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.
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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
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
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
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Ethics Committee
Data Protection
Quality Assurance
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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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