HKSTP Clinical Research Ethics Committee (CREC)

Mission of HKSTP CREC

The mission of HKSTP CREC is to ensure research projects involving human subjects are operated by the core principles of research ethics; respect for persons, beneficence and non-maleficence, integrity, consent, confidentiality and privacy protection.

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

 

When do you need to apply for CREC ethics clearance?

All clinical research projects that meet the following criteria MUST obtain research ethics clearance from HKSTP CREC before commencement of any related activities including but not limited to subject recruitment, data collection/analysis, etc.

1) Meet the definition of Clinical Research - Any medical and health related (incl. psychological) systematic investigation, intended to produce knowledge valuable for understanding, detecting, controlling, preventing and treating health conditions.

2) Project is entirely or partially conducted on HKSTP premises (partially incl. subject recruitment or intervention or bio-sample manipulation or etc.)

3) Project requires obtaining consent from human subjects

• Any form of direct interaction/ intervention on human subjects, or
• Any form of manipulation/ intervention on identifiable bio-samples, or
• Data with any form of personal identifiable information (e.g. collection, processing, manipulation or analysis of personal / health / genomic data)

Note: Projects with have obtained ethics approval from another independent CREC or IRB are still required to obtain ethics clearance (refer to section below on expedited review) from HKSTP CREC before commencing any research activities on HKSTP premises.

 

How to apply for HKSTP CREC ethics review?

Ethics Review – is a peer review process is to ensure a proper balance between innovation and ethics. The review will consider, among other aspects --- the study design; provisions for minimizing risk; an appropriate balance of risks in relation to potential individual benefits for participants and the social value of the research; safety of the study site, medical interventions and monitoring safety during the study; and feasibility of the research. Scientifically unsound research involving humans is unethical in that it may expose them to risk or inconvenience for no purpose.

 

New Application

To submit a new application for ethics review, submit the following documents to crec@hkstp.org

1. Application Form for Ethics Review
2. Consent Form
3. Recruitment Materials
4. Experiment Design Flowchart
5. Other Supporting Documents (Refer to Application Checklist)

Download Application Form for Ethical Review

DOWNLOAD Application Checklist

Applications are reviewed by HKSTP CREC on bimonthly basis. Application deadlines are the last day of February, April, June, August, October and December. Submissions received after each deadline will be reviewed in the next cycle.

 

Expedited review for Site Extension Application

Projects with existing ethics approval from external IRB/CREC, on the condition that the existing ethics approval covers the intended location(s) on HKSTP premises, is eligible to apply for expedited review. Under normal circumstances, the process time for expedited review is approximately 14 working days. Expedited review mainly focuses on safety and environmental aspects of the venue and facilities.

To apply for expedited review, submit the following documents to crec@hkstp.org

1. Application Form for Expedited Review (Site Extension Form)
2. Copy of Ethics Approval Letter/Memo
3. Copy of Approved Protocol (must indicate HKSTP address) 

Download Site Extension Application Form

 

HKSTP CREC Membership

Download Membership List

 

Post-Approval Requirements

Amendment - Any change(s) to an approved project, including but not limited to personnel, number and criteria of participants, procedures, etc., must be reported and approved by HKSTP CREC. Such change(s) shall not be implemented until approval has been granted. 

Project Extension – PIs are responsible to take note of the validity period of the approval as indicated in the approval letter.  If the approved project shall continue after the validity period, an extension application (together with relevant documents) shall be submitted at least 1-month preceding the expiry date of the approval.

Facility Inspection – Continuous review and monitoring will be conducted for 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 relevant 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