uconn health

Foreign Travel Security

Researchers who travel domestically or overseas should be aware of security considerations that apply to themselves. Our office has provided a list of some useful travel tips for those of you who work on any sponsored research.  These tips are useful for any traveler and are often overlooked in the rush to acquire tickets, hotel reservations, visas, etc.

Please remember that secure research cannot be conducted outside the United States – this includes traveling with devices that may contain research.  Please contact us or the Export Control office with any questions as they may pertain to your situation: researchsecurity@uconn.edu or exportcontrol@uconn.edu

Depending on your travel situation, we are available to provide country-specific travel briefings.  Please contact our office researchsecurity@uconn.edu to arrange an agency briefing.

All university-sponsored international travel requests are routed through the Concur system, of which the Export Control office is part of the approval workflow for specific destination countries, to included sanctioned and high-risk countries.

Travelers to sanctioned countries are prohibited from taking regular use laptops, tablets, and/or university-provided equipment.

Loaner equipment is provided to travel to high risk countries to ensure sensitive or export-controlled information, data or materials with them.

If you are planning to travel to a country which is comprehensively sanctioned by the United States Government, you are required to submit a Pre-Travel Application for Embargoed Country Travel.

Contact exportcontrol@uconn.edu with any questions, to access the Pre-Travel Application for Embargoed Country Travel form, or to request a pre-travel informational meeting.

Travel Security ‘101’

Every time you move away from your residence, place of work, or some other safe static location you need to focus on what is going on ‘around you’; to be always situationally aware.  Notice what is ‘normal’ to include people, objects, and environment and pay attention when that ‘normal’ adjusts or changes.  Never disregard your gut feeling as the human body amazingly is able to detect stimulus long before our brains consciously pull it all together.  Prepare for the unexpected.  Noticing small things consistently can better assist with preparing yourself and those you might be traveling with anything threat-wise that may come later.

Plan Ahead

Always be prepared before you travel, research where and how you are traveling, staying, or living – – what does the on-the-ground situation look like?  Are there beyond normal security and safety considerations to focus on?  Areas to avoid?  Ongoing demonstrations and/or political strife that could affect movements and onward travel?  Your pre-travel preparations should be deliberate and fulsome.

Keeping A Low Profile

Do your best to minimize unwanted attention.  Review what you are packing or wearing, clothing, jewelry, and even overtly displayed religious items if you typically display them on your person.  Avoid items that might necessarily identify you as an American by alternately wearing non-descript attire that enables you to blend in as best as possible especially moving through public venues.  Do not accept letters, personal messages, photographs, packages, or other material to be carried in or out of the country.

Airports and Airplanes

Arrive early for your flights and proceed as quickly as possible through check-in and security to your gate as this offers the best level of in-depth security against a possible terrorist or criminal threat(s).  Keep close control of all carry-on items and stay alert to those other passengers and airport personnel moving around you until you board the aircraft.  Once onboard, pay attention to the location of the closest exits by counting rows of seats, both in front and behind if that is your closest exit.  Remember if and when smoke fills the cabin, you will be unable to see the lighted strips on the floor so counting seats and placing that fact in your muscle memory can be critical in evacuating safely.  When placing carry-on bags in overhead compartments, place them with their zippers and openers towards the back making it more difficult for potential thieves to get inside.  If placing bags underneath seats, turn your bag upside down to cover the zipper or even wrap the bags strap around your foot for an additional security measure.

Hotel Safety

Request a room between the second and fifth floors as those are rooms too high typically for thieves but would allow fire equipment to reach in the event of a potential fire emergency.  Locate your closest emergency exit(s) and develop a plan when/if there is a fire or other emergency where quicker egress is necessary minus using elevators.  When in your room, always use all the provided door locking hardware, and check to ensure if there are any opening windows or sliding glass doors, that they too are secured properly.  Keep your room neat so you can quickly notice anything that might be out of place or conversely messy which might do the same trick.  When leaving the room typically use the ‘do not disturb’ sign on the door and keep a light on and the television also at a low volume to give the impression that someone is in the room.

