In addition to the requirements for approval by the Ancillary Review groups described above, the OSIRIS system will provide notifications to the following offices:
The IDS of the UPMC Department of Pharmacy is notified of all proposed human subject research that involves the evaluation of an investigational or approved drug.
Office of Sponsored Programs and Research Support (OSPARS)
All proposed human subject research at UPMC facilities or with UPMC patients involving any of the following will be reviewed and approved by the UPMC Fiscal Review Committee consistent with their policy and procedures:
- the performance of potentially billable procedures or tests;
- the provision of services or hands on care;
- the collection of biological specimens.
If required, OSPARS approval must be in place before research activities may commence within a UPMC facility. The IRB approval letter contains standard language indicating this requirement.
For research studies where investigators indicate that CTRC resources will be utilized for research study procedures, the staff at the CTRC receives a notification from the OSIRIS system.
The University’s Human Stem Cell Oversight (hSCRO) Committee oversees all human embryonic stem (hES) cell research being conducted at the University, as well as limited categories of non-embryonic human stem cell research. There are two levels of hSCRO review, administrative review and review by the convened hSCRO Committee. The hSCRO review/approval process is independent of IRB review and the submissions may be done in parallel. The OSIRIS system provides notification to the hSCRO Office when stem cells will be utilized in the research. The hSCRO Office determines if review is required; and if so, determines the appropriate review pathway per the hSCRO policies.
The IRB will require a formal data security review, at a minimum, when sensitive identifiable information is being collected, transmitted, or stored on sites other than approved servers behind Pitt or UPMC firewalls, when mobile devices such as smartphones are used to collect and transmit data, when unapproved vendors host or have access to research data, and at the discretion of the HRPO staff or IRB committee members. The purpose of the review is to consider whether adequate data security controls are in place when personally identifiable, sensitive information or protected health information is being recorded.
Ethical and Religious Directives
For research conducted at UPMC Mercy, a review to ensure compliance with the Ethical and Religious Directives will be conducted. Investigators will be notified to remove UPMC Mercy as a site if there are issues related to conduct of the study at that site.