The Participant Consent Form is a crucial legal document used in Hong Kong to obtain informed consent from individuals participating in research studies, clinical trials, or similar investigations. It serves as both a protective measure for participants and a compliance tool for researchers and institutions. The document must align with Hong Kong's Personal Data (Privacy) Ordinance, research ethics guidelines, and relevant sector-specific regulations. It typically includes comprehensive information about the study's purpose, procedures, risks, benefits, data handling practices, and participant rights. The form should be written in clear, accessible language while maintaining legal validity, and may require translation for non-English speaking participants. When clinical or medical research is involved, additional regulatory requirements under Hong Kong's Control of Medicines and Clinical Trials and Studies regulations must be addressed.
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1. Title and Document Identification: Clear identification of the document as a consent form, including the study/project title, reference numbers, and version date
2. Introduction: Brief overview of the study/project and the organizing institution(s)
3. Purpose of the Study: Clear explanation of what the study aims to achieve and why it's being conducted
4. Participation Requirements: Detailed description of what participation involves, including time commitment, activities, and procedures
5. Risks and Discomforts: Clear disclosure of any potential risks, side effects, or discomforts associated with participation
6. Benefits: Description of potential benefits to the participant and/or society
7. Confidentiality and Data Protection: Explanation of how personal information will be collected, used, stored, and protected in accordance with the Personal Data (Privacy) Ordinance
8. Voluntary Participation: Statement that participation is voluntary and participants can withdraw at any time
9. Costs and Compensation: Information about any costs involved or compensation provided
10. Contact Information: Details of who to contact for questions about the study or participants' rights
11. Declaration and Signatures: Formal declaration of consent and signature blocks for participant, researcher, and witness if required
1. Parental/Guardian Consent: Required when participants are under 18 or lack capacity to consent
2. Medical Procedures: Detailed description of any medical procedures, required for clinical trials or medical research
3. Audio/Video Recording Consent: Specific consent for recording of participants, if applicable
4. Future Research Use: Consent for using data or samples in future research
5. Translation Declaration: Required when the form is presented in multiple languages
6. Insurance Coverage: Details of insurance coverage for clinical trials or medical research
7. Commercial Interest Disclosure: Required when there are commercial interests or potential commercialization of research results
1. Participant Information Sheet: Detailed information about the study, frequently in Q&A format
2. Protocol Summary: Summary of the research protocol in lay language
3. Privacy Policy: Detailed privacy policy and data handling procedures
4. Withdrawal Form: Form for participants to formally withdraw from the study
5. Emergency Contact Form: Contact information for emergencies (required for medical studies)
6. Rights and Responsibilities: Detailed outline of participant rights and responsibilities
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