Institutional Animal Care and Use Committee

General Questions

What is the Animal Research Protection Program?
What is an ACUP?

Submission/Review/Deactivation Process


Who is eligible to be a principal investigator on an ACUP?
When is it necessary to submit an addendum to an ACUP?
What is the difference between a significant change and a minor change to an ACUP?
Is there a process in place for the IACUC to review and approve addenda outside of regularly scheduled IACUC meetings?
What should I do if I am ready to deactivate my ACUP?
I am a new investigator and I need help completing the ACUP form. Whom shall I contact?

Protocol Drift/Evolving Research

My research has evolved and I now want to study a new compound, change a medical technique, or perform a new surgical procedure that was not included in my original ACUP. How should I proceed?
I want to use a new species not included on my ACUP. What do I do?

De novo review

What is a de novo re-write?
What is the purpose of the three-year de novo?
My three-year de novo may not be finished in time for it to be approved before my current ACUP expires. Can I get an extension on my current ACUP approval?
My ACUP has expired but I still have animals. What will happen to these animals?

Semi-Annual Laboratory Inspections

What is the IACUC looking for during these inspections?
Why are laboratory inspections conducted every six months?
How do I prepare for the laboratory inspections?

Quality Assurance/Animal Welfare Issues

What will happen if I do not follow my ACUP?
Who do I contact if I suspect non-compliance or animal neglect and/or mistreatment?
Why is it necessary to search an animal welfare database in addition to other PubMed or MedLine?
Why is it necessary for the IACUC to review the vertebrate animal section of the grant(s) supporting an ACUP?
Why is a second method of euthanasia required when inhaled or injected anesthetics are used?

Rodent Census

How is an animal census counted?
What happens if I receive an overcrowding violation?
At what point are weanlings counted against the number of animals authorized for my ACUP?
If I am approaching the number of animals authorized for my ACUP how should I proceed?

Training Requirements

What training is required for new staff before beginning a study?
Why is it necessary to take an annual refresher tutorial?
What training is necessary for an Investigator who will not be directly handling animals?

USDA Pain Categories

Can you explain the USDA pain categories?

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What is the Animal Research Protection Program

The Animal Research Protection Program (ARPP) was developed to ensure the proper care, use and humane treatment of animals in research. The Institutional Animal Care and Use Committee (IACUC) is an integral part of this program. Additional components are responsible for ensuring that all personnel involved in animal research activities understand and comply with the ethical, IACUC and regulatory requirements of animal research. The ARPP coordinates oversight by incorporating all aspects of compliance related to animal research. The components of the ARPP are:

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What is an ACUP?

An ACUP is an Animal Care and Use Proposal. The IACUC requires an investigator to have an approved ACUP for all research involving animal subjects at KUMC.

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Submission/Review/Deactivation Process

Who is eligible to be a principal investigator on an ACUP?

Only KU faculty and LAR professional staff may submit an ACUP. ACUPs to support research of graduate students, residents, and post-doctoral fellows must have a faculty member or LAR professional staff as principal investigator.

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When is it necessary to submit an addendum to an ACUP?

It is necessary to submit an addendum to an ACUP if the investigator is requesting significant changes to his/her currently approved ACUP.

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What is the difference between a significant change and a minor change to an ACUP?

Significant changes to an ACUP require that the proposal be amended by submitting an addendum for IACUC review and approval. Examples of significant changes include changes in study procedures or design, addition of new surgical procedures, use of new drugs or treatments, changes in personnel, changes in approved method of euthanasia, changes in animal species, or increasing the number of authorized animals. Examples of minor changes that do not need an addendum include, changes in animal weight or age requirements, reduction in the dosage of approved drugs, reduction in the frequency of study related procedures other than husbandry, reduction in animal numbers and minor variations in the schedule of previously approved procedures.

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Is there a process in place for the IACUC to review and approve addenda outside of regularly scheduled IACUC meetings?

Addenda may be submitted to the IACUC at anytime. If the investigator requests review outside the regular review schedule, the addendum is forwarded to designated members of the IACUC for consideration.

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What should I do if I am ready to deactivate my ACUP?

Notify the IACUC and make sure that all animal subjects are transferred to other approved ACUPs or euthanized as outlined in the approved ACUP.

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I am a new investigator and I need help completing the ACUP form. Whom shall I contact?

Please feel free to contact any member of the IACUC. They are always willing to help new investigators navigate through the approval process.

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Protocol Drift/Evolving Research

My research has evolved and I now want to study a new compound, perform a new surgical procedure or medical technique that was not included in my original ACUP. How should I proceed?

Submit an addendum to your ACUP by completing the addendum form. Forward a copy of the completed form to iacuc@kumc.edu or to the Animal Research Protection Program, Mail Stop 2014, 3901 Rainbow Blvd., Kansas City, KS 66160.

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I want to use a new species not included on my ACUP. What do I do?

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De novo review

What is a de novo re-write?

ACUPs are approved for a three year period. Before the three year approval period ends, investigators are required to review their current research needs and complete a new ACUP for IACUC review. De novo re-writes have to meet the same standards as a new ACUP being submitted for initial review.

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What is the purpose of the three-year de novo?

