Animal Care

Guide to the Responsible Care & Use of Laboratory Animals at UWM

Chapter III:   Review of Animal Protocols

1. Criteria for Review of Protocols

   1. Experiments involving live, vertebrate animals and the procurement of tissues fromlive animals for teaching or research must be performed by, or under the immediate supervision of a qualified scientist with training and/or experience in animal care and use.

   2. Teaching or research studies utilizing non-human animals as subjects are required to have a reasonable expectation of contributing significant knowledge that will be beneficial to the future health and welfare of human and non-human animals.
   3. If pain or distress are necessary elements of the experimental study, these must be minimized in both intensity and duration. In particular, alternative methodologies must be sought in lieu of procedures that require continuation of severe pain and distress until the death of the subject.
   4. Procedures producing pain and distress are tolerated only if it can be demonstrated that pain and distress are the primary direct objects of research explicitly designed to produce beneficial knowledge.

      1. The following procedures must be restricted and used only when, on the basis of expert opinion, it is anticipated that their utilization will undoubtedly contribute knowledge or benefit to man or animals: prey killing and fighting experiments; experimental burn studies and fracture studies.

      2. Such procedures must be carefully supervised by the Principal Investigator or other qualified senior scientists.
      3. The procedures are not tolerated when pain and distress are avoidable byproducts of research carried out in pursuit of some other object.
      4. In general, the fewest number of subjects should be employed for the shortest period of time.
   5. Post experimental care of animals must be such as to minimize discomfort and the consequences of any disability resulting from the experiment, in accordance with acceptable practices in veterinary medicine.
   6. If it is necessary to kill an experimental animal, this must be accomplished in a humane manner, i.e., in such a way as to ensure immediate death in accordance with the American Veterinary Medical Association (AVMA’s) Euthanasia Guidelines. No animal shall be discarded until death is certain.
   7. There should be justification for the selection of the species, especially those endangered or threatened with extinction.

2. Review Process of Animal Protocols

   1. Initial Submittals

      A protocol will be prepared by the Principal Investigator and submitted to the Animal Care Program in the Department of University Safety and Assurances.

      Animal Protocol Review Forms are available on the following website: http://www.uwm.edu/Dept/EHSRM/ACP/index.html. There is a special form for field observational studies and educational observational studies that will be reviewed in the same fashion as the regular protocol form. Investigators are encouraged to submit protocols electronically along with a hard copy with signature to follow. Investigators need to complete the coversheet at a minimum for each new grant, and the entire protocol form if there are changes from previously approved protocols other than title and funding agency. If there are no changes in animal procedures the investigator will submit the new coversheet along with the previously approved protocol form.

      Investigators should also attach the animal experimental section from the grant application to the protocol since the IACUC needs to ensure that the animal use in the grant matches the animal use described in the protocol. The grant section should not be substituted for the animal protocol since the protocol must be written in lay terms and addresses specific issues that the IACUC must review.

      Original protocols will be assigned a protocol number and either the entire protocol (if submitted via e-mail) or a summary (if submitted as hard copy) will be sent to all IACUC members by the Department of University Safety & Assurances. The IACUC members will then have five days to request a full committee review of the protocol. The protocol will be available for all members to review in the Department of University Safety and Assurances upon request.

      If full committee review is requested, the protocol will be reviewed at the next scheduled meeting of the IACUC (quorum required) or a special meeting will be called. Under full IACUC review the committee will either approve or require modifications to the protocol to secure approval, or they will withhold approval of the protocol. The investigator will be notified of the review and will receive written notification of IACUC decisions.

      If the IACUC requires modifications to the protocol the investigator will be notified. If the IACUC decides to withhold approval of a protocol, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. If the IACUC requires modifications to secure approval it will determine if the full committee should review these or if a designated reviewer can be appointed to do so.

      If full committee review is not requested, the IACUC will proceed with an expedited review by designated reviewers at either the next monthly IACUC work session or sooner by a designated reviewer(s). At least four members of the IACUC will comprise each monthly working group session of designated reviewers. The investigator will be invited to the review session. At a work session the designated reviewers will review and either approve or require modifications in the protocols to secure approval, or it will request full committee review of a protocol. If the work group of designated reviewers require modifications to the protocol the investigator will be notified. The modifications will be circulated to the designated reviewers for their final approval when received from the investigator.

      The Chair may also allow an expedited review by appointing one or more qualified designated reviewers to review the protocol if time constraints require this. This method will also be used in cases where an investigator submits a previously reviewed and approved protocol to a different funding agency and there may only be a title change. These reviewer(s) may only approve, require modifications to approve or request full committee review of those research projects. If the designated reviewer(s) require modifications to the protocol the investigator will be notified. The modifications will be circulated to the designated reviewers for their final approval when received from the investigator.

