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

Ethical Review

It is a requirement of the University that all research/teaching projects involving human subjects must be reviewed for ethical appropriateness in accordance with the guidelines of the Human Subjects Ethics Sub-committee (HSESC). The Human Subjects Ethics Application Review System (HSEARS) at https://www40.polyu.edu.hk/rohsears/login.jsf will facilitate the staff and students in making applications and the approving authorities in conducting review, granting approval, and making applications enquiries.

Informed Consent Form

The informed consent form should be created by the researcher to ensure that the subject is fully aware of the nature of the research and that the subject is not required to participate in the study. The consent form is often accompanied by a separate, attached information sheet that provides detailed information about the research to the subject.

General Principles

There are three basic principles to bear in mind when creating an informed consent form/information sheet for human subject consent to participate in a research study:

• Disclosure
  There should be detailed information about the research so that the subject is aware of its procedures, and risks and benefits to him or her.
• Comprehension
  The subject must completely understand all the information provided. Consent for participation should not be sought solely by presenting the consent form and information sheet to a subject to read; a knowledgeable member of the research team should go over the information verbally with the subject to ensure that the subject fully understands what the research and participation entail.
• Voluntary Participation
  The subject must understand that he or she may freely choose to agree to or decline participation in the research study without real or perceived coercion or penalty. The subject (or her or his representative) should be given sufficient time and opportunity to decide whether he or she consents to participation or declines participation.
  
  

Specific elements for inclusion

• A statement that the study involves research.
• An explanation of the purpose of the research and the expected duration of the subject's participation.
• A description of the procedures to be followed and identification of any procedures that are experimental.
• A description of any foreseeable risks or discomforts to the subject, an estimate of their likelihood, and a description of what steps will be taken to prevent or minimize them.
• A description of any benefits to the subject or to others that may reasonably be expected from the research. Monetary compensation is not a benefit.
• A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the subject.
• A statement describing to what extent records will be kept confidential, including a description of who may have access to the research records.
• Contact details of the person with whom the subject should get in touch in the event of a research-related problem.
• An explanation of whom to contact for relevant queries about the research and the subject's rights.
• A statement that participation is voluntary and that a decline to participate or a decision to discontinue participation at any time will involve no penalty or loss of treatment or benefits to which the subject is otherwise entitled.

These guidelines are based upon those published by the US's National Institutes of Health. More information is available on its website at https://irbo.nih.gov/confluence/.