Research Resources

Export Controls and International Activities

Export control regulations and international compliance are a concern for all employees of the Children’s Hospital of Chicago Medical Center (the “Medical Center”), doing business as Ann & Robert H. Lurie Children's Hospital of Chicago, even if you do not conduct research or receive federal funding. It is important to note that the Medical Center, as well as individual physicians, researchers, and staff employees, can be held liable for export control violations, with severe monetary penalties and sanctions resulting from non-compliance. Please review the Lurie Children's Export Control and International Activities Policy for details.  

Many different scenarios may involve export controls or international compliance. Export control regulations impact foreign travel, international shipments, certain equipment procurement, sharing technical data and substances, and international collaborations.

Manne Research Institute's Export Control team is comprised of Research Compliance personnel in the Office of Research Integrity & Compliance (ORIC), and is here to assist you with navigating applicable export control regulations and ensuring compliance with the following:,

International shipments are ruled and regulated under federal jurisdictions, including the Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and the Office of Foreign Assets Control (OFAC). This includes transfers by any means (cargo shipment, courier, hand-carried, electronic), and applies to all commodities (hardware, laboratory equipment, materials, research samples), as well as technical data (software, blueprints, schematics, manuals, and information in any form).

To meet compliance obligations, all who ship items internationally from the Medical Center should:

  1. Complete the Export Control Shipping Intake Form.
    1. If sending biological substances, please utilize this flowchart to assist with ECCN determination.
  2. Wait for a response from the Research Compliance team within two business days.

Note: An export license may take approximately two months to obtain from the federal government when required; it is critical to address potential export requirements as soon as possible to allow for sufficient processing time. The Export Control team will facilitate the licensing process; communicating early will help in getting shipments to where they need be on time.

EEI Filing Requirements

International shipments may also require submission of an Electronic Export Information (EEI) filing. The EEI is required when the value of the commodity being sent is over $2,500, when an export license is required to export the commodity, or for items that are subject to the International Traffic in Arms Regulations (ITAR).  Additionally, an EEI is required in other circumstances for items on the Commerce Control List previously controlled on the United States Munitions List as well as exports under the Strategic Trade Authorization (STA). 

Note that an EEI filing is required for shipments going to China, Russia, and Venezuela for:

  • all shipments valued at more than $2,500, even if an export license is not required;
  • shipments, regardless of value or content, intended for military end-use; or
  • Shipments of items listed on the Commerce Control List (CCL), other than those identified as EAR99.

The EEI includes information about the sender, recipient of the item, and information about the item(s) being exported, including an ECCN.

The EEI may be filed directly through the shipper’s carrier of choice by completing an Agent File Form authorizing the carrier to submit the EEI filing. 

Contact the Export Conrol team for assistance with this crucial step. Once the EEI has been filed, the shipper will be given an Internal Transaction Number (ITN), which the Export Control team must use to complete the review of the shipment.

European Union Requirements: The Import Control System 2

As of March 1 2023, the European Union (EU) has implemented the Import Control System 2 (ICS2), a large-scale information system aimed at improving safety and security at customs for its citizens.  As a result, all goods being shipped into or transiting through the EU, Northern Ireland, Norway and Switzerland by air require additional information:

  1. A minimum six-digit Harmonized System (HS) code
    1. You may search for your HS Code/Schedule B Number.
  2. An accurate goods description
  3. The receiver’s Economic Operator Registration and Identification (EORI) number
    1. You must reach out to the individual recipient in the EU to obtain the EORI number.
      Note: The first 2 characters are the country code followed by a unique set of numbers for the recipient’s organization.

These rules apply to all goods (except documents), regardless of value. Please note that failure to provide the necessary information may result in delays or even rejection of your shipment by customs authorities.

The Medical Center does not regulate the travel of its personnel, but some requirements may apply based on destination or status. Traveling abroad may trigger export control regulations, particularly with hand-carried items (ex. laptops, jump drives, and prototypes or samples) that include any proprietary export-controlled information. Additionally, there are also special precautions travelers should take when going abroad, depending on the country of destination.

