uconn
Subrecipient vs. Contractor Determinations
Many grant-funded research collaborations involve issuing a subrecipient agreement (subaward or subcontract, depending upon UConn’s prime funding agreement) to collaborating institutions to provide a portion of the UConn grant award (which serves as “pass-through entity,” or PTE) to the collaborator/subrecipient. Contractor Purchase Orders, by contrast, are used to contract for consulting services. All grant-funded Subaward agreements are drafted by Sponsored Program Services (SPS) and provided to the Principal Investigator (PI) for review before they are sent to the subrecipient entity for signature. All grant-funded Contractor agreements for consulting services must be reviewed by Procurement Services and the PI before they are sent to the Contractor for execution.
The pass-through entity (PTE) is responsible for making case-by-case determinations to determine whether the entity receiving Federal funds is a subrecipient or a contractor. In determining whether an agreement between the issuing entity and another non-Federal entity is classified as a subrecipient or a contractor, the substance of the relationship is more important than the form of the agreement. All of the characteristics listed below may not be present in all cases, and UConn must use judgment in classifying each agreement appropriately.
Definitions from Uniform Guidance (2 CFR, PART 200)
Subrecipients – Per §200.1 a subrecipient is an entity that receives a subaward from a pass-through entity to carry out part of a Federal award; but does not include an individual that is a beneficiary of such program. A subrecipient may also be a recipient of other Federal awards directly from a Federal awarding agency. In general, a subrecipient relationship with UConn will include the following characteristics (per §200.331):
- Has its performance measured in relation to whether objectives of a Federal program were met;
- Has responsibility for programmatic decision making;
- Is responsible for adherence to applicable Federal program requirements specified in the Federal award; and
- Implements a program for a public purpose specified in authorizing statute, as opposed to providing goods or services for the benefit of the pass-through entity.
Contractor – Per §200.1, a contract means a legal instrument by which a non-Federal entity conducts procurement transactions under a Federal award. In general, a contractor relationship with UConn will include the following entity characteristics (per §200.331):
- Provides the goods and services within normal business operations;
- Provides similar goods or services to many different purchasers;
- Normally operates in a competitive environment;
- Provides goods or services that are ancillary to the operation of the Federal program; and
- Is not subject to compliance requirements of the Federal program as a result of the agreement, though similar requirements may apply for other reasons.
Assistance
Subaward agreement requests must be submitted to subawards@uconn.edu.
Contractor Agreement requests must be submitted to Procurement Services via the Hiring of a Consultant form
Human Subject Useful Links and Websites
UConn
- UConn Health – Human Subjects Protection Office
- UConn ClinicalTrials.gov
- Office of University Compliance
- UConn Qualtrics Online Survey Information
- Policy on the Security Requirements for Protecting University Data at Rest
- UConn Family Educational Rights and Privacy Act (FERPA)
- UConn Health Insurance Portability & Accountability Act (HIPAA)
- UConn REDCap
Connecticut Educational Institutions
- Central Connecticut State University IRB
- Eastern Connecticut State University IRB
- Southern Connecticut State University IRB
- Hartford Public Schools
- New Haven Public Schools
- The University of Hartford IRB
- Yale University IRBs
State of Connecticut
- Department of Developmental Services
- Department of Mental Health and Addiction Services (DHMAS)
- Department of Public Health Human Investigations Committee
- Connecticut Office of Early Childhood
- Department of Correction Organizational Development Unit (includes Research and Evaluation)
Greater Hartford Area Hospitals and Medical Centers
- Hartford Hospital IRB
- St. Francis Hospital and Medical Center IRB
- Connecticut Children’s Medical Center IRB
- The Hospital of Central Connecticut IRB
The Jackson Laboratory
Federal Government
- Office for Human Research Protections (OHRP)
- OHRP Human Subject Regulations Decision Charts
- 45CFR46 (2018 Requirements)
- OHRP International Standards and National Policies
- OHRP IRB Guidebook
- U.S. Food and Drug Administration (Guidance for IRBs, etc.)
- 21 CFR Parts 50 and 56
- FDA Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
- Frequently Asked Questions on Botanical Drug Product Development (Addresses Dietary Supplements and INDs)
- Development & Approval Process (Drugs)
- Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors.
