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RHEUMATOID ARTHRITIS PROJECT: ETHICAL REQUIREMENTS May 30, 2012.

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Presentation on theme: "RHEUMATOID ARTHRITIS PROJECT: ETHICAL REQUIREMENTS May 30, 2012."— Presentation transcript:

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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