• Issuance, Review and Execution of the Project Agreement: Because UConn Storrs and UCH are separate fiscal entities, a project agreement needs to be executed before funds can be transferred between the two campuses. After the lead organization has received its award, a subaward agreement is prepared by the lead institution: Sponsored Program Services (UConn Storrs) or the Procurement Office (UCH Farmington). This agreement is emailed to the subawardee’s sponsored programs office for review and execution.
  Note: Subaward agreements must be signed by authorized signatories of both parties. PIs are not authorized to sign.
• Award/Fund Setup: Separate project accounts are set up at the lead and subawardee’s campuses. Prior to account set-up, all compliance-related approvals should have been obtained, e.g., Institutional Review Board IRB)/Stem Cell Research Oversight (SCRO)/Institutional Animal Care and Use Committee (IACUC)/Institutional Biosafety Committee (IBC).
• Invoicing: Before invoices can be paid, they must be approved by the lead campus’s principal investigator.
• Amendments: Competitive project periods often span multiple budget years. If the sponsoring agency awards funds on a budget year basis, issuance and execution of amendments will be necessary to next year’s funding after it has been released to the lead organization by the sponsor.
• Carryover of Funding and No-Cost Extensions: Carryover of funds and no-cost extensions (NCE) are not authorized without the lead awardee’s written approval. If needed, at least sixty (60) days prior to the end date of the current budget period the PI(s) should seek approval for any carryover or NCE requests.
• Award Closeout: So that awards may be closed out in accordance with sponsor requirements, final invoices will normally be required no later than 45 days following the termination date of the award project period.

For assistance with cross-campus subawards:

• At UConn Storrs, contact subawards@uconn.edu
• At UConn Health, contact Wendy Walsh at wewalsh@uchc.edu

There is a mechanism in place that allows Storrs graduate students, both US and international, to be paid directly by UCH as graduate assistants; there is furthermore a mechanism to allow them to have their tuition waived at Storrs. It is not necessary to use the subaward/project agreement mechanism for use of graduate students on grants.

All graduate students (including those at UCH) are enrolled through the Graduate School at Storrs. The only significant issues in the past had been obtaining tuition waivers for graduate assistants at UCH because of the different financial systems at our campuses. UCH’s Human Resources department provides the HR Database of Graduate Assistants to the Bursar’s Office at Storrs a list of all graduate assistants at UCH and they get an automatic tuition waiver similar to graduate assistants at Storrs.

International Students at Storrs are vetted through their International Office while UCH International Students are vetted by Ms. Jaishree Duggal in UCH HR. Both offices work in concert to ensure compliance with applicable immigration laws. International Students are registered through the SEVIS system operated by the Department of Homeland Security, INS, which recognizes the two campuses as separate entities.

State-of-the-art research is carried out in the twelve schools and colleges and the more than 80 research centers and institutes at the University of Connecticut. The annual expenditures at the University exceed $250 million.

Enhancing interdisciplinary research is a strategic goal for the University. An important component of this is the strengthening of the inter-campus collaborations between Storrs and the Health Center. We can assist faculty in preparing and submitting externally funded inter-campus proposals and awards.

Because UConn (Storrs) and UConn Health (UCH) are two separate fiscal entities, proposals seeking extramural funds are administered similar to sponsored activity involving any other inter-institutional collaborations – where one institution serves as the lead applicant and the other consortium partner acts as the subawardee.

At the proposal stage, the external funding agency will typically require a statement of commitment from each collaborating organization to ensure that there is appropriate programmatic and administrative support and oversight.

In order for Sponsored Program Services (SPS) at Storrs and UCH to approve a Letter of Intent/Consortium Statement, both the lead organization and subawardee proposals need to be routed, reviewed and approved by the respective academic and administrative offices.

