- What We Offer
- Institute for Translational Research
- HKSTP Independent Ethics Committee (IEC)
- HKSTP Clinical Research Ethics Committee (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:
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.
Submit the following documents in one email to firstname.lastname@example.org, indicating the name of your company in the email subject:
*“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.
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.
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
Step 2. Report to HKSTP CREC
Notify HKSTP CREC at email@example.com of the AE
For enquiries or reporting of welfare concerns regarding research projects involving human participants/ materials, please email firstname.lastname@example.org