Review Criteria

General Guidelines

Willamette University complies with the regulations and recommendations for the care and ethical treatment of animal participants involved in research through the Animal Welfare Act [P.L. 89-544 as amended by P.L. 91-579 and P.L. 94-279 as published in the Code of Federal Regulations (CFR), Title 9 (Animals and Animal Products), Subchapter A (Animal Welfare), Parts 1, 2, and 3) and the U.S. Department of Health and Human Services published in the Guide for the Care and Use of Laboratory Animals (1985). Additional regulations may provide protection to species and all appropriate state and federal permits must be obtained prior to conducting field or laboratory research on animals protected by the Endangered Species Act of 1973 [P.L. 93-205; 87 Statute 884 as published in CFR, Title 50 (Wildlife and Fisheries), Chapter I (U.S. Fish and Wildlife Service, Department of the Interior), Subchapter B, Part 17] and other state and local regulations.

The Willamette University Institutional Animal Care and Use Committee (IACUC) for the protection of animal participants, is charged with the responsibility of reviewing, prior to its initiation, all research involving animal participants (whether the Project is funded or not). The IACUC is concerned with evaluating the care and treatment of participants in research ensuring the ethical treatment of animal participants.

The IACUC's intention is not to hinder research; its only objective is to ensure that the welfare of animal participants is protected and that the project complies with federal standards. The IACUC is composed of Willamette faculty in the biological sciences.

Review Criteria

ALL research involving vertebrate animal participants (i.e. exploratory, descriptive, and experimental) must be reviewed by the IACUC. If the proposed study has not been completely designed at the time that a research proposal is submitted to a sponsor, provisional approval may be granted. Final approval must be sought when the research plans are complete and before the involvement of animal participants in the project.

Although IACUC review of research involving non-vertebrate animals is not required, the committee strongly suggests that that spirit of the Animal Welfare Act and other federal guidelines be considered as part of the ethical responsibility of the researcher. To this end, the IACUC will conduct a Courtesy Review of such proposals at the request of the researcher and provide recommendations.

While the ultimate responsibility of conducting research in an ethical manner that complies with federal, state and local regulations rests with the researcher, the IACUC reviewers will seek to determine that (from the U.S. Department of Health and Human Services, 1985 --- NIH Publication No. 86-23, Appendix D):

  1. The transportation, care, and use of animals is in accordance with the Animal Welfare Act and other applicable federal laws, guidelines, and policies.
  2. Procedures involving animals are designed and performed with due consideration of their relevance to animal health, the advancement of knowledge, or the good of society.
  3. The animals selected for a procedure are of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulations, and in vitro biological systems should be considered.
  4. Proper use of animals, including the avoidance and minimization of discomfort, distress, and pain when consistent with sound scientific practices is imperative. Unless the contrary is established, investigators should consider that procedures cause pain or distress in humans may cause pain or distress in other animals.
  5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
  6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
  7. The living conditions of animals are appropriate for their species and contribute to their health and comfort.
  8. The investigators and other personnel are appropriately qualified and experienced for conducting procedures on living animals.

Exceptions: No Application Required

Only projects that involve hands-on work with vertebrate specimens that are alive during or immediately prior to the project require review. Projects that involve non-vertebrate species or non-living vertebrate specimens such as museum specimens, preserved specimens, or other animals that are not euthanized in order to conduct a project are not subject to review, nor are projects that consist solely of field observations of animals in their natural habitats.

Courtesy Reviews

In the case of a project that does not require a review as described in the previous section on 'Exceptions', but where the researcher desires the input of the IACUC, the researcher should complete the application and be certain to request a 'Courtesy Review' on the Application for Approval. Such reviews will be treated in the same fashion as the Expedited Reviews described below.

Expedited Reviews of Teaching/Classroom Based Use of Animals

Abbreviated reviews (turnaround times of 1 to 2 weeks) are possible for classroom initiated research and demonstrations in which animals will be used for a relatively short period of time. The results of such research must not be distributed outside the classroom and/or institutional setting. If in doubt, it is wise to have a Full Committee Review because the IACUC is unable to give post facto approval. In the case of an Expedited Review, the chairperson of the IACUC chooses a limited number of members to review the proposal by email. If the limited group of reviewers have significant concerns, a Full Committee Review may be warranted. Informal consultation with the IACUC chairperson may assist the applicant in determining the best type of review to request.

Full Committee Review

The entire IACUC will review all proposals that do not fall into the Expedited Review category. Please allow one month for Full Committee Review and subsequent notification.

Continuing Review

In its initial review of the proposal, the IACUC will consider the extent of continuing review needed. All proposals shall be reviewed annually, but in certain research the participants are exposed to more than usual risk; such proposals may be reviewed at more frequent intervals appropriate to the research. This review interval will be determined at the time the research is approved and may be changed at the discretion of the IACUC. In each such review, the principal investigator will be required to promptly report the status of the research activity, and any proposed changes in the research activity. If the research is still in progress, the investigator will affirm that the approved research protocol involving animal participants is being followed.