• Lead Organization: One campus is the lead organization; the other campus participating in the project is the subawardee. The decision regarding which campus serves as the lead applicant typically is dictated by the scope of the project – the lead organization performs a substantive role in conducting the project and maintains appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.
• Budgets: The subawardee’s proposed costs (direct and F&A) get rolled-up into the lead organization’s budget. Each site (Storrs or UCH) applies and receives its respective F&A costs. The lead organization waives F&As associated with the first $25K of inter-campus subaward.  Subawardee personnel cannot be included as personnel in the lead organization’s budget.
• Internal Review/Approval by the Subawardee Organization: At least 10 business days before the funding agency’s deadline, the subawardee principal investigator needs to submit internal forms (Storrs or UCH routing and significant financial interest, scope of work, budget and budget justification plus any additional documents requested to the subawardee’s sponsored programs office [Storrs SPS or UCH ORSP]). After review and approval by that office, the subawardee investigator will submit the approved consortium statement, scope of work, budget and budget justification plus any additional requested documents to the lead organization’s principal investigator.
• Internal Review/Approval at the Lead Organization: The principal investigator for the lead organization should route the complete application to his/her respective sponsored programs office, using the normal review, compliance, and approval processes and by that office’s stated deadline.

Staff Contacts

• Storrs
  • Forms
• UCH

Roles and Responsibilities

 

The Office of the Vice President for Research is responsible for assessing and addressing the education and information needs of UConn staff and faculty involved in sponsored research and compliance activities across UConn’s schools and colleges on all University campuses.

This section of the website provides educational information and support including tutorials, manuals, job aides, videos, and other reference guides to help and support faculty, staff, and students.

Subscribe to the UCRESADM-L Listserv for more information on educational opportunities and other OVPR notices.

The mission of the Office of University Compliance is to assist the University and UConn Health in achieving their financial, operational and strategic goals while maintaining compliance with all associated laws and/or regulations.

The Office of University Compliance accomplishes this goal by identifying institutional risks; performing audits, reviews and investigations; augmenting institutional compliance through effective education and training programs; and fostering the values of knowledge, honesty, integrity, respect and professionalism as outlined in the University’s Code of Conduct.

1. Request an account by emailing Ellen Ciesielski, UConn/UConn Health’s ClinicalTrials.gov PRS Administrator. You will be sent an automated email from the PRS system with your username and password.

2. On the PRS log-in page, in the Organization field, enter “UConnHealth” (no spaces) if your account was created under UConn Health or “UConn” if your account was created under UConn.

3. Click on the blue “Create New Record” button on the far right of the page. The system will walk you through the creation of the record. Data entered on previous pages will be retained so that you can return to complete the record at a later date.

The person who creates the record is the “Record Owner.” The Record Owner may be the Principal Investigator (PI) or someone designated by the PI to create/update the record on his/her behalf. The PI must perform the final review and approval of the record and each subsequent update in the PRS. The PI is responsible for ensuring that accurate information about the trial is entered and that updates to the record are completed in a timely manner (see table below for specific deadlines).

Complete the below fields as follows:

1. 1. • Organization’s Unique Protocol ID: Enter the IRB number.
      • Secondary IDs: Enter the grant number.
      • Record Verification Date: Enter the month and year in which you are completing the record. This field will need to be updated each time you update the record after it is registered.
      • Primary Completion Date: Enter the anticipated final data collection date, specifically regarding the Primary Outcome Measure.
      • Responsible Party: Select the Principal Investigator from the drop-down menu.
      • Collaborators: Add any other organizations providing support, including funding, design, implementation, data analysis and reporting.

