IACUC Forms and Review Process
Animal Use Protocol Submission
All testing, instructional and research proposals utilizing living vertebrate animals must be submitted for evaluation by the Institutional Animal Care and Use Committee (IACUC). Animal Use Protocol (AUP) submissions must also be submitted when utilizing dead vertebrate animals or animal parts if the animal was both sacrificed and procured solely and specifically for a research, teaching, or testing purpose. Work utilizing such living vertebrate animals and/or dead vertebrate animals or animal parts at The Ohio State University (OSU) may not be initiated until notification of IACUC approval has been received.
Submission Deadline
AUPs must be submitted to the IACUC office by the submission deadline to be evaluated during the next available IACUC review.
Review and Endorsement by the ULAR Clinical Veterinarian
Several resources are available to help investigators with protocol preparation. University Laboratory Animal Resources (ULAR) clinical veterinarians are available to aid in protocol development, including proper model selection, consultation regarding drug doses, routes of administration, anesthesia, tranquilizer selection, and surgical procedures. Protocol review and signature by an ULAR clinical veterinarian is required prior to submission of an AUP to the IACUC.
Review by Local College Review Committee and Chairperson Endorsement
Several colleges at The Ohio State University (OSU) have established local animal care and use committees, known as college review committees, to act as advisory boards to the Principal Investigators (PIs). These committees, along with the ULAR clinical veterinarians, conduct preliminary reviews of AUPs and work with PIs to refine AUPs prior to submission to the IACUC. The college review committees have no formal authority under the institution’s Assurance for action on an AUP. While it is not a requirement, it is the expectation that protocols originating from a college with such a local animal care and use committee will be reviewed and revised as needed within the college prior to the protocol’s formal submission to the IACUC. The signature of the chairperson or appropriate alternative from the college department in which an AUP originates is required prior to submission of an AUP to the IACUC.
Personnel Requirements
The IACUC maintains several requirements of personnel listed on an AUP that must be met before an individual may engage in research, teaching, or testing involving animals, before admittance to the animal facilities will be granted, and before an AUP will be reviewed by the IACUC.
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A separate IACUC Personnel Form must be completed and submitted for each individual on a protocol, including the PI. This form must briefly describe an individual’s experience and training in regards to the species involved and the procedures performed under the AUP.
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Each individual involved in the care and use of animals under the AUP must obtain a basic level of competency in these areas through either participation in the classroom or in the online Animal Use Orientation Course. This training must be updated no less than every three years.
Registration
- classroom Animal Usage Orientation Course
- online Animal Usage Orientation Course
- Each individual listed on an AUP must also receive basic training in the use of hazardous chemicals and biological agents/materials through completion of the online Occupational Health and Safety Course. This training must be updated no less than every three years.
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Each individual listed on a AUP must have completed a current Occupational Health Risk Assessment via the Occupational Health Registry.
- The PI and all Co-Investigators must have a current OSU Financial Conflict of Interest Screening/Disclosure on file with the Office of Responsible Research Practices.
Principal Investigator Assurances and Signature
The PI submitting an AUP for review must verify that the information provided in the AUP is accurate and complete and acknowledge his or her ultimate responsibility for the ethical performance of the research, instruction, or testing, the welfare of the animals involved, and strict adherence to any conditions imposed by the IACUC. This requirement is satisfied by the agreement of the PI to several assurances listed within the AUP form and indicated by the PI’s signature. The signature of the PI is required prior to submission of an AUP to the IACUC.
Animal Use Protocol Review
The PI should submit an AUP using the most recent version of the IACUC Animal Use Protocol for Research and Instruction form that, when properly completed, includes the information needed to satisfy institutional and regulatory agency requirements. The form also provides signature verification that the submission has been reviewed by an ULAR clinical veterinarian and the chairperson or appropriate alternative from the college department in which the AUP originates.
The IACUC office reviews the AUP submission for completeness. Completed AUPs are assigned a unique identification number and scheduled for review.
Protocols proposing activities that do not involve survival surgery on a USDA-covered species, unrelieved pain or distress (including prolonged restraint), death as an endpoint, multiple survival surgeries or use of primates may be evaluated by designated member review. Access to a copy of the entire protocol is provided to all IACUC members. The protocol is then evaluated by a designated reviewer if no IACUC member calls for full Committee review within a specified time. Designated reviewers are assigned by the IACUC Chair with the assignments distributed among all IACUC members. The designated member reviewer’s options regarding protocol evaluation are “Approved”, “Requires Further Information”, or “Refer to Full Committee.”
Protocols proposing activities involving survival surgery on a USDA-covered species, unrelieved pain or distress (including prolonged restraint), death as an endpoint, multiple survival surgeries or use of primates (along with any other protocols for which an IACUC member has called for full committee review) are evaluated at a convened IACUC meeting. Convened IACUC meetings typically occur once per month. A quorum for a meeting must be maintained to pass motion on any Committee actions and is considered to be one more than one-half of the current membership of the IACUC.
