The Participant Consent Form is a mandatory document required under Austrian law and EU regulations for any research involving human subjects. It serves as the primary tool for documenting informed consent and ensuring ethical research practices. This document must comply with the Austrian Data Protection Act (DSG), Research Organisation Act (FOG), and EU GDPR requirements, particularly when handling personal data. The form needs to be written in clear, understandable language and must include comprehensive information about the study's purpose, procedures, risks, benefits, and data protection measures. It's essential for protecting both participants' rights and researchers' legal compliance, while providing a clear record of informed consent for ethics committees and regulatory authorities.
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1. Title and Study Identification: Clear identification of the study/research project, including protocol number if applicable, and institution conducting the research
2. Introduction: Brief overview of the study purpose and why the participant has been invited to participate
3. Study Purpose and Procedures: Detailed explanation of what the study involves, its objectives, and what participants will be required to do
4. Risks and Discomforts: Clear description of any potential risks, side effects, or discomforts associated with participation
5. Benefits: Explanation of potential benefits to the participant and/or society from the research
6. Voluntary Participation and Withdrawal: Statement that participation is voluntary and participants can withdraw at any time without penalties
7. Confidentiality and Data Protection: Explanation of how personal data will be collected, used, stored, and protected in compliance with GDPR and Austrian law
8. Costs and Compensation: Information about any costs or compensation associated with participation
9. Contact Information: Details of who to contact for questions about the research, participants' rights, or in case of problems
10. Declaration of Consent: Formal statement of consent with space for participant signature, date, and witness signature if required
1. Medical Treatment and Compensation for Injury: Required for medical research or clinical trials - explains what happens if participants are injured during the study
2. Future Use of Data: Include when data might be used for future research projects beyond the current study
3. Genetic Testing: Required when the study involves genetic analysis or biobanking
4. Photography/Video Recording: Include when the study involves taking photographs or making video/audio recordings
5. Commercial Development: Required when research might lead to commercial products - explains participant rights regarding potential commercialization
6. Proxy Consent: Include when participants might be unable to consent for themselves (e.g., minors, incapacitated adults)
1. Detailed Study Procedures: Step-by-step description of study procedures, including time commitments and visit schedules
2. Data Protection Information Sheet: Detailed information about data processing activities, storage duration, and data subject rights under GDPR
3. Risk Assessment Details: Comprehensive list of potential risks and mitigation measures
4. Participant Information Sheet: Detailed information about the study in Q&A format for easier understanding
5. Emergency Contact Protocol: Detailed procedures and contact information for emergencies related to the study
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