Vehicle Safety

Always keep your doors locked and windows rolled up, especially if transiting busy thoroughfares with multiple stoplights or anything that reduces your vehicle speed.  Leave distance between you and the vehicle in front of you, typically if you cannot see the rear wheels of the vehicle in front, then you are too close and would be unable to move in the event you needed to. When parked, find well illuminated areas and keep any valuables you might have locked in your trunk and out of sight to passersby.

​​​​​​​Other Travel Related Resources

The U.S. Department of State, Bureau of Consular Affairs maintains a comprehensive library of information that can help you prepare for a unexpected crisis overseas. Their site includes links to additional information about other aspects of security for persons living overseas, including children.

The U.S. Department of State Smart Traveler Enrollment Program (STEP) is a free service to allow U.S. citizens and nationals traveling and living abroad to enroll their trip with the nearest U.S. Embassy or Consulate, receive information from the Embassy about safety conditions in the destination country, and help the U.S. Embassy contact you in an emergency, whether natural disaster, civil unrest, or family emergency.

Traveling overseas with mobile phones, laptops, PDAs, and other electronic devices from The National Counterintelligence and Security Center.  Additionally, the Air Force Office of Special Investigations has created a similar brochure with additional information

U.S. Department of State Current Travel Warnings are issued to describe long-term, protracted conditions that make a country dangerous or unstable. A Travel Warning is also issued when the U.S. government’s ability to assist American citizens is constrained due to the closure of an embassy or consulate or because of a drawdown of its staff.

Also see the CIA World Factbook, which contains a plethora of excellent travel data in one-page synopses.

The State Department’s annual Country Reports on Terrorism details key developments in 2020 in the global fight against international terrorist groups.​​​​​​​

Research Security

Research security at universities is crucial for safeguarding sensitive information, intellectual property, and national security interests. NSPM-33, or National Security Presidential Memorandum 33 https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf , outlines the guidelines and policies for securing research activities, particularly those involving sensitive or classified information. This memorandum emphasizes the need for universities to implement robust security measures to prevent unauthorized access, disclosure, or exploitation of research findings that could potentially harm national security or economic interests. By adhering to NSPM-33 and implementing research security measures, universities can ensure the protection of valuable research assets while also fostering a collaborative and transparent research environment. 

EXPORT CONTROLS

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 the UConn Export Control Office to ensure that the University is in compliance.

UConn adheres to multiple federal agencies’ regulations pertaining to export controls, but there are three main regulations which the university is concerned with:

  • The International Traffic in Arms (ITAR) from the U.S. Department of State, which covers defense articles and defense services.
  • The Export Administration Regulations (EAR) from the U.S. Department of Commerce, which govern some commodities, software, technology, and “dual-use” civilian/military articles and technology.
  • The Office of Foreign Assets Control (OFAC) from the U.S. Department of the Treasury, which enforces economic and trade sanctions based on U.S. foreign policy and national security goals.

UConn’s Export Control Office supports the university’s faculty, staff, and students with questions about and guidance for actions required in order to comply with these various federal regulations.

Questions about ClinicalTrials.gov?

ClinicalTrials.gov is an online database of clinical trials. At UConn Health, Principal Investigators are responsible for registering and posting results per the federal regulations as well journal policies. That National Institutes of Health definition of a clinical trial is a research study 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  

Do you have questions about ClinicalTrials.gov registration or results posting? To schedule a virtual or in-person session with the UConn Health contact for ClinicalTrials.gov, email Ellen Ciesielski, Research Compliance Monitor in Research Integrity & Compliance in the OVPR. To learn more about ClinicalTrials.gov requirements, please see our webpages.

 

 

 

 

 

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.

March Remote RCR Training 3/26

The Responsible Conduct of Research (RCR) Office within Research Integrity & Compliance in the OVPR hosts monthly remote RCR training sessions. For our March remote event, we will be discussing several case studies. This 1-hour event will count towards the 8-hour in person requirement for NIH, however all those who conduct research are strongly encouraged to attend!

