Chapter 1 General Provisions
Article 1
These Bylaws are formulated in accordance with the Guidelines for the Establishment of Ethical Review Committees for Human-related Clinical Research (2020 Edition) issued by the National Health Commission of the People’s Republic of China, the Good Clinical Practice for Drug Trials (2020) issued by the National Medical Products Administration, the Code of Ethical Review for Traditional Chinese Medicine Clinical Research issued by the State Administration of Traditional Chinese Medicine, and the Good Clinical Practice for Medical Device Trials (2022) jointly issued by the National Medical Products Administration and the National Health Commission, aiming to protect the rights and safety of clinical research subjects and standardize the organization and operation of the Medical Ethics Committee.
Article 2
The Medical Ethics Review Committee conducts prior ethical review, revision assessment, and approval judgment for all human-based clinical medical and health research projects. It undertakes ongoing follow-up review of approved projects and supervises whether researches comply with domestic and international scientific, ethical and regulatory requirements. Its fundamental purpose is to protect the rights, interests and well-being of research subjects.
Article 3
The Medical Ethics Committee completes filing with national and provincial drug supervision and health administrative authorities in accordance with law, and accepts guidance and supervision from health and drug regulatory authorities.
Chapter 2 Organizational Setup
Article 4 Name of Committee
Medical Ethics Committee
Article 5 Address
Ethics Committee Office, 16th Floor, New Building, No.2 Shajiang Road, Songgang Street, Bao’an District, Shenzhen
Article 6 Affiliation
The Medical Ethics Committee is affiliated with Shenzhen Bao’an District Songgang People’s Hospital, with a dedicated Ethics Committee Office for daily operation.
Article 7 Responsibilities
The Committee conducts independent, competent and timely ethical reviews of all medical scientific research undertaken or implemented within the hospital. The review scope covers all human-related clinical researches, including clinical epidemiological studies, researches using medical records and personal information, and researches utilizing human biological specimens.
Review types include initial review, follow-up review and re-review.
The Ethics Committee Office is responsible for daily administrative management of committee affairs.
Article 8 Authority
The operation of the Medical Ethics Committee shall be independent from sponsors and researchers, free from inappropriate intervention. The Committee has the authority to approve, disapprove, suspend or terminate clinical research projects, and conduct continuous follow-up review of approved studies.
Article 9 Administrative Resources
The hospital provides the Committee with an independent office space, complete office facilities, archives and meeting rooms to ensure functional independence. The hospital appoints sufficient full-time secretaries and staff and provides systematic professional training to ensure high-quality ethical review work.
Article 10 Financial Resources
The administrative expenses of the Medical Ethics Committee are included in the hospital’s annual financial budget and managed in accordance with hospital financial regulations.
Chapter 3 Committee Establishment and Renewal
Article 11 Committee Composition
The Committee consists of multidisciplinary members, including medical and pharmaceutical professionals, non-medical professionals, legal experts, and independent external members, with balanced gender representation. The composition and work of the Committee shall not be influenced by any research participants.
Article 12 Member Recruitment and Recommendation
Committee members are recruited through open application and institutional recommendation. All members serve on a part-time basis and shall ensure adequate time, energy and training participation to professionally evaluate the scientific, medical and ethical quality of research projects.
Article 13 Appointment
All members are officially appointed via hospital official documents and filed with relevant government authorities. Appointed members must complete GCP and ethical review training, submit personal resumes and qualification certificates, sign conflict-of-interest declarations and confidentiality commitments, and agree to publicize their names, professions and affiliations.
Article 14 Leading Members
The Committee has one Chairman and one Vice Chairman. The Chairman presides over review meetings, signs meeting minutes and official decisions. The Vice Chairman may perform the Chairman’s duties when the Chairman is unavailable.
Article 15 Term of Office
Each term of committee members lasts four years.
Article 16 Committee Renewal
Committee renewal ensures work continuity, sustainable review capacity and balanced professional coverage. Partial members shall be retained for continuity. New candidate members are selected through open recruitment and internal recommendation.
Article 17 Dismissal of Members
A member may be dismissed under the following circumstances:
1. Voluntary written resignation application;
2. Absence from more than half of scheduled review meetings;
3. Inability to perform duties due to health reasons or job transfer;
4. Violation of ethical norms or failure to declare conflicts of interest, affecting impartial review.
Dismissal is announced via official hospital documents.
Article 18 Member Replacement
Vacancies caused by resignation or dismissal may be filled through supplementary recruitment. New substitute members shall possess equivalent professional qualifications and be officially appointed by the hospital.
Article 19 Independent Consultants
For projects requiring specialized expertise beyond committee capacity, or researches involving subjects with distinct social or cultural backgrounds, independent consultants may be employed. Consultants shall submit resumes, qualification certificates, confidentiality agreements and conflict-of-interest declarations. They provide professional consultation without voting rights.
Article 20 Ethics Committee Office
The Office has one Director and one Secretary, responsible for daily operational management.
Chapter 4 Operational Rules
Article 21 Review Methods
The Committee adopts three review modes: regular meeting review, emergency meeting review, and expedited review.
A primary reviewer system is implemented for each project.
- Regular meeting review: Monthly routine ethical review meetings; members conduct pre-meeting document review.
- Emergency review: Launched for serious safety incidents endangering research subjects.
- Expedited review: Applied for minor protocol amendments without risk-benefit changes, unenrolled studies, completed intervention studies, and anticipated serious adverse event reviews, aiming to improve efficiency.
Article 22 Quorum Requirements
The number of attending members shall exceed half of the total members and shall be no less than 11 persons. Attendees shall include medical professionals, non-medical professionals, legal experts and independent external members with balanced gender distribution.
Article 23 Review Decisions
Voting is conducted after complete document verification, withdrawal of principal investigators, sponsors, independent consultants and conflicted members, and full thematic discussion. Members absent from discussions are not eligible to vote. A decision is passed by more than half of all committee members. Review results shall be issued within 10 working days.
Article 24 Conflict of Interest Management
Members with any conflict of interest shall actively declare and recuse themselves. The Committee examines researcher-project conflicts and imposes restrictive measures when necessary.
Article 25 Confidentiality
All committee members and independent consultants shall keep all review documents strictly confidential. All materials must be returned after review; no unauthorized duplication or external disclosure is permitted.
Article 26 Collaboration Mechanism
All hospital departments related to subject protection shall cooperate with the Committee to ensure all human biomedical research conducted in the hospital undergoes ethical review and fully protects subjects’ health and rights.
The Committee establishes effective communication mechanisms with external ethics committees to support multi-center clinical research reviews.
Article 27 Quality Management
The Committee accepts supervision and inspection by health and drug regulatory authorities and implements corrective measures for identified problems.
Article 28 Supervision and Reporting
The Committee Chairman reports routine work to hospital senior management and submits annual ethical review reports to the hospital and drug regulatory authorities.
Shenzhen Bao’an District Songgang People’s Hospital
May 25, 2022