June 2021 Newsletter
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Stay up-to-date with the latest news and resources from the Office of Research Protections
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Upcoming Integration of Research-Related Information Systems
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Soon, only a Pitt or UPMC email address can be used to login to the ARO or MyIBC protocol management systems. If you log into these systems with a different address (such as Gmail), follow this guidance to change your login address to your primary Pitt account.
Coming soon, an integrated, single dashboard will allow investigators to interact with all the information systems related to their research, including:
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PittPRO (for human subject research)
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ARO (for animal subject research)
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MyIBC (for research involving recombinant or synthetic nucleic acid molecules)
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MyDisclosures (for disclosure of external engagements related to a University member’s Pitt responsibilities)
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MyFunding (for funding proposals)
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MyRA (for non-financial agreements)
Some systems (PittPRO, ARO, MyIBC) use HSConnect to login, which historically has permitted the use of third-party email accounts. To prepare for the integration, users must update their login address in HSConnect to their primary Pitt (or UPMC) address. Failure to do so will result in lost access to research protocols in these systems.
Moving forward, only individuals with a Pitt or UPMC address can be added to a research protocol in ARO or MyIBC. Visiting investigators will therefore need a sponsored Pitt or UPMC account.
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University policies and federal government regulations require full-time faculty and some staff members and trainees to disclose external engagements related to their Pitt responsibilities. For the second year, MyDisclosures was used to collect these disclosures.
Over 10,500 Pitt employees were asked to file a disclosure, and more than 99% complied. Disclosers with outstanding obligations will be contacted, with the goal of 100% completion.
Thanks to all University members for their cooperation during another disclosure filing season.
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In compliance with federal regulations, the Office of Sponsored Programs cannot submit a grant application unless all key investigators have filed a disclosure through MyDisclosures.
A disclosure is generated for full-time faculty when they are added to the payroll database. However, a disclosure must be manually created for those submitting a grant in advance of their employment date.
Departments should use this form to request the early generation of a disclosure through MyDisclosures. Allow extra time for staff to manually generate disclosures, especially around major grant submission deadlines. Investigators should ensure they have a disclosure on file well ahead of grant submission deadlines.
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The Conflict of Interest (COI) Committee and the COI Division play an important role in assisting the University community with understanding federal regulations and implementing best practices for managing potential conflicts arising from interactions with industry partners and engagement in entrepreneurial activities.
One activity overseen by the COI committee and related ORP staff is engagement of Pitt faculty, staff and students by licensed startup companies (LSCs). LSCs are companies that obtained a license or option agreement for University-owned intellectual property and have an ownership interest held by the University, a University member or their immediate family.
The Conflict of Interest Policy for Research requires approval for a University member to be employed by or consult for an LSC. Contact the COI Division for more information.
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The execution of clinical trials requires the utmost levels of transparency and compliance to ensure an ethical, safe, and efficient clinical research enterprise. To that end, the US Food and Drug Administration (FDA) works with responsible parties to facilitate compliance with requirements to submit registration and summary results information to the ClinicalTrials.gov data bank, managed by the National Institutes of Health (NIH)/National Library of Medicine.
Recently, the FDA issued its first Notice of Noncompliance to a responsible party for failure to submit required summary results to ClinicalTrials.gov. If you are ever the recipient of a letter from the FDA or NIH addressing compliance with ClinicalTrials.gov requirements, it is imperative that you immediately notify us at CTgov@pitt.edu. Read more here.
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In Memoriam:
Dr. Jerome L. Rosenberg
As a University community, we mourn the passing of Dr. Jerry Rosenberg, the longest-serving member of our faculty—who retired in 2017 after 64 years of service. Dr. Rosenberg was instrumental in founding two important research protection units. As Research Integrity Officer, he established Pitt’s program of research integrity oversight and built it to be among the best in the nation. As the first chair of the Conflict of Interest (COI) Committee, he guided the formation of the Conflict of Interest Office, which oversees COI disclosure and compliance for more than 10,000 University members.
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