uconn

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

  • 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.

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.

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

Commodity Jurisdiction Ruling
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.
Deemed Export
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
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)
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 Persons
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
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.
Office of Foreign Assets Control Regulations (OFAC Regulations)
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)
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
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

Environmental Health & Safety

HuskySMS – Submit Registrations and Amendments via: uconn.scishield.com

UConn EHS – HuskySMS

UConn EHS – Biosafety

UConn EHS – Training

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

NIH Guidelines – April 2024

Dual Use Research of Concern – 2014

OSHA – Bloodborne Pathogens

Biosafety in Microbiological and Biomedical Laboratories (CDC, NIH)

CDC & USDA Federal Select Agent Program

CDC Import Permit Program

USDA – APHIS Permits and Certifications

Arthropod Containment Guidelines

Plant Containment Guide

 

 

      Last Revised 08/16/2025

      IBC FAQs

      How can I submit a registration for my research involving biological materials?

      The UConn IBC uses HuskySMS Powered by SciShield, an electronic database to complete and submit registrations and amendments to the IBC. The former registration system is no longer available. All new registrations and renewals must be submitted via HuskySMS, by completing a biological summary. The following link, uconn.scishield.com, can be used to access the new database. Personnel can log in using their UConn NetID and password.

      When can I begin a project that involves biological materials?

      Requirements to initiate life sciences research depends on the details of the project. Additional permitting or external approvals may be required for certain materials subject to state or federal regulations. IBC Registrations must be submitted using the biological summary in the HuskySMS database, which can be accessed via uconn.scishield.com. The submission must be reviewed by the IBC Coordinator and the BSO, in order to determine  when research can begin. Many experiments can commence once the preliminary review is complete and the lab has received an initial biosafety audit. However, many activities require full committee review and approval prior to initiation of research. For additional information on initiation of research, please contact the IBC Coordinator at ibc@uconn.edu.

      Who is eligible for PI status?

      UConn employees serving in the following capacity are eligible for PI status:

      Principal Investigators are University employees (permanent, temporary, post-doc) who direct the activities of a research laboratory and/or project within a research group.

      Principal Instructors can be University employees who oversee the activities of teaching laboratories and/or individual undergraduate student projects.

      A Laboratory Supervisor is a University employee who works for a PI as a technician or assistant responsible for daily laboratory functions.

      The individual responsible for overseeing a lab that is a part of the Technology Incubation Program (TIP), can act as a PI for the IBC registration process.

      Do IBC Registrations need to be updated? How often?

      IBC registrations are approved for three years, and each registration is assigned an expiration date. Labs must submit a registration renewal prior to the expiration date. The IBC office will notify PIs via e-mail renewal reminders in advance, to ensure researchers have plenty of time to submit prior to expiration.

      Does the IBC collaborate with other compliance committees?

      In the event a project must be reviewed by more than one compliance committee such as the IACUC, IRB, or SCRO, the IBC will coordinate with applicable program contacts to ensure congruency. It must be noted that IBC approval does not supersede or waive the requirement for independent review by other research compliance committees.

      Can an active IBC registration be modified?

      Yes, PIs may modify existing registrations at anytime by updating the biological summary within HuskySMS. Simply log into HuskySMS, navigate to the biological summary and make the necessary changes. Be sure to certify and submit the updated bio-summary for committee review.  Requests for amendments must be submitted to the IBC for review prior to the initiation of new experimental activities.  Amendments may include but are not limited to changes in experimental activities (new microorganisms, host-vector systems, transgenic animals, etc.), funding, personnel, and locations.

      Please note that new research activities involving RG2 organisms as a host-vector systems, cloning RG2 DNA into non-pathogenic bacteria, infectious DNA or RNA viruses and recombinant experiments with animals or plants must not begin until the committee has reviewed and approved this amendment. An exception may be made when the changes are necessary to eliminate apparent immediate hazards to human health or the environment.

      The procedures for approving amendments are the same as those described in the IBC Approval Process page. Supplementary questions may be required for the addition of biological materials. If necessary, PIs will be notified.

