July 2022 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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FY 2022 Protocol Review Data
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Between July 1, 2021 and June 30, 2022 (Fiscal Year 2022), ORP committees and staff members reviewed over 1900 new research protocols and over 8,400 modifications of existing protocols. The number of reviews conducted by the three largest ORP committees is shown above: Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC).
Thanks to our staff members and volunteer committee members who evaluated this large number of research protocol submissions.
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A federal law passed in March, 2022 requires an authorized institutional official to notify the National Institutes of Health (NIH) when individuals identified as principal investigator or key personnel in an NIH notice of award are removed from their position or are otherwise disciplined by the recipient institution due to concerns about harassment, bullying, retaliation or hostile working conditions.
The Office of Compliance, Investigations & Ethics (OCIE) will take responsibility for reporting such disciplinary actions to NIH, but that office must be aware of these actions. It is most helpful if concerns about harassment are filed via the Pitt Concern Connection, which is monitored by OCIE. A representative from OCIE will follow-up on reports made by supervisors to determine if they resulted in disciplinary actions that must be reported to NIH.
The Pitt Concern Connection makes reporting of any concern easy for both University members and others, allowing users to ask questions or file reports on a variety of topics, including (but not limited to) employee relations, financial concerns, harassment and violence, Title IX and Civil Rights, alleged conflicts of interest, and regulatory violations.
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An NIH policy effective in 2018 requires a single IRB to be responsible for the ethical review of non-exempt human subject research at all sites when multi-site studies are conducted. Other funding agencies have enacted similar requirements.
The Reliance Team in the Human Research Protection Division is responsible for the review of proposals for multi-site studies. The Pitt IRB has taken the lead in the ethical review of 133 multi-site studies, and processed over 1000 requests related to multi-site research.
To increase our capacity to develop and disseminate more dynamic educational materials, ensure the efficient review of multi-site applications, and increase opportunities to interface with the research community, we are pleased to announce the expansion of our Reliance Team.
The expanded Reliance Team is led by Deane Quillen, who was recently hired for the newly created Single IRB Associate Director position. Deane has 10 years of human subject research experience across multiple institutions including the University of Kentucky, University of North Carolina, Vanderbilt University, and Pitt.
The Reliance team also includes Megan Frame, Megan Dalzell, Lauren Runkel, and Natalie Novak.
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The University’s Academic Visitor procedures and Visitor Website were recently updated to align more closely with recommended federal research security practices.
The Office of Trade Compliance will be hosting a webinar on Tuesday, July 26th from 1-2 PM to provide an update on changes in the academic visitor process.
Register for the webinar using this link.
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ORP is hosting a symposium for new basic biomedical investigators to acquaint them with the offices, committees, and resources they need to access to successfully engage in research.
The symposium will be online, from 8:50 AM - 1 PM on August 17. You may attend individual presentations or the entire symposium.
The schedule can be downloaded from this link.
The following topics will be included:
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Institutional Animal Care and Use Committee (IACUC)
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Division of Laboratory Animal Resources (DLAR)
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Institutional Biosafety
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Radiation Safety
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Environmental Health and Safety
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Research Integrity
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Conflict of Interest
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Controlled Drugs
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Grants and Contracts
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Trade Compliance (Export Control and Visitors)
The symposium is open to all members of the Pitt community (staff, students, postdocs, faculty).
Jumpstart your career at Pitt by registering for the symposium.
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Accreditation of Pitt's Animal Research Program
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Pitt's animal research program will undergo a triennial accreditation review this fall by AAALAC International.
Stay tuned for details about the upcoming site visit and information sessions that will be provided prior to the accreditation review by AAALAC International.
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Date: July 27, 2022
Time: 1:00 p.m.
Fundamental research allows universities the greatest flexibility compared to other types of research and aligns most closely with academic principles covering non-discrimination and inclusivity. The export control regulations address this concept in detail and further explain how the results of fundamental research are exempt from export control restrictions. However, there are limits to this exemption, which can — in many cases — be invalidated by accepting publication restrictions or foreign national exclusions through research award terms and conditions.
In this session, the Office of Trade Compliance (OTC) will outline the different categories of research that are conducted at universities, describe the fundamental research exemption, explain how troublesome clauses can nullify the fundamental research exemption, and provide a summary of other helpful exemptions in the export control regulations that benefit the academic community.
Register here.
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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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