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Participant Consent Form

Participant Consent Form for Singapore

Participant Consent Form Template for Singapore

A Participant Consent Form under Singapore law is a legally binding document that outlines the terms, conditions, and implications of participating in a research study. It must comply with the Personal Data Protection Act (PDPA) 2012 and, where applicable, the Human Biomedical Research Act (HBRA) 2015. The document ensures informed consent by clearly communicating research objectives, procedures, risks, benefits, and participants' rights, including data protection measures and withdrawal options.

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What is a Participant Consent Form?

The Participant Consent Form is a crucial document in research settings, required by Singapore law and ethical guidelines. It serves as both a legal and ethical safeguard, ensuring that research participants make informed decisions about their involvement in studies. The form must comply with Singapore's PDPA 2012, HBRA 2015 (for biomedical research), and relevant institutional review board requirements. It typically includes detailed information about the research purpose, procedures, risks, benefits, confidentiality measures, and participant rights, particularly the right to withdraw. The document is essential for protecting both participants' interests and researchers' legal compliance.

What sections should be included in a Participant Consent Form?

1. Title and Introduction: Study title, principal investigator, and institution details responsible for the research

2. Purpose of Research: Clear explanation of research objectives, methodology, and expected outcomes

3. Participation Requirements: Detailed explanation of what participation involves, including time commitment, procedures, and eligibility criteria

4. Risks and Benefits: Comprehensive overview of potential risks, discomforts, and benefits associated with participation

5. Confidentiality Statement: Details on how personal data will be collected, used, stored, and protected in accordance with PDPA 2012

6. Withdrawal Rights: Clear statement of participant's right to withdraw at any time and the process for withdrawal

7. Declaration of Consent: Formal consent statement and signature blocks for participant and researcher

What sections are optional to include in a Participant Consent Form?

1. Compensation Information: Details of any payment, reimbursement, or compensation provided for participation

2. Future Research Use: Information about potential future use of data or samples and associated consent options

3. Medical Care Provisions: Details of medical care provided during and after the study, including insurance coverage

4. Audio/Video Recording Consent: Specific consent for any audio or video recording during the research process

What schedules should be included in a Participant Consent Form?

1. Schedule A - Detailed Study Procedures: Comprehensive step-by-step description of all research procedures and visits

2. Schedule B - Contact Information: List of all relevant contact persons, including researchers, ethics committee, and emergency contacts

3. Schedule C - Glossary of Terms: Definitions and explanations of technical or medical terms used in the consent form

4. Schedule D - Rights Under PDPA: Detailed explanation of participant rights under Singapore's Personal Data Protection Act

Authors

Alex Denne

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

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Jurisdiction

Singapore

Publisher

tiktok成人版

Document Type

Consent Form

Sector

Compliance

Cost

Free to use
Relevant legal definitions

























Clauses

























Industries

PDPA 2012: Personal Data Protection Act 2012 - Singapore's primary legislation governing the collection, use, disclosure and care of personal data. Essential for consent forms as it regulates how participant data must be handled.

HBRA 2015: Human Biomedical Research Act 2015 - Regulates human biomedical research in Singapore, providing specific requirements for informed consent and participant protection in biomedical research contexts.

Mental Capacity Act: Legislation protecting and empowering individuals who lack mental capacity, including specific provisions for their participation in research and requirements for proxy consent.

Singapore GCP Guidelines: Singapore Guideline for Good Clinical Practice - Provides standards for conducting clinical research, including detailed requirements for informed consent processes and documentation.

IRB Guidelines: Institutional Review Board Guidelines - Local institutional requirements for research ethics and participant protection, including specific consent form elements and review procedures.

SMC Ethical Code: Singapore Medical Council Ethical Code and Guidelines - Professional standards for medical practitioners, including requirements for obtaining informed consent and maintaining patient confidentiality.

Declaration of Helsinki: International ethical principles for medical research involving human subjects, providing fundamental guidelines for informed consent and participant protection.

ICH-GCP Guidelines: International Conference on Harmonisation - Good Clinical Practice Guidelines - International standards for conducting clinical trials, including detailed requirements for informed consent processes.

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