Changing a Protocol

  • A. Making Modifications to Approved Protocols

    In approving a protocol, the IACUC has indicated that the animal use protocol is consistent with the regulations and standards. Any change to the approved protocol must be submitted as an amendment to the IACUC and approved prior to instituting the change. Such a request must be in writing and may be in the form of a simple letter detailing the reasons for the modification and the proposed modification. This letter and any supporting documents should be sent directly to the Chair of the IACUC. Please note that, as the individual responsible for the overall conduct of the protocol, only the PI is permitted to request approval for modifications to protocols. Co-investigators and other research staff are not permitted to submit amendments to protocols.

    The IACUC Chair is empowered to approve requests for modification that are minor in nature. Minor modifications are those that do not change the basic nature of the research effort.

    Requested modifications that are not minor in nature will initiate a review of the revised protocol. This modification review will involve review by the full IACUC for consideration. As with an initial review, the requested modification may be approved, withheld pending minor revisions, or denied. If approved, the revised protocol will carry the same approval period as the original approval unless a continuation has also been requested by the Principal Investigator.

    B. Transfer of a Protocol to Another Investigator

    Infrequently, circumstances may warrant that a PI may wish to transfer his/her protocol to another investigator. To affect this change, the PI of record and the proposed PI should jointly submit an amendment to the IACUC, requesting the transfer and explaining the circumstances. If the proposed PI is not currently a member of the approved research team, the amendment request should also contain information on the training and experience of the proposed PI with the protocol, its procedures, and the species. Both the approved and proposed PI should sign the amendment form. If however, the approved PI has left Saint Francis University, a simple statement to this effect, rather than his/her signature, is sufficient.