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Frequently Asked Questions (FAQ)

About IACUC

Getting a Protocol Approved

Common Committee Concerns

Definitions

Euthanasia Death as an Endpoint

Stipulations from the committee

Requesting changes to approved protocols

Transfers, Timelines and Reactivation

Animal Care/Management

 


 

What steps do I have to take to submit an application to the IACUC for use of animals?

Download IACUC forms at: http://www.research.umn.edu/iacuc/download. Note that there are multiple appendices to select separately depending on what you are doing.

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What training do I and my staff need to complete before my protocol can be approved and we can begin working with animals?

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I'm requesting a change in protocol for a procedure that I've done previously on a prior protocol. Can I just reference that protocol in my request?

Each protocol must contain details of each procedure performed and references to other protocols are not accepted. P lease also note that regulations continue to evolve, so procedures approved in the past may require additional information before committee approval.

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Do I always need to submit an amendment for CIPs?

The IACUC should be notified of any requested changes prior to implementation. Protocol changes that require an amendment request to be submitted to the IACUC should include: changes involving increasing the number of animals used, adding additional species, including additional experimental procedures or pilot studies, adding anesthetics/analgesics, changing housing/use locations, and changing the Principal Investigator. The change of adding or removing Co-Investigators or other personnel does not require an amendment request and can be implemented by submitting an Add/Delete Change IACUC Protocol Personnel Form.

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How do I add a title to my existing IACUC protocol?

The IACUC can add additional titles if the study personnel, animal numbers and animal work remain identical to what has already been approved by the IACUC under an approved protocol and that the addition of this title does not involve any change to the protocol. Submit a letter (signed by the principal investigator) confirming the addition of titles meets this requirement.

If the protocol is receiving additional external funding for the additional title, please complete and submit Appendix O for each additional title.

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Do I need to complete appendices for alternatives to stress levels B or C, breeding, outside housing, surgery, blood draw, etc. when making a change in protocol request.

Yes. The necessary appendices are available on the IACUC web site and are required by IACUC.

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How can I make a change in the principal investigator for a study? How can I add additional personnel?

Send a letter of request to IACUC summarizing the change, explaining the reason for the change. It must contain original inked signatures from the former and future principal investigators.

Changes in study leadership may constitute significant changes in expertise therefore, the IACUC requires change in PIs to be reviewed at an IACUC meeting, so please check the submission deadlines as posted.

Changes in personnel can be handled by submitting the Additional Personnel Request Form

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Is there anything that can help my review when I request additional animals?

Complete the table found on the IACUC application entitled, "Animal Request Table" located in section 1.

This table details the species, pain class, source of animals, housing and location of procedures information that are often stipulated by IACUC. See Animal Request Table Explained: Purchasing, Breeding, & Transferring for help with this table.

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How can I determine the status of my study.

OVPR has developed eResearch Central for University of Minnesota researchers designed to provide online access to study information. Through this tool the research staff can view the action history of their IACUC protocols. Access requires an active x500 account.  All personnel who will be working with animals must have a U of M x500 ID. To obtain one the PI or dept administrator should fill out the form at: http://www.umn.edu/dirtools/sponsor or email sponsor@umn.edu for more information.

You may also contact the IACUC Office at 612-626-2126 or IACUC@umn.edu to inquire the status of any submission.

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How should I prepare my response to stipulations set by IACUC?

Your response should be written on letterhead with an original inked signature from the principal investigator. Unless directed to do so, you do not need to submit a revised application form, but rather summarize the amendments in the letter and attach any necessary appendices.

Typically, a response to stipulation letter does not need to be reviewed by the entire committee. Individual members of IACUC review these letters to ensure rapid turnaround time.

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Is a response to "deferral" the same as "stipulations"?

You may follow the same format for re-review, but if you are submitting a response to deferral, your response requires review by the full committee at the next IACUC meeting. These submissions must meet the deadlines as posted on the web site.

