The Assent Consent Form is a crucial document in Nigerian healthcare, research, and educational settings where formal agreement is needed from individuals who may not have the full legal capacity to provide informed consent. This document type is particularly important in contexts involving minors, research participants with cognitive limitations, or individuals who require simplified explanation of procedures. The form must comply with Nigerian legislation, including the National Health Act 2014, the Child Rights Act 2003, and the National Code of Health Research Ethics. It typically includes clear, simple language explaining the purpose, procedures, risks, and benefits of participation, while ensuring that the individual's rights are protected and their voice is heard in the decision-making process.
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1. Participant Information: Details of the person giving assent, including name, age, and any relevant identification information
2. Purpose Statement: Clear, simple explanation of what the assent is for, written in age-appropriate or capacity-appropriate language
3. Voluntary Nature: Statement explaining that participation is voluntary and can be withdrawn at any time
4. Activity Description: Simple explanation of what will happen or what the participant is agreeing to
5. Risks and Benefits: Clear explanation of any risks or benefits, written in simple, understandable terms
6. Confidentiality: Simple explanation of how the participant's information will be protected and used
7. Contact Information: Names and contact details of responsible parties (researchers, doctors, or relevant authorities)
8. Assent Declaration: Clear statement of assent with space for signature/thumb print and date
1. Translation Statement: Required when the form needs to be presented in multiple languages or has been translated from its original language
2. Audio-Visual Recording Consent: Include when the activity involves photographs, video, or audio recordings
3. Payment/Compensation: Include when there is any form of compensation or reimbursement involved
4. Future Use of Information: Include when data or samples might be used for future research or purposes
5. Parent/Guardian Acknowledgment: Include when the assent form needs to be acknowledged by a parent or guardian
6. Emergency Procedures: Include when the activity involves medical procedures or potential medical risks
1. Simple Pictorial Guide: Visual representations of key information to aid understanding
2. Simplified Terms Dictionary: Child-friendly or simplified explanations of technical terms used in the form
3. Contact Details Sheet: Detailed contact information for all relevant parties in an easy-to-reference format
4. Rights Summary: Simple summary of participant rights in bullet-point format
Relevant legal definitions
Clauses
Voluntary Participation
Purpose and Procedures
Risks and Discomforts
Benefits
Privacy and Confidentiality
Data Protection
Right to Withdraw
Emergency Procedures
Compensation
Documentation and Records
Contact Information
Translation and Language
Audio-Visual Recording
Future Use of Information
Rights and Responsibilities
Capacity Assessment
Guardian Acknowledgment
Witness Certification
Signature and Declaration
Purpose and Procedures
Risks and Discomforts
Benefits
Privacy and Confidentiality
Data Protection
Right to Withdraw
Emergency Procedures
Compensation
Documentation and Records
Contact Information
Translation and Language
Audio-Visual Recording
Future Use of Information
Rights and Responsibilities
Capacity Assessment
Guardian Acknowledgment
Witness Certification
Signature and Declaration
Relevant Industries
Healthcare
Medical Research
Clinical Trials
Educational Research
Pharmaceutical
Public Health
Academic Institutions
Social Services
Child Services
Mental Health Services
Relevant Teams
Legal Compliance
Research Ethics
Clinical Operations
Patient Relations
Research Administration
Medical Affairs
Quality Assurance
Clinical Research
Regulatory Affairs
Child Services
Relevant Roles
Research Coordinator
Clinical Trial Manager
Ethics Committee Officer
Medical Director
Research Ethics Manager
Legal Compliance Officer
Patient Rights Advocate
Research Nurse
Principal Investigator
Study Administrator
Healthcare Program Manager
Research Ethics Consultant
Clinical Research Associate
Child Services Coordinator
Mental Health Professional
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