香港中文大學 – 新界東醫院聯網臨床研究倫理聯席委員會

The Joint CUHK-NTEC CREC

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

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:

Undertaken by CUHK and/or NTEC (and/or the employees/appointees/students of CUHK and/or NTEC)
Conducted wholly or partially in the premises owned, managed and/or controlled by CUHK and/or NTEC
Involving the patients and/or employees/appointees/students of CUHK and/or NTEC as human subjects

Responsibilities

Receiving Applications

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

Performing continuous ethics

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

Respect to ethics

Creating and maintaining necessary records with respect to ethics and scientific review and oversight of clinical studies;

Research Reporting

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

Facilitating audits

Allowing and facilitating audits by the Research Committee of CUHK and Cluster Management Committee of NTEC and inspections by competent regulatory authorities;

Promotion

Promoting the concepts of clinical research ethics

Duties Performance

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

Performance of Ethics

Request for, collect and review information, documents and materials necessary for performance of ethics and scientific review and oversight

Recommend Modifications

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

Clinical Studies Approval

Approve or disapprove clinical studies and give other opinions with respect to the ethical and scientific aspects of such clinical studies

Clinical Studies Suspension

Suspend or terminate any approved clinical study if unacceptable risk to subjects arises

Assess Compliance

Audit clinical studies to assess compliance with study protocols, the Joint CUHK-NTEC CREC’s requirements and other applicable standards and requirements

Disclose Information

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

Exercise other Authorities

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)