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Why do I still have a stipulation for animal certification even after study staff have already completed IACUC's training?

The most common problem with verification of training is that names have been misspelled or the name was difficult to decipher on a continuing review form.

Sometimes study personnel have completed an RAR training session, ie. radiation training session, etc. and have that training confused with the IACUC training.

Occasionally a staff person is listed on an application who has a role on the project which will NOT involve animal use. In that case, submit correspondence detailing the role and the protocol can approved noting that person is not certified to work with animals.

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I have responded to the committee’s stipulations, but I have been waiting for approval for more than a week. What could be holding up my protocol?

The IACUC sends e-mail to the principal investigator(s) when IACUC has reviewed response to stipulation letters, but there may be outstanding stipulations remaining. There may be animal training certification requirements that need to be satisfied or there may be review processes outside the IACUC that are pending and delay the review.

Examples of outside reviewing include "Controlled Substances Review", "Environmental Health and Safety Review" and "Food Chain Review". To check on the status of these reviews, call the number listed on your stipulation letter to determine the nature of the delay.

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What if I have a disagreement with a committee decisions?

Please review this link and then call (612) 626-2126.

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Why is the committee asking me to consider alternatives to animal use?

Do not simply state that you need live animals, rather state what alternatives to the use of live vertebrate animals and/or animal tissues were considered. The committee needs documentation detailing how each alternative was considered and rejected for scientific reasons. For example, describe if there are problem results from specific alternative research methods (computer models, tissue culture, clinical studies).

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Why is there confusion about the number of animals I've requested? I'm not sure how to detail the number of animals I'm requesting for a breeding protocol.

Make the details regarding animal numbers easy for the committee to assess:

  • Explain justifications for group size (published results, statistical analysis based on previous established difference in measurements etc.). Detail which statistical tests are being applied (e.g., power analysis).
  • Clearly define the number of animals (e.g. 5 animals/group x 3 treatments x 4 time points x 2 different sexes = 120 animals). Define the groups, including controls, treatments, time points, etc.
  • When you have a complex protocol, in which the same animals or subsets of animals are used for multiple procedures, tables, flow charts, or named groups can be used to clarify the numbers.
  • If you have a breeding protocol, in which animals will not be used after genotyping, then please make sure the number of animals produced and the number needed for experiments is defined.
  • When describing the number of offspring used, separate your numbers into those that will be used exclusively for breeding and those that will be used in experiments.
  • Make sure your numbers add up and that they are consistent with what you enter under Animal Source in the next section.
  • When you use euthanized animals for organ culture, provide rough estimate for the number of animals (e.g. we will get 3x107 cells per liver and need 6x107 cells per experiment, for 15 experiments that means 30 animals).

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I've done this work quite often and have similar protocols with the IACUCU. Why is the committee so concerned about the details of my most recent application?

First, remember that the protocol you submit is a "stand alone" document and you cannot to procedures in other protocols or publications, or assume that they are so generally used that everyone will know what you will do. The Committee members do not have access to previous protocols, and references cannot take the place of procedure descriptions. Use the IACUC Guidelines section of the ORRP Website for descriptions of commonly used procedures.

The Committee is not interested in lengthy descriptions of in vitro experiments and will not read through grant applications for study procedures. You should briefly describe your aims and correlate it with your description and the justification for number of animals requested. It helps if you use common numbering systems in both sections.

The Committee needs to have information on all details relating to injections of drugs, virus vectors, etc. including routes of injection, volumes, site of blood draw, number of bacteria/viruses, etc.

The endpoints for all experiments need to be clearly defined. For chronic experiments, include how long will animals survive following a procedure, as well as their final disposition (e.g., euthanasia).Justify if death is an endpoint.

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I'm not sure how to answer the pain and distress questions on the application.

All sections do not have to filled in if it does not apply to your specific study. For example, if it is an acute study where the animal will not recover from anesthesia, Post surgical recognition of pain does not have to be considered. If there is no surgical procedure, you do not have to fill in the During Surgery box. Studies involving tumor development should consider During and After Surgery (implantation) signs of pain/distress.

