Chapter 1 General Provisions
Article 1
These Bylaws are formulated to protect the rights and safety of clinical trial participants and standardize the organization and operation of the Ethics Review Committee for Clinical Trials of Drugs and Medical Devices (hereinafter referred to as the Ethics Review Committee). The formulation is based on the following documents:
Good Clinical Practice for Drug Trials, Good Clinical Practice for Medical Device Trials, Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents, Guidelines for Ethical Review of Drug Clinical Trials, Measures for Ethical Review of Biomedical Research Involving Human Subjects, Measures for Ethical Review of Life Science and Medical Research Involving Human Subjects, Guidelines for the Establishment of Ethical Review Committees for Human-related Clinical Research, Code of Ethical Review for Traditional Chinese Medicine Clinical Research, Shenzhen Local Standard: Specifications for Ethical Review of Life Science and Medical Research Involving Human Subjects, WMA Declaration of Helsinki, and International Ethical Guidelines for Health-related Research Involving Humans.
These Bylaws shall come into force on September 15, 2025.
Article 2
The mission of the Ethics Review Committee is to conduct independent, competent and timely reviews of the scientific rationality and ethical appropriateness of clinical trials for drugs, medical devices and in vitro diagnostic reagents. It safeguards the dignity, safety and rights of research participants, promotes biomedical research to meet high scientific and ethical standards, and enhances public trust and support for clinical trials.
Article 3
The Ethics Review Committee shall complete filing with national and provincial drug regulatory and health administrative authorities in accordance with law, and accept guidance and supervision from health and drug regulatory authorities.
Chapter 2 Organizational Setup
Article 4 Name of the Committee
Ethics Review Committee for Clinical Trials of Drugs and Medical Devices, Shenzhen Bao’an District Songgang People’s Hospital
Article 5 Address
No.2 Shajiang Road, Songgang Street, Bao’an District, Shenzhen City
Article 6 Organizational Structure
The Ethics Review Committee is affiliated with Shenzhen Bao’an District Songgang People’s Hospital, with a dedicated Ethics Review Committee Office for daily administration.
Article 7 Responsibilities
The Committee conducts independent, competent and timely ethical reviews of all clinical trials undertaken or implemented within the hospital. The review scope covers clinical trials of drugs and medical devices (including in vitro diagnostic reagents).
Categories of ethical review include initial review, follow-up review and re-review.
The Ethics Review Committee Office is responsible for daily administrative management of the Committee’s affairs.
Article 8 Authority
The operation of the Ethics Review Committee shall be independent from sponsors and investigators, free from inappropriate external influence. The Committee has the authority to approve or disapprove a clinical trial, conduct follow-up reviews of approved trials, carry out re-reviews for trials pending approval with revisions, and suspend or terminate approved clinical trials.
Article 9 Administrative Resources
The hospital provides the Committee with an independent office, complete office facilities, archives and meeting rooms to fulfill its functional requirements. The hospital appoints sufficient secretaries and staff to guarantee high-quality review work, and delivers systematic training for all members, secretaries and staff to ensure competent performance of duties.
Article 10 Financial Resources
The administrative expenses of the Ethics Review Committee are included in the hospital’s annual financial budget and managed in compliance with hospital financial regulations.
Chapter 3 Committee Establishment and Renewal
Article 11 Committee Composition
Committee members shall be selected from experts in life sciences, clinical medicine, bioethics, law and external community representatives unaffiliated with the hospital. The total number of members shall be no less than 7, with balanced gender representation. The composition and operation of the Committee shall not be subject to influence from any trial participants.
The legal representative of the medical institution, clinical trial managers for drugs/medical devices, and heads of scientific research departments shall not serve as the Chairman or Vice Chairman.
Article 12 Member Recruitment and Recommendation
Candidate members are generated through open recruitment or institutional recommendation. All members serve on a part-time basis, and shall guarantee participation in training, allocate sufficient time and energy for review work, and possess qualifications and experience to jointly evaluate the scientific and ethical quality of clinical trials.
Article 13 Appointment
All Committee members are officially appointed via hospital official documents, which shall be filed with relevant government regulatory authorities. Appointed members must complete GCP and ethics training, submit personal resumes and qualification certificates, sign conflict-of-interest declarations, confidentiality agreements and committee commitment letters, and consent to public disclosure of their names, occupations and affiliations.
Article 14 Chairman and Vice Chairman
The Committee has one Chairman and one Vice Chairman.
The Chairman is responsible for appointing primary reviewers, determining review types, authorizing independent consultants, presiding over review meetings, signing meeting minutes and official review decisions.
When the Chairman is unable to perform duties, the Vice Chairman may be authorized to exercise all routine responsibilities of the Chairman.
