Institutional Animal Care and Use Committee (IACUC)- Procedures

Use of Animals in Research

All activities involving the use of live vertebrate animals must be approved by the IACUC. Specific examples of such activities are: Research (including field studies and clinical trials), use of blood donor animals, and breeding colonies.

IACUC approval is not required when all procedures are being carried out on tissues obtained from a slaughterhouse or from animals euthanized for another purpose. If, however, animals are procured and euthanized/slaughtered to obtain tissues for a particular project, that project must be approved by the IACUC.

Faculty are expected to obtain IACUC approval for these activities regardless of where the animals are maintained and/or the project carried out. However, if a project is to be done at a site or in cooperation with an institution that has its own Animal Care and Use Committee, a copy of that committees approved form may be submitted to the IACUC.

To obtain IACUC approval, a Protocol Review Form (PRF) must be submitted electronically to coac@iastate.edu for review and approval. Forms are available at http://www.compliance.iastate.edu ; please use the most current version available. The original, completed signature pages(s) should be sent to Sarah Zamzow , 1138 Pearson Hall.

Completed forms must be submitted to and approved by the IACUC before any animals can be used on a project. Faculty should be aware that some agencies (e.g., NIH) require verification of IACUC approval before grants are awarded.

New PRFs are sent to the IACUC after the noon submission deadline each Wednesday, for review at the following weeks subcommittee meeting. This procedure satisfies the federal requirement that all committee members have the opportunity to review all protocols. Each subcommittee is composed of the attending veterinarian and two members of the IACUC, who serve on a rotational basis. The subcommittee may approve a project, request additional information or modifications, or refer the entire protocol to the full committee for review.

Prior to IACUC review, a committee identification (log) number is assigned. Please include the log number when communicating with the IACUC about the project.

Following IACUC approval, a copy of the final, approved PRF will be sent to the PI via email, and a copy of the signed IACUC approval will be sent via campus mail. The PI should retain a copy of the application for approval, any communication from the IACUC including the approval letter, and the signed signature page.

A decision not to approve a protocol must be made at a meeting of the full committee. A majority of the quorum present is necessary to deny approval. Written notification of denial and the justification for this action will be sent to the PI, with a copy going to the Vice President for Research and Economic Development.

Because of the number of disciplines in which proposals are submitted, it is not possible for a committee such as the IACUC to have expertise in all areas. Thus, both the Animal Welfare Act and the Public Health Service Policy recognize the need for the committee to, on occasion, refer certain questions to consultants. When this situation arises, the IACUC will contact the PI and give the PI the option of agreeing that a consultant may be contacted or withdrawing the proposal from IACUC consideration. The PI may suggest individuals who may serve as consultants. The IACUC may or may not utilize these suggestions. In cases involving a consultant, the person chosen is generally asked questions regarding a specific aspect of the protocol (e.g., the species chosen as a model, a specific proposed procedure, a drug dosage or route of administration). The PI will be notified before copies of the PRF are shared with a consultant.

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Use of Animals in Teaching

IACUC approval for the use of live vertebrate animals must be obtained prior to the use of these animals in a scheduled course, continuing education offering, or special event.To obtain IACUC approval, a completed Protocol Review Form- Teaching or Protocol Review Form Special Events (whichever is applicable) must be submitted electronically tocoac@iastate.edu for review and approval. Forms are available at http://www.compliance.iastate. edu ; please use the most current version available. The original, completed signature page(s) should be sent to Sarah Zamzow, 1138 Pearson Hall. Completed forms must be submitted to, reviewed, and approved by the IACUC before any animals can be used in the class/project.

The procedures involved in the review of teaching and special events protocols are identical to those described above for research activities.

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Modifications to Approved Protocols

The IACUC must approve all changes to previously-approved protocols prior to the change taking place.To obtain approval for a modification request, a Continuing Review and/or Modification form should be sent electronically to coac@iastate.edu for review and approval. This form is available at http://www.compliance.iastate.edu; please use the most current version of the form.  The original, completed signature page should be sent to Sarah Zamzow, 1138 Pearson Hall.