For more details about RCR requirements, please visit our RCR Program website.

For questions, please contact Research Compliance Monitor, Ellen Ciesielski or Karen Moré, Director of Research Compliance.

What: March RCR remote training session featuring case study discussions

When: Tuesday, March 26th from 12:00 p.m. to 1:00 p.m.

Where: Remote WebEx Registration Link

Scholarship and Collaboration in Humanities and Arts Research (SCHARP)

The Office of the Vice President for Research (OVPR) Scholarship and Collaboration in Humanities and Arts Research (SCHARP) Awards aim to support innovative works of scholarship and creative activities in the arts and humanities that have the potential to transform a field of study, impact the common good, or chart a new direction in scholarly, creative, or artistic development.  Proposal reviews will be conducted by a committee composed of representatives from UCHI, the College of Liberal Arts and Sciences, and the School of Fine Arts.

To learn more about the SCHARP Awards, visit the OVPR Storrs site.

UConn Innovations in Quantum STEM Education

Advances in quantum science have the potential to have transformative social and economic impact.  New technologies are poised to revolutionize major industries, creating opportunities for new applications that will fuel economic growth.

Taking full advantage of emerging quantum technologies requires a STEM-educated workforce that is ready to put these new technologies to work.  The Innovations in Quantum STEM Education program seeks to inspire and seed research into quantum-ready STEM education and workforce training that will enable our communities to rise to meet the new employment opportunities that quantum technologies will bring.  We encourage collaborations between UConn and Yale faculty, as well as other academic, workforce development, and corporate/industry partner organizations, to pursue innovative educational research related to quantum.  We particularly encourage collaborations that include faculty from quantum-related fields, STEM Education or curriculum development, and/or digital media and design.

Areas of interest include (but are not limited to): assessing the current state of STEM education approaches in our region and our readiness for quantum, developing/testing new educational approaches to teaching quantum-related STEM concepts, developing training modules and game-based techniques for teaching quantum concepts, developing/implementing quantum-informed curriculum plans for all educational levels, and developing/implementing quantum-informed workforce development approaches for specific industries.

This program is offered as a companion program to the Quantum-CT Regional Innovation Engine project. Quantum-CT, led by UConn and Yale University, is an effort to build an innovation ecosystem of researchers, educators, industry, and state/local stakeholders to harness the economic impact of new quantum-enabled technologies through technology development, innovation and entrepreneurship, and advances in STEM education and workforce development.

To learn more about the program, visit the OVPR Storrs site.

UConn Quantum Innovation Seed Grants

Advances in quantum science have the potential to have transformative social and economic impact.  New technologies are poised to revolutionize major industries, creating opportunities for new applications that will fuel economic growth.

The UConn Quantum Innovation Seed Grant program is designed to encourage and catalyze collaboration among researchers from UConn, Yale University and other regional academic partners, corporate/industry partners, and other stakeholders to explore, develop, and translate innovations and applications related to quantum technologies.  Building on existing strengths at UConn and within partner organizations across the region, this program seeks to support the development of use-inspired applications of quantum technologies relevant to the following research areas and industries:

  • New materials and manufacturing methods for fabricating quantum devices
  • Quantum computing and algorithms; quantum assisted optimization, quantum simulation
  • Advancements in data science, artificial intelligence, and machine learning
  • Quantum information technologies, quantum sensing and cryptography

Quantum science is expected to have direct applications in industries in which Connecticut has a strong presence and workforce:

  • Healthcare and biotechnology
  • Insurance and financial tech
  • Cybersecurity
  • Aerospace
  • Pharmaceuticals
  • Defense
  • Other use sectors

This program is offered as a companion program to the Quantum-CT Regional Innovation Engine project. Quantum-CT, led by UConn and Yale University, is an effort to build an innovation ecosystem of researchers, educators, industry, and state/local stakeholders to harness the economic impact of new quantum-enabled technologies through technology development, innovation and entrepreneurship, and advances in STEM education and workforce development.

