May 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 Additions to Restricted Parties Lists – Foreign Engagement Conferrals Available
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On May 14, 2024, the U.S. Department of Commerce added 37 new entities to its Entity List, all of which are based in the People’s Republic of China. The Entity List is a tool used by the Bureau of Industry and Security (BIS) under the Department of Commerce to restrict the export, re-export, and transfer of items subject to the Export Administration Regulations (EAR) to persons (individuals, organizations, companies) reasonably believed to be involved, or pose a significant risk of becoming involved, in activities contrary to the national
security or foreign policy interests of the United States.
The newly added entities include several prominent institutions such as multiple locations of the Chinese Academy of Sciences, along with other renowned institutes and universities. These entities now require a license for the export, re-export, or in-country transfer of any item subject to the EAR.
As federal research security restrictions become more stringent, the risks associated with foreign research engagements are also escalating. To support Pitt’s research community in navigating these challenges, the Office of Research Protections (ORP) is here to help. If you have any questions about a current or prospective foreign research engagement, we encourage you to reach out to us for a brief consultation.
Dr. Bill Yates, Vice Chancellor for Research Protections (byates@pitt.edu), and Allen A. DiPalma, Director of Research Security and Trade Compliance (dipalma@pitt.edu), are available to address your inquiries and provide guidance. Please do not hesitate to contact them for assistance.
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On May 6, 2024, the White House Office of Science and Technology Policy (OSTP) announced an important update to the policy regarding Dual Use Research of Concern (DURC). DURC refers to life sciences research that could potentially be misapplied to pose significant threats to public health and safety, the environment, or national security. This update aims to enhance oversight and ensure that such research is conducted responsibly to mitigate potential risks.
The new rules will broaden the scope of studies requiring special reviews. However, they are more focused compared to a previous proposal from last year, which many scientists feared would complicate studies on low-risk pathogens such as cold viruses and herpesviruses. Under the updated policy, the rules for DURC—now termed Category 1 research—will include all 68 select agents, as well as approximately two dozen additional high-risk pathogens. Moreover, the list of regulated experiments will expand from seven to nine.
Notably, the policy also provides detailed guidance on conducting reviews. Initially, researchers and institutions, rather than federal agencies, will determine whether a study falls under the new regulations.
As Pitt implements the new DURC policy, we will reach out to affected investigators to offer guidance and support.
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ORP Launches Diagnostic Medical Physics Residency Program
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One of the newest initiatives at ORP is the Diagnostic Medical Physics Residency Program. Efforts to develop this program began a year and a half ago and have been substantial. With accreditation from the Commission on Accreditation of Medical Physics Education Programs (CAMPEP), the program is now operational, and the inaugural class will start in July 2024.
Given the robust medical organizations at Pitt and UPMC, ORP's Radiation Safety Division is ideally positioned to introduce and educate residents in the diverse and comprehensive field of medical physics. This residency, a collaborative effort between UPMC, Pitt, Radiology, and Radiation Safety, aims to thoroughly train medical physics graduates to pass the American Board of Radiology (ABR) certification exams and become practicing clinical diagnostic medical physicists. The program is directed by John Holmes, DMP, DABR, with contributing faculty and staff from Radiation Safety and Radiology.
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Thank you to the University community for your assistance during the recent conflict of interest disclosure period. Over 12,000 disclosures were generated for University members in MyDisclosures, and as of May 20, 97% have been completed. The small number who haven't submitted their forms will continue to receive reminders.
Supervisor reviews are due by June 15, with 95% of submitted disclosures already reviewed!
Remember to keep your disclosures up to date throughout the year and add new engagements within 30 days. For more information on required disclosures, consult the MyDisclosures page.
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Drug Enforcement Adminstration (DEA): The DEA oversees the regulation of controlled substances and listed chemicals to prevent their diversion for illegal use. Their revamped website offers resources such as registration forms, reporting tools, guidelines, and compliance information. There is also a new "We are Listening!" link for feedback and suggestions on educational events. For more details, visit the DEA website.
Office of Laboratory Animal Welfare (OLAW): OLAW, part of the National Institutes of Health, plays a pivotal role in promoting the humane care and use of laboratory animals in research. OLAW's mission includes providing guidance and interpretation of the Public Health Service Policy on Humane Care and Use of Laboratory Animals (Policy), supporting educational programs, and monitoring compliance with the Policy at assured institutions like Pitt.
OLAW’s website offers extensive regulatory guidance and, like the DEA site, has recently introduced a “We are Listening!” link. OLAW is eager to hear your suggestions for educational events and community discussions that would be most beneficial. Please take a moment to share your ideas!
While visiting the OLAW homepage, be sure to explore the useful links to the 21st Century Cures Act resources, the list of assured institutions, the PHS Policy tutorial, and more. Your engagement helps ensure the continued excellence and ethical standards in research involving laboratory animals.
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Whether you are new to Pitt or preparing to retire or relocate, we are here to assist you.
For new University members, our Onboarding Service offers customized help with protocol writing and other regulatory matters.
If you are leaving, please refer to our Departing Investigator Checklist and complete the accompanying form to receive guidance from relevant offices.
Simply reach out, and we'll provide the support you need.
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