January 2024 Newsletter
|
Stay up-to-date with the latest news and resources from the Office of Research Protections (ORP)
|
|
|
|
|
Proposed New Federal Regulations Impacting Researchers
|
|
March-In Rights
A Request for Information (RFI) published in the Federal Register on December 8th seeks responses to the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. This proposal is related to the Bayh-Dole Act (federal law 96-517, enacted in 1980), which incentivizes universities to commercialize inventions that result from federal funding. A provision in the Act — which has never been exercised to date — allows the government to “March-In” and revoke licenses executed by universities for intellectual
property stemming from federally funded research. The proposed regulations provide a framework for when the government can "March-In.” The motivation for these regulations is apparently to constrain the cost of drugs whose development was facilitated by federally funded research.
This article from Science provides additional context.
Department of Defense (DOD) Cybersecurity Requirements
Proposed new cybersecurity guidance for DOD contracts was published in the Federal Register on December 26th. This revised guidance is DOD’s attempt at creating consistent cybersecurity requirements for all of its contractors, including universities and other non-profit research organizations. Proposed mandatory cybersecurity elements include system assessments, monitoring, reporting, and training. Once a final rule is approved, new requirements for cybersecurity will likely appear in DOD award notices. Other federal agencies may subsequently adopt similar cybersecurity models for their contracts.
|
|
|
|
The Animal Welfare Act (AWA) requires that veterinarians from the United States Department of Agriculture (USDA) conduct unannounced inspections of Pitt's animal research program no less than annually. The last inspection occurred during the week of January 8th, with a finding of "no noncompliance with the AWA and related regulations." The University's continued positive inspection reports demonstrate that Pitt upholds the highest standards in its animal research program.
|
|
|
|
|
|
Pitt has two conflict of interest policies pertinent to research:
While Policy RI 01 applies to all University members, RI 11 is related to the University’s financial interests, its relationships with external entities or the external engagements of senior University officials, major gifts to the University from industry, and transactions of University-owned companies.
Two separate committees are involved in oversight of conflicts of interest and institutional conflicts of interest. The Conflict of Interest Committee provides guidance on management of financial conflicts an investigator may have with their research, such as ownership in a company sponsoring the research. The Institutional Conflict of Interest Committee, which is appointed by the University Senate, provides guidance on management of "Threshold University Transactions," such as when the University holds equity in the proposed sponsor of research at Pitt.
|
|
|
|
Complete COI Requirements to Avoid Delays in Grant Activation
All University of Pittsburgh investigators are required to complete conflict of interest (COI) training upon appointment. Investigators who are externally funded, regardless of sponsor, must renew their COI training at least every four years. The COI training course is accessible through the CITI Program.
When a proposal is funded or when a sponsored research agreement is pending, a form must be completed, signed, and uploaded in MyFunding, listing the investigators involved in the project and the dates on which they completed COI training. The Office of Sponsored Programs will not activate an award or execute an agreement until all investigators have submitted a disclosure through MyDisclosures and completed COI training.
|
|
|
|
Although users login to the ORP protocol management systems (ARO, PittPRO and MyIBC) through the Pitt Portal or UPMC Azure Authentication System, important demographic information for these systems is obtained from HSConnect. In particular, the email address, phone number, and departmental affiliation of users are populated from HSConnect. Therefore, it is important that your contact information be kept up-to-date in HSConnect. If your contact information is inaccurate, you may not receive important notifications about your study.
All users are encouraged to login to their HSConnect profile to ensure that account information is accurate. Click on the "My Details" tab to verify your email account. Subsequently, click on the "My Profile" tab to update other contact information.
|
|
|
|
Things to Know: Pitt's IRB is UPMC's IRB
The University of Pittsburgh's Institutional Review Board (IRB) serves as the IRB of Record for human subject research conducted by Pitt faculty, staff, and students, regardless of where the study is being conducted.
In addition, there is an agreement in place with UPMC for Pitt to serve as the reviewing IRB for research conducted by UPMC staff or conducted within UPMC facilities — unless the study is handled through the UPMC Office of Sponsored Programs and Research Support (OSPARS).
If you have questions about the services provided by Pitt's IRB, contact askirb@pitt.edu.
|
|
|
|
Pitt's IBC is responsible for reviewing and approving all research at the University involving recombinant or synthetic nucleic acid molecules.
The National Institutes of Health (NIH) define recombinant and synthetic nucleic acid molecules as:
-
Molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell, i.e. recombinant nucleic acids, or
-
Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids, or
-
Molecules that result from the replication of those described in (1) or (2).
In addition, the IBC is required by NIH Guidelines to report adverse events involving exposures to recombinant DNA, such as needlestick injuries, to the NIH Office of Science Policy. Reports should be provided to ORP's Institutional Biosafety Division as quickly as possible, to ensure that Pitt is meeting federal requirements.
To facilitate understanding of the IBC reporting requirements and processes, a virtual information session will be offered in February.
Please see the Pitt Research Calendar for more information.
Topic: Incident Reporting Information Session
Time: Feb 21, 2024 | 1:30 p.m.
Zoom Meeting: https://pitt.zoom.us/j/99346130511
|
|
|
|
|
|
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.
|
|
|
|
|
|
