Informed Consent Form for Ireland

Informed Consent Form Template for Ireland

A comprehensive legal document designed for use in Ireland that complies with the Health Research Regulations 2018, GDPR, and Irish Data Protection Act 2018. This document serves to obtain and record informed consent from research participants or patients before their participation in medical research, clinical trials, or medical procedures. It includes detailed information about the study or procedure, risks and benefits, data protection measures, and participant rights, ensuring that participants can make an informed decision about their participation while meeting all regulatory requirements under Irish law.

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What is a Informed Consent Form?

Informed Consent Forms are essential legal documents required for any medical research, clinical trial, or significant medical procedure in Ireland. These forms must comply with the Health Research Regulations 2018, GDPR, and the Irish Data Protection Act 2018, among other relevant regulations. The document is used to ensure that participants or patients fully understand the nature, purpose, risks, and benefits of their participation in research or medical procedures. Informed Consent Forms must be written in clear, accessible language and include comprehensive information about data protection, participant rights, and study procedures. They are particularly crucial in maintaining ethical standards in research and healthcare settings while providing legal protection for both the participant and the research institution or healthcare provider.

What sections should be included in a Informed Consent Form?

1. Study Title and Introduction: Clear identification of the study and brief introduction to the research project

2. Invitation and Purpose: Explanation of why the participant is being invited and the purpose of the research

3. Voluntary Participation: Clear statement that participation is voluntary and can be withdrawn at any time

4. Study Procedures: Detailed description of what participation involves and what procedures will be undertaken

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

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

7. Confidentiality and Data Protection: Information about how personal data will be collected, used, stored, and protected in compliance with GDPR

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

9. Contact Information: Details of researchers, medical supervisors, and relevant institutional contacts

10. Declaration of Consent: Formal consent statement and signature section for participant and researcher

What sections are optional to include in a Informed Consent Form?

1. Future Use of Data: Section to be included when data might be used for future research projects

2. Genetic Testing: Required when the study involves genetic testing or analysis

3. Photography/Video Recording: Needed when the study involves taking photos or recording videos of participants

4. Commercial Development: Required when research might lead to commercial product development

5. Translator Declaration: Include when consent form needs to be translated for non-English speaking participants

6. Witness Statement: Required when participant is unable to read or write

7. Parent/Guardian Consent: Include when participants are minors or lack capacity to consent

8. Covid-19 Specific Measures: Include during pandemic conditions or when specific health protocols are in place

What schedules should be included in a Informed Consent Form?

1. Detailed Study Protocol: Technical details of the research procedures and methodology

2. Participant Information Sheet: Detailed information about the study in plain language

3. Data Protection Notice: Comprehensive information about data protection rights and procedures

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

5. Medical Procedures Description: Detailed explanation of any medical procedures involved

6. Glossary of Terms: Definitions of technical or medical terms used in the consent form

7. Contact Details Sheet: Complete list of relevant contact information for all parties involved

8. Rights of Participants: Detailed explanation of participant rights under relevant legislation

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Cost

Free to use

Relevant legal definitions

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Healthcare

Medical Research

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Clinical Trials

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Medical Devices

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Legal

Research Ethics

Clinical Operations

Regulatory Affairs

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Relevant Roles

Clinical Research Coordinator

Principal Investigator

Research Ethics Officer

Data Protection Officer

Medical Director

Research Nurse

Clinical Trial Manager

Regulatory Affairs Manager

Research Compliance Officer

Healthcare Administrator

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Medical Officer

Study Site Manager

Research Director

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