A Consent Form For Research Questionnaire is a mandatory document required by Indian law and research ethics guidelines when conducting any research involving human participants. This document is essential for ensuring compliance with the Indian Council of Medical Research (ICMR) Guidelines, 2017, and the Digital Personal Data Protection Act, 2023. It must be obtained before any data collection can begin and should clearly outline the research purpose, methodology, risks, benefits, confidentiality measures, and participant rights. The form serves multiple purposes: protecting participant rights, ensuring ethical research practices, meeting legal requirements, and providing documentation of informed consent. It's particularly crucial in India where research regulations emphasize participant protection and informed consent, especially for vulnerable populations.
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1. Title and Research Project Information: Title of the research study, name of research institution, and principal investigator details
2. Introduction: Brief overview of the research purpose and invitation to participate
3. Purpose of the Study: Detailed explanation of research objectives and importance
4. Participation Process: Description of what participation involves, including time commitment and types of questions
5. Risks and Benefits: Clear statement of potential risks and benefits of participation
6. Confidentiality and Data Protection: Explanation of how personal information will be protected, stored, and used
7. Voluntary Participation: Statement that participation is voluntary and can be withdrawn at any time
8. Contact Information: Details of researchers, ethics committee, and who to contact with questions
9. Participant Declaration: Formal statement of consent and understanding to be signed by participant
10. Researcher Declaration: Confirmation by researcher that consent was properly obtained
1. Compensation Information: Include when participants will receive payment or reimbursement for participation
2. Future Use of Data: Include when data might be used for future research or shared with other researchers
3. Audio/Video Recording Consent: Include when interviews or sessions will be recorded
4. Translator Declaration: Include when consent form is explained through a translator
5. Witness Statement: Include for illiterate participants or those unable to provide written consent
6. Parental/Guardian Consent: Include when participants are minors or legally incompetent
7. Commercial Use Declaration: Include when research may lead to commercial products or patents
1. Research Questionnaire: Copy of the actual questionnaire or summary of topics to be covered
2. Participant Information Sheet: Detailed information about the study in simple, non-technical language
3. Data Protection Protocol: Detailed procedures for data collection, storage, and protection
4. Withdrawal Form: Form for participants to withdraw from the study if they choose
5. Ethics Committee Approval: Copy of the ethics committee approval for the research
6. Contact Details Sheet: Comprehensive list of all relevant contact information for queries or concerns
Authors
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Education
Market Research
Social Sciences
Psychology
Public Health
Pharmaceutical
Technology
Consumer Behavior
Clinical Research
Environmental Studies
Anthropology
Behavioral Sciences
Relevant Teams
Research & Development
Legal
Compliance
Ethics
Data Protection
Clinical Operations
Academic Affairs
Human Subjects Protection
Research Administration
Quality Assurance
Relevant Roles
Research Director
Principal Investigator
Research Coordinator
Ethics Committee Member
Research Compliance Officer
Legal Counsel
Data Protection Officer
Research Assistant
Clinical Research Associate
Research Ethics Officer
Research Project Manager
Academic Researcher
Research Supervisor
Graduate Student Researcher
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