uconn health

Guidelines – Stop Work Orders

Federal Stop-Work or Grant Termination Directives

These guidelines are intended to assist investigators who may be at risk for or have received a directive from a federal funding agency to stop, pause, terminate or otherwise prematurely end a research study involving animals.  Please contact the IACUC Office promptly if you receive a stop-work directive and/or would like to discuss further.

 

Coordination with Other Oversight Committees

The SCRO Committee does not replace the oversight of the Institutional Biosafety Committee (IBC), Institutional Animal Care and Use Committee (IACUC) or Institutional Review Board (IRB), or alter the scope of review of these committees. Protocols that normally require IBC, IACUC and/or IRB approval continue to require these approvals. Investigators have the responsibility of submitting the required documents to the relevant oversight committees. If any component of the research project is conducted at an institution other than UConn, the SCRO Committee must receive documentation that the relevant approvals (IBC, IACUC, or IRB) have been obtained at the institution where the research is conducted.

The SCRO Committee has the final sign-off on stem cell protocol approvals. Final SCRO Committee approval will not be given until the SCRO Committee receives documentation of all required IBC, IACUC and IRB approvals. Continued SCRO approval is contingent upon all other relevant approvals being current. Parallel review with the SCRO Committee and the IRB, IBC or IACUC is permitted. Investigators may submit their protocol applications to the SCRO Committee while IRB, IBC or IACUC approval is pending or after it is granted.

  • IBC: All use of recombinant DNA or hazardous biological materials (human cells) must be approved by the Institutional Biosafety Committee at the campus where the research will be conducted.
  • IACUC: All use of animals must be approved by the IACUC at the campus where the research will be conducted.
  • IRB: Because oversight issues of the IRB and the SCRO Committee are intertwined, it is recommended that the IRB and SCRO Committee reviews occur in parallel. Approval must be obtained from the IRB at the campus where the research will occur. Investigators should submit a copy of their IRB application to the SCRO Committee along with their SCRO Committee application. A UConn IRB must review and approve stem cell research protocols for:
    • Informed consent for the donation of human embryos, gametes, or somatic cells from human subjects to UConn researchers;
    • Receiving and coding for human biological materials with personal donor identifiers;
    • Implanting stem cells into human subjects.

     

    Documentation for acquired cells

    All stem cell projects are required to have proper documentation for the hESC and hiPSC lines that faculty plan to use before the SCRO Committee can provide final approval.

    • Cells derived at another institution or outside UConn require an executed Material Transfer Agreement (MTA).
    • Cells coming from the UConn Stem Cell Core facility but developed and owned elsewhere such as the WiCell Stem Cell Bank lines that are banked at the Core require a shortened Materials Transfer Agreement (MTA) known as a Short Letter Agreement (SLA). The procedures for obtaining these cells and the required documentation are detailed on the Core website: https://health.uconn.edu/stem-cell-core/services/distribution-of-human-pluripotent-stem-cell-lines/.
    • Investigators who plan to use hESC/iPSC lines that have not been previously approved by the UConn SCRO Committee must provide documentation of their provenance and their ethical derivation. This documentation includes:
      • A copy of the fully executed Material Transfer Agreement (MTA)
      • Evidence of IRB approval at the relevant institution
      • Documentation of the informed consent process in sufficient detail to allow for evaluation of conformity with State of Connecticut Regulations, National Academy of Science Guidelines, and standards of the UConn SCRO Committee and IRB.

    IACUC Training

    Animal Users

    It is federal and institutional policy that all animal users be trained in both the biology of the species to be used and in all procedures that users are expected to perform when they work with laboratory animals.  The IACUC requires ALL animal users to attend a 3-hour initial training class.  This class is a 3-part training session that covers:  (1) the animal care program and the IACUC (including the laws and regulations that govern such research in the US); (2) working with the Center for Comparative Medicine; and (3) working safely with research animals.  Animal users only have to take this program once while they are at UConn Health.  This 3-hour initial class is in-person.

    It is mandatory that every year, individuals who use laboratory animals take an online renewal training.

    Many people take courses through the CITI program.  Please note that these courses do not meet initial or renewal training criteria set by the UCH IACUC.  These courses are only accepted for meeting training requirements when they are assigned by the IACUC office.  Feel free to take the CITI courses – they are very informative.  But they will not replace UCH IACUC-required trainings.