International Travel Checklist

The Export Control International Travel Checklist will assist with preparation of your international travels.

International conferences can pose various export control risks, particularly when presenting. Ensure that any material presented or discussed is limited to topics not related to export-controlled items or technologies, unless the information is already in the “public domain” or qualifies as “fundamental research.” Information is considered in the “public domain” if it is published and generally accessible to the public. “Fundamental research” includes basic or applied research in science and/or engineering at an accredited U.S. institution where the resulting information is typically published and shared broadly within the scientific community, or is about to be published.

All Medical Center personnel are encouraged to contact the Research Compliance team for guidance and evaluation prior to attending or participating in an international conference or seminar. The team can assist with the following:

  • screening of potential collaborators
  • determining if the conference is "open"
  • identifying what information can be shared without a license
  • assessing whether an export license is required
  • maintaining appropriate organizational records

“Open” seminars are generally not problematic unless they occur in a sanctioned country or involve restricted parties. Exchanges of technical information, including academic discussions, may require a license. A conference is deemed “open” if all technically qualified members of the public can attend, and attendees are allowed to take notes or make a personal record (excluding recordings) of the proceedings and presentations. Access to the information must be free or for a fee that does not exceed the cost of production and distribution or the cost of holding the conference (including a reasonable profit).

Please contact the Export Control team for assistance.

When traveling abroad with electronic devices such as laptops, the devices, underlying technology, data, proprietary information, confidential records, and encryption software are subject to U.S. export control regulations. Some foreign governments may even seize travelers’ computers and review their contents.
Items with “dual-use” (commercial and military applications), proprietary information, or defense articles generally require an export control license. However, commercially available laptops and standard software are usually exempt.

Items may qualify for the temporary export exception (TMP) as a “tool of trade” if they:

  • remain under the exporter’s control (physical possession or secure environment),
  • are reasonable equipment for the trade,
  • are not taken to embargoed countries (Cuba, Iran, North Korea, Syria, Sudan),
  • are carried with the exporter or shipped within 30 days of travel,
  • contain data in the public domain,
  • are used for less than one year.

Do not take the following items abroad without specific consultation from the Research Compliance team:

  • Medical Center-owned scientific equipment (except sanitized laptops, PDAs, or storage devices)
  • Data or information under confidentiality obligations, including private research subject information
  • Data or analyses with contractual dissemination constraints
  • Devices, equipment, or software with export or access restrictions
  • Devices, systems, or software designed for military or space applications
  • Classified information

Note: If you are planning travel to an OFAC-sanctioned country with electronic devices or encryption software, please notify the Export Control team for review and referral to the Medical Center’s loaner laptop program.

For assistance, contact the Export Control team.

Depending on your destination, you may need authorization from the U.S. Treasury’s Office of Foreign Assets Control (OFAC) or the U.S. Commerce Department. Travel to embargoed or sanctioned countries (such as Iran, Cuba, North Korea, Russia, Syria, and regions like Crimea, Donetsk, and Luhansk) often requires prior authorization in the form of a license. No Medical Center equipment should be taken, and no institutional business should be conducted without prior review and approval. Most activities involving heavily sanctioned countries, even remotely, will require a license.

Additionally, if you are traveling to a country designated as a military end-user (such as Belarus, Burma, Cambodia, China, Russia, and Venezuela), authorization may be required to “export” even basic equipment like laptops and cell phones.

For assistance, contact the Export Control team.

The Research Compliance Export Control team can provide guidance when sponsors or collaborators want to share materials, data or information with you, and there are restrictions. 

Export controls may sometimes impact Medical Center activities in unexpected ways. For example, research involving attenuated select agents may require additional security procedures beyond a biosafety protocol, and foreign persons may be restricted from accessing certain licensed software or experimental data, even if used for fundamental research. We must therefore consider the application of export controls to research projects and other activities on a case-by-case basis.

Please contact the Export Control team for an export control review of any agreements or materials you have questions about. 

The Research Compliance Export Control team assists in training Medical Center personnel on export controls.

