Participant Consent Form

Participant Consent Form Template for Denmark

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Document background

The Participant Consent Form is a crucial document required for any research involving human subjects in Denmark. It serves as the primary tool for documenting informed consent and ensuring compliance with both EU GDPR and Danish research ethics legislation. This document is essential when conducting clinical trials, medical research, social studies, or any research involving human participants and their personal data. The form must be used before any research activities commence and should be regularly reviewed and updated to reflect any changes in the research protocol or applicable regulations. It includes comprehensive information about the study, its risks and benefits, data protection measures, and participant rights, all presented in clear, accessible language as required by Danish law and research ethics guidelines.

Suggested Sections

1. Study Information: Title and basic details of the research study, including protocol number and principal investigator details

2. Purpose of the Study: Clear explanation of the research objectives and why the study is being conducted

3. Participation Requirements: Detailed description of what participation involves, including time commitment, procedures, and any required activities

4. Risks and Discomforts: Description of potential risks, side effects, or discomforts associated with participation

5. Benefits: Explanation of potential benefits to the participant and/or society

6. Data Collection and Processing: Description of what personal data will be collected and how it will be used, stored, and protected (GDPR compliance)

7. Rights of the Participant: Clear statement of participant rights including withdrawal, data access, and complaint procedures

8. Costs and Compensation: Information about any costs or compensation associated with participation

9. Contact Information: Details for reaching the research team, ethics committee, and data protection officer

10. Declaration of Consent: Formal consent statements and signature blocks for participant and researcher

Optional Sections

1. Future Research Use: Optional consent for use of data/samples in future research - include when study data might be valuable for future studies

2. Genetic Testing: Specific details about genetic testing and related consent - include when study involves genetic analysis

3. Audio/Video Recording: Specific consent for recording - include when study involves audio or video recording

4. Commercial Development: Information about potential commercial applications - include when research might lead to commercial products

5. Third-Party Data Sharing: Details about sharing data with other researchers or institutions - include when data sharing is planned

6. Biobank Storage: Information about biological sample storage - include when collecting biological samples

7. Proxy Consent: Additional section for legal representatives - include when participants might lack capacity to consent

Suggested Schedules

1. Detailed Study Procedures: Step-by-step description of all study procedures and visits

2. Privacy Notice: Detailed GDPR-compliant privacy notice explaining all aspects of data processing

3. Withdrawal Form: Template form for participants to withdraw from the study

4. Glossary: Definitions of technical terms used in the consent form

5. Insurance Information: Details of research insurance coverage and compensation schemes

6. Rights Exercise Form: Template form for exercising GDPR rights (access, rectification, erasure, etc.)

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