Exercise 1
What fundamental requirements should an informed consent form meet so that the participant can decide whether or not to take part and anticipate possible consequences? If needed, refer to the ‘methods’ section. Take notes for your records.
Proposed Solution
- Information about the research project, including:
- Name of the research institution(s)
- Project title
- Content and objectives of the research
- Information on key participant rights, including:
- Voluntary participation
- Right to withdraw at any time
- Right to revoke consent with future effect
- Information on collected personal data and processing, including:
- Purpose and goals of data use
- Type of data processing
- Name of the responsible person for data collection
- Details on how research data will be stored, maintained, and used long-term
- Clarity, decision-making competence, and consent capacity, ensured through:
- Complete and clear information
- Easily understandable language
- Involvement of legal guardians when necessary
- The actual (written) consent form for research participation, including:
- Data transmission
- Data processing
- Data archiving (Separate consent required for data archiving!)