Annual Review Process

  • A. Length of Approval

    Although an approved protocol is limited to no more than three years, each protocol must be updated and reviewed annually. The PI is responsible for reporting to the IACUC the status of the research annually. When proposal funding periods do not correspond with IACUC approval periods, PI's are urged to renew protocols in advance of the triennial anniversary date.

    B. Annual Protocol Status Reports

    To comply with the regulations that are outlined in the USDA Animal Welfare Regulations, the IACUC requires an annual review process. Failure to complete the annual review process by submitting a status report will result in suspension of animal ordering privileges on that protocol. Continued failure to comply may result in the suspension of the protocol itself. If this occurs, the research approved under the protocol must cease, the animals must be either euthanized or transferred to another approved protocol.

    The Principal Investigator will be contacted on a yearly basis for renewal. Principal
    Investigators will be sent a letter from the IO requesting an Annual Protocol Status Report which the PI is required to complete, sign and return to the IO before the annual date of the protocol. Annual Protocol Status Report Requests will be mailed to the PI from the IO six weeks before the protocol’s annual date. Protocols may be approved for renewal for a maximum of three years from the original date of approval in periods not to exceed one year. Shorter approval periods may be required depending on the circumstances of the research, reporting requirements to internal or outside agencies, and the risks to the human subjects. Research protocols having had three years of approval must be resubmitted to the IACUC and reviewed as new protocols.

    Please note: Inadequate or incomplete responses will result in follow-up communication from the IACUC if necessary. The IACUC will terminate protocols that an investigator has failed to update in a timely and appropriate manner through the annual review process by the expiration date.

    The IO will send the Annual Protocol Status report to the IACUC for review. Once the IACUC chair reviews and approves the fully completed and signed annual renewal form, the IO will provide the protocol with an updated approval date. The renewal date will be effective for one year and always on the anniversary date of the original approval date, unless there is cause for interim review. Generally, the IACUC review of renewal forms can be completed in seven days once the materials are deemed complete. Changes of substance indicated on the annual review form could require an amendment to be submitted. Depending upon the content of the amendment, the amendment request will be reviewed either by the IACUC chairperson or full committee process.

    C. Triennial Resubmission

    Each protocol must be resubmitted in full every three years and reviewed by the IACUC. This IACUC policy is designed to recognize and comply with PHS policy and to IACUC and animal care and use standards and policies that are ever evolving and to allow protocols to meet the new standards, and also to recognize the science is constantly changing to adapt the protocol's hypothesis and scientific rationale as well as its procedures to the changing science.

    Resubmissions are intended to replace, in full, all previous submissions of a given protocol, as well as any amendments to the protocol. The resubmission should incorporate all of the approved amendments, any additional proposed changes and must include updated evidence of scientific merit review, whether by an external agency or the investigator's primary department. The resubmission must be complete enough to stand on its own without reference to the previously approved protocol. Existing protocols that are not approved through the triennial resubmission process on or before their anniversary date will be expired. Once expired, the research must cease. Any animals remaining in Saint Francis University facilities must be transferred to another active protocol or be euthanized unless otherwise covered under IACUC approved protocols. Accordingly, PI's are urged to respond promptly to requests for three-year resubmissions.