Policy on Protocol Review
Policy Regarding Timing of IACUC Review
A. New Proposals Involving Animal Use
B. Amendments/Modifications to Currently Approved Protocols
D. Request to Use Animal Tissue/Products
E. Annual Review and Triennial Review
In accordance with federal regulations and hospital policies, all animal research conducted at or funded through the institution must be reviewed and approved by the Institutional Animal Care and User Committee (IACUC) prior to initiation of the study. This policy applies to any vertebrate animal used for any type of research, teaching, or testing. The IACUC has the sole authority to approve, require modifications (in order to secure approval), or withhold approval of research protocols involving the use of animals at the institution.
When animal research will be performed in its entirety under the institutional auspices of the institution, the investigator will need to submit an IACUC application. Protocols can be approved for a maximum of five years, subject to both satisfactory annual reviews and satisfactory comprehensive de novo triennial review. The IACUC also must review and approve in advance any changes or modifications to previously approved protocols.
When the animal research will be performed under the auspices of multiple institutions, the investigator will need to submit:
- an IACUC application
- copies of any relevant protocols submitted to outside IACUC’s
- copies of any relevant outside IACUC approvals
- the Animal Welfare Assurance (AWA) number of all outside institutions (or equivalent, as determined by the IACUC). If the IACUC grants approval, it will oversee only the research component that is performed at the institution. Any component conducted at an outside institution will be done so under the auspices of that institution’s IACUC. In order for the protocol to remain active, the investigator must submit satisfactory IACUC annual progress reports, as well as provide annual documentation of the relevant outside IACUC approvals and AWA number(s)
When the animal research will be performed in its entirety under the auspices of an outside institution but the work will be funded in part or whole by or through the institution, the investigator should submit:
- copies of any relevant protocol submitted to the outside IACUC
- copies of any relevant outside IACUC approvals
- the AWA number of the outside institution. Note that there is no requirement in this circumstance to submit an IACUC application. If the IACUC grants approval, the protocol may be conducted at the outside institution under the auspices of that institution’s IACUC. In order for IACUC approval to remain active, the investigator must submit documentation of the outside institution’s IACUC approval and AWA number on an annual basis. When the animal research described above is funded through a United States Public Health Service (PHS) grant, the institution will use the IACUC approval date of the institution where the research will be conducted and the institution’s AWA number on the face page of the grant
Policy Regarding Timely IACUC Review
The PHS has recently revised its policy for IACUC review of animal research protocols in grant applications. In particular, IACUC approval is no longer required prior to peer review of an application. This change in policy is intended to reduce the burden on both applicants and IACUC’s. Recognizing that greater efficiency of the IACUC process can be beneficial to all, the following policies have been adopted by the IACUC.
- IACUC approval is no longer required prior to submission of a grant proposal involving animal research, unless prior IACUC approval is specifically required by the funding agency. However, the IACUC is willing to review any animal research proposal at any point prior to or during the federal grant application process.
- Consistent with PHS policy, IACUC approval must be obtained prior to the actual receipt of research funding. IACUC approval must also be obtained prior to the ordering of animals or the initiation of any animal research protocol.
- The IACUC will continue to review the scientific and ethical aspects of every animal research protocol without regard to its funding status. The presence or likelihood of funding will have no bearing upon the IACUC's decision to approve or withhold approval of a study. Investigators should understand clearly that unless full IACUC approval is obtained prior to submission to the funding agency, there is no guarantee that the study will be approved by the IACUC, even if it has already been approved for funding by an extramural peer review process. In the event that the IACUC does not approve a study that has already been approved for funding, it will be the responsibility of the investigator to revise the protocol as required by the IACUC and to resolve any resulting scientific or budgetary issues with the funding agency.
- The IACUC staff is available to advise investigators about any concerns related to the timing of submission of protocols to the IACUC, particularly those where significant animal welfare issues may exist.
- Investigators who choose to await the results of an extramural peer review prior to seeking IACUC approval should be prepared to submit their protocols promptly to the IACUC to allow sufficient time (6-8 weeks) to obtain IACUC review and to respond to any animal welfare concerns that may be identified.