The question is not what pain or distress will usually occur during the procedures you wish to perform, although this is clearly important, but whether are you prepared if things do not go as expected? If during your procedure pain or distress is experienced by animals what will you do? (example: incomplete anesthesia is recognized by xxxxx signs; it is corrected (alleviated) by increasing the anesthetic)

It is good practice to add a sentence that indicates if post-surgical pain is recognized you will consult with an attending veterinarian to discuss disposition of the animal. In some cases euthanasia may be appropriate, in others additional analgesics/antibiotics may allow you to keep the animal in the study.

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How do I transfer animals to my protocol?

  1. Animals should be listed on the IACUC Animal Usage Form (in the Animal Request Table - Section 1) to be transferred once the protocol is approved. Animals can be transferred from:
    1. an existing approved protocol, or
    2. a breeding protocol.
  2. Once the protocol is approved, animals must be transferred through Research Animal Resources (RAR). The transfer cannot occur until the Protocol Transfer Request FormLink exits IACUC web site has been completed and submitted to RAR.

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How soon can I expect to hear results from the IACUC meeting?

The IACUC posts the results of the meeting within 24 hours of a meeting on the web site and then produces its correspondence from the meetings. The goal for completion of all meeting correspondence is 10 business days.

Correspondence pertaining to protocols that are "approved as submitted" are completed first and can be faxed upon request. All letters detailing reasons for deferral or stipulations are sent via e-mail to the principal investigator as soon as possible.

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Is there any way to extend my approval period?

Federal regulations do not permit the IACUC to extend any approval periods. If a renewal protocol has not been processed and approved by the expiration date of the IACUC approval for the work will expire. Should IACUC approval expire, all activities involving the care and use of animals must cease immediately. Any activities conducted under the protocol after expiration will be in direct violation of federal regulations and institutional and IACUC policies.

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I have submitted my continuing review form. When will I receive the notification of its renewal?

Continuing review forms are reviewed by IACUC at a meeting preceding the expiration date of previous IACUC approval. Prompt response to deadlines listed on the form is essential to ensure adequate time to resolve questions before protocol expiration.

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My protocol was inactivated by the IACUC expiration, can I reactivate it?

Failure to respond to deferral, to stipulations or continuing review by the stated deadline can result in inactivation of the request. Extensions prior to deadlines can be granted by the IACUC.

Reactivation requires an explanation for failure to meet the deadline and documentation of fulfillment of the outstanding requirement.

Please note that files inactivated are eventually filed off-site and requests to reactivate files with a delinquent response may be subject to a $50 off-site retrieval fee.

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What is the role of the committee?

The Institutional Animal Care and Use Committee (IACUC) oversees the responsible use of animals in University research and instructional activities. The IACUC reviews protocols, reviews the animal care and use program, and monitors University animal facilities to ensure compliance with standards and regulatory requirements.

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What regulations and guidelines are there to dictate the committee's policies?

All research activities must conform to the statutes of the Animal Welfare Act and the guidelines of the Public Health Service as issued in the Guide for the Care and Use of Laboratory Animals (revised 1996). This site provides information to help investigators at The University of Minnesota comply with all legal requirements and provides documents and links to information that can help improve the quality of research involving animals.

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Why is my lab always being inspected?

Federal regulations governing the use of animals in research require that the IACUC review and inspect the care and treatment of animals in all animal study areas at least once every six months. These inspections must be performed by at least two IACUC members. Study areas include any place where animals are housed for greater than 12 hours and where surgical manipulations are conducted.

As part of their oversight responsibilities, the IACUC has also initiated a policy for separate inspections of facilities and areas using animals outside of an approved RAR housing.

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What are the definitions and classification for animal pain or distress ?