    All animal users are required to document the procedural training they have received from their PIs or senior laboratory members.  It is the responsibility of all animal users to document this training (you can use the “Animal training records form” below) and provide a copy of this training to the IACUC upon request.  Procedural training may be a mixture of observation and hands-on activity; however, being trained means that the individual is proficient in the procedure and can perform the procedure to the satisfaction of the PI and/or veterinarian and/or veterinary staff.  If an individual does not have training, do not upload an incorrect training log; simply state in the “responsibilities” section of the personnel page of the protocol e-form the procedures they will be expected to do and state that those procedures will not be performed independently until the individual is appropriately trained and training submitted to the IACUC upon request.

    SCRO Contacts

    Name Title Phone Email
    Meg Johnson, JD, CIP Director, Conflicts of Interest and Research Integrity 959.262.4139 meg.johnson@uconn.edu
    Audrey R. Chapman, PhD Chair, SCRO Committee 860.679.1590 achapman@uchc.edu
    Ellen Ciesielski SCRO Coordinator 860.679.6004 eciesielski@uchc.edu

     

    SCRO Committee Members

    Audrey R. Chapman, PhD, Committee Chair, Professor, School of Medicine, Public Health Sciences

    Peter Barwick, MD, Physician (retired), Community Member

    Eric Bernstein, JD, EdD, Associate Dean for Academic Affairs, School of Dental Medicine

    Stephen Clark, PhD, Associate Professor Emeritus, School of Dental Medicine, Genetics and Genome Sciences

    Caroline Dealy, PhD, Associate Professor, School of Dental Medicine, Craniofacial Sciences

    Jaime Imitola, MD, Vice Chair of Research in Neurology, School of Medicine

    James Mulrooney, PhD, Dean, Professor,  Central Connecticut State University, Biomolecular Science

    Leonard Paplauskas, UConn Health, Associate Vice President, Research Administration (retired)

    Ted Rasmussen, PhD, Associate Professor, UConn, Pharmaceutical Sciences

    Ernst Reichenberger, PhD, Professor, School of Dental Medicine, Center for Regenerative Medicine and Skeletal Development

    Richard Tombaugh, PhD, Theologian, Community Member

    Isolde Bates, ex officio member, Business Services Manager, Genetics and Genome Sciences

    Maureen Sansone, ex officio member, IRB Administrator, The Jackson Laboratory

    Ellen Ciesielski, SCRO Coordinator, UConn Health, Research Integrity & Compliance

    SCRO Policies, Regulations & Guidance

    The roles and responsibilities of human stem cell users are outlined in the University policy for Human Stem Cell Research Approval. For a detailed description of UConn/UConn Health SCRO Committee policies, please consult the SCRO Policy Manual document.

    For additional resources, please check out the following links:

    Training for Users of Stem Cells

    SCRO Committee policy requires all researchers and research staff, including students, post-docs, visitors, and faculty, to pass the Human Stem Cell Compliance tutorial quiz with 100% accuracy prior to engaging in research. The tutorial is intended to educate researchers on ethical issues associated with hESC and hiPSC research and inform them of relevant institutional, state, and federal policies and procedures.

     

    The tutorial is not required for those conducting in vitro human induced pluripotent stem cell (hiPSC) research involving the generation of gametes, embryos, or other totipotent cells. The tutorial is also not required for research that requires SCRO review to secure State of Connecticut funding but otherwise would not fall under SCRO’s jurisdiction (i.e., non-human stem cells, etc.). All other research requires that research staff complete the tutorial prior to beginning work on approved SCRO projects.

     

    To access the tutorial, quiz, and the sheet to record your answers, click on the links below. Return your answer sheet to SCRO Coordinator, Ellen Ciesielski, eciesielski@uchc.edu.

    IBC Meeting Dates/Meeting Minutes

    The UConn Health Institutional Biosafety Committee (IBC) is federally mandated to review work with recombinant or synthetic nucleic acids.

    This committee meets monthly, usually on the second Thursday of the month. Exceptions are noted (*). Receive forms from and submit to ibc@uchc.edu by the submission deadline.

