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  • 1.  Work with animal tissues

    Posted 08-06-2021 07:08
    Edited by Lisa Young 08-06-2021 08:29

    Hi all,

    I am wondering if anyone feels they have good policy regarding when an IACUC protocol is required for work with animal tissues and would be willing to share.

    We haven't really had this come up before, but we have a lab wanting to purchase hamster tissues from a commercial vendor
    and I am not sure if we should be requiring an IACUC protocol.

    I am inclined to think yes, if the animals are to be euthanized specifically for the research, but I am curious about how other institutes handle this.

    Any insights or advice appreciated.

    Thanks
    Lisa







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    Lisa Young
    Senior Compliance Administrator
    La Jolla Institute for Immunology
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  • 2.  RE: Work with animal tissues

    STAR CONTRIBUTOR
    Posted 08-06-2021 10:14
    Lisa,

    I couldn't tell you if these are good or not as I don't work in the IACUC office so wouldn't be privy to discussions about whether researchers find them helpful or if things slip through the cracks but we do have two written policies that describe how tissue research is handled.   You can find both on our website:  https://research.cuanschutz.edu/committee-support/home/iacuc-home/policies-olar

    Scroll down to the IACUC policy site and you'll see two called
    Hopefully you find them helpful or someone with direct experience might reply.

    ------------------------------
    Lorraine Bell
    Training Program Coordinator
    University of Colorado Anschutz Medical Campus
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    Original Message


  • 3.  RE: Work with animal tissues

    RISING STAR CONTRIBUTOR
    Posted 08-06-2021 13:06
    Hi Lisa,

    We do not require an IACUC review for the use of procured tissue at this time. However, since NIH is now asking about sources in grant proposals, we are having discussions about whether we need to change our stance on that. Some institutions are looking at the sources of the tissue and requiring IACUC protocols for tissues taken from animals that have been deliberately euthanized for commercial tissue collection or when the animals are manipulated prior to data collection.

    Eric

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    Eric Boerngen
    Outreach Coordinator, Research and Graduate Studies
    Illinois State University
    edboern@ilstu.edu
    ------------------------------

    Original Message


  • 4.  RE: Work with animal tissues

    CAYUSE CHAMPION
    Posted 08-10-2021 14:52
    All,

    For me, this is a particularly relevant discussion, as there have been conversations at my institution about how to track "uses" of animals that don't fit within the typical and traditional frameworks.  Tissues, cephalopods, MOUs, and similar are prime examples.  We've been thinking of ways to document and archive such decisions when made within Cayuse modules, logically Animal Oversight and SP.  And to do it in such a way that it doesn't trigger some other regulatory issue or inflate proposal and protocol numbers, besides the potential regulatory burden.

    Eric, since I'm not in the grant proposal side, could you assist me by pointing to the section of the NIH application referencing sources of tissues and (implied) welfare at other than the home institution?  thanks.

    Bruce


  • 5.  RE: Work with animal tissues

    RISING STAR CONTRIBUTOR
    Posted 08-10-2021 08:49
    Ours is not listed on our website but I have listed the guidance we provide below:

    1. PROJECTS THAT REQUIRE PROVIDENCE COLLEGE IACUC APPROVAL

    In accordance with federal regulations, (OLAW and USDA/Animal Care) any proposal involving animals to be killed for the purpose of using their tissues (including blood), or one that involves project-specific manipulation prior to euthanasia to collect tissue, bodily fluids, or excrement is subject to (not exempt from) protocol review. Therefore, if an animal is acquired and euthanized specifically for tissue or sample collection, a full animal use description protocol must be submitted and approved by the IACUC. It is important to note that Public Health Service grant applications, which propose the use of either shared tissues/samples or tissues from a commercial venue, must be clear as to the origin of the tissue.

    1. Researchers planning on using dead animals or parts of dead animals, and will be euthanizing animals for the purpose of obtaining those tissues or other materials, or
      b. will be performing project-specific manipulation of animals prior to killing them, will require Providence College IACUC review and approval prior to initiation of the research.

    The PC IACUC has determined that the use of tissues obtained from commercial sources, or as a by-product following research studies and/or euthanasia of animals in other unrelated IACUC-approved projects at other institutions does not require PC IACUC review. Sharing of tissues/samples is allowed for Principal Investigators within the Providence College Research Facility who have PC IACUC approved protocols to do so.

    1. COLLABORATIONS

    Outgoing MTAs

    Researchers conducting collaborative research with another institution may require certain agreements prior to initiation of the research. If any tissue harvested on a PC IACUC-approved protocol will be sent to a collaborating institution, additional documents including an outgoing Material Transfer Agreement (MTA) may be required between the collaborating institutions. The collaborating institution may also require their own IACUC review and approval in accordance with their institutional policies and procedures. In such cases, the PC IACUC must be provided with a copy of the collaborating institution's IACUC-approved protocol and approval letter. Please reach out to the director of Sponsored Research Projects and Research Compliance for any outgoing MTA.  The Director of Sponsored Projects and Research Compliance will work with the Providence College Office of General Counsel and the collaborating institution to ensure all applicable agreements are in place prior to initiation of the research.   

