Welcome to the University of Pittsburgh Institutional Review Board online application, OSIRIS (Online Submission for Institutional Reviews)
Alas, the time has come to bid a final farewell to OSIRIS. Effective immediately, the “create new study” button is being disabled, and all new External Pathway and Single IRB submissions (collectively referred to throughout this document as “sIRB”) must be submitted in PittPRO (www.pittpro.pitt.edu). Study teams will still have access to all documents that were previously part of an OSIRIS application regardless of the status of the project. All previously approved sIRB studies in OSIRIS will be transitioning into PittPRO as well. Please read the entirety of this message for important information. If there are studies that can be closed, please take a moment and complete that action rather than transitioning. See below for more information about when a study can be closed.
Previously Approved Studies – Pitt is not the IRB of Record
Studies that were reviewed and approved by an external IRB start with the prefix EXT in OSIRIS. At this time, Office of Research Protection staff are working to build basic information in PittPRO for each of the activated EXT submissions. IMPORTANT: Full transition must occur at the time of continuing review OR if a modification needs to be submitted. Reportable events can continue to be submitted in OSIRIS until you have fully transitioned. If you transition at the time of continuing review, you will receive a NEW activation date after submission. If you transition at the time of a modification, you will receive a transition only letter and continuing review information will have to be submitted when it is available from the external IRB.
Previously Approved Studies – Pitt is the IRB of Record
All study teams who have approved studies in OSIRIS where Pitt is serving as the IRB of Record will be contacted via email and provided instructions on how to proceed with the transition. The goal is to have all approved studies at least submitted in PittPRO by December 11, 2020. Until you are required to transition, you can continue to submit modifications, continuing review information, and reportable events in OSIRIS. You will continue to operate under the IRB approval granted in OSIRIS until you have successfully transitioned.
New Studies - sIRB
Regardless of whether Pitt is serving as the IRB of Record or Pitt is ceding to another IRB, completing the steps to establish a reliance relationship is required. To request to use an sIRB mechanism, visit the HRP website: http://www.hrpo.pitt.edu/reliance-agreementssingle-irb-review.
Closing a Study in OSIRIS
If your study is complete or you have reached a point where the only remaining activity is data analysis with a de-identified data set, submit a study closure rather than a transition. For studies with an EXT prefix, use the “Study Complete” button under My Activities. For studies where Pitt is IRB of Record, use the “Submit Final Report” button under My Activities.
If you have any questions about this announcement, contact our office at firstname.lastname@example.org. Thank you.
The HRPO website at www.hrpo.pitt.edu offers extensive information and the A-Z Guidance section provides details on specific topics to assist with preparation of the application and the conduct of your research project.