It is the Medical Center’s intention to familiarize physicians, investigators and staff as comprehensively as possible on federal requirements regarding Export Controls.

Please contact the Export Control team for personal Export Control Training.

Export Compliance training is also available for free and on-demand via the Department of Commerce’s Bureau of Industry and Security (BIS) website: BIS Online Training Room

The Research Compliance Export Control team assists with requirements during procurement on highly controlled equipment such as cameras, lasers, etc., and whenever end-user agreements are marked “export controlled” or “ITAR.” U.S. export control regulations limit access to certain sensitive materials, data, and technologies by specific foreign individuals and those with a history of prohibited conduct. To comply with these regulations, the Medical Center must identify and monitor all controlled data, materials, and technologies it procures.

Vendor Responsibilities

Whenever possible, we rely on manufacturers and vendors to provide the export control status of items and software procured. Regardless of the purchasing method, purchasers must request the ECCN or USML category for any material, data, or technology they believe may be exported.

Handling Controlled Items

If a vendor identifies an item as controlled under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR), or if an export control notice accompanies a procured item, please secure the applicable material appropriately to prevent access by affected foreign persons. Then, please forward the pertinent documentation to the Export Control team for guidance and clearance.

Uncertain Export Control Status

If a vendor is unsure of an item’s export control status or refuses to provide the information, contact the Export Control team before proceeding with the purchase so that an analysis can be performed to definitively establish the status of the material.

Export Control Support

For any questions or concerns regarding purchases with export control issues, contact the Research Compliance Export Control team. The Research Compliance Export Control team offers support for all Medical Center purchases, including:

  • Reviewing export control language in purchasing contracts
  • Screening vendors against federal watch-lists
  • Determining if purchased material is controlled
  • Assessing whether an export license is required
  • Identifying applicable license exceptions
  • Filing license applications
  • Maintaining appropriate records

Proactive Compliance

Engaging with the Export Control team well in advance of your purchase ensures compliance with export control laws and regulations.

The Office of Foreign Assets Control (OFAC) manages the United States government's sanctions and embargo programs, as well as the Specially Designated Nationals (SDNs) and Blocked Persons lists. The Medical Center's Research Compliance team can assist with review and requesting the necessary federal authorizations whenever you may need to work from or with (even virtually) a sanctioned country (Cuba, Iran, Syria and certain areas in Ukraine). Please note that as of November 2024 there are sanctions on Belarus, Russia, and China to take into consideration when you are collaborating with or conducting activities in those locations.

Please contact the Research Compliance Export Control team for consultation. 

Sanctioned Countries

Sanctions regulations vary significantly by country. The following countries are subject to restrictions on certain types of activities:

Comprehensively Sanctioned Countries

  • Cuba
  • Iran
  • North Korea
  • Russia
  • Syria
  • Ukraine (Regions: Crimea, Donetsk, Luhansk)

Note: Most transactions involving individuals or entities “ordinarily resident” in these countries require an Office of Foreign Assets Control (OFAC) License.

  • Afghanistan
  • Balkans
  • Belarus
  • Burma (Myanmar)
  • Central African Republic
  • Congo, Dem. Rep. of
  • Ethiopia
  • Hong Kong
  • Iraq
  • Lebanon
  • Libya
  • Mali
  • Nicaragua
  • Somalia
  • South Sudan
  • Sudan
  • Venezuela
  • Yemen

Note: Transactions involving specific parties in these countries are prohibited.

  • Afghanistan
  • Belarus
  • Burma (Myanmar)
  • Central African Republic
  • China
  • Cuba
  • Congo, Dem. Rep. of
  • Cyprus
  • Eritrea
  • Ethiopia
  • Haiti
  • Iran
  • Iraq
  • Lebanon
  • Libya
  • Nicaragua
  • North Korea
  • Russia
  • Somalia
  • South Sudan
  • Sudan
  • Syria
  • Venezuela
  • Zimbabwe

Note: The U.S. Department of State prohibits the export of military or space equipment and technical data to these countries, as well as to foreign nationals of these countries.

 

The Research Compliance Export Control team will help apply for export control licenses or exemptions when needed.