      What is an annual review and how do I comply with this requirement?

      Since the implementation of HuskySMS, the previous Annual Review Form has transitioned into the HuskySMS database as a Self-Inspection Log. At least annually, PIs should review their current IBC Registration / biological summary in HuskySMS to determine if any modifications are required.

      To complete the IBC Annual Review, navigate to the “Self-Inspections” in your lab’s HuskySMS dashboard. Select “Add a new Self Inspection”, and under the drop-down menu of “Inspection Type”, select “IBC Annual Review” and click “Inspect”. For additional information on this requirement, contact the IBC office via email ibc@uconn.edu.

      This helps the lab to remain in compliance and aids the IBC in determining if major changes have been made to the registration that have not been approved. In the event a PI does not receive an email, they can complete the survey during their Biosafety Audit.

      My registration contains proprietary information. Can this remain confidential?

      During the review of a submission that contains proprietary information, a conflict may exist between this proprietary information and the Freedom of Information Act (FOIA).  The State of Connecticut requires University records remain open to the public.

      To resolve this conflict, investigators may provide written documentation to justify any confidentiality request or claim.  The investigator will submit a written justification along with a copy of the IBC registration specifying that proprietary information is contained in the application.

      Types of information which may be considered proprietary:

      New and/or novel ideas. If so specified in a written contract or agreement.

      New commercial uses of a process, device, or chemical.

      Potentially patentable items.

      The above list is not all inclusive. When questions arise relating to specific guidelines or matters which may be unclear, investigators should contact the UConn Technology Partnership group.

      The submission will be discussed in closed/executive session.

      Only those portions of the registration identified in the approved written justification will be considered proprietary and as such kept confidential. Following the executive session, the IBC will reconvene in open meeting for the purpose of a formal vote on any actions conducted during the executive session.

      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.

      Initial   Refresher

      Bloodborne Pathogens Training

      Annual requirement for those working with human and/or non-human primate materials, in accordance with the OSHA Bloodborne Pathogens Standard.

      Initial   Refresher

      Laboratory Safety & Chemical Waste Management 

      Annual requirement for all personnel working in a lab due to the potential for hazardous chemicals.

      Initial   Refresher

      Shipping and Transportation of Biological Agents 

      Required for personnel responsible for shipping or transporting biological materials.

      Classroom

       

      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.

       

      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:

      1. Trials of drugs and biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation, and
      2. 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

      The mandate of the RCR Office within Research Integrity & Compliance is to promote the responsible conduct of research at UConn and UConn Health. The program’s mission is to educate and participate in an ongoing dialogue to create an environment of robust, ethical performance of all research activities, including conflict of interest, mentor/mentee relationships, safety in research and research environments, collaborative research, peer review, data acquisition and analysis, secure data use and confidentiality, and responsible authorship and and publication. In support of this commitment and to fulfill funder requirements, UConn offers Responsible Conduct of Research (RCR) training and education with the goal of engaging researchers in the exploration of best ethical practices. Projects funded by the National Science Foundation (NSF), National Institutes of Health (NIH), and National Institute of Food and Agriculture (NIFA) have specific requirements regarding training in RCR.    

      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.

      Related University Policies

      Policy Title

      Department

      Effective
      Administrative Review and Approval of Proposals for External Support Office of the Vice President for Research, Sponsored Program Services 06/24/2015
      Code of Conduct Office of the President 02/22/2011
      Consulting Policy Office of the Provost 03/25/2015
      Extra Compensation for Full-time Faculty in AAUP Human Resources & Office of the Provost 09/26/2006
      Faculty Professional Responsibilities, Policy on Office of the Provost 03/29/2011
      Financial Aid Code of Conduct Board of Trustees 01/22/2008
      General Rules of Conduct Office of Faculty & Staff Labor Relations 01/02/2004
      Guide to the State Code of Ethics Office of University Compliance 01/26/2014
      Use of Students in Outside Employment Office of University Compliance 07/14/2015