To learn more about the program, visit the OVPR Storrs site.

UConn Quantum Startup Awards

Advances in quantum science have the potential to have transformative social and economic impact.  New technologies are poised to revolutionize major industries, creating opportunities for new applications that will fuel economic growth.

To accelerate the translation of quantum technologies, UConn’s Office of the Vice President for Research is creating a new program to support faculty entrepreneurs interested in creating new startups based on quantum-related innovations – the UConn Quantum Startup Awards

This program is offered as a companion program to the Quantum-CT Regional Innovation Engine project. Quantum-CT, led by UConn and Yale University, is an effort to build an innovation ecosystem of researchers, educators, industry, and state/local stakeholders to harness the economic impact of new quantum-enabled technologies through technology development, innovation and entrepreneurship, and advances in STEM education and workforce development.

To learn more about the program, visit OVPR Storrs site.

Guidance on Closure of Human Subject Research Studies

Guidance on Closure of Human Subject Research Studies

A research study should be closed by the Principal Investigator (PI) once all human research activities are completed regardless of whether a study is subject to the continuing review requirement.  To do so, a closure form should be submitted to the IRB through the iRIS submission system for each non-exempt human research study (e.g., studies approved under Expedited review or Full Board review).  The closure form should be submitted before the expiration of IRB approval, however, the PI can also submit a closure form after they have received a notice of lapse of approval.

If the study is an exempt study, the PI may allow the IRB approval to expire. When approval of an exempt study expires, the IRB will administratively close the study, but this does not invalidate the exemption. The research, as proposed to the IRB, may continue; it is not necessary to keep the exemption actively registered with the IRB.

A closure form allows the IRB to have a summary of the following information:

  • the findings of the study
  • the final enrollment data
  • whether the study met the recruitment goals, and
  • whether any of the following events occurred since the last approval (initial or continuing review):
    • subject complaints
    • unanticipated problems involving risk to subjects or others,
    • unexpected profile of adverse events in terms of frequency and/or severity,
    • non-compliance with or deviation from the approved protocol or procedures,
    • audits, inspections or monitoring visits by internal or external personnel.
    • any publications, presentations, trademarks, patents, etc. related to the study.

This guidance explains the circumstances in which a non-exempt human research study may be closed from IRB oversight, as well as ongoing researcher responsibilities that apply to closed studies.

 

Things to Consider before Closing Research Studies

  • Investigators should honor wishes of the sponsor or funding source to keep the study open or to close the study.  Some funding entities require IRB approval for the duration of the funding, even if human research activities are complete, or they may not allow the study to close without the sponsor’s permission. It is the PI’s responsibility to be aware of, and comply with, those requirements.
  • Sponsors, contract research organizations (CROs), or coordinating center personnel may need to verify or monitor individually identifiable study data at a specific site where human subjects activities have been completed. The study team should verify whether these organizations require the studies to be open when conducting their monitoring visits. IRB approval must be maintained while these activities are occurring.
  • Whenever possible, prior to closing a study, data should be permanently de-identified.

When to Close a Study

  • For studies requiring continuing review (e.g., some Expedited studies and all full board studies ) a requests for closure should be submitted at the time the next continuation application is due or within 30 days after the completion of all study activity involving the use of private identifiable information or biospecimens, whichever comes first.
  • Moreover, a closure form should be submitted to the IRB if the if the research study was not conducted or was canceled, or if each of the following conditions exist:
    • The research is permanently closed to the enrollment of subjects
    • The subjects have completed all research-related interventions
    • The research is no longer active for long-term follow up of subjects
    • Data has been de-identified.
  • When a Principal Investigator terminates employment with UConn Health, the PI may submit a closure form to the IRB. Alternatively, the PI may submit a modification form requesting transfer of the study to another eligible Principal Investigator.   Retired investigators with Emeritus status at UConn Health may be permitted to keep the study open and continue as the PI with approval from the HSPP Director.
  • When a student-led project is completed, the study should be closed with the IRB.  This should occur prior to the student’s departure / graduation.