Article 15 Term of Office
Each committee term lasts five years, and members may be reappointed with no maximum cumulative service limit. Upon a member’s departure, the Committee Secretary shall promptly notify the institution and competent regulatory authorities.
Article 16 Independent Consultants
Independent consultants may be retained when the Committee lacks specialized expertise to review a trial, or when trial participants have distinct social and cultural backgrounds different from Committee members. Consultants shall submit resumes, qualification certificates, and sign confidentiality agreements and conflict-of-interest declarations. They provide professional advisory opinions on specific trial issues without voting rights.
Article 17 Ethics Review Committee Office
The Office is staffed with one Director, one Secretary and several administrative staff, responsible for all daily operational work of the Committee.
Article 18 Committee Renewal
Renewal shall maintain work continuity, sustain review capacity and balance multidisciplinary coverage of members. Partial incumbent members shall be retained to secure consistent operation, alongside newly recruited members. Candidate members for renewal are sourced via open recruitment or recommendations from relevant departments and incumbent members.
Article 19 Dismissal of Members
A member may be dismissed under the following circumstances:
1. Voluntary written resignation application;
2. Absence from more than half of all scheduled review meetings;
3. Inability to fulfill duties due to health conditions or job transfer;
4. Violation of ethical norms and committee obligations (e.g., failure to proactively declare conflicts of interest with reviewed trials), rendering the member unfit to continue service.
Dismissal decisions shall be formally announced via official hospital documents.
Article 20 Member Replacement
Vacancies arising from resignation or dismissal may be filled through supplementary recruitment. The Committee Chairman shall recruit or recommend substitute candidates with equivalent professional qualifications, who shall be officially appointed via hospital documents upon selection.
Chapter 4 Operational Rules
Article 21 Review Modes
The Committee adopts three review modes: Full Board Meeting Review, Emergency Meeting Review, and Expedited Review.
1. Full Board Meeting Review: The primary review mode. One routine review meeting shall be held every month; additional meetings may be convened as required.
2. Emergency Meeting Review: To be held for urgent ethical deliberation and decision-making in cases involving major or severe incidents endangering participant safety, medical research related to sudden major epidemic risk control, other public health emergencies, or any other circumstances requiring immediate ethical review.
3. Expedited Review: A supplementary mode to improve operational efficiency, applicable to:
- Research with no more than minimal risk to participants;
- Minor amendments to approved protocols that do not alter the risk-benefit ratio of the trial;
- Partial follow-up reviews of approved trials;
- Confirmation of ethical review opinions issued by lead site committees for multi-center clinical trials;
- Reviews of protocol deviations and safety information that do not materially increase participant risks or interfere with trial implementation.
Article 22 Primary Reviewer System
A designated primary reviewer shall be assigned for every submitted trial project. All members shall conduct pre-meeting review of submitted materials in advance.
Article 23 Quorum Requirements
A valid meeting requires attendance of more than half of all Committee members. Attendees shall include medical and pharmaceutical professionals, non-medical professionals, legal experts, external independent members unaffiliated with the trial institution, and members of both genders.
Article 24 Review Decisions
After complete document verification, principal investigators, sponsors and conflicted members shall withdraw from the meeting. Following full thematic discussion in compliance with standard review criteria, decisions shall be made by anonymous voting. Members absent from deliberation shall not cast votes. A decision is valid only when supported by more than half of the total Committee members. Review conclusions and opinions shall be issued promptly after the meeting.
Article 25 Conflict of Interest Management
All members shall sign conflict-of-interest declarations. Members with any conflict of interest related to the trial shall proactively declare and recuse themselves from discussion and voting. The Committee shall assess conflicts of interest between members and trial projects, and impose restrictive measures (including recusal from voting) when necessary.
Article 26 Confidentiality
All Committee members, independent consultants and staff shall sign confidentiality agreements and bear legal obligations to keep all submitted trial documents strictly confidential. All review materials must be returned upon completion of review; unauthorized duplication or external disclosure is prohibited.
Article 27 Collaboration Mechanism
All hospital departments responsible for participant protection shall cooperate with the Committee, clarify respective duties in ethical review and trial supervision, and ensure all human biomedical research undertaken or implemented within the hospital undergoes mandatory ethical review to fully protect participants’ health and rights.
The Committee shall establish effective communication channels with ethics committees of other institutions to jointly complete ethical reviews for multi-center clinical trials.
Article 28 Quality Management
The Committee establishes an internal assessment mechanism to conduct regular evaluation and appraisal of internal management and staff competency. It accepts supervision and inspection by health and drug regulatory authorities, and implements corrective actions for identified non-conformities to guarantee consistent quality of ethical review work.
Article 29 Supervision and Reporting
The Committee Chairman shall submit regular work reports to the hospital’s deputy and principal leaders, and deliver annual ethical review work reports to the hospital and competent drug regulatory authorities.