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Establishment

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC) (香港中文大學 – 新界東醫院聯網臨床研究倫理聯席委員會) was established by The Chinese University of Hong Kong (CUHK) and New Territories East Cluster (NTEC) in accordance with its terms of reference for overseeing research involving human subjects undertaken by and/or conducted in the premises owned, managed and/or controlled by CUHK and/or NTEC, and/or involving patients and/or staff thereof as human subjects in such clinical studies.

Mission

The mission of the Joint CUHK-NTEC CREC is protecting the rights, safety and well-being of human subjects with respect to their participation in clinical studies through initial review and continuous oversight of such clinical studies from the ethical and scientific perspectives.

Jurisdiction

The Joint CUHK-NTEC CREC is responsible for performing ethics and scientific review and oversight of clinical studies:

(a) undertaken by CUHK and/or NTEC (and/or the employees/appointees/students of CUHK and/or NTEC);

(b) conducted wholly or partially in the premises owned, managed and/or controlled by CUHK and/or NTEC; and

(c) involving the patients and/or employees/appointees/students of CUHK and/or NTEC as human subjects.

Responsibilities

The Joint CUHK-NTEC CREC has the responsibilities to protect the rights, safety and well-being of human subjects with respect to their participation in clinical studies under its jurisdiction through:

(a) receiving applications for initial review of clinical studies from principal investigators, performing initial ethics and scientific review of such studies, and giving its decision(s)/opinion(s) on each application;

(b) performing continuous ethics and scientific oversight during the period of each approved clinical study and giving its decision(s)/opinion(s);

(c) creating and maintaining necessary records with respect to ethics and scientific review and oversight of clinical studies;

(d) reporting to the Research Committee of CUHK and Cluster Management Committee of NTEC the status of operation of the Joint CUHK-NTEC CREC and any significant issue with respect to the clinical studies under the Joint CUHK-NTEC CREC’s oversight;

(e) allowing and facilitating audits by the Research Committee of CUHK and Cluster Management Committee of NTEC and inspections by competent regulatory authorities;

(f) promoting the concepts of clinical research ethics; and

(g) perform other duties related to ethics and scientific review and oversight of clinical studies as delegated by the Research Committee of CUHK and Cluster Management Committee of NTEC or the Governing Body(ies).

Powers

The Joint CUHK-NTEC CREC has the powers to:

(a) request for, collect and review information, documents and materials necessary for performance of ethics and scientific review and oversight;

(b) recommend modifications to study designs and arrangements on sound ethical or scientific basis and in line with the Joint CUHK-NTEC CREC’s mission;

(c) approve or disapprove clinical studies and give other opinions with respect to the ethical and scientific aspects of such clinical studies;

(d) suspend or terminate any approved clinical study if unacceptable risk to subjects arises;

(e) audit clinical studies to assess compliance with study protocols, the Joint CUHK-NTEC CREC’s requirements and other applicable standards and requirements;

(f) disclose information of clinical studies to the Research Committee of CUHK and Cluster Management Committee of NTEC, the Governing Body(ies) and competent regulatory authorities; and

(g) exercise other authorities related to ethics and scientific review and oversight of clinical studies as delegated by the Research Committee of CUHK and Cluster Management Committee of NTEC or the Governing Body(ies).