uconn health

Laws, Policies, and Guidelines for Animal Research

American Veterinary Medical Association (AVMA)

Institutional Animal Care and Use Committee (IACUC), UConn Health Center

National Institutes of Health (NIH)

National Research Council

Office of Laboratory Animal Welfare, U.S. Department of Health & Human Services

Public Health Service (PHS)

UConn Health Center

U.S. Department of Agriculture (USDA)

U.S. Fish and Wildlife Service (USFWS)

Coordination with Other Oversight Committees

The SCRO Committee does not replace the oversight of the Institutional Biosafety Committee (IBC), 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(s) at the campus(es) where the research will be conducted.
  • IACUC: All use of animals must be approved by the IACUC(s) at the campus(es) 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(s) at the campus(es) 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 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
    Karen Moré, MS, CPIA Director of Research Compliance 860.486.2459 karen.more@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

    Miller Brown, PhD, Professor of Philosophy (retired), Community Member

    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

    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 Compliance Services

    SCRO Policies, Regulations & Guidance

    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

    University 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. You will be notified of your quiz results and receive a certificate upon successful completion.

    Institutional Biosafety Committee Meeting Dates

    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 2023:

    Date Time Location Submission Deadline
    December 14, 2023 3:10 pm WebEx December 5, 2023
    January 11, 2024 3:10 pm WebEx January 2, 2024
    February 8, 2024 3:10 pm WebEx January 30, 2024
    March 14, 2024 3:10 pm WebEx March 4, 2024
    April 11, 2024 3:10 pm WebEx April 2, 2024
    May 9, 2024 3:10 pm WebEx April 30, 2024
    June 13, 2024 3:10 pm WebEx June 4, 2024
    July 11, 2024 3:10 pm WebEx July 2, 2024
    August 8, 2024 3:10 pm WebEx July 30, 2024
    September 12, 2024 3:10 pm WebEx September 3, 2024
    October 10, 2024 3:10 pm WebEx October 1, 2024
    November 14, 2024 3:10 pm WebEx November 5, 2024
    December 12, 2024 3:10 pm WebEx December 3, 2024

     

    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 an IBC representative 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.

     

     

     

    What If I’m Doing Exempt or Non-exempt Recombinant or Synthetic Nucleic Acids (r/s NA) Experiments?

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

    FACTS
    • If you will be working with rDNA and funded by NIH or working at an Institution where work involving rDNA 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 r/s NA Guidelines). Compliance to these guidelines is required as a condition of NIH funding (and that of many other agencies) for research involving rDNA at the whole institution.
    • Institutions (UConn Health), Institutional Biosafety Committees (IBCs) and Principal Investigators (PIs) are all responsible for compliance under the NIH rDNA Guidelines.
    • All faculty are required to take the IBC/DURC/Biosafety training available at the CITI training site every three years. Contact the BioSafety Program Coordinator to get instructions how to do this.
    • Many rDNA experiments are exempt to the NIH r/s NA 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 rDNA 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 r/s NA Guidelines, is for the IBC to determine that the PI’s experiment is exempt and document it. Fortunately, the BSO may serve as the IBC’s proxy to make this determination and perform the documentation. This makes the decision about whether an experiment needs to be registered or not, quicker and not too hard.
    • Do not begin any rDNA work without UCH IBC authorization or determination that the work is exempt by the BSO.

     

     Additional information regarding the IBC and r/s NA experiments

    IBC Contacts

    Please direct all submissions to the IBC Coordinator.

    Name Title Phone Email
    TBD Biological Safety Officer
    Victoria Scranton BioSafety Program Coordinator 860.679.7533 vscranton@uchc.edu
    Karen Moré Director of Research Compliance–Animal Research & Safety 860.486.2459 karen.more@uconn.edu