Each AUP handled in full Committee is evaluated by a minimum of two but usually by a team of four (4) primary reviewers. The reviewers typically consist of the college representative to the IACUC in whose college the protocol is to be conducted, a ULAR veterinarian, and two other members of the IACUC selected at random. Committee discussion is initiated by the primary reviewers for a given AUP and is open for discussion by the full Committee.
In its review of protocols involving animals (whether by designated member review or by full Committee review), the IACUC will determine that the proposed activities are congruent with the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training” as enunciated in the PHS Policy, “The Guide for the Care and Use of Laboratory Animals”, and “The Animal Welfare Act.” After evaluation, an AUP is specified to have one of four outcomes: “Approved”; “Requires Further Information”; “Deferred (major modifications requiring re-review)”; or “Disapproved.” For full Committee review, a majority vote of the quorum present is required to pass a motion for any of these proposed actions. The count of the vote is recorded in the Minutes of the meeting. Members who vote against an action of the Committee are encouraged to identify the reason(s) for their vote. They may also submit a written minority report. Members of the IACUC are instructed to disclose any real or perceived conflicting interests and to leave the meeting room during the IACUC’s discussion and vote of such protocols.
At the time of review, the Committee specifies which reviewers, along with the IACUC Chair,
will evaluate the PI’s response(s) to requested protocol clarification(s) or modification(s). The Committee may select any number of reviewers to evaluate the investigator’s response(s) along with the Chair. For some, the IACUC Chair may be chosen to review and evaluate clarification(s) or modification(s) alone. In the case of designated member review, the designated reviewer evaluates the investigator’s response whenever clarifications other than completions of administrative requirements are needed. In cases when only completion of administrative requirements (completed housing request, completed chemical hygiene plan, or approval by the Institutional Biosafety Committee) are needed, the IACUC Chair will coordinate final approval. (See IACUC Required Clarifications, Modifications, and Revisions to Animal Use Protocols)
Continuing Annual Reviews (First and Second Year)
The IACUC conducts continuing review of each previously approved, ongoing AUP on the first and second annual anniversary of an AUP utilizing the IACUC Animal Use Protocol Annual Review form. The annual review form collects information regarding protocol personnel and contact information, animal housing and use locations, and several other pieces of key information required to satisfy institutional and regulatory agency requirements. The IACUC staff will initiate reminders and make every effort to direct PIs to submit an IACUC Animal Use Protocol Annual Review form in advance of the annual anniversary of the IACUC review of an AUP. However, the PI is ultimately responsible for submitting annual review materials in advance of the annual review due dates to ensure continuing IACUC approval.It is very important that the annual review deadlines are not missed.Failure to submit annual review materials on time will result in all persons listed under an AUP to lose access to animal facilities and animal ordering, and may result in the early termination of the AUP.
If an Animal Use Protocol Annual Review form involves the addition of personnel, each individual must have a completed personnel form. Individuals are verified for relevant training, including completion of the mandatory Animal Usage Orientation course, the mandatory Occupational Health and Safety Training course, and compliance with the Conflict of Interest and Occupational Health programs. These requirements must be met before approval of these individuals to work under the AUP is given.
Responses contained in the annual review form are reviewed by the IACUC staff and the IACUC Chair for congruence with the approved IACUC AUP. If there are any discrepancies between the annual review information provided by the PI and the information available to the IACUC staff and IACUC Chair, an audit of the AUP will occur. The discrepancies and any findings of the AUP audit must be resolved before the AUP will be approved to continue within the approved period.
If there are no discrepancies between the annual review information provided by the PI and the information available to the IACUC staff and IACUC Chair, the annual review information is used to update IACUC records, and the AUP is continued within the approved period.
Protocol Renewals (Third Year)
Animal Use Protocols are approved for a period not to exceed three (3) years. To continue an AUP beyond the three year approval period, a new AUP submission is required.To avoid a lapse in IACUC approval, it is essential that a completed renewal AUP be submitted and approved by the IACUC prior to the expiration date of the AUP.To allow sufficient time for the review and approval process, the IACUC requires that a renewal AUP be submitted two meetings in advance of the AUP expiration date. The IACUC staff will initiate reminders and make every effort to direct PIs to submit a new AUP in advance of the third year anniversary of the Committee review of an AUP. However, the PI is ultimately responsible for submitting AUP renewal materials by the renewal submission deadline to ensure continuing IACUC approval. PIs are to indicate that the new AUP submission is a renewal of a previously approved and soon to expire AUP when completing the AUP renewal submission. The IACUC staff assigns the renewal AUP a new unique identification number and the AUP is processed utilizing the initial submission review process (detailed above).
Approval Periods
Federal regulations do not permit the IACUC to extend any approval periods.If a renewal protocol has not been processed and approved by the expiration date of the AUP, IACUC approval for the work under the AUP will expire.Should IACUC approval expire, all activities involving the care and use of animals must cease immediately.Any activities conducted under the protocol after expiration will be in direct violation of federal regulations and institutional and IACUC policies.