The IACUC requires investigator's to complete a de novo re-write to remain in compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals. The Policy requires the IACUC to conduct a complete review of on-going research at least once every three years. By completing this process, the investigator does a full review of his/her current research and future plans.

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My three-year de novo may not be finished in time for it to be approved before my current ACUP expires. Can I get an extension on my current ACUP approval?

The IACUC is not allowed to administratively extend the life an ACUP. Investigators are notified that their ACUP will expire four months before expiration. This allows the investigator to have approximately, two months to complete the de novo re-write and approximately two months to acquire IACUC approval.

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My ACUP has expired but I still have animals. What will happen to these animals?

These animals will be temporarily transferred to a holding protocol. This will allow the investigator time to seek IACUC approval for a replacement ACUP or transfer the animals to another approved ACUP. During the time that the animals are on the holding protocol, the investigator will be responsible for per diems and the animals will not be available for research activity. If the animals are not transferred to an approved ACUP, they will be euthaized by the method indicated in the original ACUP.

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Semi-Annual Laboratory Inspections

What is the IACUC looking for during these inspections?

The IACUC audits include (but are not limited to): knowledge of approved protocol. Inspections also provide an opportunity for investigators to ask questions and to discuss issues with the inspector(s).

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Why are laboratory inspections conducted every six months?

Laboratory inspections are conducted every six months to comply with USDA and PHS Policy. Inspections also provide regular contact between IACUC members and research staff.

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How do I prepare for the laboratory inspections?

Investigators can prepare for laboratory inspections by being knowledgeable of his/her ACUP and ensuring that laboratory staff are knowledge of the ACUP. Investigators and staff should be familiar with the OLAW IACUC Inspection checklist.

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Quality Assurance/Animal Welfare Issues

What will happen if I do not follow my ACUP?

If a researcher is found to be out of compliance with the approved ACUP, this will be reported to the IACUC and to the Director, ARPP. An investigation will be performed to determine the cause of the noncompliance. Additionally, the noncompliance will determine any implications for animal health and welfare. Depending on the results of the investigation, the situation may need to be reported to OLAW and AAALAC.

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What do I do if suspect non-compliance or animal neglect and/or mistreatment?

You may discuss this concern with Laboratory Animal Resource (LAR) veterinary staff, IACUC chair or another member of the IACUC, or the Director, ARPP at 588-5492. You may also report your concerns to the Compliance Helpline at (913) 588-5757 or TDD (913) 588-7963. Such a report can be made anonymously. These reports must be made in "good faith" and not with malicious intent.

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Why is it necessary to search an animal welfare database in addition to PubMed or MedLine?

The USDA requires that investigators specifically search animal welfare databases for alternatives to procedures that have the potential to cause pain and/or distress. This is in addition to the literature search performed for your area of research. « Back to Top

Why is it necessary for the IACUC to review the vertebrate animal section of the grant(s) supporting an ACUP?

PHS Policy requires that the institution confirms the research proposal submitted for funding is the same as that approved by the IACUC.

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Why is a secondary method of euthanasia required when inhaled or injected anesthetics are used?

The likelihood of a failed euthanasia attempt increases with inhaled or injected anesthetics. Failed euthanasia must be reported to OLAW and AAALAC. To ensure death and reduce potential pain and suffering from failed euthanasia attempts, a new SOP was implemented.

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Rodent Census

How is animal census counted?

LAR staff conduct a manual census count weekly. During this time, the staff look for overcrowding, cage card violations, and pups that need to be weaned.

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What happens if I receive an overcrowding violation?

If overcrowding is noted a non-compliance sticker is placed on the cage. The PI then has 48-hours to correct the problem. If the problem is not corrected with in 48-hours, LAR staff will wean the cage(s) and bill the PI for this service. Note LAR staff will wean the cages to achieve proper stocking densities but the integrity of lines will not be ensured.

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At what point are weanlings counted against the number of animals authorized for my ACUP?

On the 21st day of age, juvenile rodents are added to the current census sheet and are subtracted from the number of animals authorized for that ACUP. If the PI wants to make sure that these pups are not counted against his/her ACUP, he/she should consider weaning pups before they reach 21 days.

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What do I do if I am approaching the number of animals authorized for my ACUP?

If an investigator receives a notice that he/she is approaching the number of animal authorized for his/her ACUP, the investigator should review his/her research objectives and determine if more animals will be needed before the ACUP is scheduled to expire. If more animals are needed, the investigator should submit an addendum to his/her ACUP requesting to increase the number of animals authorized. Statistical justification for this increase must be provided.

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Training Requirements

I am a new investigator or I have new staff in my lab. What training is required?

New investigators and new research staff are required to attend an instructor led session in the LAR and to complete the Animal Welfare Tutorial offered through Chalk. During the instructor led training session, additional training requirements, such as species and procedure specific hands-on training or videos, will be determined.

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Why is it necessary to take an annual refresher tutorial?

The annual Animal Welfare Refresher Tutorial was designed to be a vehicle for sharing new guidelines, regulations, and updated information related to animal welfare.

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I am the PI on an ACUP but I will not be handling the animals. Will I need to complete any training?

Yes. As the principal investigator, you are responsible for the conduct and compliance of the proposed research. With this in mind, you need to be aware of regulations, guidelines and university requirements relating to your research.

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USDA Pain Categories

Can you explain the USDA pain categories?

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