1 Purpose
These Articles are formulated to protect the rights and safety of clinical trial subjects and to standardize the organization and operation of the Ethics Committee for Clinical Trials.
2 Scope
These Articles apply to the organization, establishment and operation of the Ethics Committee for Clinical Trials.
3 Articles of Incorporation
3.1 General Provisions
3.1.1 Legal Basis
These Articles are formulated in accordance with the following regulations and documents:
Good Clinical Practice for Drugs (2020) by the National Medical Products Administration;
Good Clinical Practice for Medical Devices (2022);
Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (2021);
Guidelines for Ethical Review of Clinical Trials of Drugs (2010);
Measures for Ethical Review of Biomedical Research Involving Humans (2016) by the National Health Commission;
Standards for Ethical Review of Clinical Research of Traditional Chinese Medicine (2010) by the National Administration of Traditional Chinese Medicine;
Requirements for Ethical Review System of Biomedical Research Involving Humans (2020) by the Certification and Accreditation Administration;
Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) by the National Health Commission, Ministry of Education, Ministry of Science and Technology and National Administration of Traditional Chinese Medicine;
Relevant documents of Shenzhen Bao'an Women's and Children's Hospital.
The Ethics Committee (hereinafter referred to as “the Committee”) operates in accordance with internationally recognized principles of non‑maleficence, beneficence, justice and respect, as well as the working principles of legality, independence, competence, timeliness and effectiveness.
3.1.2 Purpose
Through reviewing the scientificity and ethics of clinical trial projects, the Committee ensures that the dignity, safety and rights of subjects are protected, promotes biomedical research to meet high scientific and ethical standards, and enhances public trust and support for clinical research.
3.2 Organization of the Ethics Committee
3.2.1 Full Name, Address and Contact Number
Full name: Ethics Committee for Clinical Trials, Shenzhen Bao'an Women's and Children's Hospital Address: No. 56 Yulu Road, Bao’an District, Shenzhen Bao'an Women's and Children's Hospital Contact number: 0755‑29615220
3.2.2 Organizational Structure
The Ethics Committee is affiliated to Shenzhen Bao'an Women's and Children's Hospital as a sub‑committee of the Hospital Ethics Committee.
3.2.3 Membership
The composition and number of members shall match the types and volume of projects under review. Members include medical and pharmaceutical professionals, ethics specialists, legal professionals and external community representatives, with balanced gender representation. The total number of members shall be no fewer than seven.The Committee has one Chairperson, one Vice Chairperson, several members and one Secretary.
3.2.4 Recruitment / Nomination
Members are recruited through open application or nomination. A candidate list is formed based on recommendations from relevant parties and confirmation of willingness.
3.2.5 Appointment
Appointment of members is managed by the hospital. The candidate list is reviewed and approved by the Hospital Executive Meeting.Members, Chairperson, Vice Chairperson and Secretary are formally appointed by official hospital document, with clear job responsibilities.
Appointed members shall sign a Letter of Commitment, agreeing:
to disclose name, profession and affiliation;
to comply with conflict‑of‑interest policy and disclose relevant conflicts;
to disclose review compensation upon request;
to maintain confidentiality of review materials;
to participate in ethics and GCP training to maintain competence.
3.2.6 Term of Office
Each term of office is five years, with re‑election allowed. Membership may be adjusted as needed, with timely replacements to ensure sufficient capacity.
3.2.7 Re‑election
Re‑election shall ensure continuity, enhance review capacity, maintain professional diversity and absorb new perspectives. Candidates are generated through open recruitment and multi‑party nomination.
3.2.8 Resignation
A member may resign in writing due to health, reassignment or other personal reasons.
3.2.9 Dismissal
Dismissal is processed by the hospital. A member may be dismissed if:
unable to attend review meetings for a long time;
in violation of ethical conduct or conflict‑of‑interest requirements.
Dismissal is approved by the Hospital Executive Meeting and announced by official document.
3.2.10 Replacement / New Appointment
Replacement or new appointment may be initiated due to resignation, dismissal or operational needs. The term of mid‑term appointees shall expire at the end of the current term.Candidates are selected based on equivalent qualifications and expertise, reviewed and approved by the Hospital Executive Meeting, and announced by official document.
