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1. Title and Document Identification: Clear identification of the document as an Assent Form, including study/procedure title and reference numbers
2. Introduction: Age-appropriate introduction explaining who is conducting the study/procedure and general purpose
3. Purpose and Background: Simple explanation of why the study/procedure is being done and what it hopes to achieve
4. What Will Happen: Step-by-step description of what the participant will experience, written in clear, age-appropriate language
5. Time Commitment: How long participation will take, including number and length of visits if applicable
6. Risks and Discomforts: Clear, honest explanation of any possible discomfort or risks, written appropriately for the age group
7. Benefits: Explanation of any direct benefits to the participant and/or broader benefits to others
8. Your Rights: Clear statement that participation is voluntary and can be stopped at any time
9. Privacy Protection: Simple explanation of how the participant's information will be protected and used
10. Questions and Contacts: Who to ask if there are questions or concerns, including researcher and ethics committee contacts
11. Signature Section: Space for child's signature/mark, date, and witness signature
1. Compensation: Include when there is payment or reimbursement for participation
2. Alternative Procedures: Include when there are other options available for treatment/participation
3. Audio/Visual Recording: Include when the study/procedure involves recording of the participant
4. Future Use of Information: Include when data might be used for future research
5. Cultural/Religious Considerations: Include when specific cultural or religious aspects need to be addressed
6. Translator Statement: Include when the form needs to be translated for non-English/non-Malay speaking participants
1. Age-Appropriate Information Sheet: Detailed information about the study/procedure in child-friendly format
2. Visual Aids: Pictures or diagrams explaining procedures or equipment that will be used
3. Contact Information Card: Separate card with important contact numbers and information
4. Schedule of Visits: If applicable, calendar or timeline of required visits and procedures
5. Glossary: Child-friendly definitions of medical or technical terms used in the form
Healthcare
Medical Research
Pharmaceutical
Clinical Trials
Academic Research
Biotechnology
Public Health
Pediatric Care
Mental Health Services
Educational Research
Legal
Clinical Operations
Research Ethics
Regulatory Affairs
Medical Affairs
Clinical Research
Patient Safety
Quality Assurance
Documentation
Compliance
Research Administration
Research Coordinator
Clinical Trial Manager
Ethics Committee Member
Legal Counsel
Medical Director
Principal Investigator
Pediatrician
Research Nurse
Regulatory Affairs Specialist
Patient Safety Officer
Research Ethics Officer
Clinical Research Associate
Study Protocol Manager
Compliance Officer
Medical Writer
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