For studies reviewed by UConn Health:

1. 1. • Board Name: UConn Health IRB
      • Board Affiliation: UConn Health
      • Board Contact phone and e-mail: 860.679.8729; irb@uchc.edu
      • Board Contact Address:  UConn Health IRB, 263 Farmington Avenue, Farmington, CT 06030-1511

For studies reviewed by UConn Storrs and Regional Campuses:

1. 1. • Board Name: UConn IRB
      • Board Affiliation: UConn
      • Board Contact phone and e-mail: 860.486.0986; irb@uconn.edu
      • Board Contact Address: UConn IRB, 438 Whitney Road Extension, Unit 1246, Storrs, CT 06269

The Final Rule dictates that ClinicalTrials.gov record fields are updated on the below schedule:

Data Field	Deadline for Updating (i.e., not later than the specified date)
Study Start Date	30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration).
Intervention Name(s)	30 calendar days after a nonproprietary name is established.
Availability of Expanded Access	30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record.
Expanded Access Status	30 calendar days after a change in the availability of expanded access.
Expanded Access Type	30 calendar days after a change in the type(s) of available expanded access.
Overall Recruitment Status	30 calendar days after a change in overall recruitment status. If Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the Why Study Stopped data element must be submitted at the time the update is made.
Individual Site Status	30 calendar days after a change in status of any individual site.
Human Subjects Protection Review Board Status	30 calendar days after a change in status.
Primary Completion Date	30 calendar days after the clinical trial reaches its actual primary completion date.
Enrollment	At the time the primary completion date is changed to “actual,” the actual number of participants enrolled must be submitted.
Study Completion Date	30 calendar days after the clinical trial reaches its actual study completion date.
Responsible Party, by Official Title	30 calendar days after a change in the responsible party or the official title of the responsible party.
Responsible Party Contact Information	30 calendar days after a change in the responsible party or the contact information for the responsible party.
Device Product Not Approved or Cleared by U.S. FDA	15 calendar days after a change in approval or clearance status has occurred.
Device Product Not Approved or Cleared by U.S. FDA	15 calendar days after a change in approval or clearance status has occurred.
Record Verification Date	Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

The InfoEd portal is secured with your UConn NetID single sign-on. If you have forgotten your NetID or password, call the University Information Technology Services (UITS) Service Desk at 860.486.4357 or email at helpcenter@uconn.edu. You can also access the NetID website (https://netid.uconn.edu) to obtain your NetID and change/reset your password.  

How To: Change Your InfoEd (NetID) PasswordHow To: Reset You Forgotten InfoEd (NetID) Password

Basic InfoEd Access

The InfoEd eRA portal is secured with the UConn NetID single sign-on. All users are required to have a valid UConn NetID. UConn faculty and staff including UConn Health faculty and staff are automatically set up with an account. Graduate students and external users (e.g. UConn affiliates) should request access after obtaining an UConn NetID through University Information Technology Services (UITS).

1. If you have an UConn NetID, first try to see if you can login to the InfoEd eRA system at https://www.infoed.uconn.edu.  If you are trying to access the UConn Health instance of InfoEd please login at https://uchealth.infoed.uconn.edu.
2. If you cannot login, make sure you are using your correct NetID and password combination or your correct username and password. Consult the https://netid.uconn.edu website tools to verify your NetID and password credentials or contact the eRA Help Desk at 860.486.7944.
3. Faculty may also add undergraduate students to InfoEd using a new automated process

If you still cannot access the InfoEd eRA portal after verifying your correct credentials and attempting to login, contact the eRA Help Desk at 860.486.7944 to verify that you have an account on the particular system. If you do not have an account or you need additional permissions, you can request access by completing the eRA Access Request Form.

Account Access Request Form

This form is also used if you are requesting additional security permissions for InfoEd (e.g. a Department Administrator requesting view access to proposals/protocols/accounts in his/her department or school) or another system. It is also for revoking access. You may type directly on the form and print it. The form must be signed by the applicant/requester and the applicant’s/requester’s supervisor and scanned or emailed to era-support@uconn.edu.

