June 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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Departing Investigators and Data Use
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With few exceptions, all data collected by University members is owned by Pitt, which has both rights and responsibilities for the data. Generally, if you leave the University, you may take copies of the data to your new institution provided a data use agreement has been executed through the Office of Sponsored Programs via the MyRA system.
The University's guidelines on research data management are available here.
If you have any questions about this requirement, please email ORP_Support@pitt.edu.
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The National Institutes of Health (NIH) utilize the “just-in-time” (JIT) process for certain programs and award mechanisms. JIT refers to the application timeframe in which applicants are required to submit updated time-sensitive information to the NIH if an award is likely. The JIT notice usually includes a request for content that was not included in the initial application, including:
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Certification of Institutional Review Board (IRB) approval of the project's proposed use of human subjects.
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Certification of Institutional Animal Care and Use Committee (IACUC) approval of the project's proposed use of live vertebrate animals.
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Evidence of compliance with the education in the protection of human research participants requirement.
If your research involves recombinant or synthetic DNA, approval by the Institutional Biosafety Committee (IBC) is required prior to the IRB or IACUC issuing approval.
Obtaining IRB or IACUC approval for a project takes several weeks, and in some cases longer, depending on the complexity of the study and the number of concerns raised by reviewers. Thus, as soon as you presume that your NIH grant is likely to be competitive for an award, you should begin the process of obtaining IRB or IACUC approval, if not already in place.
When the IRB or IACUC protocol is submitted, make sure the financial interest questions are answered correctly. This will help ensure any required conflict of interest reviews can be completed in a timely manner.
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All new basic biomedical researchers at Pitt (as well as current University members), including faculty, staff, and trainees, are invited to attend a workshop on August 16th. The symposium will be hybrid (both in-person and streamed via Zoom).
This symposium will provide an introduction to:
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Key committees involved with research oversight: IACUC and IBC
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Department of Environmental Health and Safety (EH&S)
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Division of Laboratory Animal Resources (DLAR)
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Research integrity
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Conflict of interest and disclosure process
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Radiation safety
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Management of controlled substances
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Office of Sponsored Programs
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Export control, research security, and visitor policy
You may attend selected presentations or the entire symposium.
Further details will be provided at a later date.
Please let new colleagues in your department know about
this event!
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Pitt Comments on Draft Research Security Programs Standard Requirement
The White House Office of Science and Technology Policy (OSTP) released for public comment a Draft Research Security Programs Standard Requirement developed in response to National Security Presidential Memorandum 33 (NSPM-33). Pitt submitted comments in early June after speaking with faculty and staff to gauge the overall impact this draft would have on operations.
Once OSTP releases a Final Research Security Program Standard Requirement, universities receiving more than $50 million in federal R&D support will have one year to implement a compliant research security program. ORP will continue to update the community on this future compliance obligation as more information becomes available.
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Pitt is part of a consortium of universities funded by the National Science Foundation to produce research security training that will be required by the Final Research Security Program Standard Requirement. We are looking for volunteers to provide feedback on a preliminary version of the training module.
Students, staff and faculty members are welcome to participate.
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Annual Disclosure Certifications were due by April 15th. University employees who are required to disclose receive weekly email reminders from MyDisclosures with links to their Certifications. If you are required to disclose but have not yet submitted your Certification, please do so as soon as possible.
Supervisor reviews were due by June 15th. If you are a supervisor who has not yet completed your reviews, please do so as soon as possible.
As a general reminder, investigators in University research must disclose their financial interests in research associated with MyRA, ARO or PittPRO submissions. Following are two examples:
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An investigator consults for a company and conducts University research sponsored by that company. The investigator must indicate a financial interest in the sponsored research agreement in MyRA.
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An investigator creates a start-up company and conducts University animal research that will evaluate technology the start-up company has optioned from the University. The investigator must indicate a financial interest in the IACUC protocol.
Training videos for disclosers, supervisors and administrators are available here. Step-by-step instructions on how to complete disclosures, supervisor reviews and access MyDisclosures reports are available here. Guidance regarding disclosure requirements is available here.
If you have questions, please contact the University's Conflict of Interest Division at mydisclosures_support@pitt.edu.
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MyIBC, the online review system for the Institutional Biosafety Committee (IBC) and the Stem Cell Research Oversight Committee, will be upgraded late summer/early fall 2023. The upgrade will include functional and visual changes. Some of the updates include:
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New visual features such as slide-in windows, left-hand navigation, and more.
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Enhanced reviewer comment functionality.
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Improved and streamlined smartforms including document management, validation and error checking, and compare versions.
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Future ability to integrate with other Pitt Research systems such as MyFunding and MyIACUC.
We will continue to provide information about the upgrade, including the timeline and training documentation. If you have any questions, please email Natalie Kaczmarek at nem44@pitt.edu.
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Did You Know?
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The Institutional Biosafety website has "How-To" videos in the Video Library located under the Training tab.
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Institutional Biosafety support staff offers in-person or remote consultations or training sessions. To sign up for a consultation/training session, email IBC_Support@pitt.edu.
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The University must be in compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules by accepting federal grant funds.
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Research activities with transgenic or knockout animals, or transfected/transformed cells or commercially available cell lines with inserted "marker" genes such as Green Fluorescent Protein, may require Institutional Biosafety Committee (IBC) registration. If you need help determining whether your research activities fall under IBC review, contact the IBC support staff at IBC_Support@pitt.edu.
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In addition to video training related to recombinant materials, ORP maintains a comprehensive video library, including videos on the following topics:
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Animal Research
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Conflict of Interest
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Human Subject Research
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Data Security
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Good Clinical Practice (Clinical Trials)
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Trade Compliance
Check out our videos, and if you have suggestions for other topics please contact us!
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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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