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Common Informed Consent Problems and Solutions

The Office of Human Subjects Research s Compliance Monitoring Program Educational Seminars: Common Informed Consent Problems and SolutionsBarbara Starklauf, MAS, CIPJ enna Tress, BA, CCRPF rederick W. Luthardt, MA, CCRPJune 12, 2007 (JHBMC Carroll Auditorium)June 13, 2007 (EBMC BRB G01,03)Presentation Content Awareness of Common Informed Consent Form Problems Understanding Common Informed Consent Process Problems Offer strategies to improve Informed Consent compliance Interactive examination of Consent problemsInformed Consent Main Findings from Monitoring and Audits: The Consent Form: expired altered non-IRB approved (no stamp or logo) incorrect ( , e-mailed version or for another study) The Consent Process.

Dear Dr. Welby, Attached is the IRB approval memo for the continuing review, for your protocol number ... Consent Designee, Parent, Legally Authorized Representative, and/or witness (if required) • Form signed by unapproved signatories – Personnel not added to the study ... signed by each subject or guardian prior to enrollment into the ...

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