- In order to be fair to all investigators, complete applications will continue to be reviewed monthly in the order of receipt at the IACUC office. The IACUC has no mechanism for expedited review of new protocols, as each IACUC member must be provided with a list of research projects to be reviewed and must be provided the opportunity to call for full committee review of those research projects. This is according to the Office of Laboratory Animal Welfare Public Health Service Policy on Humane Care and Use of Laboratory Animals. (IV.C.2.) The IACUC utilizes guidelines to automatically assign some studies to both full review, e.g. covered species, animal welfare issues, and designated review while still providing IACUC members with a list of all research projects to be reviewed and the opportunity to call for full review of any research project.
All new proposals for animal research and all amendments/modifications to currently approved protocols must be reviewed by the IACUC. This review will be conducted as either a full committee review or a designated member review. The full committee makes the determination of the level of review. These processes are described below.
Full Committee Review: The IACUC meets as a full committee once each month. New proposals and amendments/modifications to currently approved protocols are circulated to all members of the IACUC prior to the monthly meeting.Two committee members are assigned by the IACUC Chair or a designee to serve as primary and secondary reviewers of the proposal. They have the responsibility of making a comprehensive presentation of the proposal to the full committee.
The IACUC then discusses the proposal and takes action on the proposal by vote by IACUC members present at that meeting.
The IACUC may:
- require modifications (in order to secure approval)
- withhold approval
Any such action requires a simple majority vote of a properly constituted quorum. If approval is withheld, the proposal must be rewritten and resubmitted to the IACUC for full committee review. If modifications are required to secure approval, the modified proposal may be reviewed by the designated member review process (see below), at the discretion of the full committee.
Designated Member Review: With the assent of the full committee, the Chair or a designee may assign new proposals and amendments/modifications to currently approved protocols for designated member review.
Designated member review of a given protocol must be conducted by at least two members of the IACUC.
These reviewers must reach agreement to:
- require modifications (in order to secure approval)
- request full IACUC review
In the case of new proposals potentially suitable for designated member review, abstracts of the new proposals will be circulated to all committee members prior to the monthly meeting. If unanimous agreement is reached, the proposal may then proceed to designated member review. However, any committee member has the authority to request full committee review. In the case of amendments/modifications to currently approved protocols, the committee has agreed in advance to permit designated member review of minor protocol changes (see Table1 below). Major protocol changes (see Table 2 below) will be brought before the full committee for determination of the level of review. The actions of the designated member reviewers are reported back to the full committee each month.
A. New Proposals involving Animal use
- If the proposal involves the use of hazardous materials in vivo, complete and submit an Application to Use Hazardous Materials in Animals to the Safety Office for review and approval. Note: Applications that involve the use of hazardous materials in vivo will not be reviewed by the IACUC without documentation of approval by the appropriate safety officers.
- Complete and submit the IACUC Application form.
- If the proposal involves the use of hazardous materials in vivo, please include a copy of the approved (signed) Application to Use Hazardous Materials in Animals, along with the executed Protection and Control form provided by the Safety Office.
- If the proposal relates to the conduct of work to be funded by the PHS, a complete copy of the research plan of the application for PHS funding must be submitted. Note: Federal regulations now require the IACUC to perform a crosscheck in order to ensure that the research proposed in the grant application is identical to that described in and approved through the IACUC application process.
- Application forms will be pre-viewed for completeness by the IACUC administrative staff. Incomplete applications will be returned for completion.
- As a service to investigators, applications will then be pre-viewed by the IACUC veterinarian, if time permits. Areas of the protocol requiring clarification, if any, will be communicated to the investigator in writing for a written response prior to the IACUC meeting.
- Protocols (or abstracts of protocols) are distributed to the IACUC members in advance of the scheduled convened meeting, and the protocol is either brought before the IACUC for full committee review at the convened meeting or referred for designated member review.
- The investigator will be notified in writing of the action of the IACUC. If the protocol is not approved, the investigator will be sent a list of questions and/or concerns that need to be addressed before the proposal is reconsidered for approval. The investigator will be asked to submit a point-by-point written response to these questions and concerns, along with a revised IACUC application incorporating the requested modifications.
- If the IACUC initially withheld approval, the investigator's written response will be reviewed by the full committee at the next monthly meeting scheduled after the response is received by the IACUC office. If the IACUC required modifications to secure approval, the investigator’s response will be sent to designated member review.
