The Consent Form For Research is a crucial document required for any research involving human participants in India. It serves as a formal agreement between researchers and participants, ensuring that individuals are fully informed about and voluntarily agree to participate in research studies. This document is mandatory under Indian law and must comply with the ICMR National Ethical Guidelines for Biomedical Research (2017), the New Drugs and Clinical Trials Rules (2019), and other relevant regulations. The form must be written in clear, accessible language and typically requires approval from an institutional ethics committee before use. It includes detailed information about the study, potential risks and benefits, confidentiality measures, and participant rights, while ensuring compliance with data protection requirements and research ethics principles.
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1. Title of Research Study: Clear identification of the research project and institution conducting it
2. Introduction: Brief overview of the research study and purpose of the consent form
3. Purpose of the Research: Detailed explanation of why the research is being conducted and its potential benefits to society
4. Study Procedures: Step-by-step description of what participants will be expected to do and the duration of their involvement
5. Risks and Discomforts: Clear explanation of potential risks, side effects, or discomforts participants might experience
6. Benefits: Description of direct benefits to participants (if any) and broader benefits to society
7. Confidentiality: Explanation of how participant data will be protected, stored, and used
8. Compensation: Details of any payment or reimbursement for participation
9. Voluntary Participation: Statement clarifying that participation is voluntary and can be withdrawn at any time
10. Contact Information: Details of researchers, ethics committee, and who to contact for questions or concerns
11. Declaration of Consent: Formal statement of consent with space for signatures
1. Audio/Video Recording Consent: Required when research involves recording of participants
2. Future Use of Data: Needed when data might be used for future research projects
3. Genetic Testing Information: Required for studies involving genetic analysis
4. Translation Declaration: Required when consent form is translated into local languages
5. Witness Statement: Required for illiterate participants or those unable to provide written consent
6. Biological Sample Collection: Required when research involves collection of blood, tissue, or other biological samples
7. COVID-19 Safety Measures: Required for in-person research during pandemic conditions
1. Appendix A: Detailed Study Procedures: Step-by-step breakdown of study procedures and timeline
2. Appendix B: Participant Information Sheet: Detailed information about the study in simple, non-technical language
3. Appendix C: Data Privacy Notice: Detailed information about data handling and privacy protection measures
4. Appendix D: Emergency Contact Information: List of emergency contacts and medical facilities
5. Appendix E: Rights of Research Participants: Detailed explanation of participant rights and protections
6. Schedule 1: Compensation Details: Breakdown of any payments or reimbursements
7. Schedule 2: Medical Procedures: Detailed description of any medical procedures involved in the research
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Healthcare
Pharmaceuticals
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Academic Research
Clinical Research
Social Sciences
Psychology
Public Health
Medical Devices
Educational Institutions
Relevant Teams
Research Operations
Legal
Compliance
Ethics
Clinical Operations
Regulatory Affairs
Data Protection
Human Subjects Protection
Research Administration
Quality Assurance
Relevant Roles
Research Director
Principal Investigator
Research Coordinator
Ethics Committee Member
Clinical Trial Manager
Research Compliance Officer
Data Protection Officer
Legal Counsel
Research Administrator
Medical Director
Study Physician
Research Ethics Officer
Regulatory Affairs Manager
Research Project Manager
Human Subjects Protection Specialist
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