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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 Informed Consent
Process Document
Documentation
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
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
Communication
Regular Communication Progress and Enrollment Planned protocol changes
Ethical Approval status First approval (done 2011) Annual approvals Amendments Completion
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
Quality Assurance
Documentation may be verified by: Your local/national agencies Dr. Thurayya’s team WCMC-Q QNRF SCH
Future
Possible changes QNRF SCH
I will communicate through Dr. Thurayya
