October 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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University Enacts Research Data Management Policy
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The University has formalized its data management practices by enacting the Research Data Management Policy (RI-14), which was approved by Chancellor Gabel on October 16.
This policy informs data management throughout the lifecycle of a research project, including the archiving of research records when an investigator leaves the University. This policy also aligns University standards with evolving federal research security requirements.
Please ensure that you are managing your research data in accordance with Policy RI-14.
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The following training sessions are being offered to assist researchers and adminstrators in understanding this new University policy and how to manage research data in accordance with the policy.
When: November 3, 2023 | 9:00 a.m.
Register in advance for this webinar.
When: November 6, 2023 | 4:00 p.m.
Register in advance for this webinar.
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U.S. government agencies maintain lists of individuals and entities barred or restricted from entering into certain types of transactions with U.S. persons. Consequences for transferring items to—or transacting with—Restricted Parties are severe, and the U.S. government has increased the breadth and use of restricted party lists over the past 5 years in response to increased threats from malign foreign governments and other bad actors.
Federal security and funding agencies strongly encourage universities to regularly screen third party collaborators and vendors against these lists. In addition, many federal agencies, such as the Department of Defense, have introduced new risk matrices that highlight past and current relationships with known restricted parties as a high risk that may affect new research awards.
To protect against these risks, the Office of Trade Compliance (OTC) makes an electronic tool available that comprehensively screens against all known U.S. restricted party lists. While some central office systems and staff conduct these screenings as part of their standard processes, we encourage the Pitt community to integrate these screenings as part of their research and business processes to identify and manage this type of risk early on. The OTC is also available for questions and training on this topic and can be reached at tradecompliance@pitt.edu.
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ORP's Organizational Charts
The ORP organizational chart visually depicts our internal structure, and provides insight into the roles and responsibilities of individuals who comprise our divisions. View our current organizational chart to learn about the many functions within ORP.
The dedicated committees supported by ORP play a key role in the conduct of ethical research at Pitt. This organizational chart outlines the committees that are critical to our operation.
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If you receive royalties, milestone payments or other proceeds from intellectual property, you must report those payments on your Certification in MyDisclosures. This includes payments you receive directly from the company and payments made to you through Pitt or UPMC.
Additional guidance about what to include on your Certification is available here. Detailed instructions on how to complete a Certification are available here.
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To protect the integrity and authenticity of clinical trials, the Food and Drug Administration (FDA) imposes strict requirements for the management of electronic records and signatures. The University now has an instance of the web application REDCap (Research Electronic Data Capture) that has been validated to be in compliance with FDA regulations. REDCap is a secure web application for building and managing online data collection forms and databases.
The new REDCap system is available now, but its use will be mandatory after January 1, 2024 for management of electronic records and signatures by any sponsor submitting to the FDA a new Investigational New Drug (IND) or Investigational Device Exemption (IDE) application, or a new protocol under an existing IND or IDE approval. The only exception to this requirement will be the use of an external data capture system that has been validated to be in compliance with FDA regulations and approved by the Office of the Vice Chancellor and Chief Information Officer, Health Sciences, 412-383-7211.
Studies that do not require compliance with FDA regulations may continue to use the original REDCap instance. Learn more about Pitt’s REDCap instances. If you have questions, please direct them to: hs.appsupport@pitt.edu
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All ORP divisions, including the Human Research Protection, Animal Research Protection, and Institutional Biosafety divisions, will be closed during upcoming University recesses:
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Thanksgiving break: Nov. 23 — Nov. 26, 2023
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Winter break: 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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