| Major item 1: Understanding the outline of related laws and guidelines |
| Middle item A: Ethical Guidelines for Medical and Health Research Involving Human Subjects |
| Middle item B: Ethical Guidelines for Human Genome/Gene Analysis Research |
| Middle item C: Scope of application of the Clinical Trials Act |
| Middle item D: Scope of application of the Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices |
| Middle item E: Scope of application of the Act on Securing Safety of Regenerative Medicine |
| Middle item F: Norms such as the Declaration of Helsinki and Belmont Report |
| Middle item G: About past cases |
| Middle item H: Update of the latest information on each related laws/guidelines |
| Major item 2: Committee management support |
| Middle item A: Membership requirements (sciences, law/humanities, general position), committee establishment requirements |
| Middle item B: Support for researchers (until the start, amendment, stop, and end of research) |
| Middle item C: Committee holding procedure |
| Middle item D: Cooperation with the Conflict of Interest Committee/Secretariat |
| Middle item E: Cooperation with ethics examination-related departments |
| Middle item F: Correspondence to external surveys, etc. |
| Major item 3: Committee document preparation/storage and contract |
| Middle item A: Preparation of materials used by the committee |
| Middle item B: Preparation of committee meeting minutes |
| Middle item C: Examination result notification |
| Middle item D: Confidentiality pledge of committee members/Conflict of Interest |
| Medium item E: Procedures required for contracts (clinical trials and clinical research) |
| Middle item F: Storage of committee-related documents |
| Middle item G: Disclosure of committee member list and minutes |
| Major item 4: Correspondence to individual cases |
| Middle item A: Judgment that the guideline is not applicable |
| Middle item B: Judgment of quick review |
| Middle item C: Correspondence to deviation |
| Middle item D: Response to adverse events and compensation insurance |
| Middle item E: Responding to complaints from research subjects |
| Major item 5: Understanding the status of research implementation |
| Middle item A: Implementation status report (status of obtaining consent to participate in research, status of continuation, etc.) |
| Middle item B: Monitoring/audit |
| Middle item C: Safety report |
| Middle item D: Report of adverse events |
| Major item 6: Implementation and recording of education and training for the committee secretariat, researchers, institution heads, and committee members |
| Middle item A: Education and training for the committee secretariat, researchers, institution heads, and committee members |
| Middle item B: Records related to education/training implementation, records of training for committee members |
