Participant Consent Form

Participant Consent Form Template for Philippines

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Key Requirements PROMPT example:

"I need a Participant Consent Form for a clinical trial studying new diabetes treatments, which will involve blood sampling and regular medical check-ups over six months starting March 2025, compliant with Philippine regulations and including provisions for data sharing with international research partners."

Document background

The Participant Consent Form is a crucial document required by Philippine law and research ethics guidelines for any study involving human subjects. It serves as a formal agreement between researchers and participants, ensuring that individuals are fully informed about their involvement in research activities. The document must comply with the Data Privacy Act of 2012, PHREB Guidelines, and other relevant Philippine regulations. This form is essential for protecting participants' rights and researchers' interests, documenting that participants understand the nature, risks, and benefits of their participation. It should be used before commencing any research activity, clinical trial, or medical procedure that requires informed consent, and must be available in both English and local languages when necessary.

Suggested Sections

1. Study Title and Introduction: Clear identification of the research study and brief introduction to the purpose

2. Researcher Information: Names and contact details of the researchers, institutions involved, and sponsor information if applicable

3. Purpose of the Study: Detailed explanation of why the research is being conducted and its importance

4. Study Procedures: Step-by-step description of what participation involves, including time commitment and activities

5. Risks and Discomforts: Clear explanation of potential risks, side effects, or inconveniences participants might experience

6. Benefits: Description of direct and indirect benefits to participants and society

7. Privacy and Confidentiality: Explanation of how personal information will be protected, used, and stored in compliance with the Data Privacy Act

8. Rights of the Participant: Clear statement of participant rights including withdrawal without penalty

9. Costs and Compensation: Information about any costs involved and compensation provided for participation

10. Declaration of Consent: Formal statement of consent with space for signatures, dates, and witnesses

Optional Sections

1. Medical Emergency Procedures: Required for studies involving medical procedures or potential health risks

2. Future Use of Data: Include when data might be used for future research or shared with other researchers

3. Audio/Video Recording Consent: Required when the study involves recording of participants

4. Genetic Testing Information: Include for studies involving genetic testing or DNA sampling

5. Translator Declaration: Required when consent form is translated from English to local languages

6. Parental/Guardian Consent: Required for participants under 18 or those lacking capacity to consent

7. Commercial Use of Data: Include when research data might be used for commercial purposes

Suggested Schedules

1. Detailed Study Protocol: Technical description of the research methodology and procedures

2. Risk Assessment Matrix: Detailed breakdown of potential risks and mitigation measures

3. Contact Information Sheet: Complete list of contact details for research team, ethics board, and emergency contacts

4. Data Privacy Notice: Detailed information about data processing activities as required by the Data Privacy Act

5. Withdrawal Form: Template form for participants to withdraw from the study

6. Compensation Schedule: Detailed breakdown of any compensation or reimbursement structure

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

Pharmaceuticals

Academic Research

Clinical Research

Biotechnology

Social Sciences

Psychology

Education

Medical Devices

Public Health

Relevant Teams

Legal

Research & Development

Clinical Operations

Regulatory Affairs

Ethics Committee

Data Protection

Quality Assurance

Medical Affairs

Clinical Research

Compliance

Relevant Roles

Research Director

Principal Investigator

Clinical Trial Manager

Research Ethics Officer

Data Protection Officer

Research Coordinator

Clinical Research Associate

Study Nurse

Research Administrator

Medical Director

Legal Counsel

Compliance Officer

Research Ethics Committee Member

Project Manager

Research Assistant

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