Drug Evaluation Committee Summary and Key Points of the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects
Medical Affairs Subcommittee
July 2024
The "Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects" (the Ethical Guidelines) have been developed through numerous consolidations and revisions, and the scope of application and contents to be considered have become extremely complex due to the revision of the Personal Information Protection Law and the integration with the "Ethical Guidelines for Human Genome and Genetic Analysis Research. In addition, the scope of application and contents to be considered have become extremely complex due to the revision of the Act on the Protection of Personal Information and integration with the "Ethical Guidelines for Human Genome and Genetic Analysis Research. In addition, there are cases in which the decision on how to separate the "Clinical Research Act" from the "Clinical Research Act" must be left to the Ethical Review Committee or the Authorized Clinical Research Review Committee. In light of this situation, the MA Subcommittee KT4 (Task Force for Continuing Consideration of Corporate Responsibility in Clinical Research) in FY2023 has prepared an overview document to assist those involved in clinical research conducted under the Ethical Guidelines.
This document is not intended to be an exhaustive explanation of the ethical guidelines, but rather to provide points to keep in mind when involved in clinical research under the ethical guidelines as a pharmaceutical company. The order of the slides can be changed or the slides can be selected according to the purpose of use.
We hope that the slides will be widely used by those involved in clinical research under the ethical guidelines, including companies and research institutions other than pharmaceutical association member companies, for education, training, self-study, interviews, etc., and that they will help deepen understanding of the ethical guidelines.
Please refrain from altering the content of the slides (including illustrations). If modification is unavoidable, it is necessary to clarify the quoted portions and obtain permission according to the content of the modification (including modification of illustrations). In addition, the Pharmaceutical Cooperative Association will not be liable for any damage caused by the use of the information.
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