Principal Investigators

  • A. Role of Principal Investigators

    While all members of a research team must be adequately trained and fully understand the proposed research project, it is the Principal Investigator (PI) who is responsible for the implementation of the protocol, for the actions of his/her research staff, and for ensuring that all policies of the IACUC and the IO are followed. The PI of a vertebrate protocol is responsible for all aspects of the research contained therein. All correspondence regarding PI protocols from the IACUC, including results of Committee deliberations and annual surveys, are directed to the PI because of his/her special role. Because of these responsibilities and the importance of compliance to the institution, the PI on all submitted protocols must be a SFU faculty/staff/administrative member. Students may be included as qualified personnel or co-PI's on a protocol if the principal investigator on that protocol assures their qualifications. The IACUC committee members can be consulted by the PI with issues of training, protocol development, and compliance.


    B. PI Responsibilities

    A PI is accountable for all aspects of the development and implementation of a protocol. While this list is not complete, PI responsibilities include:

     

    • Development and submission of an IACUC protocol and ensuring that no research is initiated until IACUC approval is obtained;
    • Responding to the comments of the IACUC;
    • Ensuring that all members of the research team are trained in the appropriate and relevant methods, species, and procedures as well as being extremely familiar with the IACUC manual and the protocol;
    • Conducting the protocol/research as approved;
    • Submitting reports as required by the IACUC;
    • Maintaining approval for the duration of the project; and
    • Submitting any changes to the protocol for approval and initiating changes only after IACUC approval is received.


    Investigators should note that failure to comply with federal, state, or local regulations on animal use or with University and IACUC policies and procedures may result in suspension of the approved protocol and notification sent, and a report to the regulatory agencies and PI funding agencies. Equally important as the result of such a violation to an individual PI, such failure can also jeopardize the University's Animal Welfare Assurance on file with NIH and may lead to revocation of PHS research funding, as well as monetary fines and sanctions imposed by the USDA. Accordingly, it is important for all animal users to recognize that research with animals is a privilege, not a right and that all parts of the animal use community - PI's, research staff, SFU Animal Care Facility, IACUC and the Institutional Official - share a responsibility to protect the institution's ability to continue to conduct animal use.

    The research team listed on a protocol can be composed of co-investigators, fellows, technicians, and students. The research team needs to be listed in the protocol and updated as needed. While the PI is held responsible for all aspects of the conduct of animal use, each member of the research team bears a responsibility to ensure that animals are used in strict accordance with the protocol, institutional policy, and the ethical principles governing animal use. Therefore, each member of a research team must receive appropriate training, must understand the protocol, and must be committed to the humane care and use of animals.

    C. Requirements for IACUC Review

    When live vertebrate animals are proposed for use in research and teaching, a full protocol must be submitted for review. A complete submission will include the basic protocol form as well as relevant appendices.

    Research involving only the procurement of tissue from commercial sources or salvaged
    animals, the use of preserved animals obtained commercially, or obtained from museums does not require IACUC review.

    Field research, including the capture and tagging of vertebrate animals, the taking of blood samples, or other invasive or manipulative procedures requires the approval of the IACUC. Investigators who plan to conduct field studies are required to submit an animal protocol to the IACUC for approval

    Investigators who plan to do collaborative vertebrate animal research with individuals at other institutions are not required to submit an animal protocol if the protocol has already been approved at another institution for work to be completed at the other institution or an offsite location and funding is through the collaborative facility. However, Saint Francis University requires a copy of the protocol and approval letter from the other institution before work commences. The IACUC would expect the PI's to collaborate only on projects where all of the basic ethical principles of animal care and use still apply.

    Several categories of research are exempt from IACUC protocol review. These include but are not limited to field research involving only observation with no manipulation, research on vertebrate or invertebrate eggs, tissues from colleagues who have protocols that are approved for the harvesting and sharing of such, and tissues obtained from commercial vendors or salvaged animals (found dead). Also exempt are commercially available "off-the-shelf" blood products, the use of exclosures that are not lethal or pain inducing, and ecological restoration solely for management purposes. To conduct research under these situations does not require the submission of a protocol to the IACUC. PI's with questions regarding exemptions should contact the IACUC.

    The use of vertebrate animals in teaching has come under closer scrutiny in recent years. The use of animals in teaching, demonstration or training is reviewed by the full IACUC at a convened meeting unless it falls under one of the previously described exemptions. The IACUC ensures that the use of animals is justified, that due consideration has been given to modeling or other means to communicate the same concepts and that, when appropriate, alternatives are available for students who are uncomfortable with the use of animal models. Committee members are available to discuss proposed courses with the instructors and educate them about various issues or concerns, which may be raised by current or prospective students.