January 2025 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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Federal Funding Agencies Intensify Verification of Application Data
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Federal funding agencies require applicants to disclose all resources available for their proposed research, including financial support and in-kind contributions such as equipment, supplies, or personnel. Key personnel must also report all positions, scientific appointments, and affiliations, both domestic and foreign.
Notably, if the research involves a foreign component—defined as significant scientific work conducted outside the United States—prior approval from the funding agency is necessary.
Federal funding agencies have implemented advanced methods to verify the accuracy of reported support, collaborations, and affiliations. They may scrutinize instances where a federal award is cited alongside foreign grants in publications or where a federally funded researcher is listed with an unreported foreign affiliation, as this implies a potential foreign component or research support that was not disclosed in the funding application.
Therefore, it is imperative to fully disclose in an application or after the receipt of an award all resources, appointments, and affiliations, especially when collaborating with international investigators. Failure to provide required information can result in disallowed costs, repayment of awards, withholding of future awards, or termination of current awards.
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Research involving human, animal, or plant pathogens—particularly those modified in laboratories—plays a crucial role in developing vaccines and therapeutics. However, this research may inadvertently pose risks to public health, agriculture, the environment, the economy, or national security if misapplied.
Such studies are categorized as Dual Use Research of Concern (DURC) by the U.S. Government. Thus, researchers and institutions must assess biosafety and biosecurity risks and implement measures to mitigate potential threats.
Currently, studies involving any of the 14 agents or toxins specified in the 2014 U.S. Government DURC policy are reviewed by the University’s DURC Committee. In May 2024, the federal government issued an updated U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (USG DURC PEPP
Policy). Effective May 6, 2025, the policy expands oversight for federally funded research involving Select Agents, Toxins, and many Risk Group 3 pathogens (which cause human or animal disease but do not ordinarily spread from one infected individual to another). These agents must undergo review to determine whether they fall within two categories:
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DURC (Category 1): Research meeting existing DURC criteria.
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Pathogens with Enhanced Pandemic Potential (PEPP; Category 2): Research involving pathogens with heightened transmissibility or virulence.
The University will soon provide guidance and resources to help researchers identify and document whether their work falls under DURC or PEPP criteria. For now, the NIH video Dual Use Research: A Dialogue offers an introduction to these concepts, and the following additional resources are available for further information:
In addition, investigators may email durc@pitt.edu or biosafe@pitt.edu.
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Gift Authorship: An Ethical Concern in Academic Research
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Gift authorship, also referred to as honorary authorship, occurs when someone is listed as an author on a paper despite not having made a meaningful contribution to the work. Although it was once commonplace for department chairs and other leaders to be automatically included on publications originating from their units, this practice is now widely regarded as unethical. Including a gift author on a paper also violates the University’s guidelines for the responsible conduct of research.
By inflating an individual’s publication record, gift authorship not only misrepresents that person’s productivity and expertise, but it can also undermine their credibility over time. Recognizing these concerns, many journals now require detailed statements outlining each author’s specific contributions. Misrepresenting authorship in these declarations can lead to serious consequences, such as article retractions and sanctions from publishers.
Furthermore, adding a gift author from another country could prompt funding agencies to conclude that the research involves a foreign component.
The International Committee of Medical Journal Editors recommends that authorship be based on the following four criteria:
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Making a substantial contribution to the work’s conception or design—or to data acquisition, analysis, or interpretation.
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Drafting the work or critically revising it for significant intellectual content.
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Giving final approval of the version to be published.
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Accepting accountability for all aspects of the work.
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Biological materials, including animals, viruses, bacteria, human samples, soil, and plants, may require special permits for international or interstate transfers. Researchers receiving these materials must obtain the necessary permits, as the University does not provide blanket permits for all items.
Even materials exempt from permits must include proper documentation to clear U.S. Customs without delays. ORP’s Research Security and Trade Compliance Division assists researchers by advising on permit requirements and providing document templates.
If you need help with biological imports, email researchsecurity@pitt.edu. The Office of Research Security and Trade Compliance website has additional details in the Imports section.
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Upcoming Educational & Training Opportunities
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Consider signing up for these training opportunities offered by the Office of Research Protections:
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Coffee Break with the Division of Education and Compliance Support for Human Subject Research (ECS-HSR)
January 30, 2025 | 9 - 10 a.m.
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Single IRB (sIRB) – Pitt as IRB of Record
January 30, 2025 | 12 - 1 p.m.
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The Publication Process: An Editor's View (conducted through CTSI)
February 4, 2025 | 12 - 1 p.m.
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Reporting Non-Compliance and Adverse Events to the IRB
February 5, 2025 12 - 1 p.m.
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An Overview of the IBC Process: IBC Protocol Requirements, Workflows, and Timelines
February 12, 2025 | 10 a.m.
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IRB 101: Exempt and Expedited Studies
February 12, 2025 | 12 - 1 p.m.
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PittPRO Crash Course
February 19, 2025 | 12 - 1:15 p.m.
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Responsible Conduct of Research (conducted through CTSI) – Conflicts of Interest (COI) Disclosures
February 20, 2025 | 12 - 2 p.m.
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