3.3 Rights and Responsibilities of the Ethics Committee
3.3.1 Rights
The Committee’s review is independent from investigators, sponsors and other departments of the institution, free from inappropriate influence.The Committee has the right to:
approve;
approve with necessary modifications;
disapprove;
suspend or terminate approved research;
observe or have a third party observe the informed consent process and research conduct.
3.3.2 Responsibilities
The Committee shall:
develop management documents;
conduct ethical review of all clinical trials conducted at the institution, including initial review, continuing review and re‑review for drugs, medical devices and in vitro diagnostic reagents;
perform review independently, competently and promptly;
conduct training and publicity on ethical review;
handle and respond to inquiries and complaints from subjects.
Within three months of establishment, the Committee shall file with the institution’s registration authority and upload information to the medical research registration system. It shall provide required ethics‑related information for the institution’s registration in the clinical trial institution platform.
By March 31 each year, the Committee shall submit an annual work report to the registration authority. By January 31 each year, it shall provide information required for the annual report of the clinical trial institution.
3.4 Resources of the Ethics Committee
3.4.1 Administrative Resources
The hospital appoints sufficient members and secretary to support high‑quality review. It provides necessary office conditions including independent office, dedicated archives room and meeting rooms.
3.4.2 Training Resources
The hospital provides adequate training (at least one dedicated ethics training every five years) and time to ensure competence.
3.4.3 Financial Resources
Administrative funds are included in the hospital budget to cover training, equipment, supplies and review compensation. Funds are used in accordance with hospital financial regulations. Compensation to members may be disclosed upon request.
3.5 Operation of the Ethics Committee
3.5.1 Review Modes
Review modes include: convened review, emergency convened review and expedited review.Convened review is the primary mode. Members shall pre‑review projects before meetings.Emergency review is held when serious issues threaten subject safety.Expedited review is supplementary and applies to:
minor protocol amendments not affecting risk‑benefit ratio;
annual/periodic review of trials not yet enrolling subjects;
annual/periodic review of trials with completed interventions;
non‑expected issues not increasing risk or significantly affecting conduct;
re‑review of minor or specified amendments.
3.5.2 Lead Reviewer / Pre‑review
A lead reviewer system is implemented. Each project is assigned two lead reviewers who complete review worksheets. Pre‑review is required for all meetings.
3.5.3 Independent Consultants
Independent consultants may be invited when expertise is insufficient or when subject background differs significantly from members.Consultants may be experts in ethics, law, specific diseases, methodology, or representatives of specific populations.Consultants shall submit resume, ID copy, qualification documents and sign confidentiality and conflict‑of‑interest statements.Consultants provide advisory opinions but do not have voting rights.
3.5.4 Quorum
Attendance shall exceed two‑thirds of all members, including all categories and balanced gender representation.
3.5.5 Review and Decision
The Committee reviews and discusses projects thoroughly. The Chair summarizes opinions before voting.A decision is adopted by more than half of all members. Decisions include:
approve;
approve with modifications;
disapprove;
suspend or terminate approved research.
Decisions are communicated promptly after the meeting.
Investigators or sponsors may request re‑review or direct communication if disagreeing with the decision.
3.5.6 Conflict of Interest Management
Members with conflicting interests shall declare and recuse themselves from discussion and voting.Consultants with conflicting interests shall declare in a timely manner.The Committee reviews conflict‑of‑interest declarations from researchers in accordance with institutional policy.
3.5.7 Confidentiality
Members and consultants shall maintain confidentiality of all review materials. Documents shall be returned promptly after review; no unauthorized copying or disclosure is allowed. Confidential information shall not be used for personal or third‑party commercial gain.
3.5.8 Collaboration
The Committee collaborates with all subject protection departments to ensure all trials are reviewed, subject welfare is protected, and financial conflicts are minimized. It establishes effective communication with subjects and with other ethics committees for multi‑center trials.
3.5.9 Quality Management
The Committee is administered by Shenzhen Bao'an Women's and Children's Hospital and accepts supervision. It responds to feedback and implements improvements.The Committee accepts regular quality assessment by hospital authorities, inspection by health and drug regulatory agencies, and third‑party evaluation or certification. Corrective actions are taken for identified deficiencies.