to address various ethical issues. The current state of research facilities regarding IFs and investigator attitudes as well as potentially eligible research participants must be assessed prior to future discussions and before the development of policies and guidelines. To this end, we conducted two questionnaire surveys to clarify i) how IFs are addressed at neuroimaging research facilities in Japan and ii) the views of investigators and potential research participants regarding the handling of IFs. [Methods]Thirty-one principal investigators (PIs) involved in the Strategic Research Program for Brain Sciences (SRPBS), a government-funded project, were asked to fill out a questionnaire regarding ways IFs were handled at the facility. A total of 110 investigators engaged in SRPBS tasks, including 31 PIs who participated in the research facility survey and researchers conducting studies under the management of the PIs, and 500 individuals from the general public (i.e., general population) were asked to select the most appropriate way to deal with IFs in two scenarios, namely the medical school and humanities and social sciences department scenarios. [Results]More than 40% of PIs responded that they did not know or were unsure of what type of approach was employed to handle IFs at their research facilities. Nevertheless, they were willing to improve the current status if sufficient resources were provided. With regard to specialist involvement, 37.7% of investigators responded that it was appropriate to have a specialist check all images in the medical school scenario, whereas 13.3% responded that such involvement was appropriate in the humanities and social sciences department scenario. In contrast, 76.1% and 61.0% of the general population indicated that specialist involvement was appropriate in the medical school and humanities and social sciences department scenarios, respectively. These results show that expectations of the general population exceed those of investigators regarding measures to address IFs. Both investigators and the general population demanded more responsibility from PIs at medical institutions, compared to PIs at non-medical institutions. [Conclusions]Based on our preliminary results, we recommended that a licensed physician perform a screening test to appropriately examine clear abnormalities. These recommendations were implemented by the SRPBS as guidelines for handling IFs in national research projects in Japan