Table 1. Core Competencies for CReP.

From: Establishment of the Certified Research Ethics Professionals: An Ethical Review Expert―Translated in English from Japanese Version―

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