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Informed Assent Form for Malaysia

Informed Assent Form Template for Malaysia

An Informed Assent Form is a legal and ethical document used in Malaysia when involving minors in research studies, medical procedures, or clinical trials. It complements the parental consent form and is written in age-appropriate language to ensure that young participants understand and voluntarily agree to their participation. The document must comply with Malaysian legal requirements, including the Child Act 2001 and relevant healthcare regulations, while following ethical guidelines established by the Medical Research and Ethics Committee (MREC) of Malaysia. It includes clear explanations of procedures, risks, benefits, and rights in simple terms, with provisions for privacy protection under the Personal Data Protection Act 2010.

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What is a Informed Assent Form?

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.

What sections should be included in a Informed Assent Form?

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

What sections are optional to include in a Informed Assent Form?

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

What schedules should be included in a Informed Assent Form?

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

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Jurisdiction

Malaysia

Publisher

Genie AI

Document Type

Consent Form

Cost

Free to use
Relevant legal definitions
























Clauses























Relevant Industries

Healthcare

Medical Research

Pharmaceutical

Clinical Trials

Academic Research

Biotechnology

Public Health

Pediatric Care

Mental Health Services

Educational Research

Relevant Teams

Legal

Clinical Operations

Research Ethics

Regulatory Affairs

Medical Affairs

Clinical Research

Patient Safety

Quality Assurance

Documentation

Compliance

Research Administration

Relevant Roles

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

Industries






Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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