uconn health

Institutional Review Board (IRB) Information

Statement of Compliance

The University of Connecticut (UConn) Health Center Institutional Review Boards (UConn Health IRBs) are organized and operate in accordance with applicable laws, regulations, and guidelines in the United States including, but not limited to, U.S. Food and Drug Administration (FDA) 21 CFR Parts 50 and 56, U.S. Department of Health and Human Services regulations 45 CFR Part 46,  International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and the Belmont Report. Where appropriate, UConn Health IRBs comply with additional regulations and guidelines as required in specific research jurisdictions.

UConn Health IRBs are registered with FDA and OHRP and UConn Health Federalwide Assurance (FWA) is approved by OHRP:

  • UConn Health IRB Panel 1 Registration #: IRB00000451
  • UConn Health IRB Panel 2 Registration #: IRB00000452
  • IRB Organization (IORG) #: IORG0000266
  • FWA#: 00006064

The UConn Health Human Subjects Protection Program has been fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) since 2006.

The primary responsibility of UConn Health IRBs is to ensure that the rights and welfare of the human subjects who participate in research studies are protected.

Download the Compliance Statement

Federalwide Assurance

FWA#00006064, Expiration Date: April 23, 2029

Terms of the FWA

IRB Panel Information

  • IRB Rosters
    • Panel 1
    • Panel 2

IRB Registration Numbers

  • UConn Health IRB Panel 1 Registration #: IRB00000451
  • UConn Health IRB Panel 2 Registration #: IRB00000452

IRB Review Fees

ResearchMatch

Did you know that UConn Health is part of the ResearchMatch Network? ResearchMatch.org is a national online recruitment tool, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects interested participants with health-related research studies that might be a good “match” for them through its secure, online matching tool. There is no cost to UConn Health researchers who use ResearchMatch to conduct recruitment feasibility analysis or participant recruitment.

 

For more information, including the process for using ResearchMatch as a recruitment tool, visit our ResearchMatch webpage or contact Ellen Ciesielski in Research Integrity & Compliance.

Other Resources

Chemical Safety Forms

Chemical Safety Guidance Documents:

Lab Specific Operating Procedures (LSOPs)

Chem Cards

Safety Postings

Academic Solicitation

What Is Academic Solicitation?

Academic Solicitation is the use of students, professors, scientists, or researchers as collectors improperly attempting to obtain sensitive information. Placing academics at, and requesting to collaborate with, U.S. research institutions under the guise of legitimate research in order to access developing technologies and cutting-edge research. These attempts can include requests for, or arrangement of, peer or scientific board reviews of academic papers or presentations; requests to study or consult with faculty members; and requests for and access to software and dual-use technology. Academic solicitation can also occur when a faculty member, student, employee, or visiting scholar seeks access to this same information. The number of foreign academics requesting to work with classified programs continues to rise, and the academic community will likely remain a top target for the foreseeable future. Although most academic contacts are likely legitimate, some foreign academics may ultimately take advantage of their placement and access to further their country’s research and development goals. 

 

Who Is Being Targeting? 

  • Researchers, scientists, and subject matter experts conducting research/ projects on behalf of a U.S. Government customer 
  • Researchers, scientists, and subject matter experts employed at academic institutions or with published in scientific or technical journals or presented at conferences
  • Students, professors, and researchers with access to research and technical information (especially graduate and post-doctorate students) 
  • Researchers, scientists, and subject matter experts working on cutting-edge technology 
  • Subject matter experts teaching technical courses

 

What To Report  

Any contact (i.e., emails, telephone, personal contact) that is suspicious because of the manner or subject matter of the request. This may include requests from U.S. persons or from foreign nationals located in the United States or abroad, and may consist of:  

  • Unsolicited applications or requests for undergraduate, graduate, postgraduate, or other research positions 
  • Unsolicited requests for access to research papers or other research-related publications or documents 
  • Unsolicited requests for assistance with or review of thesis papers, draft publications, or other research related documents 
  • Unsolicited invitations to attend and/or present at international conferences
  • Unsolicited grants or gifting of funds/equipment to conduct joint research projects from foreign academic institutions or foreign governments

 Contact the UConn Research Security Office at researchsecurity@uconn.edu with any concerns or questions.  If you suspect academic solicitation is taking place you can also file an anonymous report at compliance.uconn.edu. 