 

IRB Process of Expired studies, Lapsed Studies and Closure Forms

  • Expired studies : If approval for continuation of non-exempt research is not sought, or a request to extend the expected completion date has not been received within a reasonable time frame (e.g., 30 days), IRB staff will administratively close the study and send a written notification to the Principal Investigator of the administrative closure.  The research activity may not continue and a new application may be required to resume research activity.
  • Lapsed studies: If approval of the study has lapsed due to lack of a response to contingencies or a request for continuing approval or to extend the completion date has not been received the study may administratively be closed.  The IRB will send a written notification to the PI. Prior to closure the IRB will issue a final request for response by email to the PI and study contacts and the PI will be given a reasonable period within which to respond (e.g. one or two weeks).
  • Closure forms:  When a closure form is submitted, the IRB will review any new information provided in the closure form and determine whether any additional action is required on the part of the IRB or the investigator. Upon review of the closure form, the status of the study is changed in the iRIS system (e.g., “Closed by PI”) and an outcome letter is issued confirming the closure.

Principal Investigator Responsibilities with Closed Studies

The principal investigator (PI) continues to have responsibilities for a study even when IRB oversight of a study is no longer required. These responsibilities include:

  • Verifying all research activities have been completed. The PI should ensure that all research-related activities, interventions or interactions with human subjects or individually identifiable data have been completed at the site(s) approved under the Principal Investigator’s IRB application at the time a closure form is submitted to the IRB or at the time of approval expiration, whichever occurs first.

If after a study is closed, the PI wishes to engage in an activity such that the criteria for closure listed above would no longer be met, the Principal Investigator must submit a new application for IRB review and approval for the use of the previously collected data.

  • Record Retention Research data from the completed study should be stored and protected in the manner approved by the IRB and consented to by the research participant so as to maintain the privacy and confidentiality of the participants.

Per HSPP Policy 2011-024.0 – File Requirements & Record Retention Requirements, investigators must maintain research records for three years beyond the completion/termination of the study. Investigators should be aware that other laws and requirements (e.g., funding agency) may require a longer record retention period. Per the HIPAA regulation, investigators are to retain documents relating to uses and disclosures, authorization forms for 6 years from the date of creation or the date when it last was in effect, whichever is later.  Per the State of Connecticut records retention schedules, the retention period for signed research authorizations is six years after the study closure date, unless a longer retention period is specified in a contract with a sponsor/funding source in which case, the longer retention period specified in the contract must be followed.

Investigator should be familiar with the record retention format described in the UConn Health HSPP Policy 2015-024.1 – Record Retention Format.

Investigators should ensure that any specific regulatory and/or sponsor requirements are met for record retention or submission of reports.

  • Confidentiality and Data Security. If the PI is maintaining identifiable private data or specimens, the protections described in the IRB application and to subjects must be maintained for the time frame described. The PI must continue to honor any commitments made to participants as part of the approved research (e.g., providing information about study results; payment for research participation).
  • HIPAA authorization. The PI may have obtained HIPAA authorization from subjects to access their medical records, with an expiration date that is far in the future. If the PI still has permission to access medical records at the time they want to close the study that permission expires upon study closure.

New NSF Responsible Conduct of Research Requirement— Effective 7/31/23

UConn Health is committed to maintaining the highest ethical standards in the performance, reporting, reviewing and proposing of research and scholarly activity. In support of this commitment and to fulfill funder requirements, UConn Health offers Responsible Conduct of Research (RCR) training and education with the goal of engaging researchers in the exploration of best ethical practices.

A recent National Science Foundation (NSF) requirement expansion includes RCR training for faculty and other senior personnel, and will require that the training address mentor training and mentorship. These new requirements apply to NSF proposals submitted on or after July 31, 2023.

A list of RCR trainings at UConn Health that fulfill NSF RCR requirements can be found on our UConn Health RCR webpage. Be on the lookout for additions to the RCR offerings in the coming months!