• Account Request Form – A fillable PDF file

Websites

• • Council On Governmental Relations (COGR)
  • Higher Education Compliance Alliance
  • AUECO – Association of University Export Control Officers
  • Foreign Malign Influence and Higher Education – FBI
  • Export Law Blog
  • White House Directive on Fundamental Research – National Security Decision Directive 189

PowerPoint Presentations and Audio Presentations

• • 2013: The Impact of Export Controls on Higher Education Scientific Institutions Conference
  • COGR Deemed Export Controls Presentation
  • BIS Essentials of Export Controls

Other Resources

• • Deemed Export Form

Export Administration Regulations (EAR)

• U.S. Department of Commerce
• Commerce Department Export Controls
• Commerce Control List Index

International Traffic in Arms Regulations (ITAR)

• U.S. Department of State
• ITAR Regulations and Reference

Office of Foreign Assets Control (OFAC)

• U.S. Department of Treasury ~ Office of Foreign Assets Control
• List of Specially Designated Nationals and Blocked Persons

The University of Connecticut has implemented mandatory export control training for UConn researchers involved in any research that is export controlled.

As a result, any UConn investigator listed as project personnel for a grant, contract, or cooperative agreement where export control regulations apply must complete export control training certification prior to starting any work on that project.  Such certification is valid for one (1) year from the date the training is completed.  Certification must be completed annually if the investigator is still personnel on a project where export control regulations apply.

The training is available online and offered through the CITI Program.  The Export Control Course offers eleven modules.  They are:

Introduction to Export Compliance (ID: 16800)
Export Compliance for Researchers: Part I (ID: 16801)
Export Compliance for Researchers: Part II (ID: 16802)
Export Compliance for Research Administrators (ID: 16803)
Export Compliance and Biosafety (ID: 16805)
Export Compliance for Operational Departments (ID: 16806)
Export Compliance for International Shipping (ID: 16807)
Export Compliance and Purchasing (ID: 16808)
Export Compliance and International and Foreign Waters (ID: 16809)
Export Compliance and Collaborations (ID: 16810)
Export Compliance and United States Sanctions Programs (ID: 16812)

You will need to complete three modules to meet the training requirement. 

Under Required, complete Introduction to Export Compliance (ID: 16800).
And under Supplemental, complete:
Export Compliance for Researchers: Part I (ID: 16801).
Export Compliance for Researchers: Part II (ID: 16802)

You may be required to complete other modules based on the nature of the regulations that apply to your research project.  Research Integrity and Compliance Services will let you know if additional modules are required.

Once the required training certification has been completed, you will have met your export control training requirements for the year.  Please make a note of the date of the certification as you will be required to complete the training again prior to the annual expiration date.

Export Control Compliance Requirements for Project Personnel Export control compliance package (technical review, project personnel information, technology control plan) Annual Training Compliance letter to be signed/certified Project account will not be set up and no funding will be released until the compliance requirements are complete. Adding new personnel: New personnel cannot begin work on an active export controlled project unless the personnel has been approved by OVPR and the sponsor. Contact exportcontrol@uconn.edu if you wish to add someone new to an active export controlled project.

Policy

UConn’s Export Control Policy can be found here.

Note that, as outlined in UConn’s Export Control Policy, certain national and state export and economic sanctions restrict transactions with certain countries, institutions, and individuals. UConn cannot accept sponsorships or engage in procurement with entities or individuals on a US or State of Connecticut barred party list. Direct questions to UConn Export Control exportcontrol@uconn.edu early in the process if exploring unique international sponsorships or engagements.

Guidelines

These guidelines and sample documents are designed to determine if the EAR or the ITAR affect a particular research project, and to take appropriate action to ensure compliance with the Federal Export Control regulations.

