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Assent Consent Form
"I need an Assent Consent Form for a pediatric medical research study starting in March 2025, specifically for participants aged 7-12 years old who will be participating in a 6-month sleep pattern study, with special consideration for Māori cultural protocols."
1. Title and Introduction: Clear identification of the document as an assent form and brief introduction of its purpose
2. Participant Information: Space for the participant's name, age, and any relevant identification details
3. Project/Study/Procedure Description: Simple, clear explanation of what the participant is being asked to participate in
4. What Will Happen: Step-by-step explanation of what the participant will experience or need to do
5. Time Commitment: Clear statement of how long participation will take
6. Risks and Benefits: Simple explanation of any potential risks and benefits, written in accessible language
7. Voluntary Participation: Clear statement that participation is voluntary and can be stopped at any time
8. Privacy Protection: Simple explanation of how the participant's information will be protected and used
9. Contact Information: Names and contact details of responsible persons/organizations
10. Assent Declaration: The actual assent statement written in first person ('I understand...') with signature blocks
1. Compensation Information: Include when there is any form of payment or reward for participation
2. Photography/Recording Consent: Include when the project involves taking photos, videos, or recordings
3. Future Use of Information: Include when data might be used for future research or other purposes
4. Cultural Considerations: Include specific cultural considerations, particularly relevant for Māori participants
5. Medical Procedures: Include when the assent involves any medical procedures or treatments
6. Group Activities: Include when participation involves group activities or interaction with others
7. Translation Statement: Include when the form has been translated from English to another language
1. Visual Aids Schedule: Pictures, diagrams, or illustrations helping to explain the procedure/study
2. Age-Appropriate Information Sheet: Detailed information about the study/procedure written in age-appropriate language
3. Parent/Guardian Acknowledgment: Additional form for parent/guardian to acknowledge their child's assent
4. Withdrawal Form: Simple form that can be used if the participant wishes to withdraw later
5. Cultural Protocol Guide: When relevant, explanation of cultural protocols that will be followed
Authors
Participant
Study/Project
Parent/Guardian
Researcher/Investigator
Research Team
Personal Information
Confidentiality
Voluntary Participation
Withdrawal
Ethics Committee
Privacy
Data Collection
Recording
Documentation
Risk
Benefit
Support Person
Medical Procedure
Treatment
Cultural Support
Whānau
Research Institution
Side Effects
Emergency Contact
Adverse Event
Follow-up
Study Materials
Compensation
Rights
Voluntary Participation
Confidentiality
Privacy Protection
Data Collection and Use
Rights and Responsibilities
Risk Disclosure
Benefits
Withdrawal Rights
Emergency Procedures
Cultural Considerations
Recording Consent
Access to Information
Contact Details
Duration and Timeline
Compensation
Parent/Guardian Authorization
Medical Procedures
Safety Measures
Reporting Concerns
Future Use of Data
Translation Rights
Support Services
Documentation Requirements
Healthcare
Medical Research
Clinical Trials
Education
Social Sciences
Psychology
Pediatrics
Public Health
Academic Research
Behavioral Studies
Mental Health Services
Community Services
Research Administration
Clinical Operations
Legal Compliance
Ethics Review
Medical Affairs
Child Services
Research Governance
Clinical Research
Patient Protection
Research Ethics
Study Management
Documentation
Research Coordinator
Clinical Trial Manager
Ethics Committee Officer
Pediatrician
Child Psychologist
Research Nurse
Study Administrator
Legal Compliance Officer
Research Ethics Director
Principal Investigator
Child Protection Officer
Research Assistant
Medical Director
Educational Researcher
Clinical Research Associate
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