Criteria of Review
Basic Criteria of IACUC Review
IACUC’s overall task is to determine whether a project's societal benefit justifies any animal pain and suffering that it might cause, and whether whatever animal pain or suffering occurs will be kept to a minimum.
All proposed activities are reviewed to ensure that the following requirements for IACUC approval are met:
- All activities involving animals are in accord with PHS Policy, the Animal Welfare Act, University and IACUC policy, etc.
- A clear rationale is provided for involving animals and for the appropriateness of the species and numbers of animals to be used.
- Animal living conditions must be consistent with standards of housing, feeding, and care as directed by a veterinarian or scientist with appropriate expertise. Medical care must be provided by a qualified veterinarian. Investigators are responsible for arranging suitable housing pursuant to the regulations and in accordance with any permits for the usage.
- The investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animal and has provided a written narrative description of the methods and sources used to determine that alternatives are not available.
- The application includes a complete description of the proposed use of the animals and procedures designed to assure that discomfort and pain will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain.
- The investigator has planned for the appropriate monitoring of animals, reasonable surgical interventions, and the responsible euthanasia of those animals consistent with AVMA recommendations under specified conditions.
- Documentation or copies of any necessary permits are included.
- All personnel are appropriately trained and qualified to conduct the research or other activity at hand.
The assessment also includes any additional factors important in the context of the specific proposal to ensure compliance with all applicable federal regulations and IACUC and institutional policies.
Considerations of Committee to Aquire Approval
PHS policy and the Animal Welfare Act require that the IACUC “review and approve the proposed use of animals in research before it is conducted.” While each institution is allowed flexibility in determining how this information will be collected and reviewed, The Guide for the Care and Use of Laboratory Animals and the USDA do list general topics to be considered during the review of an IACUC protocol. Below is a list of the items outlined in the guide along with where this information is collected in the U of M form.
|Suggested Review Topics from the Guide||Location in UMN IACUC Form|
|Rationale and purpose of the proposed use of animals||Rationale Page|
|Clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee||Experimental Design Section 1|
|Availability or appropriateness of the use of less invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation||Ancillary Information: Alternative Search
Note: This section is only applicable if the protocol contains pain class B or C procedures
|Justification of the species and number of animals proposed; whenever possible, the number of animals and experimental group sizes should be statistically justified||Experimental Design Section 2|
|Unnecessary duplication of experiments||Aspects are collected in Species Section 3 and Experimental Design Section 2|
|Nonstandard housing and husbandry requirements||Species Section under IMHA and in the Health and Monitoring Section questions 4 and 5|
|Impact of the proposed procedures on animals’ well-being||Health and Monitoring|
|Appropriate sedation, analgesia, and anesthesia||Procedure Details|
|Conduct of surgical procedures, including multiple operative procedures||Procedure Details|
|Postprocedural care and observation (e.g., inclusion of post-treatment or postsurgical animal assessment forms)||Procedure Details Under Surgery|
|Description and rationale for anticipated or selected endpoints||Experimental Design and Euthanasia|
|Criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated||Euthanasia, Procedure Details, and Health and Monitoring|
|Method of euthanasia or disposition of animals, including planning for care of long-lived species after study completion||Euthanasia|
|Adequacy of training and experience of personnel in the procedures used, and roles and responsibilities of the personnel involved||Personnel and Procedure Details for Surgery|
|Use of hazardous materials and provision of a safe working environment||Ancillary Information under “DEHS & OHS”|
We encourage investigators to incorporate some flexibility within their protocol. For example, protocols can contain ranges for treatments given, alternate acceptable regimens for analgesics and anesthetics, maximum values for repeated treatments, and maximum values for endpoints. Investigators are required to list all procedures outlined in their grants prior to receiving awards. Consequently, labs may not know the exact details of procedures to be performed in later aims of a particular study and incorporating ranges will hopefully decrease the number of times the investigator needs to amend the protocol to account for new findings.
This approach does not mean that protocols can forego providing any detail for their procedures and experimental design.
The expectation of the Federal Enforcement agencies that review animal use is that the content of the IACUC protocol be written in layman’s terms so that a nonscientist from the general public could determine what will be done with animals.