Joint CUHK-NTEC Clinical Research Ethics Committee

Number of Projects Reviewed by CREC

The Joint Chinese University of Hong Kong (CUHK) and New Territories East Cluster (NTEC) Clinical Research Ethics Committee (CREC) operates under ICH-GCP guidelines, and complies with established standard operation procedure (SOP). Supported by CUHK and NTEC of the Hospital Authority, CREC operates out of the 3rd floor of Block B of the Nursing Quarter in Prince of Wales Hospital and is served by experienced staff. It comprises around 20 members, among whom are scientists, experts in ethics, law and independent members without any affiliation to CUHK, NTEC, or the operational body of CREC.

The Joint CUHK-NTEC CREC has developed a Web-based Serious Adverse Events (SAE) Reporting System to document local SAEs and to allow efficient reporting and evaluation based on cumulative statistics. This provides CREC members with an overview of all SAEs in CUHK and NTEC. A separate SAEs subcommittee with clear SOP has been established to monitor the safety of our patients and ensure that studies follow the highest of ethical standards. The SAE subcommittee makes recommendations to the CREC, which in turn also conducts an SAE review on a quarterly basis during CREC meetings.

The Joint CUHK-NTEC CREC is registered with the U.S. Department of Health and Human Services (HHS) under IRB00002883. HHS has also granted CUHK the Federalwide Assurance for the Protection of Human Subjects for International (Non U.S.) Institutions as FWA00004034.

Experienced staff, the latest facilities and equipment, together with dedicated professional members and lay members enable CREC to work effectively. Every year, CREC reviews over 400 new applications, 200 amendments to previously approved studies, and around 1,000 SAEs. It also holds regular monthly meetings and special meetings when the need arises. The average duration for an ethics review is about 3.5 weeks.