The IRB has been receiving a tremendous increase in the number of undeliverable Emails. These notifications are important so please manage your mailboxes appropriately to ensure you have not exceeded your limits. It is also important to remind you to use your employer email addresses (personal email addresses such as gmail should not be used). If you leave the university but plan to remain as a co-investigator, be sure and go to www.hsconnect.pitt.edu to update your profile.
In order for the IRB to conduct a review of changes to the application, it is required that the investigator provide a justification or rationale for each item. The justification should summarize the requested changes and explain why the change is necessary or desired. Without this information, the IRB does not have the information to base a decision on whether the changes are approvable.
To prevent delays in IRB review, please remember to open each document uploaded into OSIRIS to make sure it is viewable. We frequently start a review and then cannot open a document and then must stop and send the study back to the investigators. OSIRIS best supports Word and PDF attachments.
Response to Comments:
OSIRIS is designed so that only the PI can submit an application. This is not only true for the initial application, but also when responding to comments issued by the IRB. The study team can work on modifying the application, but ultimately the PI must 'submit changes' in order for the IRB to conduct the review. Study team members will often inquire about the status of the IRB review as they have answered all the questions but the application was never submitted back to the IRB. The review status can easily be determined by looking at the Current State displayed in the top left corner of the study workspace.
We have now posted a document which will list all the changes to the IRB application and it is available on the IRB website, A-Z Guidance section, OSIRIS.