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.
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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 Voluntary Participation: Clear statement that participation is voluntary and can be withdrawn at any time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
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
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
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Medical Research
Pharmaceutical
Biotechnology
Clinical Trials
Academic Research
Public Health
Mental Health Services
Medical Devices
Healthcare Technology
Relevant Teams
Legal
Research Ethics
Clinical Operations
Regulatory Affairs
Data Protection
Clinical Research
Quality Assurance
Medical Affairs
Research Administration
Compliance
Patient Safety
Research Governance
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
Legal Counsel
Medical Officer
Study Site Manager
Research Director
Quality Assurance Manager
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