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Published byJonah Long Modified over 9 years ago
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RHEUMATOID ARTHRITIS PROJECT: ETHICAL REQUIREMENTS May 30, 2012
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Responsibilities To subjects To your local and national agencies To QNRF Through WCMC-Q To Supreme Council of Health Through QNRF Through WCMC-Q
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Consistency Protocols Amendments SOPs Data Confidentiality Informed Consent Process Document Documentation
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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
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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
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Communication Regular Communication Progress and Enrollment Planned protocol changes Ethical Approval status First approval (done 2011) Annual approvals Amendments Completion
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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
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Quality Assurance Documentation may be verified by: Your local/national agencies Dr. Thurayya’s team WCMC-Q QNRF SCH
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Future Possible changes QNRF SCH I will communicate through Dr. Thurayya
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Questions? Contact information: kmk2008@qatar-med.cornell.edu Copy to Dr. Thurayya
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