Informed Consent Form

Informed Consent Form Template for Denmark

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Informed Consent Forms

Document background

Informed Consent Forms are essential documents required under Danish law and EU regulations for any medical research, clinical trials, or significant medical procedures. These forms must comply with the Danish Health Act, the Danish Act on Research Ethics Review, and GDPR requirements. The document serves as both a legal record and an educational tool, ensuring that participants understand what they're agreeing to and their rights. Informed Consent Forms must be written in clear, accessible language while meeting all regulatory requirements. They're particularly crucial in Denmark's healthcare system, where patient autonomy and informed decision-making are fundamental principles. The forms must include comprehensive information about procedures, risks, benefits, data processing, and participant rights, while remaining understandable to lay persons.

Suggested Sections

1. Title and Document Identification: Clear identification of the document as an Informed Consent Form, including project/study title and version number

2. Introduction: Brief overview of the purpose of the consent form and the organization/institution seeking consent

3. Purpose and Background: Detailed explanation of why consent is being sought and the context of the research/treatment

4. Participation Details: Clear explanation of what participation involves, including procedures, duration, and requirements

5. Risks and Discomfort: Description of potential risks, side effects, or discomfort associated with participation

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

7. Data Processing Information: GDPR-compliant explanation of how personal data will be collected, used, stored, and protected

8. Rights of the Participant: Clear statement of participant rights, including right to withdraw consent

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

10. Contact Information: Details of who to contact for questions or concerns

11. Declaration of Consent: Formal consent statement and signature section

Optional Sections

1. Alternative Procedures: Information about alternative treatments or procedures when applicable to medical research

2. Commercial Use: Information about potential commercial applications of research results

3. Future Research: Details about potential use of data/samples in future research projects

4. Genetic Information: Specific section for studies involving genetic testing or analysis

5. Insurance Coverage: Information about insurance coverage for clinical trials or medical procedures

6. Translation Statement: For non-Danish speaking participants, confirmation that information has been properly translated

7. Vulnerable Groups: Additional protections and information for vulnerable participants (minors, mentally impaired, etc.)

Suggested Schedules

1. Detailed Project Protocol: Technical details of the research protocol or medical procedure

2. Data Protection Impact Assessment Summary: Summary of GDPR-required assessment of data processing risks

3. Glossary of Terms: Definitions of technical or medical terms used in the main document

4. Visual Aids: Diagrams, charts, or images explaining procedures or processes

5. Rights Exercise Form: Template form for exercising GDPR rights

6. Withdrawal Form: Template form for withdrawing consent

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