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FAQs for Human Subjects Ethics Clearance

No ethics approval will be required for discussions. But if work involving human subjects is really being planned at a later stage, ethics clearance will be required.

However, you are advised to have a non-disclosure agreement with your informant in case you need to discuss some new ideas/technologies. The firm/industrial partner likely will want this agreement also. The non-disclosure agreement should be two sided to protect the PI’s ideas and intellectual property (IP) as well as the IP and trade secrets of the firm.

Funding source is not the deciding factor for human subjects ethics clearance. Any student or staff who will engage human subjects in his/her student (formal or informal) and will interact with them, needs ethical clearance.

If your study is basically an "audit" on pre-existing, archived data collected from human subjects, ethical clearance may not be required.

If new, different data are to be generated from archived samples from human subjects, i.e. something else is to be measured for a different purpose than the samples were originally collected for in an approved project, then new ethical approval is needed – and new informed consent from the original subjects is needed also. The exception to new informed consent being required is when the samples are truly 'anonymized' – that is, they are coded and no-one can trace back any individual samples to an individual subject – but new ethical approval is still needed and the reason why no new informed consent will be sought should be explained.

However, it is always be safer for an investigator to go through the ethical clearance process if there is any doubt on the case.


As far as you are a staff member and/or student of the PolyU, you are required to seek human subjects ethics clearance at PolyU even if the work is to be performed outside Hong Kong.

At the same time, you may well have to get clearance from the authority wherein the actual work will be conducted.

No ethics clearance is required under this circumstance because it appears to be simply a request for facilitation for recruitment of subjects for an external project which does not involve our staff directly in the project.

BUT it is important that the students are not 'referred to participate in the project' – i.e. there must be no pressure on them, or any sense of coercion or obligation for the students to join. It is acceptable only for the students to be informed of the call for volunteers (this is the extent of the facilitation). They have to decide to join (or not) with their free and independent consent.

If the Co-I is conducting the study according to the set protocol specified in the original research proposal approved by Ethics Committee of the PI institute, there is no need for the Co-I to seek approval from PolyU for the reason that the governance of the study operation is under the responsibility of the PI and the ethics issue is assumingly thoroughly examined by the PI institute. The above view should be read with the understanding that the original approved protocol is strictly adhered to by all researchers of the team.

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