Animal Use Protocol Submission And Review Process - Teaching and Research Protocols
The ACUC meets once a month. The ACUC Protocol Review Form should be submitted for review 60 days in advance of the submittal of the grant proposal to a funding agency, to assure adequate time for ACUC review and approval. Protocols submitted by the 1st of the month are reviewed during the same month. Principal Investigators wishing to use the newly instituted NIH (as well as other funding agencies) ‘Just-In-Time’ grant proposal review process must bear in mind that the ACUC is under no obligation to perform expedited reviews nor grant approval; such protocols will be routed through the usual in-house review process.
Protocols for animal research or teaching are submitted to the ACUC Secretary in the Department of Laboratory Animal Resources office. The ACUC Secretary screens the protocols to determine that all questions have been answered and checks on the medical monitoring enrollment as well as training status of all listed personnel. The ACUC Secretary then forwards a copy of the protocol to the LAR facility manager and LAR veterinarians as well as representatives from FSU Environmental Health and Safety for a pre-review. These individuals conduct a preliminary review of the entire protocol with an eye to helping the investigator eliminate any stumbling blocks to approval by the full Committee. Suggested modifications are provided to the principal investigator (PI); the PI may choose to modify the protocol based upon the suggestions or may request that the protocol go forward in the approval process without change.
Copies of all protocols are distributed to the ACUC members at least four calendar days prior to the ACUC meeting. The Committee meets, reviews and takes action on all protocols on the monthly agenda. Each new or re-written protocol is assigned a primary reviewer who presents the protocol to the committee for discussion at its meeting. Following discussion, protocols may undergo a vote for approval, require modification, or may be disapproved. Protocols may also be tabled until the next meeting. Protocols with required modifications status are returned to the principal investigator for revision and presented at the next ACUC meeting for discussion of changes and approval (if required modifications have been made).
A majority vote of a quorum of the ACUC is required for protocol approval. If the submission fails to gain approval, the committee may require modifications in writing that can be approved by a designated reviewer or the committee may require modifications or clarifications in writing that must be approved by the full committee. If the committee votes to withhold approval, it will notify the PI in writing, stating the reasons. The PI will then be given the opportunity to respond in person or in writing, at which time the ACUC may reconsider the protocol, with documentation of the discussion in the committee meeting minutes. The ACUC may suspend an activity not being conducted in accordance with the description provided by the PI. Suspension requires a majority vote of a quorum at a convened meeting of the committee.
Minutes of the ACUC meetings and related correspondence are maintained in the ACUC Secretary’s office. Following approval of the minutes by the Chair and the Attending Veterinarian, the ACUC Secretary provides each investigator with a letter describing the action taken on their request along with a copy of the relevant minutes.
The FSU ACUC has a designated reviewer system that is initiated upon request and with justification by the principal investigator. The protocol or significant change to the protocol is submitted to the entire ACUC for a 48 hour review. ACUC members may send comments or questions to the designated reviewers. The designated reviewers will contact the investigator for clarifications or modifications. Any member of the committee may call for a full committee review during the 48 hours period. Such a call will terminate the accelerated review process and will place the request on the agenda for the next scheduled ACUC meeting. The designated reviewers vote on approving the significant change or protocol. There must be unanimous agreement by the designated reviewers for approval or the request for protocol approval/significant change will be referred for consideration at the next scheduled meeting of the ACUC. The PI is promptly informed of all developments related to the designated reviewer process. A report on the outcome of any designated member reviews is made to the full committee at the next scheduled meeting however committee members may request full review at this time. Accelerated review approval is ratified by the full Committee at the meeting following the initial approval. All records of the process are maintained by the ACUC Secretary.
Investigators should be aware that submittal of an ACUC Protocol Review Form does not generate an automatic approval. The FSU Animal Care and Use Committee may take one of three actions with regard to an individual protocol: approve, require modifications for approval or withhold approval. Only the first action allows for the use of animals. In an effort to increase the chance for approval during the first review by the ACUC (and to decrease the total amount of time from submission to approval), LAR offers a pre-review process that helps identify issues of concern and works with investigators to help with corrections and modifications.
Protocols lasting more than one year are reviewed at intervals appropriate for the species employed. For species covered by the USDA Animal Welfare Act, an annual review of the protocol by the ACUC is required. For both USDA covered species and all other vertebrate species, a tri-annual protocol de novo re-submission and review is required. All protocols (with the exception of the film school or other Arts related projects) are treated equally in terms of the forms that are required and the review process. The only difference is the frequency of review. Fine Arts, Theatre and Film School projects all are approved for single specific projects of 2-4 days duration and have a modified protocol form; in addition they are granted approval for only one-year.
Principal investigators are responsible for submitting significant changes to protocols to the ACUC for review and approval. Significant changes are defined by the ACUC in the instructions for completing the protocol form. Committee approval must be secured prior to implementing any significant change. Requests for significant changes follow the same procedures as new protocols and re-write reviews.