The Informed Consent Form Template is a critical document used across Australian healthcare and research institutions to ensure proper documentation of participant/patient consent. It is designed to comply with Australian legislation, including the Privacy Act 1988, state-specific health records acts, and the National Statement on Ethical Conduct in Human Research. This template should be used whenever informed consent is required for medical procedures, research participation, clinical trials, or collection of personal health information. It includes comprehensive sections covering project details, risks, benefits, privacy provisions, and participant rights, with flexibility to adapt to specific requirements while maintaining legal compliance. The template is structured to ensure that consent is properly informed, voluntary, and documented in accordance with Australian legal and ethical standards.
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1. Project Title and Institution Details: Clear identification of the research project/medical procedure and the responsible institution
2. Investigator/Healthcare Provider Information: Names, titles, and contact information of the principal investigator(s) or healthcare providers
3. Purpose and Background: Clear explanation of why the research/procedure is being conducted and relevant background information
4. Participant Requirements: Detailed description of what participation involves, including time commitment and specific activities
5. Risks and Discomforts: Clear explanation of potential risks, side effects, or discomforts associated with participation
6. Benefits: Description of potential benefits to the participant and/or wider community
7. Privacy and Confidentiality: Explanation of how personal information will be collected, used, stored, and protected
8. Costs and Compensation: Information about any costs involved and/or compensation provided
9. Voluntary Participation: Statement emphasizing voluntary nature of participation and right to withdraw
10. Declaration and Signatures: Formal declaration of consent and signature blocks for all relevant parties
1. Alternative Treatments: Description of alternative treatments or procedures when applicable to medical procedures
2. Audio/Visual Recording Consent: Specific consent for any audio or visual recording during research/procedure
3. Future Use of Data: Consent for future use of collected data in other research projects
4. Genetic Testing Information: Specific information and consent for genetic testing if applicable
5. Interpreter Declaration: Required when participant requires language interpretation services
6. Commercial Applications: Information about potential commercial applications of research findings
7. Indigenous Considerations: Specific considerations for Aboriginal and Torres Strait Islander participants
1. Schedule A - Detailed Procedure Description: Technical details of the research methodology or medical procedure
2. Schedule B - Risk Assessment: Detailed breakdown of potential risks and mitigation strategies
3. Schedule C - Privacy Policy: Detailed privacy policy and data protection measures
4. Appendix 1 - Glossary: Definitions of technical terms used in the consent form
5. Appendix 2 - Contact Information: Comprehensive list of relevant contacts including ethics committee details
6. Appendix 3 - Withdrawal Form: Form for participants to formally withdraw from the study/procedure
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Medical Research
Clinical Trials
Pharmaceuticals
Biotechnology
Academic Research
Public Health
Mental Health Services
Allied Health Services
Aged Care
Disability Services
Indigenous Health Services
Relevant Teams
Legal
Compliance
Research Ethics
Clinical Operations
Medical Affairs
Quality Assurance
Research Administration
Healthcare Operations
Risk Management
Privacy and Data Protection
Relevant Roles
Research Director
Principal Investigator
Clinical Trial Manager
Medical Director
Research Ethics Officer
Legal Counsel
Privacy Officer
Healthcare Provider
Research Coordinator
Clinical Research Associate
Medical Officer
Study Coordinator
Compliance Manager
Quality Assurance Manager
Research Ethics Committee Chair
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