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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
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
Environmental Health & Safety
HuskySMS – Submit Registrations and Amendments via: uconn.scishield.com
Incident Reporting Form:
To report incidents involving biological materials, please download and complete the Incident Reporting Form linked below. Examples of incidents that should be reported include: needlesticks, percutaneous or mucous membrane exposures, spills outside of primary containment, etc.
Biological Incident Reporting Form
Lab Specific Biosafety Manual:
Lab Specific Biosafety Manual (LSBM)
Due to state and federal regulations, LSBMs are required for all BSL-2 laboratories. Regulators such as CT DPH and NIH, will inspect to ensure BSL-2 labs LSBMs are available and accessible. Lab members must review the LSBM on an annual basis. Training dates can be handwritten on the form, or lab member training records can printed from HuskySMS and added to the binder.
Biosafety will provide template LSBM binders as needed. If you would like to schedule a time for an LSBM binder to be delivered to your lab prior to the Biosafety Audit, please send an email request to ibc@uconn.edu.
PIs are responsible for including laboratory specific information within the LSBM, to ensure the manual is specific to the biohazards in the lab. This may include, but is not limited to: Standard Operating Procedures (SOPs), agent specific Pathogen Safety Data Sheets, Bloodborne Pathogens fact sheets, etc.
Pathogen Risk Assessments:
Print pathogen safety data sheets and risk assessment documents to incorporate into the LSBM as applicable. Documents below can also be used as a reference to create your own.
Public Health Agency of Canada – Pathogen Safety Data Sheets
Pathogen Risk Assessment- Human Cell Lines.pdf
Pathogen Risk Assessment- Listeria monocytogenes.pdf
Pathogen Risk Assessment- Lentivirus and Lentiviral Vectors.pdf
Pathogen Risk Assessment- Staphylococcus aureus.pdf
Pathogen Risk Assessment- Streptococcal sp..pdf
Regulations & Guidelines
NIH OSP – Biosafety and Biosecurity Policy
Dual Use Research of Concern – 2014
Biosafety in Microbiological and Biomedical Laboratories (CDC, NIH)
CDC & USDA Federal Select Agent Program
USDA – APHIS Permits and Certifications
Arthropod Containment Guidelines
Last Revised 08/16/2025
IBC FAQs
Training
NIH Guidelines
PIs with research subject to the NIH Guidelines, must complete NIH Guidelines Training, which is available online through HuskySMS: uconn.scishield.com. To access the Course Directory, log into HuksySMS with your UConn NetID and password.
All EHS trainings are available through HuskySMS. can be accessed under the “Training” tab in the left navigation pane, and you can register for courses using the “Course Directory”. Trainings are immediately accessible for completion at your convenience.
Once you have completed the NIH Guidelines Training, the quiz must be completed with a 100%, in order to receive credit for completing the training. The quiz can be taken as many times as necessary, and it can be done in multiple sittings if need be.
For additional information on HuskySMS, please visit the EHS website: ehs.uconn.edu/huskysms/
Depending on the work in the lab, the following is a list of trainings that may also be required prior to IBC approval.
Biosafety General Training
Annual requirement for personnel handling biological materials.
Bloodborne Pathogens Training
Annual requirement for those working with human and/or non-human primate materials, in accordance with the OSHA Bloodborne Pathogens Standard.
Laboratory Safety & Chemical Waste Management
Annual requirement for all personnel working in a lab due to the potential for hazardous chemicals.
Shipping and Transportation of Biological Agents
Required for personnel responsible for shipping or transporting biological materials.
It should be noted that some “in-person” trainings are offered remotely via live-stream. Once registered, you will receive notification on how to attend a remote training session.
For a complete list of Environmental Health & Safety (EHS) trainings, please visit ehs.uconn.edu/training/.
Meeting Dates & Deadlines
Research and Teaching Labs — Storrs, Groton, Hartford, Stamford, Waterbury
Submission Deadlines & Review Process
Please submit your biological summary by the appropriate deadline listed below. Timely submissions help ensure that proposed projects are reviewed during the next scheduled IBC meeting.
Important Notice – Avoid Approval Delays:
To prevent delays in the review and approval process, please do not edit your bio-summary while your submission is pending—unless specifically requested by the IBC.
