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Participant Consent Form Template for Hong Kong

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Key Requirements PROMPT example:

Participant Consent Form

"I need a Participant Consent Form for a medical research study in Hong Kong involving blood sampling and genetic testing, with specific provisions for data sharing with international research partners and potential commercial applications."

Document background
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.
Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈ˰æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions






























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Relevant Industries

Healthcare

Medical Research

Academic Research

Clinical Trials

Pharmaceutical

Psychology

Social Sciences

Education

Market Research

Technology Research

Biotechnology

Public Health

Relevant Teams

Legal

Compliance

Research & Development

Clinical Operations

Data Protection

Ethics & Governance

Quality Assurance

Regulatory Affairs

Human Subject Protection

Research Administration

Relevant Roles

Research Director

Principal Investigator

Clinical Trial Manager

Research Ethics Officer

Data Protection Officer

Legal Counsel

Compliance Manager

Research Coordinator

Human Subjects Protection Specialist

Ethics Committee Chair

Research Administrator

Quality Assurance Manager

Research Nurse

Study Doctor

Research Assistant

Industries






Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

Find the exact document you need

Participant Consent Form

A Hong Kong law-governed document obtaining informed consent from research participants, ensuring compliance with local privacy laws and ethical guidelines.

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