I. Purpose

These procedures are formulated to protect the rights and safety of clinical research subjects, standardize the organization and operation of this Ethics Committee, and provide standardized guidelines for all work of the Committee.

II. Scope

This document applies to the Medical Ethics Committee of our hospital.

III. Operating Procedures

1. The Ethics Committee Secretary shall receive all application materials submitted by applicants, including ethical review application form, clinical research protocol, financial conflict of interest statement, informed consent form, subject recruitment materials, case report form, investigator’s brochure, curriculum vitae of principal investigator, official approval document for scientific research project, and other relevant attachments.

2. The Secretary shall conduct a preliminary formal review of the submitted materials, determine the applicable review type, report to the Director of the Ethics Committee Office to assign primary reviewers, and submit the whole set of materials to the Chairman (or Vice Chairman) of the Ethics Committee.

3. The Ethics Committee shall hold one regular review meeting per month. Additional meetings may be convened when necessary. An emergency meeting shall be held to conduct urgent ethical review and make rulings in case of serious adverse events occurring during research or other incidents requiring immediate ethical deliberation.

4. The Secretary shall issue meeting notifications and confirm the quorum for review meetings. A valid meeting requires the attendance of more than half of all committee members, with a minimum of 11 attendees. Attendees shall include medical and pharmaceutical professionals, non-medical professionals, legal experts, external independent members unaffiliated with the research institution, and members of both genders.

5. The Secretary shall distribute all pending review documents to each attending member in advance to ensure sufficient time for members to review the research protocols thoroughly.

6. The Chairman (or Vice Chairman) shall preside over the Ethics Committee meeting. Principal investigators and sponsors may attend the meeting to introduce the research protocol or elaborate on specific questions. The Secretary shall record, summarize discussion contents and review decisions to form official meeting minutes, which shall be submitted for ratification at the subsequent ethics review meeting. The Secretary shall coordinate on-site affairs and document the whole meeting.

7. Decisions shall be made by voting during the ethical review meeting. A review ruling is adopted when supported by more than half of the attending members. Any committee member involved in the clinical trial under review must recuse themselves from voting and discussion.

8. The Secretary shall draft the ethical review letter and official approval document based on the meeting’s deliberation outcomes. The Ethics Committee may issue one of the following rulings:

(1) Approval;

(2) Approval pending necessary revisions;

(3) Re-review required after necessary revisions;

(4) Disapproval;

(5) Termination or suspension of an approved research project.

9. The official approval document shall take effect after being affixed with the official seal of the Ethics Committee.

10. The Secretary shall promptly deliver the signed ethical review letter and approval document, verified by the Chairman (or Vice Chairman), to the applicant.

11. All review records shall be archived and retained for 5 years after the completion of the clinical trial.

IV. Reference Documents

1. Good Clinical Practice for Drug Trials

2. Guidelines for Ethical Review of Drug Clinical Trials

3. Measures for Ethical Review of Biomedical Research Involving Human Subjects