Participant Consent Form

Participant Consent Form Template for Singapore

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Key Requirements PROMPT example:

"I need a Participant Consent Form for a medical research study at Singapore General Hospital, involving collection of blood samples and genetic data from 100 participants, with specific provisions for data sharing with international research partners."

Document background

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.

Suggested Sections

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

Optional Sections

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

Suggested Schedules

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) @ ��Ƶ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Healthcare
Academic Institutions
Pharmaceutical
Psychology
Market Research

Relevant Teams

Research & Development
Legal
Ethics & Compliance
Data Protection
Clinical Operations

Relevant Roles

Research Director
Principal Investigator
Research Coordinator
Ethics Officer
Data Protection Officer
Legal Counsel

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Let's create your Participant Consent Form

Authors

Alex Denne

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