- Medical Devices
- Mobile Medical Applications
- Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors
- Department of Health and Human Services – HIPAA
- National Institutes of Health (NIH) Office of Research Integrity (ORI) Research Involving Human Subjects
- ClinicalTrials.gov
- Department of Energy – Human Subjects Protection Program
- NASA Human Research Program
- National Science Foundation (NSF)
- U.S. Department of Education Protection of Human Subjects in Research
- Family Policy Compliance Office (FPCO) – Information about FERPA and PPRA
- U.S. Department of Energy Human Subject Protection Program
- U.S. Department of Veterans Affairs Program for Research Integrity Development & Education (PRIDE)
- Walter Reed Army Institute of Research Human Subject Protection Branch (HSPB)
- Department of the Navy – Human Research Protection Program
- National Institute of Justice – Human Subjects and Privacy Protection
- Department of Education
Training for Research with Human Participants
IRB Professional Organizations/Forums/Accreditation
- Public Responsibility in Medicine and Research (PRIM&R)
- Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
- IRB Discussion and News Forum
IRB/Bioethics
International Research Ethics Guidelines
- Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Nuffield Council on Bioethics (UK)
- World Health Organization (WHO) Ethics Publications
- Listing of International Bioethics Organizations
- General Data Protection Regulation (GDPR)
Recruitment
- ResearchMatch at UConn – Information about UConn and UConn Health’s participation in Research Match.
- ResearchMatch – National volunteer registry used by over 120 institutions to match volunteers with active research studies.
Resources
- The Center for Health Studies – Project to Review and Improve Study Materials (PRISM)
- The Researcher’s Guide provides investigators and students with information that will be helpful for meeting the standards set by the UConn IRB policies and by the Federal Regulations for the protection of human subjects in research.
- Download the entire Researcher’s Guide
Or go to each section in the guide:
- Secondary Data Analysis
Guidance on analysis of existing data sets. - Data Security and Internet-Based Research
Protecting and securing data on devices and during transmission over the internet. Conducting research on the web. - Closure of Human Subjects Research Studies
Guidance on study closure procedures, record retention, and adverse events learned after study closure - Consent Process
Informed consent is more than the form. - Deception/Debriefing
Guidance for use of deception in research and debriefing requirements. - Documentation
Good research documentation habits are essential to reliable research data. - Does Evaluation Require IRB Review?
The decision about whether review is required should be made in concert with the IRB. - Ethnographic/Naturalistic Research
Guidelines for submission of ethnographic/naturalistic research protocols. - Focus Groups
Guidance on when research involves focus groups to obtain data. - Investigator Responsibilities
Your part in the compliance partnership. - Normal Educational Practice
What type of educational research may or may not qualify for review under the exempt criteria? - OHRP Guidance
A brief introduction to the Federal office that oversees research with human participants. - Oral Histories
When are oral histories “human subject research” under the federal rules definition? - PI Mentoring of Student Researchers Conducting Research with Human Participants
Guidance regarding the importance of mentoring student researchers and the responsibilities of mentorship. - Recruitment and Advertising Guidance
Guidance for recruitment and advertising, including a recruitment flyer template. - Student Athlete Involvement in Research Studies
Guidance regarding recruitment and compensation. - Study Design and Scientific Review
How design is related to participant protection. - Wording Tips
Need to simplify language for participants?- Download the PRISM Toolkit Word List
- Download the full PRISM Readability Toolkit
Animal Care Services
Animal Care Services (NetID restricted link) provides animal husbandry and veterinary care for vertebrate animals housed at the Storrs Campus, excluding the farm animals under the supervision of the Department of Animal Science. ACS veterinarians have University-wide responsibilities for assisting faculty and the IACUC in protocol review, facility inspections, and training. The Animal Care and Use Program is accredited by AAALAC International.
For further information, please contact acsinfo@uconn.edu.
Request System Access Changes
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).
- 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.
- 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.
- 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
Submission to the IRB
IRB approval must be obtained prior to initiating any research activity that meets either the DHHS definition of research involving human participants or the FDA definition of clinical investigation involving human participants and prior to implementing amendments to previously approved research (except when necessary to eliminate apparent immediate hazards to participants). The IRB will publish submission deadlines for studies requiring review by the convened board at the start of each semester. New submissions requesting expedited review or exempt status can be submitted at any time and are reviewed on an on-going basis.
