October 2021 Newsletter
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Stay up-to-date with the latest news and resources from the Office of Research Protections
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ORP by the Numbers: FY 2021
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Some have asked us how many studies are overseen by the Office of Research Protections. The following numbers from FY 2021 (July 2020-June 2021) provide some insight:
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The Institutional Review Board (IRB) reviewed 12,150 protocols (1,841 new protocols, 5,093 protocol modifications, 1,255 protocol renewals).
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The Institutional Animal Care and Use Committee (IACUC) reviewed 3,961 protocols (561 new protocols, 2,480 protocol modifications, 921 protocol renewals).
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The Institutional Biosafety Committee (IBC) reviewed 1,153 protocols (122 new protocols, 600 protocol modifications, 431 protocol renewals).
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Radiation Safety Division staff conducted 1,786 laboratory audits.
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The Conflict of Interest Division (COI) addressed 5,663 inquiries related to the MyDisclosures system.
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The Education and Compliance Support for Human Subject Research Division made 275 submissions to the Food and Drug Administration (FDA).
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The Office of Trade Compliance conducted 1,693 export control reviews.
These numbers--and many others we could list--reflect the large scale and diversity of PITT research, and the effort required to support these activities in accordance with all applicable laws, regulations, and ethical requirements.
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It is the University's responsibility to ensure that all research on animals has been approved by the IACUC.
NIH Grants Policy requires a verification that procedures on animals described in an NIH grant or contract are approved by the IACUC. This procedure was recently renamed as an IACUC Congruency Review. The review process is described here.
The American Heart Association and National Science Foundation also require a similar verification process for grants they fund.
Read more about Congruency Reviews.
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ORP Division Spotlight
The University of Pittsburgh was at the forefront when it established the Education and Compliance Office for Human Subject Research in 1996. While its original focus was auditing, the office has evolved over the years, and is now called the Education and Compliance Support Division for Human Subject Research (ECS-HSR). The Division offers support services in three main areas:
Clinical Trial Registration and Transparency Support: educating and assisting investigators with registration and results submissions to ClinicalTrials.gov.
IND and IDE Support (IIS): educating and assisting University faculty who serve as the sponsor of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application.
Monitoring and Compliance Support: educating and assisting University investigators and study team members in conducting research in compliance with Good Clinical Practices.
Learn more about ECS-HSR, contact individual units at CTgov@pitt.edu, IIS@pitt.edu, ecs-hsr@pitt.edu, or contact Ms. Kelly Dornin-Koss, who serves as the ECS-HSR Director.
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Pitt's annual United Way campaign has kicked off, and we’d love for you to join! Despite many of us working remotely last year, over 1,900 faculty, staff and retirees donated more than $694,500 to the Pitt United Way Campaign! Through this campaign, we strive to directly address our community’s most critical needs.
To make an online pledge that will support your passions and help families meet basic needs, please go to my.pitt.edu and search for “United Way” or email the Pitt United Way team at pittunitedway@pitt.edu.
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