Submission Deadline Meeting Date
January 10th → February 6, 2025
February 7th → March 6, 2025
March 7th → April 3, 2025
April 4th → May 1, 2025 *canceled
May 15th → June 12, 2025
July 10th → August 7, 2025
August 8th → September 4, 2025
September 5th → October 2, 2025
October 10th → November 6, 2025
November 14th → December 11, 2025
December 12th → January 8, 2026
*Denotes a meeting date that has been postponed or rescheduled.
IBC Meeting Schedule & Attendance
IBC meetings are held via web conferencing and typically begin at 1:30 PM. Please note that meeting dates are subject to change. If a meeting is rescheduled, Principal Investigators (PIs) with submissions on the affected agenda will be contacted directly. If you are a member of the community interested in attending an IBC meeting, please contact the IBC Program Director at ibc@uconn.edu for more information.
In accordance with NIH Notice NOT-OD-25-082, approved IBC meeting minutes from sessions convened on or after June 1, 2025, are available at the following link: Approved IBC Minutes.
IBC Policy & Procedure
ClinicalTrials.gov
Over the past two decades, government agencies and the International Committee of Medical Journal Editors (ICMJE) have issued laws and directives on the subject of clinical trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinical trials are publicly available. The registration effort began with the development of a publicly available website, ClinicalTrials.gov, a service of the National Institutes of Health (NIH), developed by the National Library of Medicine.
In 1997, the Food and Drug Administration (FDA)/NIH began requiring registration for only a limited number of trials. Then in September 2007, the FDA Amendments Act (Title VIII. Sec. 801) significantly expanded the scope of clinical trials that must be registered and set civil monetary penalties for failing to register “applicable trials.” In 2004, the ICMJE defined trials that must be registered in order to be considered for publication in journals that adhere to ICMJE standards. In 2007, the ICMJE expanded the definition of trials that must be registered. Scores of journals (not limited to medical journals) have adopted the registration policy. In 2016, the final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), which clarifies and expands the requirements in FDAAA 801, was released, and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information was published.
The bottom line:
The FDA, NIH and the ICMJE each have their own requirements for registration, and while some of the requirements overlap, there are some differences. In order to comply with the law and preserve the ability to publish in many journals, all sets of requirements must be met. UConn Health is committed to supporting Principal Investigators (PIs) with meeting the requirements concerning the public availability of clinical trial data in ClinicalTrials.gov, as outlined in our University ClinicalTrials.gov policy.
How is “clinical trial” defined and what are the registration deadlines?
According to NIH:
A clinical trial is a research study1 in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5 All clinical trials must be registered within 21 days of enrollment of the first participant.
1See Common Rule definition of research at 45 CFR 46.102(d).
2See Common Rule definition of human subject at 45 CFR 46.102(f).
3The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
4An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
Registration Deadline: The NIH Policy on Dissemination of NIH-funded Clinical Trial Information applies to applications for funding submitted to NIH on or after 1/18/17. Registration is required no later than 21 days after the first patient is enrolled. The consent form for the trial is required to include the following language: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Website will not include information that can identify you. At most, the Website will include a summary of the results. You can search this Website at any time.”
According to the ICMJE:
A clinical trial is any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.
Registration Deadline: Registration at or before the time of first patient enrollment is as a condition of consideration for publication in an ICMJE journal.
According to the FDA:
The U.S. Department of Health and Human Services in September 2016 issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological, and device products. The FDA Amendments Act (Title VIII. Sec. 801) requires registration for all “applicable clinical trials,” regardless of funder, that are:
- Trials of drugs and biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation, and
- Trials of devices: Prospective clinical studies of health outcomes comparing an intervention with a device against a control in human subjects (other than small clinical trials to determine the feasibility of a device, or clinical trials to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and pediatric postmarket surveillance studies, as required under the Federal Food, Drug and Cosmetic Act.
Registration Deadline: The FDA Amendments Act of 2007 requires that all trials, regardless of sponsor, must be registered in full no later than 21 days after the first patient was enrolled.
Who is responsible for registering a trial?
The PI is ultimately responsible for determining that registration requirements are met. Although some industry sponsors will do the actual registration work, it is still the PI’s responsibility to ensure that the registration has been accomplished and is accurate.
What are the penalties for failing to register?
According to the ICMJE:
Unregistered trials will not be considered for publication in journals that adhere to ICMJE standards. Questions about policies of a specific journal should be addressed to that journal directly.
According to the FDA/NIH:
Penalties may include civil monetary penalties up to $14,724 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $14,724 per day until resolved. For federally-funded grants, penalties may include the withholding or recovery of grant funds.