Minor modifications are reviewed by the IACUC Chair (or Designated Alternate Chair , in the Chairs absence).The procedures involved in the review of major modifications are the same as those described above for research activities. A sample list of major vs. minor modifications follows:

Major vs. minor protocol modifications

In an attempt to help Iowa State University investigators determine what course of action is necessary when making modifications to an existing animal protocol, we have generated two lists of examples. These lists are in no way complete and are shown here only as a guide to help investigators make informed decisions when modifying existing protocols.

Please note:  per the Research Compliance Advisory Committee, a change in Principal Investigator (PI) is not a modification, but rather requires submission of a new Protocol Review Form (PRF).

The following is a list of modifications that the Institutional Animal Care and Use Committee deems as major, and as such require submission of a Continuing Review and/or Modification form by the PI (via email to coac@iastate.edu), and review and approval by the IACUC (please note: if the changes are considered significant enough, the IACUC may require submission of a new PRF):

1. Changing the Principal Investigator.
2. Applying the protocol to a new species [however, PRFs in which several species are already studied are exempt (i.e. survey studies)].
3. Changing the number or age of animals used on the study.
4. Changing the humane use category.
5. Changing when an intervention will be administered to an animal on trial.
6. Changing the duration, frequency or number of procedures to be performed on an animal.
7. Changing from terminal to survival or repeat surgery.
8. Changing to a different surgical approach or medical treatment.
9. Changing the dosage or dose of hazardous agent or an infectious or biohazardous material already in the protocol.
10. Addition of a new hazardous agent (e.g. betamercaptoethanol).
11. Addition of a new biohazardous material or new infection protocol (e.g. adenovirus vs. lentovirus).
12. Changing or adding objectives to the study.
13. Changing the anesthetic agent(s) or the use or withholding of analgesics. PIs should give an acceptable range so that a modification is not needed.
14. Changing the method of euthanasia.

The following is a list of modifications that the Institutional Animal Care and Use Committee deems as minor, and as such require submission of a Continuing Review and/or Modification form by the PI (via email to coac@iastate.edu) for approval by the IACUC Chair

1. Changes in personnel other than the principal investigator. When adding personnel, list their role/duties on the project and list their training.
2. Changing the sex of animals used on a protocol.
3. Changing the supply source of animals.
4. Changing the campus housing location.
5. Changing the disposal of animals.
6. Changing the amount of blood drawn, if within guidelines.
7. Changing the person monitoring anesthesia (if person is properly trained).

Forms are available at http://www. compliance.iastate.edu.

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Continuing Review of Protocols (formerly "Protocol Renewal")

All approved, ongoing research, blood and tissue collection, breeding colony, teaching, and special events protocols must be reviewed and approved annually. Approximately 45 days prior to a projects expiration date, a continuing review notice will be sent via campus mail as a courtesy to the PI. This will be the only reminder. The investigator is responsible for ensuring that the form is submitted with adequate time for IACUC review and approval before the continuing review date.

If the project is to continue, is entering its second or third year, and there have been no significant changes, the PI may request approval by submitting a completed Continuing Review and/or Modification Form (available at http://www.compliance.iastate.edu to coac@iastate.edu. Please use the most current version of the form. The original, completed signature page should be forwarded to Sarah Zamzow, 1138 Pearson Hall.

If approved, the project will retain the original Committee identification (log number) assigned. The procedures involved in the review of continuing reviews are identical to those described above for research activities.

If a project is to continue beyond three years, or if a significant change has been made to the protocol, a new Protocol Review Form (PRF) must be submitted to the IACUC for review and approval.

If a Continuing Review form or new PRF has not been submitted to, reviewed by, and approved by the expiration date, the project will be considered expired, and the PI notified in writing that no animals (including any currently being housed) can be used on the project until a new PRF has been submitted to, reviewed by, and approved by the IACUC.

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