HKSTP Clinical Research Ethics Committee (CREC)

What is HKSTP CREC?

HKSTP recognized the importance of human participants involved in scientific research that benefits the public by ingraining and demonstrating the inherent worth of all human beings and the respect and consideration they are due. In line with this philosophy, the HKSTP CREC is tasked to ensure research projects involving human participants are operated by the core principles of research ethics; respect for persons, beneficence and non-maleficence, integrity, consent, confidentiality and privacy protection, etc.

In general, the HKSTP CREC is responsible for:

• Reviewing and approving/rejecting applications, modifications and extensions of research projects involving the use of human participants/ materials
• Conducting continuous review and monitoring of approved projects
• Investigating reported ethical concerns regarding research projects involving the use of human participants/ materials

 

What projects must obtain HKSTP CREC approval prior to commencement?

Any research project which involves human participants/ materials conducted on HKSTP premises is required to obtain research ethics approval from HKSTP CREC.

*No intervention or interaction with human participants in research, including recruitment, may begin until approval is granted by HKSTP CREC*

Note: Projects with ethics approval from another independent CREC or REB is still required to obtain approval from HKSTP CREC before starting any research activities on HKSTP premises. It is highly recommended for applicants to attach the approved protocol and approval letter from another independent ethics approval body in the submission of application as reference materials. 

Please refer to clinical research site facility and personnel requirements before submitting your application for review.

HKSTP CREC - Clinical Research Site Facility and Personnel Requirements

 

HKSTP CREC Membership

Membership of HKSTP CREC 22/24

 

How to apply for HKSTP CREC ethics review?

Submit the following documents in one email to crec@hkstp.org, indicating the name of your company in the email subject:

• Completed application form
• Supporting documents (refer to application checklist)

Application forms:

Download Application Form for Ethical Review

Download Application Form for LOW-RISK Ethical Review*

*“Application Form for Low Risk Ethical Review of a Research Project Involving the Use of Retrospective Clinical Data” is only applicable for research projects solely relying on retrospective/ existing clinical data, it should not involve direct contact with participants. 

DOWNLOAD Application Checklist

 

Application Deadlines

• Applications are reviewed by HKSTP CREC on bimonthly basis.
• The application deadlines are February 28, April 30, June 30, August 31, October 31, December 31.
• Submissions received after each deadline will be reviewed in the next cycle.

 

Post-Approval Requirements

Any change(s) in an approved project, including but not limited to personnel, number and criteria of participants, procedures, etc., requires amendment review by HKSTP CREC and such change(s) may not be implemented until approval has been granted. 

Kindly take note of the validity period of the approval as indicated in the approval letter.  If the approved research project will be continued after the validity period, submission of application for project extension is required. Please provide relevant documents to HKSTP CREC in advance by the submission deadline preceding the expiry date.

HKSTP CREC will conduct continuing review and monitoring of each ongoing projects at intervals appropriate to the degree of risk to human subjects to ensure the highest standards of ethics. CREC members have the authority to immediately suspend / terminate the study should it be found absolutely necessary.

 

Adverse Event Requirements

In case of an adverse events (“AE”), research teams are responsible to comply with the following reporting procedures for reporting of the adverse event and any unanticipated problems.

Step 1. Report to Hong Kong Department of Health (DH) Refer to relavant DH division for reporting procedures, i.e., report to drug office for AEs related to adverse drug reactions https://www.drugoffice.gov.hk/eps/do/en/healthcare_providers/adr_reporting/index.html or i.e., report to medical device division for AEs related to medical devices https://www.mdd.gov.hk/en/mdacs/report-adverse-events/index.html   Step 2. Report to HKSTP CREC Notify HKSTP CREC at crec@hkstp.org of the AE

 

Enquiry

For enquiries or reporting of welfare concerns regarding research projects involving human participants/ materials, please email crec@hkstp.org

 

Additional Resources