The Consent Form For Research is a mandatory legal document required for conducting research involving human subjects in the United Arab Emirates. It must comply with UAE Federal Law No. 4 of 2016, UAE Cabinet Resolution No. 28 of 2021, and relevant data protection regulations. This document is essential for any organization conducting research to obtain informed consent from participants, ensuring they understand the study's nature, risks, benefits, and their rights. The form must be provided in both English and Arabic, include clear explanations of data handling procedures, and contain specific provisions required by UAE research ethics guidelines. It serves as legal protection for both the research institution and participants, documenting that proper consent was obtained and all necessary information was disclosed according to UAE law.
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1. Research Project Title and Identification: Clear identification of the research project, including protocol number and institutional affiliations
2. Introduction to the Research Study: Brief overview of the research purpose and context
3. Purpose and Procedures: Detailed explanation of why the research is being conducted and what procedures participants will undergo
4. Risks and Discomforts: Clear explanation of potential risks, side effects, or discomforts associated with participation
5. Benefits: Description of potential benefits to the participant and/or society
6. Confidentiality and Data Protection: Explanation of how personal information will be protected, stored, and used, in compliance with UAE data protection laws
7. Voluntary Participation and Withdrawal: Statement that participation is voluntary and participants can withdraw at any time
8. Costs and Compensation: Information about any costs or compensation associated with participation
9. Contact Information: Details of researchers, ethics committee, and who to contact for questions or concerns
10. Declaration of Consent: Formal statement of consent with signature lines for participant, researcher, and witness
1. Future Use of Data: Required when collected data may be used for future research projects
2. Genetic Testing Information: Required for studies involving genetic testing or DNA analysis
3. Photography/Video Recording Consent: Required when the research involves recording participants
4. Translation Declaration: Required when the form is presented in multiple languages
5. Vulnerable Population Protections: Required for research involving minors, pregnant women, or other vulnerable groups
6. Commercial Development: Required when research may lead to commercial products or patents
1. Detailed Research Protocol: Technical description of research procedures and methodology
2. Risk Assessment Details: Comprehensive breakdown of potential risks and mitigation measures
3. Data Management Plan: Detailed information about data collection, storage, and protection procedures
4. Participant Information Sheet: Detailed information about the study in plain language
5. Arabic Translation: Arabic version of the consent form as required by UAE law
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Pharmaceuticals
Medical Devices
Biotechnology
Academic Research
Clinical Research
Psychology
Social Sciences
Education
Technology Research
Environmental Research
Market Research
Relevant Teams
Research & Development
Legal & Compliance
Clinical Operations
Regulatory Affairs
Ethics Committee
Data Protection
Quality Assurance
Medical Affairs
Research Administration
Clinical Research Unit
Relevant Roles
Research Director
Principal Investigator
Research Ethics Officer
Clinical Trial Manager
Research Coordinator
Legal Counsel
Compliance Officer
Data Protection Officer
Research Administrator
Medical Director
Study Manager
Research Ethics Committee Member
Research Quality Assurance Manager
Regulatory Affairs Specialist
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