POLICY

Principles of Research Ethics Review Policy

Objectives of the policy

• Ensure that the dignity, well-being and privacy of research participants are respected and protected.
• Ensure the safety of research participants is taken into account and adequately protected when conducting research

Data collection

• All types of research which require collection of new data or existing data must be subject to research ethics review. Collection of new data extends to all types of data collection, including but not limited to interviews, observations, focus group discussions, treatments and surveys.
• Existing data refers to data which is already collected and filed from existing records, research or other sources. The use of existing data is also subject to review, regardless of whether it is public in nature, and whether it has been used in prior research.
• When research investigators wish to make use of existing data, they should fill in an “Existing Data Form” and explain how the investigation is consistent with the purpose and use of data when it is originally collected.

Privacy

• Pursuant to the Personal Data (Privacy) Ordinance, the research investigators shall not use the data collected for any other purpose than research, and shall ensure the data is stored safely, security, and kept for a period no more than necessary.
• The method and purpose of data collection shall be clearly indicated, and made known to the public.
• Personal identifiers, such as the participant’s name, contact, address or other personal characteristics, shall not appear in any report or public document, in order to avoid identification of the participants.

Risk

• The research would be subject to risk assessment, where the investigators shall consider the possibility of harm to participants in conducting the research. The investigator should consider the possibility of harm with respect to the particular sensitivity and predisposition of the participants.
• Under any situation, research and investigation shall not pose any harm above the “Minimal Risk” level, defined as “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 examinations or tests”
• For investigation involving children participants, the possible harm shall be no greater than what “ a normal, average, healthy child may be exposed to in the course of that child’s everyday life, or those risks encountered by normal, average, healthy children living in safe environments in daily life or during the performance or routine physical or psychological examinations or tests”

Reasonable, equitable, and public interest

• The reasonable and equitable requirements ensure that the purposes of the investigation are equitable and reasonable with regard to the entire situation
• The investigators shall ensure that the selection of research participants is equitable, with regard to the particular sensitivities, physical and mental characteristics of the participants. The investigators must ensure that, with reference to the participants’ particular vulnerabilities, the inconvenience and harm posed by the experiment are equitable and not undue.
• The investigators shall make sure that the degree, extent and methodology of the investigation are reasonable and no more than necessary with regard to the objective of the investigation. In assessing whether the investigation is reasonable, the impact to the participants, the potential benefits/help to participants and public interest element will be considered.

Informed consent/waiver

• Informed consent shall be obtained from participants before the research investigation commences. This is to ensure that the participants have full knowledge and understanding of the impact and implications of the investigation.
• Investigators must give participants sufficient information to allow them to understand the nature of the investigation, together with the potential impact to participants, before the investigation begins
• Investigators shall disseminate such information in a manner clearly comprehensible to the audience intended to conduct research, or their guardians in case of underaged participants
• The participants should be given enough time to perform independent judgment
• consider the possibility of harm to participants in conducting the research. The investigator should consider the possibility of harm with respect to the particular sensitivity and predisposition of the participants.
• Under any situation, research and investigation shall not pose any harm above the “Minimal Risk” level, defined as “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 examinations or tests”
• For investigation involving children participants, the possible harm shall be no greater than what “ a normal, average, healthy child may be exposed to in the course of that child’s everyday life, or those risks encountered by normal, average, healthy children living in safe environments in daily life or during the performance or routine physical or psychological examinations or tests”

Reasonable, equitable, and public interest

• The reasonable and equitable requirements ensure that the purposes of the investigation are equitable and reasonable with regard to the entire situation
• The investigators shall ensure that the selection of research participants is equitable, with regard to the particular sensitivities, physical and mental characteristics of the participants. The investigators must ensure that, with reference to the participants’ particular vulnerabilities, the inconvenience and harm posed by the experiment are equitable and not undue.
• The investigators shall make sure that the degree, extent and methodology of the investigation are reasonable and no more than necessary with regard to the objective of the investigation. In assessing whether the investigation is reasonable, the impact to the participants, the potential benefits/help to participants and public interest element will be considered.

Informed consent/waiver

• Informed consent shall be obtained from participants before the research investigation commences. This is to ensure that the participants have full knowledge and understanding of the impact and implications of the investigation.
• Investigators must give participants sufficient information to allow them to understand the nature of the investigation, together with the potential impact to participants, before the investigation begins
• Investigators shall disseminate such information in a manner clearly comprehensible to the audience intended to conduct research, or their guardians in case of underaged participants
• The participants should be given enough time to perform independent judgment on whether or not to participate. The investigators must not exert influence or pressure, or entice the participants in any other means
• Consent must be recorded and documented in an Informed Consent Form.

Form of consent

• Written consent shall be obtained when the participant has the ability to read a form, and legal capacity to sign the form. When the matter investigated is complex, or may pose possible harm to the participant, written consent shall be obtained
• When the research matter is trivial or only poses very minimal risk to the participant, or when the participant is illiterate, oral consent or informal consent (through emails, SMS, etc) can be obtained in lieu of written consent

Consent for underaged participants

• Due to the sensitive nature of the participants, active parental consent shall be obtained for any participants aged 16 or below.
• For participants with intellectual disabilities, the information given shall be phrased as simple and straight-forward as possible.

Studies which are exempt from ethics review

• Collection of anonymous data which will only be used for internal purposes, and not made into reports or other form of public academic document
• Use of existing data, from which participant’s personal identity is not identifiable, does not require ethics review

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