June 2024 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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Dr. Susan Sesack Appointed Research Integrity Officer
Chancellor Gabel has appointed Dr. Susan Sesack as the University's Research Integrity Officer (RIO), effective July 1. Dr. Sesack joined ORP in 2022 as Deputy RIO to prepare for this role. Dr. Sesack succeeds Dr. Craig Wilcox, who has served with exceptional professionalism as RIO since 2017.
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"Integrity has been an important radiant in my life, and I have always held the ethical standards of science in the highest regard," says Dr. Sesack. "It is with this mindset that I assume the responsibilities of RIO for the University of Pittsburgh."
Dr. Sesack joined the faculty of the Department of Neuroscience in Pitt's Dietrich School of Arts & Sciences in 1992, and has been Professor of Neuroscience and Psychiatry since 2005. She served as the Director for Undergraduate Studies in Neuroscience for 20 years and spent two years as Co-Director of the Graduate Program for the Center for Neuroscience (CNUP).
ORP thanks Dr. Craig Wilcox for his seven years of service as RIO. Dr. Wilcox began his service with the Research Conduct and Compliance Office (now known as ORP) in 1997 as one of the first members of the Entrepreneurial Oversight Committee (EOC), which became the Conflict of Interest Committee (COIC) in 2004. He served as Vice Chair of the COIC from 2004 to 2017, and was appointed Chair in 2017. Dr. Wilcox will continue to serve as COIC chair until the end of 2024.
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The receipt of some biological materials into the University may require permits from federal entities such as the USDA or CDC, among others. This applies to international and interstate/domestic shipments of some agents such as Clostridium and Klebsiella.
To inform our research community about potential requirements for permits or shipping documentation for items in PantherExpress, we have implemented an informational pop-up feature. This notification will appear on the "Submit Requisition Screen" to alert users about necessary permits and provide a contact email for further inquiries. It is important to note that this pop-up will not prevent the submission of the cart in PantherExpress; rather, it serves as guidance concerning the requisite permits. For additional information, please contact the Office of Research Security and Trade Compliance at researchsecurity@pitt.edu.
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FDA Audit of Institutional Review Board
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From May 16-24, the Food and Drug Administration (FDA) conducted a routine "Surveillance Inspection" of the University's Institutional Review Board (IRB). These periodic, scheduled inspections are mandated under FDA regulations to ensure that IRBs are operating in compliance with current FDA regulations and statutory requirements.
The FDA offered commendatory remarks regarding the performance of Pitt's IRB and found no instances of noncompliance with FDA regulations or the University's internal policies.
We extend our sincere gratitude to the IRB staff and committee members for their dedication to maintaining high-quality oversight of human subject research at Pitt and UPMC.
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Many federal agencies, including the National Institutes of Health (NIH), require communications and requests to be endorsed by an Authorized Organization Representative (AOR). At Pitt, this requirement is met by routing requests and questions through specialists in the Office of Sponsored Programs (OSP). After review, the OSP specialist will provide the official University endorsement and submit your communication/request to the federal sponsor.
Sponsor communication requests should be submitted to OSP in MyFunding through the related proposal (FP) or award (AWD) record. You can find the OSP specialist assigned to your department on the OSP website.
For additional information, see the OSP-related Tip of the Week for submitting federal contract documents through OSP.
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No activities involving animals may be conducted or supported by the Public Health Service (PHS) until the institution responsible for the activity has provided a written Assurance acceptable to the PHS, affirming compliance with the PHS Policy on Humane Care and Use of Laboratory Animals. All Assurances submitted to the PHS are evaluated to determine the adequacy of the institution's proposed program for the care and use of animals in PHS-conducted or supported activities. These Assurances are approved for a period of up to four years and must be resubmitted and reevaluated at the end of that term.
The University of Pittsburgh's Animal Welfare Assurance was renewed on May 22, 2024, and will remain valid until May 31, 2028. We extend our gratitude to ORP's Animal Research Protection division for their efforts in preparing the detailed report required to continue PHS-funded animal studies at the University.
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Whether you are new to Pitt or preparing to retire or relocate, we are here to assist you.
For new University members, our Onboarding Service offers customized help with protocol writing and other regulatory matters.
If you are leaving, please refer to our Departing Investigator Checklist and complete the accompanying form to receive guidance from relevant offices.
Simply reach out, and we'll provide the support you need.
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