The And Informed Consent Form is a critical document used in Philippine healthcare and research settings to obtain and document voluntary, informed consent from patients or research participants. This document is essential for compliance with Philippine regulations, including the Data Privacy Act of 2012 (RA 10173), the Medical Act of 1959 (RA 2382), and the National Ethical Guidelines for Health Research. It should be used before conducting any medical procedure, treatment, or research involving human subjects, ensuring that participants are fully informed about the nature, risks, and benefits of their involvement. The form must be written in clear, understandable language, with provisions for translation when necessary, and must include specific elements required by Philippine law regarding data privacy, patient rights, and medical ethics.
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1. Title and Document Identification: Clear identification of the document as an Informed Consent Form, including any relevant protocol or procedure numbers
2. Parties: Identification of all parties involved (healthcare provider/researcher and participant/patient)
3. Background: Brief introduction explaining the purpose of the consent form and the context of the procedure/research
4. Definitions: Clear definitions of technical terms and important concepts used in the document
5. Purpose and Procedures: Detailed description of the medical procedure/research and its purpose
6. Risks and Discomforts: Comprehensive explanation of potential risks, side effects, and discomforts
7. Benefits: Description of potential benefits to the participant and/or society
8. Alternative Procedures: Information about alternative options or treatments available
9. Confidentiality: Explanation of how personal information will be protected and used
10. Costs and Compensation: Information about any costs involved and/or compensation provided
11. Voluntary Participation: Statement affirming voluntary nature of participation and right to withdraw
12. Contact Information: Details of who to contact for questions or concerns
13. Declaration and Signatures: Formal declarations and signature blocks for all parties
1. Research-Specific Information: Additional details about research methodology and duration, required for research studies only
2. Future Use of Data: Section describing potential future uses of collected data or samples, needed when data might be used beyond immediate purpose
3. Photography/Video Recording Consent: Additional consent for visual documentation, when applicable
4. Translator Declaration: Required when consent form is translated or when translator is needed for communication
5. Emergency Contact Information: Required for procedures with significant risks or extended duration
6. Insurance Coverage: Details about insurance coverage for clinical trials or specific procedures
7. Genetic Testing Information: Required when procedure involves genetic testing or storage of genetic material
1. Detailed Procedure Description: Technical details of the procedure or research protocol
2. Risk Assessment Matrix: Detailed breakdown of potential risks and their likelihood
3. Data Privacy Notice: Comprehensive information about data handling practices as required by the Data Privacy Act
4. Patient Rights Summary: Detailed explanation of patient/participant rights
5. Medical Terms Glossary: Definitions of medical terms used in the document
6. Emergency Procedures: Detailed emergency protocols and contact information
7. Financial Schedule: Breakdown of costs or compensation details when applicable
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Relevant Teams
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Clinical Operations
Research Ethics
Quality Assurance
Data Protection
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Patient Services
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