Chapter I. General provisions

Article 1  In order to protect the rights and interests and safety of clinical research subjects and regulate the organisation and operation of this Ethics Committee, this charter is formulated in accordance with the Code for Quality Management of Drug Clinical Trials (2020), the Code for Quality Management of Medical Device Clinical Trials (2022), the Guiding Principles for Ethical Review of Drug Clinical Trials (2010), the Measures for the Ethical Review of Biomedical Research Involving Human Beings (2016 ), and Measures for Ethical Review of Life Science and Medical Research Involving Human Beings (2023) to formulate this charter.

article 2  The purpose of the Ethics Committee is to ensure that the dignity, safety and rights and interests of subjects are protected by reviewing the scientific and ethical soundness of clinical research projects, to promote biomedical research to meet high scientific and ethical standards, and to enhance the public's trust in and support for clinical research.

Article 3 Ethics committees are filed with the State and the Drug Administration and Health Administration at the provincial level where they are located in accordance with the law, and are subject to the guidance and supervision of the government's Health Administration and Drug Administration.

Chapter II Organisation

Article 4 Name of Ethics Committee: Ethics Committee for Drug Clinical Trials of Liaocheng Second People's Hospital.

Article 5  Address of the Ethics Committee: No. 306, Health Street, Linqing City, Shandong Province, Liaocheng City Second People's Hospital.

Article 6  Organisational structure: The Ethics Committee is affiliated with Liaocheng Second People's Hospital.    

Article 7  Duties: The Ethics Committee conducts independent, competent and timely review of the scientific and ethical soundness of biomedical research projects involving human beings. The scope of review includes drug clinical trial projects and medical device clinical trial projects (including in vitro diagnostic reagents). The review categories include initial review, follow-up review and re-examination. The Office of the Ethics Committee is responsible for the management of the daily administrative affairs of the Ethics Committee.

Article 8  Powers: The Ethics Committee has the power to approve/disapprove a clinical study, to conduct follow-up reviews of approved clinical studies, and to terminate or suspend approved clinical studies.

Article 9  The hospital provides the Ethics Committee with a separate office with a dedicated filing room and accessible meeting rooms. Adequate training is provided to members, independent consultants, secretaries and staff to enable them to perform their duties.

Article 10  Financial resources: The funds of the Ethics Committee are earmarked for specific purposes and are collected and managed by the financial department of the hospital, and the expenditure of the fees is subject to the signature of the Chairperson of the Ethics Committee.

Chapter III. Formation and renewal

Article 11 Composition of the Ethics Committee members: pharmaceutical professionals, non-pharmaceutical professionals, legal experts, social personnel who do not have administrative affiliation with the hospital, and members of different genders, and not less than seven members.

Article 12  Recruitment/recommendation of members: The members of the Ethics Committee are selected through recruitment and recommendation. The hospital appoints the members by documents, and later on, it adopts the methods of self-recommendation and recommendation, and consults the person's opinion to determine the list of candidates for membership.

Article 13 Appointment mechanism and procedure: The chairperson and vice-chairperson are elected by all members, and the hospital appoints all members in the form of a document.

                      Appointed members of the Ethics Committee shall participate in the training of GCP and ethical review; submit their curriculum vitae, qualification documents, and training certificates of GCP and ethical review; and agree to and sign a declaration of conflict of interest and a confidentiality agreement.

Article 14  The Ethics Committee consists of a chairman and a deputy chairman. The chairperson is responsible for presiding over the work of the Ethics Committee, chairing the review meetings, and reviewing and signing the minutes and decision documents. In the absence of the chairperson, the vice-chairperson shall replace the chairperson in exercising his/her duties.

Article 15  Members of the Ethics Committee shall be appointed for a period of five years.

Article 16  Renewal: The renewal at the end of the term should take into account the need to ensure the continuity of the work of the Ethics Committee, the development of its review capacity, the professional categories of its members, and the continuous incorporation of new perspectives and approaches. Candidates for renewal are recruited by open recruitment, recommended by interested parties and members, and appointed by the hospital.

