uconn health

Guidelines – Stop Work Orders

IRB Guidance for Investigators:  Federal Stop-Work Directives

These guidelines are intended to assist investigators who may or have received a directive from a federal funding agency to stop, pause, terminate or otherwise prematurely end a human research study. Such orders can come in a variety of forms and are collectively referred to in this document as “stop-work” orders or directives.

What Should I Do If I Believe My Research Is at Risk for a Stop-Work Order?

  • Evaluate whether your research can be modified to reduce the risk of a stop-work directive while maintaining its objectives
  • Determine whether a sudden stop would put participants at risk (e.g., therapeutic studies)

If study participants would be AT RISK due to a sudden stop:

  • Develop an Action Plan outlining steps that would be taken to safely wind down your research if necessary, considering factors such as:
    • The nature and severity of the risks to participants
    • Procedures that may be necessary for participants to safely stop (e.g., tapering meds, removing devices, labs and imaging, follow up assessments, referrals)
    • Alternative options for participants (e.g., arranging for therapeutic care outside of research)
    • Communication plans for:
      • Participants
      • Stakeholders (e.g., study personnel, collaborators, subcontractors)
      • Service providers (e.g., labs, imaging centers) and facilities where study activities take place (e.g., schools, clinics)
    • What will happen with study data and biospecimens (when applicable)
    • Participant compensation obligations
    • Work with your SPS Post Award Team to alert them of unavoidable costs due to participant safety

NOTE: For non-exempt research, Action Plans (other than the communication plans for stakeholders, service providers, and facilities) must be approved by the IRB prior to implementation. Action Plans should be submitted when a stop work directive is received. Alert your SPS Post Award Team if they are not already aware of the Stop Work order.

If study participants would NOT be at risk due to a sudden stop:

  • Develop an Action Plan outlining steps that would be taken to safely wind down your research if necessary, considering factors such as:
    • The current status of the research (e.g., open to enrollment, closed to enrollment but with active participants, follow up only, data analysis only)
    • Managing scheduled visits or tests
    • Communication plans for:
      • Participants
      • Stakeholders (e.g., study personnel, collaborators, subcontractors)
      • Service providers (e.g., labs, imaging centers) and facilities where study activities take place (e.g., schools, clinics)
    • What will happen with study data and biospecimens (when applicable)
    • Participant compensation obligations
    • Work with your SPS Post Award Team to alert them of unavoidable costs obligations.

    NOTE: For non-exempt research, Action Plans (other than the communication plans for stakeholders, service providers, and facilities) must be approved by the IRB prior to implementation. Action Plans should be submitted when a stop work directive is received.

    • Contact the IRB office if you have questions or need

    What Do I Do If I Receive a Funding Agency Directive to Stop or Pause Research?

    • Notify Key Offices Immediately
      • Contact SPS (when not informed of the directive by SPS)
        • Contact your designated Post-Award Specialist:
        • Contact the IRB (if the IRB of record is an external IRB, contact both the external IRB and the Storrs IRB office or UConn Health IRB office
        • Implement Your Communication Plans
          • Inform Stakeholders, Service Providers, and Facilities about the stop-work directive
          • Participant communication plans must be approved by the IRB for non-exempt research
        • Mitigate Immediate Risks to Participants
          • If applicable, take any actions necessary to mitigate immediate risks to participants
          • Document and report those actions to the IRB
        • Submit an amendment to the IRB with your Action Plan to safely wind down research activities (see prior section)

    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: March 10, 2030

    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

    Posted on by

    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.