The Informed Assent Form is a crucial document required in Malaysia whenever minors are involved in research studies, clinical trials, or medical procedures. While parental consent is legally required, obtaining the minor's assent demonstrates respect for their developing autonomy and ensures their willing participation. The document must be drafted in accordance with Malaysian legal frameworks, including the Child Act 2001 and Medical Act 1971, while adhering to international ethical standards for research involving children. The form includes clear, age-appropriate explanations of procedures, potential risks and benefits, privacy protections, and the voluntary nature of participation. It serves as both a legal record and an educational tool, helping young participants understand their role in the research or procedure while protecting their rights and interests.
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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
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