    Upcoming meetings 2026/7:

    Date Time Location Submission Deadline
    January 8, 2026 3:10 pm WebEx December 30, 2025
    February 12, 2026 3:10 pm WebEx February 3, 2026
    March 12, 2026 3:10 pm WebEx March 3, 2026
    April 9, 2026 3:10 pm WebEx May 31, 2026
    May 14, 2026 3:10 pm WebEx May 5, 2026
    June 11, 2026 3:10 pm WebEx June 2, 2026
    July 9, 2026 3:10 pm WebEx June 30, 2026
    August 13, 2026 3:10 pm WebEx August 3, 2026
    September 10, 2026 3:10 pm WebEx September 1, 2026
    October 8, 2026 3:10 pm WebEx September 29, 2026
    November 12, 2026 3:10 pm WebEx November 3, 2026
    December 10, 2026 3:10 pm WebEx December 1, 2026
    January 14, 2027 3:10 pm WebEx January 5, 2027

     

    If you are a person interested in or concerned about this type of research, you are invited to attend a meeting of the UCONN Health IBC. Meetings will be held virtually for the foreseeable future. Please contact IBC@uchc.edu for more information.

    WCG Institutional Biosafety Committee Services periodically convenes open meetings regarding a human gene transfer study at UCONN Health. Announcements about these meetings will appear below when they are scheduled.

    Meeting Minutes:

    2025 2026 2027
    January 2026
    February 2026
    March 2026
    April 2026
    May 2026
    June 2025 June 2026
    July 2025 July 2026
    August 2025 August 2026
    September 2025 September 2026
    October 2025 October 2026
    November 2025 November 2026
    December 2025 December 2026

    As required by NOT-OD-25-082, effective June 1, 2025, approved IBC meeting minutes may be accessed by the public.

    FAQs about IBC meetings and minutes is available on the NIH OSP website. In particular, refer to “What is the expected content of IBC minutes?” UCH follows this guidance.

     

     

    Exempt or Non-Exempt Recombinant/Synthetic Nucleic Acids (rsNA) Work?

    This page gives you some facts and a strategy for what you need to do about compliance when working with rsNA.

    FACTS
    • If you will be working with rsNA and funded by NIH or working at an Institution where work involving rsNA is funded by NIH (like it is at UConn Health), you are working under the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH rsNA Guidelines). Compliance to these guidelines is required as a condition of NIH funding (and that of many other agencies) for research involving rsNA at the whole institution.
    • Institutions (UConn Health), Institutional Biosafety Committees (IBCs) and Principal Investigators (PIs) are all responsible for compliance under the NIH rsNA Guidelines.
    • All faculty are required to take the PI Biosafety & Biosecurity training available at the CITI training site every three years. Contact the BioSafety Program Coordinator if you need assistance with this.
    • Many rsNA experiments are exempt to the NIH rsNA Guidelines, but some that you might think are exempt may not be. Experiments that are not exempt need to be registered with the IBC before they are started. In some cases the application needs only to be submitted and accepted by the IBC before work may start.
    • Viral Vector rsNA experiments need to be registered with the IBC.
    STRATEGY (What to Do and Not Do)
    • Determine if your experiment or set of experiments is exempt or not exempt.
    • If you know your experiment(s) is not exempt, contact the BioSafety Program Coordinator to begin the registration process.
    • Even if you believe your experiment(s) is exempt (or safe or used elsewhere), please contact the BioSafety Program Coordinator. The only way for a PI to be sure they have done all they can to ensure their compliance with the NIH rsNA Molecules Guidelines, is for the IBC to determine that the PI’s experiment is exempt and document it. Fortunately, exempt research can undergo an administrative review which can facilitate the process.
    • Do not begin any rsNA work without UCH IBC authorization or determination that the work is exempt by the Biosafety Office.

     

     Additional information regarding the IBC and rsNA experiments

    Biosafety Contacts

    Please direct all submissions to the BioSafety Program Coordinator.

    Name Title Phone Email
    TBD Biological Safety Officer
    Victoria Scranton BioSafety Program Coordinator 860.679.7533 vscranton@uchc.edu
    Melanie Lucas Director of Research Compliance–Animal Research & Safety 860-4862459 melanie.lucas@uconn.edu