• Decision Tree: Overview of Process
• Export Control Compliance Package (Blank)
• Investigator Compliance Letter (Sample)
• Final Compliance Report (Sample)

Marking Documents

In order to ensure that items are appropriately identified as EAR or ITAR controlled, the following processes will be implemented for all hardcopy or electronic documents that contain EAR or ITAR controlled Technical Data:

The following statement shall be included on the cover page, sleeve, or cover of any design file, software disc, or document (hardcopy or electronic) containing EAR or ITAR controlled Technical Data:

This document contains technical data whose export is restricted by the Arms Export Control Act (Title 22, U.S.C., Sec 2751, et q.) or the Export Administration Act of 1979, as amended, Title 50, U.S.C., App. 2401 et seq. Violations of these export laws are subject to severe criminal penalties.

Include the appropriate following statement in the footer on each page of design files or documents (hardcopy or electronic) which contains EAR or ITAR controlled Technical Data:

This page contains EAR Restricted Data.

This page contains ITAR Restricted Data.

Export: Any oral, written, electronic (such as email, internet, etc.) or visual disclosure, shipment, transfer or transmission outside the U.S. to anyone, including a U.S. citizen, of any commodity, technology (information, technical data, or assistance), software, source codes, or equipment.

Deemed Export: A deemed export refers to the sharing or release of controlled technology, technical data or source code to a foreign person within the United States. Deemed exports may occur through such means as an in-person demonstration of lab processes, an oral briefing, or a lab visit, as well as electronic transmission of non-public data to a foreign person. This exchange is “deemed” to be an export to the country of the foreign national.

Commerce Control List: The US Department of Commerce’s Export Administration Regulation (EAR) Commerce Control List (CCL) categorizes items by type and function.

(0) Nuclear Materials, Facilities and Equipment, Firearms, Ammunition, and Miscellaneous Items

(1) Special Materials and Related Equipment, Chemicals, “Microorganisms,” and “Toxins”

(2) Materials Processing

(3) Electronics

(4) Computers

(5) Telecommunications and Information Security

(6) Sensors and Lasers

(7) Navigation and Avionics

(8) Marine

(9) Aerospace, Propulsion Systems, Space Vehicles, and Related Equipment

If an item is subject to the EAR but not specifically listed on the CCL, then it may considered “EAR99” with some restrictions.

US Munitions List: The US Department of State’s  International Traffic in Arms Regulations (ITAR) U.S. Munitions List (USML) regulates defense articles, services, and related technical data through 21 categories of articles.

• Firearms, Close Assault Weapons and Combat Shotgun
• Guns and Armament
• Ammunition/Ordnance
• Launch Vehicles, Guided Missiles, Ballistic Missiles, Rockets, Torpedoes, Bombs, and Mines
• Explosives and Energetic Materials, Propellants, Incendiary Agents, and Their Constituents
• Surface Vessels of War and Special Naval Equipment
• Ground Vehicles
• Aircraft and Related Articles
• Military Training Equipment and Training
• Personal Protective Equipment
• Military Electronics
• Fire Control, Range Finder, Optical and Guidance and Control Equipment, Night vision goggles
• Materials and Miscellaneous Articles
• Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment
• Spacecraft and Related Articles
• Nuclear Weapons Related Articles
• Classified Articles, Technical Data, and Defense Services Not Otherwise Enumerated
• Directed Energy Weapons
• Gas Turbine Engines and Associated Equipment
• Submersible Vessels and Related Articles
• Articles, Technical Data, and Defense Services Not Otherwise Enumerated

US Person: A citizen of United States, a lawful permanent resident of the US (a “Green Card” holder), a refugee, or someone here as a protected political asylee or under amnesty. US Persons also include organizations and entities in the US, including US universities. The general rule is that only US Persons are eligible to receive controlled items, software or information without first obtaining an export license from the appropriate agency unless a license exception or exclusion is available.

Foreign Person: Any person who is not a US Person. It also means any foreign corporation, business association, partnership, trust, society or any other entity or group that is not incorporated or organized to do business in the United States. Examples of foreign persons include those in F-1, J-1, or H-1B status at UConn, such as international students, post-doctoral scholars, research staff, and UConn/UCHC foreign national employees.

