International Research Relationships and Activities

U.S. Sanctions and Export Controls Update

Additions and Revisions of Export Restrictions Imposed on Restricted Entities, March 2, 2023

April 4th, 2023
The Bureau of Industry and Security (BIS) amended the Export Administration Regulations (EAR) by adding 37 entities to the Restricted Entity List.

Disclosures to Funding Agencies

The National Institutes of Health (NIH), the National Science Foundation (NSF), and the Department of Defense (DOD) have all recently issued new policies or further guidance clarifying investigators’ obligations to disclose all other support they receive for their research activities. While the requirements vary slightly among the different agencies, all agencies require disclosure not just of research funding received through the University, but also of other funding and affiliations investigators may have in their individual capacities.

NSF recently updated its disclosure guidance.

Previous guidance from NIH in NIH Notice NOT-OD-19-114, “Reminders of NIH Policies on Other Support and on Policies Related to Financial Conflicts of Interest and Foreign Components,” July 10, 2019, stated that investigators must disclose:

• All paid or unpaid scientific or titled academic, professional or institutional, full time, part-time, or voluntary appointments (including adjunct, visiting or honorary) at all foreign and domestic entities.
• Paid or unpaid collaborations with foreign or domestic researchers that directly benefit the project (for example, collaborations that produce data that will be used in the research or resulting publications).
• All current projects and activities undertaken by the PI or senior/key personnel that involve paid or in-kind support from domestic or foreign entities in the form of laboratory personnel, lab space, scientific materials or instrumentation (e.g., biologics, chemical, model systems, data sets, technology, etc.)
• All resources and other support from any source for other paid or unpaid individuals who contribute to the scientific development or execution of the project. This would include any support provided by other institutions/governments to visiting scientists or volunteers who are participating in the research while at Georgetown (even if such visiting scientists or volunteers are not paid by Georgetown).
• Any participation in foreign “talent” or similar programs.

More recently, NIH Notice NOT-OD-21-110, effective for grant applications, Just in Time (JIT) information, or Research Performance Progress Reports (RPPRs) submitted on or after January 25, 2022, NIH has revised the Biosketch format (and included separate formats for non-fellowship and fellowship applications) and added new requirements related to Other Support.

The following information must be disclosed by the principal investigator and all key personnel in their biosketches:

• All paid or unpaid scientific or titled academic, professional or institutional, full time, part-time, or voluntary appointments (including adjunct, visiting or honorary) at all foreign and domestic entities. If the appointment is with a foreign entity, an English-language version of the investigator’s agreement with the foreign entity must be provided at the Just In Time (JIT) stage as part of the Other Support submission.

The principal investigator and all key personnel must submit a signed Other Support page that includes the following information related to all of the investigator’s research activities:

• Consulting engagements that involve a research component.
• Paid or unpaid collaborations with foreign or domestic researchers that directly benefit the project (for example, collaborations that produce data that will be used in the project or resulting publications).
• All current projects and activities undertaken by the PI or senior/key personnel that involve paid or in-kind support from domestic or foreign entities in the form of laboratory personnel, lab space, scientific materials or instrumentation (e.g., biologics, chemical, model systems, technology, etc.)
• All resources and other support from any source for other paid or unpaid individuals who contribute to the scientific development or execution of the project. This would include any support provided by other institutions/governments to visiting scientists who are participating in the project while at Georgetown (even if such scientists are not paid by Georgetown).
• Any participation in foreign “talent” or similar programs.

In-Kind Contributions

• In-kind is defined as contributions such as office or laboratory space, equipment, chemicals, supplies, technology or employees, students, visitors, or volunteers in the lab that are paid by an outside organization.
• In-kind contributions that are intended to be used on the project being proposed should be disclosed in the Facilities and Other Resources or Equipment section.

In addition, any “foreign components” of federally funded research should be fully disclosed in proposals, progress reports, and final technical reports. NIH defines a foreign component as “any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended” (emphasis added). This includes collaborations with investigators at a foreign institution anticipated to result in co-authorship (even if no funding is provided to the other institution); use of facilities or instrumentation at a foreign site; or receipt of financial support or resources from a foreign entity.

Staff in the Joint Office of Research Administration (“JORA”) will remind faculty of the relevant disclosure requirements during the proposal submission and the annual progress report processes and are available to answer any questions, but investigators are ultimately responsible for ensuring that their disclosures are complete. Failure to fully disclose all other support or foreign components could subject both faculty and the University to numerous consequences from funding agencies, including suspension or termination of awards, withholding of future awards, and federal prosecution.

Compliance with University Financial Conflict of Interest (FCOI) and Intellectual Property (IP) Policies

In addition to federal disclosure requirements, Georgetown policies also require disclosures of certain activities and interests:

• Under the FCOI Policy, University faculty and staff must disclose “significant financial interests” that they or their family members have if such interests are reasonably related to their University responsibilities. The definition of “significant financial interests” is broad and the dollar threshold for disclosure differs depending on whether an individual is an “investigator” (basically one who engages in sponsored research) or not. An investigator who receives more than $5,000 in a two-year period from a domestic or foreign external source (including the payment of travel by that entity), must disclose it unless such payments are not related to the person’s research activities or other University responsibilities. Questions about the University FCOI policy or its requirements may be directed to the Mary Schmiedel, Senior Director, Office of Research Oversight, at mary.schmiedel@georgetown.edu or (202) 687-3911, Nabeel Qureshi, Deputy Conflicts Officer and Senior Research Compliance Officer, at nabeel.qureshi@georgetown.edu or Lila Sisbarro, Research Compliance Officer, at LS1302@georgetown.edu.
• Pursuant to the University’s Intellectual Property Policy, University faculty, staff, students, fellows and visitors must disclose any inventions and tangible research property, whether patentable or not, and any related intellectual property that they make or conceive in their University research or other assignments, or with more than incidental use of the University’s facilities, equipment, funds or other resources. Researchers also must notify the Office of Technology Commercialization (OTC) prior to public disclosure of any research results that could embody reportable inventions, and may not enter into any agreements that may involve University intellectual property or confidential information with outside organizations without consulting with OTC. Questions related to the Intellectual Property Policy may be directed to OTC at techlicensing@georgetown.edu.

Export Controls and Foreign Travel

Export control laws governing technology used for defense purposes (the International Traffic in Arms Regulations, administered by the Department of State’s Directorate of Defense Trade Controls) and technology that can be used both for defense and civilian purposes (the Export Administration Regulations, administered by the Department of Commerce’s Bureau of Information and Security) have implications both for research conducted in the United States and the activities the University pursues overseas. In addition, sanctions imposed by the United States on other countries may restrict travel to and doing business with certain countries, including Iran, Cuba, North Korea, Russia, and Syria.

Faculty should also be aware of the risks of traveling overseas with sensitive or confidential information on their laptops: such information may be restricted from foreign “export” under the export control laws, and be at greater risk of being “hacked,” stolen, or otherwise compromised. UIS can assist travelers in protecting against such threats to their data while traveling overseas, including by the use of additional encryption, loaner laptops, or other mechanisms.

For additional guidance on IT security while traveling overseas, please review the document entitled Effective Practice: Cybersecurity for the International Traveler, provided by the Research and Education Networks Information Sharing and Analysis Center (REN-ISAC), which serves over 620 member institutions within the higher education and research community by promoting cybersecurity operational protections and response. For more information about these requirements and the University’s procedures for export control compliance and foreign travel, please visit the Office of Research Oversight; questions may be directed to Mary Schmiedel, Senior Director, or Greg Madison, Export Control Officer at ExportControl@georgetown.edu.