Article 17  Removal from office: A member may be removed from office in the following cases: a person who applies in writing for resignation from the office of member; a person who is unable to participate in the ethics review meeting for a long period of time for various reasons; a person who is unable to continue to perform the duties of a member due to reasons of health or work transfer; a person who is unfit to continue to serve as a member due to behavioural and ethical norms that are in contradiction with the duties of a member (e.g., conflict of interest with the project under review without declaring it of his/her own accord).

Procedures for removal: the removal of a member shall be discussed and decided by the Ethics Committee, and the number of votes agreeing to the removal shall be more than half of the quorum present at the meeting, and the decision on the removal shall be announced by means of an official document of the hospital.

Article 18  Replacement: The procedure of member replacement can be initiated due to resignation or removal of a member. Candidates for replacement members are recruited/recommended based on the principle of equivalence of qualifications and expertise, and the replacement members are discussed and decided by the Ethics Committee, with the affirmative vote of more than half of the quorum present at the meeting. The elected replacement member is appointed by means of an official document of the hospital.

Article 19  Independent Consultant: An independent consultant may be retained if the expertise of the member is not sufficient for the review of a clinical research project, or if the social and cultural backgrounds of the subjects in a clinical research project are significantly different from those of the member. The independent consultant should submit his/her curriculum vitae, qualification documents, and sign a confidentiality pledge and conflict of interest statement. The independent consultant shall be invited to advise on an aspect of the clinical research project, but shall not have the right to vote.

Article 20 The Ethics Committee shall have a secretary. The secretary shall be appointed by the Chairperson of the Ethics Committee.

Chapter IV. Operation

Article 21 Review methods: The review methods of the Ethics Committee are meeting review, emergency meeting review and rapid review. The principal review system is implemented, and two or more principal review members should be arranged to review each project and fill in the review worksheet. Meeting review is the main review method of the Ethics Committee, and the members should pre-review the projects submitted for review before the meeting. If major or serious problems arise in the course of the study, endangering the safety of the subjects, an emergency meeting should be convened for review. Rapid review is a supplementary form of meeting review for the purpose of improving work efficiency, and is mainly applicable to studies with research risks not greater than the minimum risk, studies with smaller modifications to the approved research protocols that do not affect the risk-benefit ratio of the study, follow-up review of approved studies and projects of multi-centre studies, and confirmation of the review opinions of the team leader unit.

Article 22  Quorum: The number of members present should be more than half of the members; the members present should include members from the pharmaceutical and non-pharmaceutical professions, members independent of the research and implementation organisation, and members should be gender-balanced.

Article 23Votes for decisions: Opinions with more than 1/2 of the votes of all members are taken as review decisions.

Article 24  Conflict of interest management: Every time a research project is reviewed/consulted, a member or independent consultant who has a conflict of interest with the research project should voluntarily declare and recuse himself/herself. A conflict of interest policy is in place to identify any conflicts of interest related to ethical review and scientific research and to manage them accordingly.施。    

Article 25Confidentiality: Ethics committee members/independent consultants signed a confidentiality agreement to protect the confidentiality of documents submitted for review, and returned all submitted documents and review materials in a timely manner after completion of the review, and were not allowed to make copies or disseminate them to other parties.

Article 26  Collaboration: The Ethics Committee works in collaboration with all departments of the hospital related to the protection of subjects, and clarifies their respective responsibilities in ethical review and research regulation to ensure that all biomedical research projects involving human subjects undertaken and conducted by the organisational unit are submitted for ethical review, and that the health and rights of subjects in all research projects involving human subjects are protected; to effectively report and deal with situations that are contrary to the regulations and protocols; and to establish Effective channels of communication with subjects and responsiveness to subjects' concerns. To establish an effective communication mechanism with other ethics committees and to collaborate in the ethical review of multi-centre clinical studies.

Article 27  Quality management: Ethics committees are subject to the management of the institution in which they are located; to the supervision and management of the health administrative department and the drug supervision and management department; and to independent, external quality assessment or accreditation. Ethics committees take appropriate improvement measures for problems identified by inspections.

chapter v. by-laws

Article 28  Problems and accidents identified by the Committee in the course of its work that are beyond its functions are referred to the relevant authorities.

Article 29 The present statute shall enter into force on the date of its publication.