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Rheumatoid arthritis Project: ethical requirements

Rheumatoid arthritis Project: ethical requirements. May 30, 2012. Responsibilities. To subjects To your local and national agencies To QNRF Through WCMC-Q To Supreme Council of Health Through QNRF Through WCMC-Q. Consistency. Protocols Amendments SOPs Data Confidentiality

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Rheumatoid arthritis Project: ethical requirements

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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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