 

Economic Espionage

Economic espionage is foreign power-sponsored or coordinated intelligence activity directed at the U.S. government or U.S. corporations, establishments, or persons, designed to unlawfully or clandestinely influence sensitive economic policy decisions or to unlawfully obtain sensitive financial, trade, or economic policy information; proprietary economic information; or critical technologies. This theft, through open and clandestine methods, can provide foreign entities with vital proprietary economic information at a fraction of the true cost of its research and development, causing significant economic losses. 

 Our Nation’s secrets are in jeopardy, the same secrets that make your company profitable. The FBI estimates billions of US dollars are lost to foreign competitors every year. These foreign competitors deliberately target economic intelligence in advanced technologies and flourishing US industries.  

Foreign competitors operate under three categories to create an elaborate network of spies: 

  • Aggressively target present and former foreign nationals working for US companies and research institutions;
  • Recruit and perform technical operations to include bribery, discreet theft, dumpster diving (in search of discarded trade secrets) and wiretapping; and,
  • Establish seemingly innocent business relationships between foreign companies and US industries to gather economic intelligence including proprietary information.

 What Are Trade Secrets? 

Trade secrets are all forms and types of financial, business, scientific, technical, economic or engineering information, including patterns, plans, compilations, program devices, formulas, designs, prototypes, methods, techniques, processes, procedures, programs, or codes, whether tangible or intangible, and whether or how stored, complied, or memorialized physically, electronically, graphically, photographically or in writing, (1) which the owner has taken reasonable measures to protect; and (2) which have an independent economic value from not being generally known to the public.  

Commonly referred to as proprietary information, economic policy information, trade information, proprietary technology, or critical technology. 

 What Are Some Methods Of Targeting Or Acquiring Trade Secrets? 

  • Steal, conceal, or carry away by fraud, artifice, or deception;
  • Copy, duplicate, sketch, draw, photograph, download, upload, alter, destroy, photocopy, replicate, transmit, deliver, send, mail, communicate, or convey; and,
  • Receive, buy, or possess a trade secret, knowing the same to have been stolen or appropriated, obtained, or converted without authorization.

 Know The Signs 

  • Working odd hours without authorization 
  • Taking proprietary information home without authorization
  • Unnecessarily copying material 
  • Disregarding company policies on personal software and hardware 
  • Accessing restricted websites
  • Downloading confidential material 
  • Conducting unauthorized research

Personal Behaviors 

  • Unexplained short trips to foreign countries 
  • Engaging in suspicious personal contacts with competitors, business partners or unauthorized individuals 
  • Buying items they normally cannot afford
  • Overwhelmed by life crises or career disappointments 
  • Showing concern about being investigated

Common Factors  

  • Financial need 
  • Greed 
  • Unhappiness in the workplace 
  • Different allegiances to another company or country 
  • Drug/Alcohol abuse 
  • Vulnerability to blackmail 
  • Job offers from other organizations

Targeted Industries Or Sectors 

  • Information and communication technology 
  • Business information that pertains to supplies of scarce natural resources or that provides global actors an edge in negotiations with U.S. businesses or the U.S. government 
  • Military technologies (marine systems, unmanned aerial vehicles, and aerospace/aeronautic technologies) 
  • Civilian and dual-use technologies in fast-growing sectors (clean energy, health care and pharmaceuticals, and agricultural technology)
  • Academia

 https://www.fbi.gov/video-repository/newss-the-company-man-protecting-americas-secrets/view 

As part of a nationwide campaign to raise awareness of the growing economic espionage threat, the FBI has released a short video, “The Company Man: Protecting America’s Secrets.” Based on an actual case, the video illustrates how one company was targeted by foreign actors and what the FBI did to help. 

 Contact the UConn Research Security Office at researchsecurity@uconn.edu with any concerns or questions.  If you suspect economic espionage is taking place you can also file an anonymous report at compliance.uconn.edu.

Controlled Unclassified Information

Controlled Unclassified Information (CUI) is information the Government creates or possesses, or that an entity creates or possesses for or on behalf of the Government, that requires safeguarding or dissemination controls consistent with applicable laws, regulations, and Government-wide policies but is not classified under Executive Order 13556 “Classified National Security Information” or the Atomic Energy Act, as amended. 

  CUI Regulations

The CUI security controls must be compliant with the federal regulations specified in 32 CFR Part 2002(link is external) and by the National Archives and Records Administration (NARA), who acts as the CUI Executive Agent (EA) to oversee the federal agency CUI compliance. The most commonly encountered Federal CUI requirements and guidelines include:

NATIONAL INSTITUTES OF STANDARDS AND TECHNOLOGY (NIST) SPECIAL PUBLICATION (SP)

FEDERAL ACQUISITION REGULATION (FAR) SECURITY REQUIREMENTS

DEPARTMENT OF DEFENSE FEDERAL ACQUISITION REGULATION (DFARS)

Other requirements and guidance as directed in agency-specific regulations and certain legal documents may also apply.

