Jurisdiction of the University of Pittsburgh IRB
The University of Pittsburgh’s Human Research Protection Program (HRPP) has jurisdiction over human subject research projects that meet the following criteria:
- Conducted by University of Pittsburgh faculty, staff, or students regardless of funding source and/or the location at which the research will be conducted;
- Conducted within the facilities of the University of Pittsburgh by outside investigators. Note that the University of Pittsburgh does not permit an individual outside of the institution to be named as the principal investigator of a study;
- Conducted utilizing the private records of the University of Pittsburgh;
- Conducted in any UPMC owned, operated, or controlled domestic facility or program and/or by any University of Pittsburgh Physicians (UPP) member and/or by any UPMC employee of any UPMC nonprofit corporations, program or facility.
Research not falling under the jurisdiction of the IRB is outlined in points 1A, 2, and 4 below.
A. The VAPHS IRB serves as the IRB of Record for all human subject research studies in which all of the following are true:
- A VAPHS staff member or University faculty member who is dually appointed with the VA is the principal investigator or a co-investigator of the study
- The research is conducted using only VAPHS records
- Research subjects are recruited solely through the VA
- No University or UPMC facilities are engaged in the conduct of the research
- No University funds or federal funds received by the University are expended in direct support of the research
- No University staff are engaged in the conduct of the research
B. Approval of both the VAPHS IRB and University IRB is required for all other cases.
UPMC Office of Sponsored Programs and Research Support (OSPARS)
Effective August 24, 2004, as amended November 1, 2008, the University of Pittsburgh and the University of Pittsburgh Medical Center (UPMC) entered into an agreement whereby, with certain limited exceptions, all industry-initiated and sponsored clinical trials conducted within the facilities of UPMC or University of Pittsburgh Physicians (UPP) by University faculty or staff, who are also UPMC or UPP staff members, became the responsibility of UPMC, and will be processed through the UPMC OSPARS. Therefore, industry-initiated and sponsored clinical trials conducted by University faculty and staff and subject to the terms of this agreement are not part of the University of Pittsburgh’s HRPP.
Through an IRB Designation agreement dated December 15, 2003, as amended August 24, 2004 and May 16, 2013, and Amended and Restated on February 15, 2016, and amended on January 1, 2018, UPMC has delegated authority to the University of Pittsburgh IRB to review initially and periodically and to approve, require modifications to , and/or disapprove all human subject research conducted at mutually agreed upon domestic UPMC or UPP facilities, by UPMC or UPP staff and/or with the private records of the UPMC or UPP with the exception of industry-sponsored clinical trials processed through the UPMC OSPARS.
Magee Women’s Research Institute (MWRI)
Through a collaborative agreement dated April 1, 2004, the MWRI has delegated authority to the University of Pittsburgh IRB to review initially and periodically and to approve, require modifications to and/or disapprove all human subject research conducted in MWRI facilities, by MWRI staff, or with the private records of the MWRI.
IRB Reliance Mechanisms
The University of Pittsburgh may enter into agreements with external entities in order to streamline the IRB review process. See Chapter 24 for procedures related to this issue.