The Informed Assent Form is a crucial document used in the Philippines when seeking participation from minors or individuals who cannot provide full legal consent but whose agreement to participate is ethically necessary. This document type is mandated by Philippine healthcare regulations and research ethics guidelines, particularly when conducting medical procedures, research studies, or treatments involving vulnerable populations. The form must be written in clear, age-appropriate language while adhering to requirements set forth by the Philippine Health Research Ethics Board and relevant legislation such as RA 11223 and RA 7610. It typically accompanies a more comprehensive informed consent form signed by parents or legal guardians, and may require approval from institutional ethics committees. The document demonstrates respect for participant autonomy while ensuring compliance with legal and ethical standards in the Philippine healthcare and research context.
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1. Title and Document Identification: Clear identification of the document as an Assent Form, including any relevant protocol or procedure numbers
2. Introduction: Simple explanation of why the form is being presented and who is asking for assent
3. Purpose: Clear, age-appropriate explanation of what the procedure/study is about and why it is being done
4. Procedures: Step-by-step description of what will happen, written in simple language
5. Risks and Discomforts: Honest but appropriate explanation of possible risks or uncomfortable aspects
6. Benefits: Clear description of any direct benefits to the participant and/or broader benefits to others
7. Alternatives: Description of other options or the choice not to participate
8. Rights and Voluntariness: Explanation that participation is voluntary and can be stopped at any time
9. Confidentiality: Simple explanation of how privacy will be protected
10. Contact Information: Names and contact details of responsible persons who can answer questions
11. Assent Declaration: Clear statement of assent and space for signatures
1. Compensation: Information about any payment or reimbursement, included when applicable to research studies
2. Photo/Video Release: Added when the procedure or study involves taking pictures or videos
3. Future Use of Information: Included when data might be used for future research or other purposes
4. Genetic Testing Information: Required when the procedure involves genetic testing or DNA analysis
5. Cultural Considerations: Added when specific cultural or religious aspects need to be addressed
6. Emergency Procedures: Included for high-risk procedures or studies
7. Cost Information: Added when there are any costs associated with participation
1. Visual Aid Appendix: Age-appropriate drawings or diagrams explaining procedures
2. Simplified Terms Glossary: Child-friendly definitions of medical or technical terms used
3. Parent/Guardian Information Sheet: Detailed information for parents/guardians accompanying the assent form
4. Rights and Resources Sheet: List of support services and additional resources
5. Schedule of Procedures: Timeline or calendar of events if multiple visits are involved
6. Emergency Contact Card: Detachable card with important contact information
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Medical Research
Clinical Trials
Pharmaceutical
Academic Research
Mental Health Services
Pediatric Care
Biomedical Research
Educational Research
Psychology
Social Services
Relevant Teams
Legal
Clinical Operations
Research Ethics
Regulatory Affairs
Patient Safety
Clinical Research
Data Protection
Medical Affairs
Quality Assurance
Research Administration
Clinical Compliance
Patient Relations
Relevant Roles
Clinical Research Coordinator
Research Ethics Officer
Medical Director
Pediatrician
Research Principal Investigator
Clinical Trial Manager
Healthcare Compliance Officer
Legal Counsel
Research Nurse
Study Coordinator
Child Psychologist
Patient Safety Officer
Research Administrator
Medical Ethics Committee Member
Data Protection Officer
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