Who can help with questions about meeting the requirements?
To comply with University policy regarding ClinicalTrials.gov, please direct any questions to the local Protocol Registration and Results System (PRS) Administrator for UConn/UConn Health, Ellen Ciesielski, Research Integrity & Compliance. The local PRS Administrator serves as a point of contact for resolving requests by ClinicalTrials.gov and regularly monitors to promote compliance with the requirements.
Research Integrity & Compliance
The University of Connecticut is committed to the highest standards of integrity in fulfilling its mission to expand human knowledge and benefit society through research. All research activities undertaken by faculty, staff, and students at UConn will be conducted in accordance with strict ethical principles and in compliance with federal, state, and institutional regulations and policies. Research Integrity & Compliance (RIC) reports to the Vice President for Research, Innovation and Entrepreneurship. RIC is responsible for providing support and training to faculty, students and staff in order to meet these requirements and maintain a robust research compliance program at UConn.
RIC works with the faculty oversight committees to promote the ethical and responsible conduct of research and to ensure compliance with regulatory requirements relating to research involving human participants, vertebrate animal subjects, biological materials, recombinant/synthetic nucleic acids, biohazards, radiation hazards, chemical hazards, and stem cells. The committees supported by this office include the Institutional Animal Care and Use Committee (IACUC), the Institutional Review Board (IRB), the Institutional Biosafety Committee (IBC), the Financial Conflict of Interest in Research Committee (FCOI), the Stem Cell Research Oversight Committee (SCRO) the Radiation Safety Committee, the Laser Safety Committee, and the Chemical Hygiene Committee. RIC also has responsibilities relating to ClinicalTrials.gov and Responsible Conduct of Research.
Responsible Conduct of Research
Faculty Consulting
Consulting is a time honored and frequent activity of faculty throughout U.S. research universities. The ability to consult is important in promoting recruitment and retention of faculty of the highest quality. Often, such consulting activities provide a range of benefits including fostering economic development, enhancing the reputation of the University, promoting faculty development and enhancing the faculty’s ability to bring to the classroom current and relevant “real world” experiences, among others.
Consulting is an activity performed by a faculty member for compensation as a result of his/her expertise or prominence in his/her field while not acting in his/her official capacity as a State employee (i.e. in his/her own time.) The University’s Laws and Bylaws prohibit faculty from consulting on “time due to the University.”
Visit the UConn Faculty Consulting Website for faculty consulting requests and other resources.
Key Definitions
Who is an investigator?
Per the U.S. Public Health Service (PHS) definition, an “investigator” is the principal investigator (PI) and any other person (regardless of title or position) identified by the PI as someone responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.
How has the UConn FCOI policy changed?
UConn’s revised FCOI policy was effective on August 24, 2012 and corresponds with the 2011 Public Health Service revised financial conflict of interest (FCOI) regulations (42 CFR 50). These regulations apply to any institution receiving funds from a PHS entity.
Significant Financial Interest (SFI) – PHS funding:
- With regard to any publicly traded entity, an SFI exists if the value of any remuneration* received from the entity in the twelve months preceding the disclosure and the value of any equity interest* in the entity as of the date of disclosure, when aggregated, exceeds $5,000; or
- With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s Immediate Family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities.
*For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value
Significant Financial Interest (SFI) – Non-PHS funding:
- An equity interest that when aggregated for the Investigator and the Investigator’s Immediate Family exceeded $5,000 over the last 12 months, and/or is expected to exceed $5,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; or when the Investigator (or the Investigator’s Immediate Family) holds a 5% or greater equity interest (e.g., partnership, ownership, stock, stock option, or other ownership interest) in a single publicly traded entity or holds any equity interest in a non-publicly traded entity; or
- Salary, royalties or other payments not from the University for services (e.g., consulting fees or honoraria) that when aggregated for the Investigator and the Immediate Family over the last 12 months exceeded $5,000 or are expected to exceed $5,000 over the next 12 months.
Investigators governed by FDA regulations would also have a Significant Financial Interest if one or more of the following apply:
- Compensation made to the investigator in which the value of compensation could be affected by the outcome of the study/research project.
- A proprietary interest in the tested product, including but not limited to, a patent, trademark, copyright or licensing agreement.
- Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for one year following completion of the study.
The term Significant Financial Interest does not include the following types of financial interests:
- Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
- Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
- Travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.