All forms required for an IRB submission are available on the IRB website. The PI is responsible for submitting complete forms and required supporting documentation. The PI must sign all submissions. Students are required to sign the submission when the research is student initiated (research is related to the doctoral dissertation or master’s degree). The signature of the Department Head or Dean is required for all submissions unless the research is funded by an external grant or contract. The signature of the medical monitor is required for interventional studies that are monitored by a physician. The IRB staff and reviewer reserve the right to return any submission that is incomplete or on out-dated forms.
Determination of Level of Review
Investigators make an initial determination for which type of review is appropriate for their study (full board, expedited, or exempt) and submit the required number of copies of the protocol and supporting documentation. Upon receipt, the IRB staff, in consultation with the Chair or an IRB member, screens the protocol to verify the PI’s initial determination. The protocol is then placed into the appropriate queue for review. The Chair, or his/her designee, makes the final determination of the type of review required and the appropriate expedited or exempt category.
When Submission to the IRB is Required
A protocol application must be submitted to the IRB for any study for which research is the intent and the researcher proposes to use or involve any of the following:
- identifiable data collected for non-research purposes (e.g., academic or medical records);
- interaction (communication or interpersonal contact between investigator and participant) through interviews, surveys, and other forms of communication;
- intervention (physical procedures by which data are gathered and manipulations of the participant or the participant’s environment that are performed for research purposes);
- student research projects conducted as part of Research Methods Courses;
- access to medical records and data through the medical information systems;
- pathological specimens (directly identifiable or identifiable via codes);
- diagnostic specimens (directly identifiable or identifiable via codes).
The IRB reviews projects when the research:
- is sponsored by the institution;
- is conducted by or under the direction of an employee or agent of the institution in relation to his/her institutional responsibilities;
- is conducted by or under the direction of an employee or agent of the institution using resources of the institution; or
- involves the use of the institution’s non-public information (i.e. alumni, students, staff, etc.) to identify or contact human research participants or prospective participants.
Pilot Research and Protocol Development
Per 45 CFR 46.102, Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
In some cases, the UConn IRB must review pilot research and protocol development, including but not limited to the following activities:
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- Development and testing of instruments or measures on human subjects* (even if it is just one subject);
- Testing of research procedures on human subjects*;
- Procedures done on human subjects* for the purpose of refining research design.
- Data collected that will be used solely or in combination with other data for purposes of publication, reports or presentation;
- Development and testing procedures on human subjects* involving needles, catheters, radiation, drugs or devices that are swallowed or inserted in an orifice require IRB approval.
*Please note that the Office for Human Research Protections (OHRP) considers the Principal Investigator as well as all research personnel to be human subjects if testing procedures are to be conducted on them. Therefore, even when pilot tests are conducted on study personnel, the protocol must be reviewed and approved by the IRB prior to initiation. Please refer to the policy on the Involvement of UConn Students and Employees in Research.
Pilot studies should be identified as such in applications to the IRB. The informed consent process must explain to subjects that the research is a pilot study.
Procedures that are not considered to be pilot research and do not need to be reviewed by the IRB include, but may not be limited to, the following:
- Training programs designed to teach proven methods that will be used during the conduct of research (i.e., blood drawing training, interview techniques training);
- Refining data collection procedures or preparation of an instrument, such as a survey. For instance, “How could this survey question be misunderstood?”, or “In what order should survey instruments be distributed?” This type of study development does not contribute to generalizable knowledge, and therefore is not considered research and does not require IRB review. Such data cannot be used in publications or reports.
Meeting Schedule and Submission Deadlines
The meeting schedule and submission deadlines are posted on the web. Adjustments to the meeting schedule may be made due to holidays or other issues. Adjustments will either be noted in the published meeting schedule (when known in advance) or announced via e-mail. The submission deadline for full board reviews is 10 working days prior to the meeting date.
Material requiring full-board review must be submitted by the published submission deadlines to provide sufficient time for screening and review prior to the meeting date. The IRB staff will send the agenda and material to IRB members via hand delivery or express mail within 2 – 3 working days after the submission deadline to allow members to have at least 7 working days for review of the material prior to the meeting date.
