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Message from the University of Pittsburgh Institutional Review Board
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IRB Announcements
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IRB Meeting/Deadline Schedule for 2008
The IRB meeting/deadline schedule for 2008 is available on the IRB website at www.irb.pitt.edu under IRB Committees.
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Renewal Submissions - Reminders
A few reminders when submitting for renewal:
- Submit well in advance of the renewal date. The IRB recommends a lead time of at least six weeks. This is particularly important for those studies that are required to be reviewed at a full board specialty (pediatric) or cluster committee (oncology; pregnant women, fetuses and neonates). The schedule of meetings on the IRB website includes information about which committees are specialities and/or clusters.
For the research teams that currently have an approved full board protocol in OSIRIS that are preparing to submit for renewal, make sure to allow enough time for the submission to go to a meeting and for the response to comments to be submitted, if necessary. The OSIRIS system automatically marks the record as "expired" on the date of IRB expiration regardless of whether the renewal is in process.
- There have been a number of renewals submitted with incomplete paperwork in the past several weeks which can cause an unnecessary delay in processing. Make certain that all necessary documents are submitted. This includes a current data and safety monitoring report (local, central, or both).
- Research studies that are originally approved by the full board will always be reviewed at that level unless: 1) the committee designates the study as minimal risk; 2) the study is permanently closed to further enrollment and the only remaining research activity is long-term follow-up; or 3) the study is permanently closed to further enrollment and the only remaining research activity is data analysis. IMPORTANT NOTE: Once the study is closed to additional enrollment, at no time can the study be reopened for that purpose. If it is necessary to do additional recruitment, a NEW submission is required.
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Ask the IRB for 2008 – On the Road
The IRB staff will be traveling to different locations for the Ask the IRB sessions in 2008. The first session will be held on January 8, 2008 at noon at the University of Pittsburgh Cancer Institute in Shadyside. Further details about the location of the program will be announced in a future message.
The Exempt/Expedite Ask the IRB session will continue to be held on the 3rd Thursday of the month in David Lawrence Hall at noon.
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OSIRIS Tip of the Week
All consent forms uploaded into OSIRIS must be in Microsoft Word format. Please make sure that your document has a .doc extension and NOT an .rtf extension. Also, documents created using Word 2007 with a .docx extension may not work in OSIRIS. Please save these documents in Word 2003 format. If you have any questions, contact us at irb@pitt.edu .
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