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Ethical Requirements and Responsibilities for Rheumatoid Arthritis Research Project

This document outlines the ethical requirements and responsibilities for researchers involved in the Rheumatoid Arthritis project, effective May 30, 2012. It highlights obligations to subjects, local and national agencies, QNRF, and WCMC-Q, ensuring compliance with the Supreme Council of Health. Key elements include informed consent procedures, the importance of documentation, communication with ethics committees, and quality assurance practices. Researchers are reminded to minimize pressure on participants and provide comprehensive information while maintaining confidentiality and integrity throughout the research process.

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Ethical Requirements and Responsibilities for Rheumatoid Arthritis Research Project

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  1. Rheumatoid arthritis Project: ethical requirements May 30, 2012

  2. Responsibilities • To subjects • To your local and national agencies • To QNRF • Through WCMC-Q • To Supreme Council of Health • Through QNRF • Through WCMC-Q

  3. Consistency • Protocols • Amendments • SOPs • Data • Confidentiality • Informed Consent • Process • Document • Documentation

  4. Informed Consent • Consent Form • Stay close to template set by Dr. Thurayya • Signed and dated • Consent Process • Before participation • Minimize pressure • Give information • Genetic research • Future use of samples • Confirm understanding

  5. Documentation • Keep the following documents locally • Signed and dated consent forms • Records of participation • Communication with ethics committee(s) • Send ethical approvals to Dr. Thurayya • Keep for at least 3 years after project completion • Or longer (if local standard) • Any format

  6. Communication • Regular Communication • Progress and Enrollment • Planned protocol changes • Ethical Approval status • First approval (done 2011) • Annual approvals • Amendments • Completion

  7. Communication • Notify Dr. Thurayya about: • Unexpected events that suggest increased risk • Deviation from the protocol • Withdrawals of your ethical approval • Reporting problems helps fix problems • Information may be important to all sites

  8. Quality Assurance • Documentation may be verified by: • Your local/national agencies • Dr. Thurayya’s team • WCMC-Q • QNRF • SCH

  9. Future • Possible changes • QNRF • SCH • I will communicate through Dr. Thurayya

  10. Questions? • Contact information: • kmk2008@qatar-med.cornell.edu • Copy to Dr. Thurayya

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