Under unusual circumstances, the Chair may call an emergency meeting of the board. However, such a meeting will not be called due to the negligence of the investigator to submit material on time. An emergency meeting may be called, for example, when a quorum for the originally scheduled meeting was not met and review is required to prevent lapse of a study, or if an investigator is faced with a situation beyond his/her control. If not already distributed, material must be distributed to members as soon as possible to allow for sufficient review. The investigator may be asked to attend the meeting to address questions, or provide additional information or clarification.
Under unusual circumstances, the IRB staff, in consultation with the Chair, may also add an item to the agenda after the submission deadline. Such circumstances generally involve situations in which an investigator is faced with a situation beyond his/her control and an amendment must be made to the protocol. The material must be distributed (via hand delivery, e-mail or express mail) to members as soon as possible to allow for sufficient review.
Proposals
NEW: Important information regarding the University’s proposal submission policy and due dates
Pre-Award Services is housed within Sponsored Program Services (SPS) and reports to the Vice President for Research. Pre-Award Services consists of a team of expert research administrators who serve as dedicated central resources in all matters related to University and sponsor policies for proposal development and submission. Pre-Award Services is responsible for the review, approval and, in many cases, submission of research proposals on behalf of the University. All proposals are reviewed for compliance with sponsor guidelines as well as federal, state, local and University regulations and policies prior to approval and submission to the sponsor.
For more information, please visit the Pre-Award Contact page.
Other Export Control Resources
Websites
Export Control Federal Regulations
Export Administration Regulations (EAR)
International Traffic in Arms Regulations (ITAR)
Office of Foreign Assets Control (OFAC)
Export Control Training
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.
Policy and Procedures
Export Control Compliance Requirements for Project Personnel
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.
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 Control Definitions
Where an article is arguably covered by both the EAR and ITAR, a request can be made to the State Department to determine which agency will have jurisdiction over the export of the article.
The transfer, release, or disclosure of technical data or technology to a foreign national within the United States (including university campuses). A transfer is the same as exporting it to the home country of the foreign national.
Export as used in export control regulations, has an expansive meaning. Generally, an export includes any: (1) actual shipment of any covered goods or items; (2) the electronic or digital transmission of any covered goods, items or related goods or items; (3) any release or disclosure, including verbal disclosures or visual inspections, of any technology, software or technical data to any foreign national; or (4) actual use or application of covered technology on behalf of or for the benefit of any foreign entity or person anywhere. The official definition of export under the EAR and ITAR should be consulted when determining whether a specific act constitutes an export. As is evident, export is defined so as to preclude the participation of foreign graduate students in research that involves covered technology without first obtaining a license from the appropriate government agency.
The Export Administration Regulations (EAR), Title 15, sections 730-774 of the Code of Federal Regulations (CFR) are promulgated and implemented by the Department of Commerce. The EAR regulate the export of goods and technology identified on the Commerce Control List (CCL), Title 15 CFR 774, Supp. 1. Technology means specific information necessary for the development, production, or use of a product. The information takes the form of technical data or technical assistance. Technical data may take forms such as blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions written or recorded on other media or devices such as disk, tape, read-only memories. Each good or technology listed on the CCL is associated with a unique Export Control Classification Number, which consists of a set of digits and a letter. (Refer to § 738.2(c) of the EAR for a complete description of each ECCN’s composition.) The Country Chart in Supplement No. 1 to part 738 of the EAR contains licensing requirements based on destination and reason for control. The reasons for control are: Anti-Terrorism (AT); Chemical and Biological Weapons (CB); Crime Control (CC); High Performance Computer (XP); Missile Technology (MT); National Security (NS); Nuclear Nonproliferation (NP); Regional Stability (RS); Short Supply (SS); and United Nations Sanctions (UN). Items controlled within a particular ECCN may be controlled for more than one reason. The complete text of the EAR and CCL are available online.
Foreign person means any natural person who is not a lawful permanent resident as defined by 8 U.S.C. 1101(a)(20, http://www.law.cornell.edu/uscode/text/8/1101 or who is not a protected individual as defined by 8 U.S.C. 1324(a)(3), http://www4.law.cornell.edu/uscode/8/1324.html. 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, as well as international organizations, foreign governments and any agency or subdivision of foreign governments (e.g. diplomatic missions).