Fundamental Research: Research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have not accepted restrictions for proprietary or national security reasons.

Technical Data: Information that is required for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance, or modification of defense articles. This includes information in the form of blueprints, drawings, photographs, plans, instructions and documentation. It also includes software directly related to defense articles. This definition does not include information concerning general scientific, mathematical, or engineering principles commonly taught in schools, colleges, and universities. This definition also does not include basic marketing information on function or purpose or general system descriptions of defense articles.

Technology: Technology refers to specific information necessary for the development, production, or use of a product. Under U.S. export control regulations, this includes technical data, blueprints, plans, diagrams, models, formulas, and instructions, whether in tangible or intangible form. Technology is controlled when it is listed on the Commerce Control List (CCL) or U.S. Munitions List (USML) and may require authorization before being shared with foreign persons or entities.

Dual Use: Dual use refers to items, information, and software that are primarily commercial or civil in nature but also have potential military applications. Dual use items that are identified on the Export Administration Regulation‘s Commerce Control List (CCL) have an Export Control Commodity Number (ECCN) and are of elevated strategic concern. Dual use items that are subject to regulation but are not identified on the CCL are termed “EAR99.” Dual use items may require an export license depending on the item, the recipient, the recipient’s citizenship or country of destination, and the item’s application.

Defense Service: The following situations are considered Defense Service:

• Furnishing assistance (including training) to foreign persons, whether in the United States or abroad, in the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, modification, operation, demilitarization, destruction, processing, or use of defense articles.
• Furnishing to foreign persons any technical data controlled under the ITAR, whether in the United States or abroad.
• Military training of foreign units and forces, regular and irregular, including formal or informal instruction of foreign persons in the United States or abroad or by correspondence courses, technical, educational, or information publications and media of all kinds, training aid, orientation, training exercise, and military advice.

Controlled Unclassified Information (CUI): Information that the U.S. Government creates or possesses—or that an entity creates or possesses for or on behalf of the government—that requires safeguarding or dissemination controls in accordance with applicable laws, regulations, and government-wide policies.

Country of Concern: A foreign country of concern (FCOC) is a nation identified by the U.S. government as posing heightened risks to national security, research integrity, or economic competitiveness. Entities outside these countries but owned or controlled by them are also subject to restrictions.

License: A formal authorization issued by a U.S. government agency—such as the Department of Commerce (BIS) or Department of State (DDTC)—that permits the export, reexport, transfer, or disclosure of controlled items, technology, or services to a foreign person or destination. A license is typically required when an export cannot be made under a license exception or general authorization due to the item’s classification, end use, end user, or destination.

Export control laws are federal regulations that govern how certain information, technologies, and commodities can be transmitted overseas or to a foreign national on U.S. soil. The scope of the regulations is broad: they cover exports in virtually all fields of science, engineering, and technology and apply to research activities regardless of the source of funding. Failure to comply with these laws can have serious consequences, both for the institution and for the individual researcher. Potential penalties include fines and possibly imprisonment. It is thus critical for UConn researchers to understand their obligations under these regulations and to work with Research Integrity and Compliance Services to ensure that the University is in compliance.

The International Traffic in Arms Regulations (ITAR) regulate defense articles, services, and related technical data that are identified on the Munitions Control List. They are administered by the Department of State. The Export Administration Regulations regulate the export of dual use items, i.e. items with both military and commercial applications, identified on the Commerce Control List. They are administered by the Department of Commerce. The Office of Foreign Assets Control Regulations (OFAC Regulations) regulate economic trade with foreign countries and administer the statutory economic trade sanctions imposed against several foreign countries. They are administered by the U.S. Department of the Treasury, through the Office of Foreign Assets Control.

Material on this website is intended to assist faculty and staff in understanding the regulations. Furthermore, it outlines UConn guidelines and procedures that are designed to ensure compliance.

If you have any questions about Export Control, please email exportcontrol@uconn.edu.