“Information” as defined by the Federal CUI Program may include research data and other project information, including non-public Federal Contract Information (FCI).  FCI is normally protected in accordance with FAR 52.204-21 when a research team receives, possesses, or creates FCI in the performance of a sponsored contract.

“Information system” means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information. Information systems may include electronic media, non-electronic media, and physical environments.

 

CUI Onboarding

UConn research contracts, projects, and/or meetings that have Controlled Unclassified Information (CUI) as indicated in the research contract, we will need to meet with the University Research Security Office to display the documents listed below in order to complete their USPERS/citizenship verification.

 The United States Government has instituted a requirement that United States Persons (USPERS) be granted access to CUI. The Government defines a USPERS for the purpose of CUI access as those naturalized citizens, Lawful Permanent Resident Aliens, and those born in the United States.  The following acceptable forms of documentation will be utilized to establish USPER status for UConn CUI project participants: 

 List A: Valid US Passport, I-551 Permanent Resident Card 

List B: US Military Photo ID, State Issued Driver’s License, or Government issued photo ID 

List C: Original or Certified Copy of State Issued Birth Certificate, US Consular Report of Birth FS-240, DoS Certificate of Birth Abroad DS-1350, Certificate of US Citizenship, or Certificate of US Naturalization 

 A determination of USPER status will require one item from List A; or one item from List B and one item from List C. All documents produced to verify birth in the US must be either the originals or certified copies. 

 Training Requirements 

DoD CUI Training (as mandated by DoD and provided by DCSA) 

All Personnel handling (CUI) must receive initial and annual refresher CUI education and training, and maintain documentation of this training for audit purposes. The University of Connecticut provides a mandatory training course for all DOD personnel with access to CUI. This course also fulfills CUI training requirements for industry when it is required by Government Contracting Activities for contracts with CUI requirements. 

University of Connecticut Technology Control Plan Briefing Acknowledgement and Non-Disclosure Statement 

 

OVPR Export Control trainings required (2 modules, offered by CITI) 

  • Authorized USPER project participants will be required to successfully complete the following CITI online export training prior to working on the project and shall provide proof of completion to the Director of Export Compliance. CITI training can be accessed at https://www.citiprogram.org/?pageID=668 
  • Then, type in “UConn” to find the university. 
  • Then, sign in with your UConn SSO login.
  • Under the “Learner Tools” section of the website after you log in (you’ll have to scroll down in the webpage to see this section), click “Add a Course”
  • Then, check the box for the Export Compliance course, and follow the remaining steps to enroll and take the courses.
  • Contact the Export Control Officer, exportcontrol@uconn.edu if you have any difficulty accessing these required trainings.

NIST 800-171 compliance training (2023 version) 

NIUVT User Agreement (NIUVT projects only) 

OVPR Export Control User Agreement (for all non-NIUVT projects)           

 

 Background Screening for CUI 

 All university researchers and staff who handle or have access to Controlled Unclassified Information (CUI) are required to undergo background investigations as a condition of their access as required by NIST 800-171. Background investigations are necessary to verify the trustworthiness, reliability, and suitability of individuals with access to sensitive information.

Employee Background Checks:

Employees of the university will have their background checks conducted by the Human Resources department as part of the standard hiring process as required by the Pre-Employment Background Check Policy. Any employee hired prior to the implementation of background checks by the university will be required to undergo a background investigation prior to accessing CUI.  The University Research Security Office will provide you with additional information during your onboarding.

Undergraduate and Graduate Student Background Checks:

Undergraduate student and graduate students who are state employees are also required to undergo a background check in order to handle or have access to CUI as part of their research activities. The background investigation process for these students must be initiated through the Research Security Office prior to beginning any CUI research.

Background Investigation Process:

Background investigations may include, but are not limited to, criminal history checks, employment verification, education verification, and reference checks. The results of background investigations will be used to assess the suitability of individuals for access to CUI.

FAQ:

https://research-compliance.umich.edu/research-information-security/controlled-unclassified-information-cui

Additional Resources:

National Policy 

DOD Policy 

 Useful Links 

CUI Resources: https://www.dcsa.mil/Portals/91/Documents/CTP/CUI/DOD-CUI_Resources_One-Pager_for_DOD.pdf