   2. Deferred Review

      If the animal work is being done at another institution with an NIH Assurance in collaboration with one of UWM’s investigators, the UWM IACUC may opt to defer the review to the other institution’s IACUC. The UWM IACUC must receive a copy of the approval letter from the other institution as well as a copy of the protocol. The local investigator should complete the UWM coversheet for this project. The local investigator will be sent annual renewal notices for this project. The UWM IACUC will notify the other institution’s IACUC that they are deferring the review to them, and request that UWM be notified of any changes in the status of the protocol or any relevant findings on their facility tours.

   3. Term

      Protocol approval remains in effect for three years with continual reviews on at least an annual basis. Annual renewal notices will automatically be sent to investigators prior to the first and second anniversary dates of the original approval date. The IACUC will be notified of the review at the time the renewal notices are sent out so they have the opportunity to participate in the review. Otherwise the attending veterinarian and the Chair of the IACUC will review annual renewals. To renew a protocol on the third anniversary date of the original approval date the principal investigator will submit a current protocol form. The protocol will then go through the normal IACUC review process for original protocols.

   4. Modifications

      All modifications to protocols must be inserted into the original protocol and put in bold or highlighted and submitted to the Animal Care Program as an email attachment. Minor protocol modifications will be reviewed by the Chair of the IACUC or his/her designee. Minor modifications include changes in title or funding agency with the animal protocol being the same, and changes in personnel other than the Principal Investigator. The IACUC must ensure that all such personnel are appropriately identified and adequately trained and qualified, enrolled in applicable occupational health and safety programs, and meet other criteria as required by the IACUC. Individuals will be added to protocols once they are trained by the Veterinarian and/or Lab Manager.

      Major modifications will be treated the same as a new protocol submission. If no Committee member requests a full review the significant protocol modifications will be reviewed at the next monthly IACUC work group of designated reviewers or via an expedited fashion as described previously. Major modifications include: changes in the objectives of the study; proposals to switch from non-survival to survival surgery; changes in the degree of invasiveness of a procedure or discomfort to an animal; changes in species or in the approximate number of animals used; and changes in anesthetic agents, the use or withholding of analgesics, and methods of euthanasia. Additional factors may involve changes in the duration, frequency or number of procedures performed on animals.

   5. Other Important Information

      The Animal Care Program will send appropriate communications to granting agencies and will keep a file of all approved protocols. All protocol review actions will be listed in meeting agendas to keep the entire IACUC abreast of all protocol approvals.

      No IACUC member may participate in the review or approval of a protocol in which the member has conflicting interest (e.g. if the member is personally involved in the project), except to provide information requested by IACUC; nor may a member who has a conflicting interest be counted towards the constitution of a quorum.

      Animal care and use protocols that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the institution. These officials may not approve sections of the protocol related to the care and use of animals, however, if they have not been approved by the IACUC.

      If the protocol involves the use of radionuclides, the Animal Use of Radionuclide form must be submitted and approved by the Radiation Safety Office. IACUC approval is required prior to the approval of this form. The approved form should be sent to the Department of University Safety & Assurances, to be processed along with the Animal Protocol Review Form.

      If the project involves the use of bio-hazardous agents (e.g. infectious agents) the "Biologic Agent Registration Form" must be submitted to the Department of University Safety & Assurances. Once approved, it will be processed along with the Animal Protocol Review Form. If the project involves that use of hazardous chemical agents the PI should submit the "Investigation Involving the Use of Hazardous Chemicals” to the Department of University Safety & Assurances. Protocol forms will be sent to the appropriate Department of University Safety and Assurances personnel for review to determine if hazardous chemicals are involved and the form should be completed.

3. Appealing a Decision in the Review Process

   1. If concern is raised at the initial stages of the review process, the PI should discuss the decision or recommendations for modifications with the appropriate reviewer, within 30 working days from the date of action. If the appropriate reviewer is not available, the PI may request that the period be extended by the IACUC chair.

   2. The individual may appeal a reviewer’s findings to the IACUC chair by submitting a written request for appeal within 10 working days. The IACUC will try to resolve the problem through discussion, or if no resolution is apparent, ask that the IACUC convene a meeting as soon as possible. The decision of the IACUC will be forwarded to the Principal Investigator, Director of the Department of University Safety & Assurances, and the Vice Chancellor of Administrative Affairs.

4. Frequency of Committee Review

   Working groups of designated reviewers of the IACUC meet monthly to review protocols. The deadline for protocol submission for review at these meetings is one week prior to the scheduled meeting. The entire IACUC meets quarterly unless a specific meeting is called for another time. Meeting dates are posted on the Animal Care Program website. All meetings are subject to the open meeting law.

Updated September 14, 2007 by SAK