As part of our ongoing efforts to improve the operations of OSIRIS, we are introducing four major changes that will be effective as of April 29, 2012. For more information, contact the IRB at email@example.com.
Some users have experienced “timeout” problems when trying to create a modification, particularly when the application is very large. To prevent this from happening in the future, we are introducing a new process that permits the modifiable study to be created in the background. This means that when creating a modification, you will complete the first page as usual and the system will begin to create the modification in the background, rather than halting other activities to immediately clone the entire application. The cloning process will continue even after you logout of OSIRIS.
Updates on the cloning process will be provided every 2 minutes on the ‘conclusion’ page of the Modification Cover Sheet. A link is also available to restart the cloning process should it fail for some reason.
When cloning is complete, the link to the modifiable study will appear on the modification workspace. At that point, you can complete the modification and submit it to the IRB.
Based on feedback from the IRB Board Members, the following questions have been added:
On the Modification Cover Sheet:
M5.1 – Will currently enrolled subjects be re-consented?
If No, indicate why re-consent is not needed:
NOTE: Not all modifications require re-consent of subjects. However, subjects must be told about any new information that might affect their willingness to continue to participate in a research study. This might include the addition of research procedures or new adverse events. Click on the “guidance” tab to review information related to this issue.
On the Renewal: (Multicenter Studies Only)
3.1.1 How many subjects have been enrolled at all sites since the beginning of the study?
New textbox for approval letter wording CS2.0.1
Based on requests from the research community, OSIRIS now permits investigators to include specific study and/or sponsor-related information that must be included in an approval letter. For example, sponsors often want a listing of all documents approved by the IRB for a particular submission. In the past, this information had to be included as part of the study title in order for it to appear in the letter. There is now a box under CS2.0 in which you can include this information. The IRB approval letter will reflect whatever is provided in the text box so it is important to include only information that you want to appear in the approval letter. Do not include the grant number; that information is already inserted automatically. Do not indicate “none,” “not applicable,” etc; if you have no need to insert additional information, leave the text box blank.
Users can now select multiple CTRCs in question CS7.1
Based on feedback from the staff at the Clinical and Translational Research Centers, researchers are now able to select multiple CTRCs which enables each CTRC access to your study. The IRB would recommend that you update this section the next time you submit a modification to ensure that all applicable CTRCs have access to your application.
The fee structure for industry-sponsored studies submitted to the University of Pittsburgh IRB after July 1, 2012 will be as follows:
|New submission – Full Board||$2000|
|New submission – Exempt or Expedite||$1000|
|Continuing review – Full Board||$1000|
|Continuing review – Expedite||$ 500|
Studies that were approved prior to July 1 2012 can continue to use the earlier fee structure:
|New submission – Full Board||$1500|
|New submission – Exempt or Expedite||$ 500|
|Continuing review – Full Board||$ 500|
|Continuing review – Expedite||$ 250|
Under certain circumstances, the IRB will consider investigators’ requests for a well-justified waiver of the industry fee (CS11.1 in OSIRIS).
Contact the IRB (firstname.lastname@example.org) if you have any questions.