Human Research Ethics
Human Research Ethics for VTC (Non-THEi) Staff
Human research is broadly defined as research conducted with or about people, or their data. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:
Enquiries: Miss Jackie Lai, Secretary of Human Subjects Ethics Panel (Tel.: 2256-7404; Email: firstname.lastname@example.org)
Prior to research, the Principal Investigator (PI), who has to be a VTC staff, should conduct an appropriate risk assessment, prepare necessary Informed Consent Forms, consider availability of reimbursement and incentives for participants, and formulate procedures to ensure privacy and confidentiality of data.
1. Risk Assessment
To ensure that participants' interests and rights are protected, PI is required to undertake a “Risk Assessment”. For this, PI should consider carefully if the research study will involve any possible risks which could induce greater than minimal physical and/or psychological stress/pain/discomfort to participants. Under normal circumstances, participants should not be exposed to risks which are greater than minimal risks1. In cases where there are risks, PI should inform participants clearly about the type and degree of the risk they may be undertaking, the measures that will be taken to minimise the risk, and remedial support given. PI should safeguard participants' privacy and confidentiality. PI should let participants know the data collected from the participants will be deployed in the research, whether the data will be in an identifiable or anonymous2 format, and how and how long the data will be safely kept. PI should also assess if there is any potential conflict of interest that needs to be declared and addressed.
2. Preparation of Informed Consent Forms
Research participants should be given the opportunity to choose what shall or shall not happen to them. Researchers must accordingly prepare and obtain appropriate informed consent, and shall:
The process of obtaining informed consent has two mandatory components, which have to be completed:
In addition to new data collection targeting adult participants, informed consent is also required when conducting pilot studies, conducting studies that involve children under 18 years old, and conducting school-based research:
There is a need to seek consent before obtaining data in pilot studies on the grounds that the Informed Consent Form could be tested and be refined for use in any subsequent study.
The best practice should be to seek written consent from parents and to obtain assent from students themselves for research involving children under 18 years old, even in cases where children were able to decline participation. The Assent Form should be written in an easily comprehensible manner at children's reading level, in order to facilitate their decision-making on participation. For research with only minimal risk (including privacy risk), the PI should determine if passive parental consent3 can be used for participants who are children under 18 years old. PI seeking approval of passive parental consent should provide a full justification and an Information Sheet.
For school-based studies of children below Secondary level, active consent of parents is normally required. For school-based studies of children at Secondary level (i.e. 11 years old and above), parental passive consent is normally sufficient for studies involving minimal risk. For Adolescent-research outside school involving adolescents aged 16 or above, parental consent is not normally required on the basis that they are mature minors.
Other than written consent, online/email recorded response can also serve as a means of obtaining informed consent, as long as it is in response to a proper Information Sheet. Also, when conducting research where seeking written consent is not practical (e.g. illiterate respondents) or too sensitive, audio-recorded oral consent might be less of a privacy risk than written consent and can be considered as an alternative to written consent. When both written and oral consent is not practical (e.g. telephone interviews, door-to-door interviews), a full justification and an Information Sheet should be provided together with the application for ethical approval.
3. Reimbursement and Incentives for Participants
Prospective participants should not be adversely induced by financial reward or be pressured to participate in research. All reimbursement of expenses, such as traveling expenses and incentives, should be commensurate with standard practice and be reasonable.
1 "Minimal Risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or test.
2 Anonymous data: Data without the personal identifier (e.g. name, ID card, and DNA profile). Data is anonymous when there is no possible way to identify the participants from the data collected. Data are not anonymous if procedures, such as accessing a computer database, will identify the participant. For most specific cases, the omission of names and other personal identifiers such as HKID/Passport numbers is sufficient to qualify data as anonymous.
3 Passive parental consent means that parents are fully informed of the right to refuse participation by their children. Parent/guardian must be given reasonable time (e.g. two weeks) to object to the child's participation.
Research participants should be given the opportunity to choose what shall or shall not happen to them. Researchers must obtain appropriate informed consent before the start of the research (refer to Section 2 in “Prior to Research” for details of "Preparation of Informed Consent Forms").
Data containing personal identifiers could normally be kept for a maximum of six years. PI is strongly advised to remove all personal identifiers for long-term retention of their research data, in order to minimize privacy risks. No data with personal identifiers should be kept beyond six years unless there is explicit written consent to retaining the data with personal identifiers preserved, such as in oral history.
The PI should report to the Head of Operation Unit any research-related incidents, such as physical or emotional harm to the participant during the research process or breaches of confidentiality.
The Human Subjects Ethics Panel (HSEP) is responsible to all matters related to the human subjects research in the Vocational Training Council.
Terms of Reference
1. The term of office for external members is three years.
2. The maximum number of terms of office for external members is two.
Participants should be assured that the information collected will not be publicly disclosed in a way that specific persons can be identified unless they expressively consented to public disclosure, and that every precaution will be taken in relation to the storage, use and disposition of data (e.g. locking up raw data). For private sensitive data, PI is suggested to use indirect identifiers and keep the direct identifiers separate from the data. Measures should be taken to ensure the integrity, prudence and competence of persons having access to data.
To comply with the Personal Data and Privacy Ordinance, researchers must maintain the confidentiality of data related to individual research participants. Except by public observation, researchers should clearly indicate the purpose of the collection of data and the method to ensure the confidentiality of collected data. Researchers must also avoid use of any personal identifiers such as individual names and addresses in their research reports which could lead to the human participants being identified.