November 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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ORP Launches Responsible Conduct of Research (RCR) Website
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A steadfast commitment to the Responsible Conduct of Research (RCR) is paramount to the University’s standing as one of the nation’s leading institutions of higher learning and scientific discovery. The University has official RCR guidelines in place to ensure that researchers are equipped and empowered to conduct research that meets the highest ethical standards.
To ensure that these guidelines remain close-at-hand and easy to digest, ORP is pleased to launch its new RCR website. The new RCR site also incorporates the principles related to research integrity. This site will serve as an important resource for all investigators, offering guidance on best practices, data management, reporting misconduct and more.
Explore ORP’s new RCR website.
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The University recently enacted a new Research Data Management Policy. This policy addresses the ownership, management, access, sharing, and retention of research data collected under the auspices of the University.
A recorded presentation provides additional insights into the policy and its implementation:
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The University of Pittsburgh's Controlled Substance Guidelines require that expired or unwanted containers of controlled substances (containing a residual volume) must be discarded through a Reverse Distributor.
To reduce costs and to simplify the process of discarding expired or unwanted controlled substances, the Department of Environmental Health and Safety (EH&S) has arranged for a Reverse Distributor (Heritage Environmental Services) to visit Campus on a quarterly basis.
The following are the controlled substance pickup dates for 2024:
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Wednesday, January 17
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Wednesday, April 17
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Wednesday, July 17
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Wednesday, October 16
Click to learn more about the Controlled Substance Collection Program
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Need Information about the Management of Controlled Substances?
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The following resources are available to answer questions about the management of controlled substances in research laboratories:
If you have questions that are not answered in these resources, please contact the Office of Research Protections.
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Purchasing Services recently revised the Directed or Sole Source Justification Form, commonly known as the “DSSJF.” In accordance with University policy FN 08, Purchasing Services uses the DSSJF to document why a designated supplier was not selected through the University’s competitive bidding process.
The updated DSSJF clarifies that the Requestor must be the University Member who will use or manage the service or product, and not the department administrator placing the order. The Requestor’s Primary Supervisor, as identified in MyDisclosures, must also sign the DSSJF. Additionally, Requestors and their Primary Supervisors must inform Purchasing Services about any relationships they or a family member have with the recommended supplier, including an ownership or managerial role in the supplier by their spouse, domestic partner, children, siblings, or parents.
Starting December 1, 2023, all directed or sole source requests must be submitted to Purchasing Services using the new DSSJF.
Click here for more information
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REDCap is a secure web application for building and managing electronic research records. A new REDCap instance for clinical studies requiring compliance with the Food and Drug Administration (FDA) 21 part 11 requirements is now available for voluntary use by investigators. During this voluntary phase, processes are being finalized and educational sessions are being planned for early 2024 when use of the new REDCap instance becomes mandatory for those submitting new protocols to the FDA.
The Institutional Review Board's PittPRO protocol submission system has been updated to include the new REDCap instance on the Electronic Data Management page. New studies should indicate whether they will utilize the FDA-compliant instance of REDCap.
Click this link for more information, or send questions to IIS@pitt.edu.
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Call for Members on ORP Committees
The committees supported by the ORP are mandated by the federal government to ensure that all research is conducted ethically and in compliance with regulations. These committees are comprised of both University members and representatives of the public ("community members").
ORP-supported committees include the following:
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Institutional Review Board (IRB)
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Institutional Animal Care and Use Committee (IACUC)
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Institutional Biosafety Committee (IBC)
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Human Stem Cell Research Oversight Committee (hSCRO)
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Radiation Safety Committee
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Radioactive Drug Research Committee
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Human Use Subcommittee (for radiation use in research)
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Conflict of Interest Committee
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Institutional Conflict of Interest Committee
We are always looking for both University and community members to serve on our committees. It is important that community members not have any affiliation with the University. If you, or a community member you know, would be interested in serving on an ORP committee, please contact Bill Yates, Vice Chancellor of ORP at byates@pitt.edu.
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ORP Welcomes New Staff
In recent months, ORP has been pleased to welcome a number of new staff members—across many of our divisions:
Animal Research Protection
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Lacy Mock, Compliance Coordinator
Human Research Protection
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Carolyn Baker, Research Review Coordinator
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Zylphia Ford, Research Review Analyst
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Melissa Ilnicki, Reliance Specialist
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Larry Ivanco, Regulatory Affairs Specialist
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Sarah Onesi, Research Review Analyst
Conflict of Interest
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Emily Bird, Senior COI Analyst
Radiation Safety
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Jamison Pamer, Radiation Safety Technologist
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Matthew Stefanovski, Health Physicist Assistant
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Casey Tuxward, X-Ray Technician
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William Walker appointed as IBC Chair
Dr. William Walker, Associate Professor of Obstetrics and Gynecology, has been appointed as the Chair of the Institutional Biosafety Committee (IBC), replacing outgoing Chair William Klimstra.
We thank Dr. Klimstra for his leadership of the IBC for the past two years.
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All ORP divisions, including the Human Research Protection, Animal Research Protection, and Institutional Biosafety divisions, will be closed during the upcoming Winter recess:
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Dec. 22, 2023 — Jan. 1, 2024
Protocols submitted to the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC) will not be processed during these recesses, so please plan ahead and submit protocols early.
Note that federal regulations require the IACUC to reconsider animal research protocols de novo every three years. If your IACUC protocol will expire in December or January, please submit the three-year renewal early to ensure it will be processed in time to avoid a suspension of your animal study.
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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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