- As before, the investigator will be notified in writing of the action of the IACUC.
B. Amendments/Modifications to Currently Approval Protocol
- Investigator should submit a letter outlining the proposed amendment and a revised flow chart. The letter should contain specific details of the changes in the procedures from those previously approved and should clearly indicate how this amendment will affect the welfare of the animals. If a small number of additional animals is being requested, scientific justification must be made.
- Minor amendments/modifications (Table 1 below) will be reviewed by the designated member review process. Major amendments/modifications (Table 2 below) will be brought before the full committee for action.
- Investigator will be notified in writing of the action of the IACUC and, if applicable, questions and concerns raised by the IACUC.
Note that a change in the overall scientific goal, the request to use a different species, or the request for a significant increase in animal numbers would generally require the submission of a new proposal, and cannot be handled by amendment. If in doubt, please contact the IACUC office for guidance.
Table 1. Common Minor Amendments/Modifications to Existing Protocols:
- Change/addition of study staff (student, technician, collaborator)
- Change in performance site or housing
- Addition of another strain of the same species
- Change in sex of animal to be used
- Change in experimental timeline
- Addition of new medical or pharmacological intervention
- Addition of new non-invasive testing (e.g., imaging, behavioral testing)
- Addition of a new non-surgical procedure (e.g., catheterization, G-I endoscopy)
- Addition of a new minor surgical procedure (biopsy, vascular cut-down)
- Increase in animal number due to need for repetition of experiment
- Increase in animal number to allow statistical significance to be reached
- Addition of a new non-survival major surgical procedure
- Small increase in animal numbers to allow investigation of a related aim/goal
Table 2. Common Major Amendments/Modifications to Existing Protocols
- Change of principal investigator
- Large increase in animal numbers
- Addition of survival surgery
- Revision of specific aims and experimental plan to achieve original scientific goal
C. Urgent Situations
Veterinarians may perform emergency veterinary medical procedures to alleviate unnecessary pain or distress and/or prevent the loss of life or limb without prior IACUC approval. The veterinarians are available for direct consultation 24 hours a day, 7 days per week.
D. Request to Use Animal Tissue/Products
All studies involving the procurement and use of animal tissues or products, not otherwise approved by the IACUC as part of the investigator’s own animal research protocol, must be submitted to the IACUC for approval using the Request to Use Animal Tissue/Products Form. These requests will be reviewed by the designated member review process. Studies involving the use of blood or blood products (serum, blood cells, platelets, plasma, etc.), when obtained from a licensed biological supply company, are excluded from this requirement.
Please note that this policy also applies to the use of fetal or neonatal tissues (obtained by means other than live birth) that are intended for immediate terminal use.
E. Annual Review and Triennel Review
The approval of all animal research protocols is contingent upon the receipt of satisfactory annual progress reports. Two months prior to the anniversary date of the original approval, an Annual Progress Report form will be sent to the investigator. The form must be completed and returned to the IACUC office prior to the annual expiration date to receive continuation of IACUC approval. In the event that a satisfactory annual progress report is not received by the anniversary date of IACUC approval of the protocol, the protocol will be considered to have expired. Any animals that remain after expiration of a protocol will be transferred to the care of a facility veterinarian, who may reassign or euthanize the animals, as appropriate.
Federal regulations require that the third annual review be conducted as a comprehensive de novo triennial review. At this time, the investigator will be required to submit both the Annual Progress Report and a Triennial Review Form. After receipt of these forms, the entire protocol file, including the original proposal, all subsequent amendments and modifications, and the annual and triennial review documents will be sent to two designated members of the IACUC for comprehensive review. If there are no concerns regarding animal welfare, the protocol will be renewed. If concerns arise, the investigator will have an opportunity to make those modifications that are needed to secure renewal.
The following points should be considered in the review of animal care and use protocols:
- Rationale and purpose of the proposed use of animals
- Justification of the species and number of animals requested. Whenever possible, the number of animals requested should be justified statistically
- Availability or appropriateness of the use of less-invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation
- Adequacy of training and experience of personnel in the procedures used
- Unusual housing and husbandry requirements