Fundamental Research , as used in the export control regulations, includes basic or applied research in science and/or engineering at an accredited institution of higher learning in the United States where the resulting information is ordinarily published and shared broadly in the scientific community. Fundamental research is distinguished from research which results in information which is restricted for proprietary reasons or pursuant to specific U.S. Government access and dissemination controls. University research will not be deemed to qualify as Fundamental Research if: (1) the University or researcher accepts any restrictions on the publication of the information resulting from the research, other than limited prepublication reviews by research sponsors to prevent inadvertent divulging of proprietary information provided to the researcher by sponsor or to insure that publication will not compromise patent rights of the sponsor; or (2) the research is federally funded and specific access and dissemination controls regarding the resulting information have been accepted by University or the researcher. The EAR definition of Fundamental Research can be found at 15 CFR 734.8, the ITAR definition at 22 CFR 120.11.
The Office of Foreign Assets Control Regulations ( OFAC Regulations), 31 C.F.R. Parts 500-597, are administered by the U.S. Department of the Treasury, through the Office of Foreign Assets Control . They regulate economic trade with foreign countries and administer the statutory economic trade sanctions imposed against several foreign countries. The sanctions range from partial to full trade embargoes and are imposed in addition to other U. S. export control law penalties. Information regarding sanctions in effect can be found at the OFAC web site (http://www.treasury.gov/about/organizational-structure/offices/Pages/Office-of-Foreign-Assets-Control.aspx). OFAC regulations apply to all persons subject to U.S. jurisdiction. This includes American citizens and permanent resident aliens wherever they are located; any individual or entity located in the U.S.; corporations organized under U.S. laws, including foreign branches; and—solely in the case of Cuba—entities owned or controlled by any of the above (including foreign-organized subsidiaries of U.S. corporations). The regulations define prohibited transactions with foreign countries and set forth sanctions for engaging in such conduct. Such prohibited transactions include transactions involving designated foreign countries or their nationals; transactions with respect to securities registered or inscribed in the name of a designated national; importation of and dealings in certain merchandise; and holding certain types of blocked property in interest-bearing accounts. Persons subject to U.S. jurisdiction are also prohibited from dealing with specific entities or individuals known as “specially designated nationals,” found in the Specially Designated Nationals List ( SDNL), appended to the OFAC regulations and available at http://www.treas.gov/offices/enforcement/ofac/sdn/index.html. No one subject to U.S. jurisdiction may participate in any activity with anyone on the SDNL.
The International Traffic in Arms Regulations (ITAR), 22 CFR 120-130, are promulgated and implemented by the Department of State to regulate defense articles, services, and related technical data that are identified on the Munitions Control List (MCL), 22 CFR 121.1. Defense Article refers to any item or technical data designated in the MCL. This term includes technical data recorded or stored in any physical form, models, mock‑ups or other items that reveal technical data directly relating to items designated in the MCL. It does not include basic marketing information on function or purpose or general system descriptions. Defense Service is defined as the furnishing of 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; t he furnishing to foreign persons of any technical data controlled under the ITAR, whether in the United States or abroad; and the military training of foreign units and forces, regular and irregular, including formal or informal instruction of foreign persons in the United States or abroad by correspondence courses, technical, educational, or information publications and media of all kinds, training aid, orientation training exercise, and military advice. Technical Data refers to information (other than software as defined in 22 C.F.R. § 120.10(4)) 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 as well as software as defined in 22 C.F.R. § 121.8(f) 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 or information in the public domain as defined in § 120.11. It also does not include basic marketing information on function or purpose or general system descriptions of defense articles. Complete, on-line versions of the ITAR and MCL are available at: http://www.gpoaccess.gov/cfr/ (Government Printing Office site) and at http://fas.org/spp/starwars/offdocs/itar (Web site for the Federation of American Scientists).
Public Domain (22 CFR 120.11) means information that is published and that is generally accessible or available to the public: (1) through sales at newsstands and bookstores; (2) through subscriptions which are available without restriction to any individual who desires to obtain or purchase the published information; (3) through second class mailing privileges granted by the U.S. Government; (4) at libraries open to the public or from which the public can obtain documents; (5) through patents available at any patent office; (6) through unlimited distribution at a conference, meeting, seminar, trade show or exhibition, generally accessible to the public, in the United States; (7) through public release (i.e., unlimited distribution) in any form (e.g., not necessarily in published form) after approval by the cognizant U.S. government department or agency; and (8) through fundamental research.
Export Control
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.
IBC & Biosafety Resources
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Last Revised 05/30/2025