The Assent Consent Form is a crucial legal document used in the Philippines when seeking participation of minors or vulnerable individuals in research studies, medical procedures, or similar activities. It serves a dual purpose: obtaining formal assent from the participant and consent from their legal guardian(s). The document must comply with Philippine legislation, including the Data Privacy Act of 2012, the Child and Youth Welfare Code, and relevant healthcare/research guidelines. It typically includes comprehensive information about the procedure or study, written in age-appropriate language, along with details about risks, benefits, confidentiality measures, and participant rights. The form is particularly important in medical, research, and educational settings where ethical considerations and protection of vulnerable participants are paramount.
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1. Title and Document Identification: Clear identification of the document as an Assent Form, including the project/procedure name and institution
2. Parties: Identification of all parties involved: the participant (minor/subject), legal guardian(s), and the institution/researcher
3. Background: Simple explanation of why the assent is being requested and the context of the project/procedure
4. Definitions: Clear, simple definitions of key terms used in the document, written in age-appropriate language
5. Purpose and Procedures: Clear explanation of what will happen and what the participant is being asked to do
6. Risks and Discomforts: Simple explanation of any potential risks or discomforts in age-appropriate language
7. Benefits: Description of direct benefits (if any) and broader benefits of participation
8. Voluntary Participation: Clear statement that participation is voluntary and can be withdrawn at any time
9. Confidentiality: Simple explanation of how privacy will be protected and information will be used
10. Contact Information: Clear listing of who to contact with questions or concerns
11. Signature Block: Space for signatures of the participant, legal guardian(s), and witness if required
1. Compensation: Include when there is payment or reimbursement for participation
2. Alternative Procedures: Include when there are other options available besides participation
3. Future Use of Information: Include when data/samples might be used for future research
4. Photography/Recording Consent: Include when the project involves taking photos or making recordings
5. Translation Declaration: Include when the form has been translated from another language
6. Emergency Procedures: Include for medical procedures or research with potential emergency situations
1. Schedule A - Detailed Procedure Description: Detailed, step-by-step description of procedures, may include diagrams or illustrations
2. Schedule B - Rights and Responsibilities: Detailed listing of participant rights and responsibilities
3. Schedule C - Emergency Contact Information: Comprehensive list of emergency contacts and procedures
4. Appendix 1 - Age-Appropriate Information Sheet: Simplified explanation of the project/procedure for younger participants
5. Appendix 2 - Data Privacy Notice: Detailed information about data collection and processing as required by the Data Privacy Act
6. Appendix 3 - Withdrawal Form: Form to be used if participant wishes to withdraw from the project/procedure
Authors
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Medical Research
Clinical Trials
Education
Social Sciences Research
Psychology
Pediatrics
Public Health
Pharmaceutical
Academic Research
Relevant Teams
Legal
Compliance
Research Administration
Clinical Operations
Medical Affairs
Data Protection
Ethics Committee
Patient Services
Research Ethics
Clinical Research
Relevant Roles
Research Coordinator
Clinical Trial Manager
Medical Director
Ethics Committee Member
Legal Counsel
Compliance Officer
Principal Investigator
Study Administrator
Research Ethics Officer
Data Protection Officer
Healthcare Provider
Research Assistant
Pediatrician
Child Psychologist
Social Worker
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