FHSS Human Subjects Ethics Sub-Committee
(A sub-committee of the Faculty Research Committee)

Frequently Asked Questions

1. Do non-funded research projects need ethical approval before they can commence?

A. All research projects should obtain ethical approval regardless of the source of funding because ethical review and the consideration of funding of research projects are separate issues. The principal investigator of a research project is ultimately responsible for ensuring ethical protection for all human subjects involved in the project.

2. If I am a member of a research team whose principal investigator is from another university, do I need to apply for ethical approval from PolyU for the project?

A. It is not necessary to obtain approval from PolyU if the principal investigator is not a PolyU staff member. However, ethical approval (or at least approval for access to the subjects or confidential information about them) is required from PolyU and the other educational institute(s) concerned if the subjects are to be selected from hospitals or other health or social care institutions.

3. How long does it usually take for ethical approval to be granted?

A. The processing period for an ethical approval application is normally one or two weeks. However, it often takes longer to process a complicated application.

4. How much information should I include in an informed consent form?

A. Basic information such as participants' particulars, level of risks and potential benefits of the project to the participants should be included in the informed consent form. It is important to include a statement that any participant may withdraw from the study at any time without penalty. Furthermore, the consent form should be written in clear, simple language and be in an easy and readable format that is manageable for the participant. There is no need to require an independent witness for the participant's signing of the consent form unless the participant is vulnerable, such as having an intellectual, language or cultural difficulty, but who is deemed capable of giving informed consent to take part in the study. There is no restriction on who can be the independent witness, so long as this third party is independent. A sample ethics review checklist is available here.)

5. What is meant by repetitive measurements?

A. In principle, when there is more than one episode of measurement, it is a 'repeated' measurement. A classic pre-post test design could also be regarded as a repeated measurement. Subjecting participants to unnecessary or inappropriate measurements or repeated measurements without a valid reason to do so in the context of the study design may be deemed unethical.

6. How do I decide how much to pay a subject to compensate for his or her time and expenses if he or she volunteers to participate in the study?

A. The amount offered to the participant should be the total of travelling expenses and the cost of food incurred during the actual research activity (e.g., in a study involving fasting) within a reasonable limit.

7. If my application for ethical approval is turned down, where can I get advice or a second opinion about the Departmental Research Committee's (DRC) decision?

A. In the event of disagreement about the DRC's decision not to grant approval, the principal investigator should seek dialogue with the DRC Chairperson to find out the reasons why your application for ethical approval was not granted. If after this you are unable to resolve the situation with the DRC Chairperson and wish to seek a second opinion, you may submit your application to the Secretary of the FHSS Human Subjects Ethics Sub-Committee. Your application should include a memo with a clear explanation of the disagreement and actions that you have taken to resolve the situation and the outcomes of your attempts. A copy of the application and memo should also be sent to the DRC Chairperson.

8. I only want to review patient records in my project. Do I still need ethical approval beforehand?

A. YES. A person's medical record is private and is only intended for the purpose of providing health care to the person as well as for other legitimate medical purposes. Apart from these, the person has the right to know that his or her medical record is being kept confidential. Thus any proposed research involving data from medical records needs to be reviewed for ethical approval of the handling of the subject's personal information. Even though your type of project audits existing information and does not generate empirical data per se, you are still required to submit an ethics review checklist per the University's ethical review protocol. If your project does not necessitate submitting an application for ethics approval, you must state the reasons why.

9. Why do I have to get prior informed consent from a participant?

A. You have to ensure that the participant fully understands what he or she is being asked to do in the project, the potential risks and benefits of the research, and that he or she CHOOSES to take part in the study out of free will without real or perceived coercion.

10. What is coercion?

A. Coercion is when someone is forced or 'persuaded' to do something because of real or perceived fear, obligation, subordination or a threat of a penalty or disfavour. Care must be taken to ensure that there is no coercion of subjects who are considering volunteering to participate in a research study. This is particularly important when someone could be perceived as having 'power' over the 'volunteer,' such as may occur in a doctor-patient or teacher-student relationship. This does not mean that a member of academic staff (or a doctor) cannot invite students (or patients) to consider volunteering to participate in his or her research. It means that the researcher must make it absolutely clear to the subjects that their participation is really voluntary and unforced, and that whether the students or patients decide to take part or not in the research makes absolutely no difference to how the students will be taught or assessed or to the quality of care that will be provided to the patients.