March 2024 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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New Executive Order to Protect Americans’ Sensitive Personal Data
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President Biden recently issued an Executive Order directing the Department of Justice to create new regulations to protect Americans’ sensitive personal data from being accessed and exploited by countries of concern. The Department of Justice subsequently released an Advance Notice of Proposed Rulemaking in the Federal Register that contains the proposed regulations. Public comments are due by April 19th.
This new draft rule is in response to the President’s determination “that additional measures are necessary to counter the unusual and extraordinary threat to U.S. national security posed by the continuing efforts of certain countries of concern to access and exploit Americans’ bulk sensitive personal data and U.S. Government-related data.” Americans’ sensitive personal data includes genomic data, biometric data, personal health data, geolocation data, financial data, and certain kinds of personal identifiers.
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The Animal Research Online (ARO) system, which is used for processing protocol submissions to the Institutional Animal Care and Use Committee (IACUC), is undergoing a backend update to ensure continued functionality. This update will also enhance the presentation of information through the following features:
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Introduction of new visual elements such as slide-in windows, left-hand navigation, and more
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Enhanced functionality for reviewer comments
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Improved and streamlined smartforms with validation, error checking, and version comparison capabilities
Although the display of information will be enhanced, the core functionalities of ARO will remain the same, and the protocol content will remain consistent.
ARO will be unavailable to users from 5 p.m. on Friday, April 26, until 8 a.m. on Monday, April 29, while the upgrade is being implemented.
A short video showcasing the new features has been added to the IACUC Video Library and can be directly accessed through this link.
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Investigators must complete applicable training to comply with regulations governing research activities. The Office of Research Protections (ORP) provides guidance on necessary training requirements, including a summary document for reference.
Most trainings must be repeated at regular intervals, usually every four years, although specific regulations may require more frequent refreshers for certain topics.
Delays in protocol approvals may occur if team members' training is not current. Both the ARO and PittPRO (utilized for Institutional Review Board [IRB] submissions) systems include a training tab that allows principal investigators to monitor the training status of their team members.
To prevent delays, it is crucial to stay up-to-date with training requirements and repeat training on schedule.
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Protocols evaluated by committees supported by ORP, including the IACUC and IRB, require the documentation of team members involved in a study. Maintaining up-to-date personnel lists is crucial to validate their training and ensure effective communication to all team members. It is particularly vital to update study coordinators or lab managers tasked with overseeing study deadlines and compliance, so they promptly receive important notifications such as upcoming protocol expirations.
To update study personnel, complete a protocol amendment within the ARO, Pitt-Pro, and MyIBC systems.
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Remember to Complete Your Annual Disclosure by April 15!
If you are required to complete an Annual Disclosure, you received an email from MyDisclosures between March 18 and 20.
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 ORP's Conflict of Interest Division at mydisclosures_support@pitt.edu.
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The University's Institutional Biosafety Committee (IBC) evaluates all studies utilizing recombinant or synthetic nucleic acids.
To aid researchers in determining the suitable biosafety level (BSL) for their work, the IBC website provides a Resource page with a table detailing commonly used recombinant agents. Importantly, this table incorporates influenza guidance recently approved by the IBC.
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An agreement may be needed when animal research involves collaborations or partnerships between different institutions. The Guide for the Care and Use of Laboratory Animals states that collaborating institutions conducting animal research should execute a formal written document (e.g., a contract, MOU, or agreement) that defines the responsibility for animal care and use, animal ownership, and IACUC evaluation and oversight. If the research is funded through a subcontract between institutions, the required language is typically included, although in some cases a separate ageement may also be required.
This webpage provides more information about the requirement for inter-institutional agreements when conducting collaborative animal research.
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Leaving Pitt? ORP Can Ease the Transition
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When preparing to depart from the University, whether due to retirement or relocation, investigators must complete many tasks such as lab decommissioning, study closure, data archiving, and grant transfer. Fortunately, ORP can provide assistance!
If you're departing from Pitt, please consult our Checklist for Investigators Leaving the University.
By filling out this online form, you'll also notify pertinent offices of your departure, prompting them to reach out with necessary information.
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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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