Licensing Under Export Administration Regulations

Under the Export Administration Regulations (EAR), exporting controlled items that do not qualify for certain license exceptions requires prior authorization from the Bureau of Industry and Security (BIS). 

This applies to outbound shipments, reexports, and exports to entities on the Government’s Denied Party/Restricted Entity lists. Various BIS licenses may be required, such as individual licenses or deemed export licenses, depending on the transaction type. All license templates are available in the BIS SNAP-R licensing system, which specifies the necessary data for each application. It is crucial for the Research Compliance team to gather and verify all required data before submitting a license application.

Note: Please contact the Export Control team promptly to initiate a license request, as government responses can take several months.

Licensing Under International Traffic in Arms Regulations

Items and activities controlled under the International Traffic in Arms Regulations (ITAR) may require licensing or other authorization from the Directorate of Defense Trade Controls (DDTC). Unless otherwise authorized, ITAR items must not be exported without proper licensing from the Department of State. The specific license or authorization needed depends on the type of export transaction, such as temporary versus permanent export licenses. ITAR authorizations also include Technical Assistance Agreements (TAAs) and Manufacturing License Agreements (MLAs).

Each license type requires specific data points collected through the DDTC’s DTrade application process and associated documentation, such as Transmittal Letters. These letters detail the transaction, including end use, end user profile, and ultimate disposition of the item. Before applying for an ITAR license, the Medical Center must comply with all DDTC requirements, including registration as an ITAR exporter, Empowered Official (EO) designation, and DTrade User status.

For assistance with ITAR and/or EAR licensing, please contact the Export Control team. 

Pleasae contact the Research Compliance Export Control team to help with screening any international collaborators, including individuals and organizations, to ensure that they are not on a prohibited government list. 

The Office of Foreign Assets Control (OFAC) oversees and enforces economic and trade sanctions against specific foreign countries, businesses, regimes, and individuals identified by the U.S. Government as terrorists, narcotics traffickers, or those involved in the proliferation of weapons of mass destruction, among other threats to national security, foreign policy, or the economy of the United States. U.S. citizens, permanent residents, and protected individuals are generally prohibited from conducting business with, or providing services to, individuals, entities, or countries listed on the Specially Designated Nationals (SDN) List without a specific license. Due to this prohibition, it is essential to screen all international individuals before engaging with them to verify they are not on the Specially Designated Nationals or Blocked Persons list. 

The following research-related activities may necessitate Restricted Party Screening:

  • International shipping
  • Online educational services
  • International collaborations
  • International financial transactions (e.g., payments to or from foreign nationals for talks, interviews, travel, and lodging arrangements)
  • Hosting international visitors to Lurie Children’s laboratories and departments
  • Sponsoring Visas (H1B, J1, or other)

If the Restricted Party Screening review indicates that a license is required, an export license must be obtained before conducting business with the restricted individual or entity. The Export Control team will assist you in applying for a license prior to shipment or transfer. Please note that it may take 2 months or longer to receive a decision on a license application. For any questions or to request a screening, please contact us.

The Medical Center must make every effort to identify suspected or actual violations that occur in conjunction with its export activities. All known or suspected export compliance problems should be documented as soon as possible. Every instance of a suspected violation should be reviewed by the Director of Research Compliance.

All export shipments and releases of technical data related to the suspected issue must be placed on hold until otherwise authorized. The Director of Research Compliance shall escalate compliance issues to the Office of General Counsel as appropriate and consider Voluntary Disclosure to the relevant agency (agencies) as applicable.

Timeliness of reporting is a key issue, since export violations are evaluated not only in terms of their content, but also frequency of occurrence, and system-wide implication. Consideration should be given to how and when the Office of General Counsel authorizes an investigative process to ensure Attorney Client Privilege.

Please contact Research Compliance directly with any suspected violations or simple questions. 

Additionally, the Medical Center maintains a range of reporting options, including a telephone hotline (1-833-416-6297), and an online Web Reporting Hotline System for confidential reporting of concerns about compliance with applicable laws, rules, regulations, and policies at the Medical Center.