     

    Incoming MTAs

    Researchers conducting collaborative research with another institution and receiving harvested tissue from that institution under the conditions specified in section Ia. and 1b. must submit an IACUC-approved protocol application and approval letter from that institution to the PC IACUC. A Material Transfer Agreement (MTA) may also be required between the collaborating institutions. Incoming MTAs willmust be accompanied by a completing routing form. https://friarsprovidence.sharepoint.com/sponsored-projects-research/Shared%20Documents/MTA%20Routing%20Form.pdf 

     

    The institution that is the grant awardee of any funds awarded is typically responsible for initiating any documents. If outside institutions fail to initiate these agreements, Principal Investigators are encouraged to notify the Director of Sponsored Projects and Research Compliance. The Director of Sponsored Projects and Research Compliance will work with the Providence College Office of General Counsel and the collaborating institution to ensure all applicable agreements are in place prior to initiation of the research.  

     

    III. COMPLIANCE WITH OTHER REGULATIONS

    Acquisition of Animal Tissues/Samples

    The PI must have knowledge of all regulations pertaining to the acquisition of animal tissues/samples under study, have obtained all permits necessary for carrying out the proposed studies prior to their initiation, and ensure that studies will be conducted in accordance with all wildlife regulations when applicable.

    Shipping

    Shipping and receiving of animal tissues/specimens must be conducted in accordance with federal safety and importation guidelines and regulations. The PI must act in accordance with the United States Department of Agriculture, Animal and Plant Health Inspection Service regulations regarding the limits on importation of animals or tissues that may have been exposed to an exotic livestock or poultry disease agent, and the limits on the importation of plants and other vegetable matter. The PI must act in accordance with the Public Health Service Foreign Quarantine Regulations (42 CFR 71.54) which govern the importation and transfer of etiologic agents and vectors of human disease. U.S. Fish and Wildlife Service regulations must also be followed. The movement of other non-infectious materials such as formalin-fixed tissues, sterile cell cultures, and other preserved tissues or materials where no evidence or indication exists that they contain an infectious agent of animal or public health significance are not governed by these regulations.

    Transportation Regulations

     

    Public Health Service 42 CFR Part 72. Interstate Shipment of Etiologic Agents. This regulation is in revision to harmonize it with the other U.S. and international regulations. A copy of the current regulation may be obtained from the Internet at: http://www.cdc.gov/od/ohs/lrsat/42cfr72.htm

     

    Department of Transportation. 49 CFR Parts 171-178. Hazardous Materials Regulations. Applies to the shipment of both biological agents and clinical specimens. Information may be obtained from the Internet at:  https://www.ecfr.gov/cgi-bin/text-idx?SID=028795e5b4a0b194cc473338c7237c13&mc=true&tpl=/ecfrbrowse/Title49/49CIsubchapC.tpl

     

    United States Postal Service. 39 CFR Part 111. Mailability of Etiologic Agents. Codified in the Domestic Mail Manual 124.38: Etiologic Agent Preparations. A copy of the Domestic Mail Manual may be obtained from the Government Printing Office by calling 1-202-512-1800 or from the Internet at: 

    http://www.access.gpo.gov

    Occupational Health and Safety

    Occupational health and safety principles require that personnel using animal tissues know the hazards associated with their work, understand how these hazards are controlled, exercise safe practices, and use proper personal protective equipment and supplies.

    The use of fresh or frozen animal tissue may pose a risk to the health of researchers and technicians through the transfer of disease (zoonosis) such as brucellosis, leptospirosis, and listeriosis. The College maintains a program for occupational health and safety for employees working with animals.

    The PI must ensure that prior to beginning research involving animals and/or animal tissues, personnel/students are familiar with the health risks associated with the species involved in the work.

    Researchers using biohazardous agents, radioactive materials, or chemical hazards require appropriate compliance committee approval prior to initiation of the research.

    Researchers shipping tissue to another institution that is infected with any biohazardous agents, has had radioactive materials administered, or has been subjected to chemical hazards, must contact the Environmental Health and Safety Department at Providence College to ensure compliance with shipping regulations.

    Occupational Health and Safety Administration (OSHA). 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens. Provides minimal packaging and labeling requirements for transport of blood and body fluids within the laboratory and outside of it. Information may be obtained from your local OSHA office or from the Internet: http://osha.gov

     

    Dangerous Goods Regulations (DGR). International Air Transport Association (IATA). These regulations provide packaging and labeling requirements for infectious substances and materials, as well as clinical specimens that have a low probability of containing an infectious substance. These are the regulations followed by the airlines. These regulations are derived from the Committee of Experts on the Transport of Dangerous Goods, United Nations Secretariat, and the Technical Instructions for the Transport of Dangerous Goods by air which is provided by the International Civil Aviation Organization (ICAO). A copy of the DGR may be obtained by calling 1-800-716-6326 or through the Internet at: 

    http://www.iata.org/Pages/default.aspx, or http://www.who.org

     

    References:

    Adapted from University of Louisville Institutional Animal Care and Use Committee
    Florida State University, Laboratory Animal Resources Policy, Applicability of the Animal Welfare Act and PHS Policy to Dead Animals and Shared Tissues



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    Kris A. Monahan, Ph.D.
    Director Sponsored Projects and Research Compliance
    Providence College
    Providence, RI
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    Original Message


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