The Assent Consent Form is a crucial document in Australian healthcare and research contexts, designed to protect the rights and dignity of participants who may not have full legal capacity to consent. It is primarily used in situations involving minors, individuals with cognitive impairments, or those who require additional protection in decision-making processes. The form must comply with the Privacy Act 1988 (Cth), relevant state health records legislation, and the National Statement on Ethical Conduct in Human Research. It typically includes clear, simple explanations of procedures or research, potential risks and benefits, privacy protections, and statements of voluntary participation. This document bridges the gap between legal requirements for consent and ethical obligations to respect participant autonomy.
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1. Participant Information: Full name, date of birth, and contact details of the person giving assent
2. Parent/Guardian Information: Full name and contact details of parent/guardian (if applicable)
3. Project/Procedure Details: Clear, simple explanation of the research/medical procedure, including purpose and what will happen
4. Risks and Benefits: Simple explanation of potential risks and benefits in age-appropriate language
5. Voluntary Participation Statement: Clear statement that participation is voluntary and can be withdrawn at any time
6. Privacy Statement: Simple explanation of how personal information will be collected, used, and protected
7. Declaration of Assent: Formal statement of assent with space for signature
8. Witness Statement: Space for witness name, signature, and date
1. Interpreter Declaration: Required when the participant needs language assistance to understand the form
2. Audio/Visual Recording Consent: Include when the project involves recording of the participant
3. Future Research Use: Include when data/samples might be used in future research
4. Payment/Reimbursement Details: Include when participation involves payment or expense reimbursement
5. Emergency Contact Information: Include for medical procedures or longer-term studies
1. Schedule A - Detailed Project Information: More detailed information about the project/procedure in simple language
2. Schedule B - Rights and Responsibilities: Detailed list of participant rights and responsibilities
3. Appendix 1 - Glossary: Simple definitions of technical terms used in the form
4. Appendix 2 - Contact Information: Complete list of relevant contact persons including researchers, ethics committee, complaints
Authors
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Medical Research
Clinical Trials
Academic Research
Pharmaceutical
Biotechnology
Public Health
Mental Health Services
Pediatric Care
Social Sciences Research
Relevant Teams
Research Administration
Clinical Operations
Legal
Compliance
Ethics
Medical Affairs
Clinical Research
Patient Safety
Quality Assurance
Regulatory Affairs
Relevant Roles
Research Coordinator
Clinical Trial Manager
Ethics Committee Officer
Principal Investigator
Research Nurse
Pediatrician
Clinical Research Associate
Human Research Ethics Manager
Legal Counsel
Compliance Officer
Research Administrator
Medical Director
Study Coordinator
Patient Safety Manager
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