September 2023 Newsletter
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Stay up-to-date with the latest news and resources from the Office of Research Protections (ORP)
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MyIBC, the online review system for the Institutional Biosafety Committee (IBC) and the Stem Cell Research Oversight Committee, was upgraded last weekend (September 22-23). Some updates include:
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New visual features such as slide-in windows, left-hand navigation, and more;
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Enhanced reviewer comment functionality; and
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Improved and streamlined smartforms, validation and error-checking, and the ability to compare versions.
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Since 2018, PittPRO has been used to manage protocol submissions to the Institutional Review Board (IRB). Access to OSIRIS, the system used for IRB protocol management prior to PittPRO, is scheduled to be discontinued by the end of 2025. Microsoft will be phasing out core tools in their operating system required for OSIRIS functionality.
Investigators who use OSIRIS for historic documentation must make plans to retrieve and archive their records in the coming two years. More details will be provided soon.
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Department of Defense Gives High Marks to Pitt's Animal Program
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Officers from the Department of Defense (DOD) recently inspected Pitt's animal research program, focused on the studies that they fund. The DOD officers discovered no major deficiencies, and provided high praise for our program, including the following commendations:
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"Very well-maintained animal enclosure/housing areas. Immaculate food enrichment and drug storage areas."
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"Overall, an extremely clean facility."
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"The IACUC office has devised model methods for documentation, organization, process management, and execution of critical IACUC functions. The quality of the IACUC oversight and documentation reflects the high level of expertise and engagement by the IACUC administrative staff and IACUC members."
The University members who contribute to maintaining high quality animal care at the institution are to be congratulated.
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Proposed Changes in Federal Regulations
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The U.S. federal government recently proposed for comment several regulatory changes. These regulatory changes are highlighted below:
One key change is expanded requirements for biosafety containment of transgenic animals. Comments are due by October 10.
NIH is considering new oversight for the use of cephalopods (squid, octopus, cuttlefish, or nautilus) in research. Comments are due by December 22.
This policy would: articulate a definition of scientific integrity that is shared across the United States Government; establish the new positions of NIH Chief Scientist and NIH Scientific Integrity Official and define the roles and responsibilities of these positions; and protect against inappropriate political interference. Comments are due by November 9.
DURC is a small subset of life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. The proposed policy changes would increase the number of agents that must be evaluated as DURC. Comments are due by October 16.
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ORP's Conflict of Interest Division (COID) supports the University’s two standing committees that are responsible for the oversight and management of potential conflicts of interest (COIs).
The Conflict of Interest Committee (COIC), established by University policy RI 01, ensures that the financial engagements of faculty, staff, and students don't compromise the research they conduct at the University. Dr. Craig Wilcox serves as Chair of the COIC. The Committee Vice Chairs are Drs. Mara Horwitz and John Maier.
The Institutional Conflict of Interest Committee (ICOIC), established by University policy RI 11 and appointed by the University Senate, primarily addresses institutional COIs, including potential COIs involving University financial interests and senior University Officials. Drs. Lisa Parker and Sunil Saxena serve as Co-Chairs of the ICOIC.
More information about these Committees is available here. For questions about the COIC and ICOIC, contact the COID at coi@pitt.edu.
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ORP began in 1999 as the Research Conduct and Compliance Office, consolidating four key research oversight areas:
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IACUC (Animal Research Protection)
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IRB (Human Research Protection)
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Education and Compliance Office for Human Subject Research
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Radiation Safety
Over time, additional functions were added:
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Institutional Biosafety in 2001
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Conflict of Interest in 2004
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Research Integrity in 2015
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Trade Compliance in 2021
In 2020, our name was changed to the Office of Research Protections to reflect our mission: to aid investigators in designing and performing research studies so they meet current ethical standards and conform to all applicable laws and regulations.
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Remembering Cindy Kern
We fondly remember our dear friend and colleague, Cindy Kern, who passed away on August 17, 2023. Cindy had a passion for conducting quality clinical research, and she provided her insights to the University of Pittsburgh/UPMC research community.
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Amongst her accomplishments during a 30-year career at Pitt, Cindy directed the Office of Investigator-Sponsored IND and IDE Support (O3IS) from 2013 until her retirement in 2020. Cindy also served as the Pittsburgh Chapter President of the Association of Clinical Research Professionals. She was a strong advocate for professional certification and served as both a Certified IRB Professional and a Certified Clinical Research Coordinator.
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Need help in ensuring that your research meets regulatory requirements and ethical standards?
Then use the ORP Support Service!
Just answer a few questions and we will put you in touch with the right professionals to help facilitate your research.
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