Potential Pain/Distress: Procedures are classified according to the level of potential pain or distress that the animal may experience. If more than slight or momentary pain and distress could be caused by the procedure, then relief must be provided (pain class B). If relief cannot be provided (pain class C), there must be scientific justification for withholding of relief, the justification must be included in the animal use protocol, and must be approved by the IACUC. Additional information can be found in USDA Animal Care Resource Guide, Policy #11, Painful Procedures.

USDA Pain Codes
C - No Pain or Distress
D - Pain or Distress with Relief
E - Pain or Distress Without Relief

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What are the attributes of major survival surgery and multiple survival surgery?

Multiple Major Survival Surgery: A major survival surgery penetrates and exposes the body cavity or produces substantial impairment of physical or physiologic functions (such as laparotomy, thoracotomy, craniotomy, joint replacement and limb amputation). Scientific justification is required in the animal use protocol if more than one major survival surgery is to be performed on an animal during the course of the protocol experiment.

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What is food and fluid restriction?

General

 

 

Certain experimental paradigms require the use of food or water restriction in order to accomplish studies such as operant conditioning work. The IACUC is required to approve these restrictions to ensure they are scientifically justified, minimize the level of restriction, and have criteria in place to monitor the health of animals on these studies.

Specifics

 

 

Animal use protocols employing food or water restriction must provide the duration of restriction, level of restriction, and justification for the restriction as part of the protocol description. Furthermore, the early removal criteria must provide methods to assess the animal's health while on restriction. Typically this will require a frequent monitoring method such as daily weighing of the animal. Note that pre-surgical food restriction is detailed in the surgery procedure as part of the animal use protocol, and does not need specific justification.

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What are the general requirements in euthanasia?

It is the IACUC's responsibility to assure that every effort has been made to ensure that death is as painless and distress-free as possible. Euthanasia techniques should result in rapid loss of consciousness followed by cardiac or respiratory arrest and ultimately loss of brain function. The IACUC requires the selected method of euthanasia to be consistent with the recommendations of the the report of the Americal Veterinary Medical Association Panel on Euthanasia unless scientifically justified. The American College of Laboratory Medicine has issued a report on rodent euthanasia that has many useful references and guidelines.

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What are the recommendations to follow when animals are euthanized using carbon dioxide?

Compressed CO2 gas in cylinders is the only recommended source of carbon dioxide because the inflow to the chamber can be regulated precisely. Carbon dioxide generated by other methods such as from dry ice, fire extinguishers, or chemical means is unacceptable. It is important to verify that an animal is dead before removing it from the chamber. If an animal is not dead, CO2 narcosis must be followed with another approved method of euthanasia.

Also see RAR's carbon dioxide chamber use information. 

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What are the recommendations to follow when animals are euthanized using cervical dislocation?

Cervical dislocation of small birds, poultry, rodents, rats weighing < 200 gm, and rabbits weighing < 2kg by individuals that have demonstrated a high degree of technical proficiency is considered an acceptable method of euthanasia by the AVMA and, thus, the IACUC.  In lieu of demonstrated technical competency, cervical dislocation must be preceded by anesthesia or heavy sedation unless scientifically justified and approved by the IACUC as an exception. 

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What are the general requirements for when death is used as an endpoint?

Death as an endpoint in animal experiments must be appropriately justified by the investigator and approved by the IACUC. The justification must include the following:

  • Alternative endpoints that were considered and why death as an endpoint was selected.
  • If analgesics cannot be used, a justification for why they cannot be used whenever possible.

The earliest endpoint of an experiment must be chosen, and the animal should be euthanized to avoid a prolonged or painful death if possible (see Institute for Laboratory Animal Research 41(2): , 2000).

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What procedures should be followed if individual identification is required?

Ear punch/notch: Rodents should be firmly restrained and a sharp punch or scissor used on the pinna (ear). Removed tissue may also be used for DNA analysis. The ear punch schematic should be standardized by the laboratory to ensure correct interpretation of the identification number.

Ear Tags: Individually numbered ear tags are widely used for rodent identification. The tag must be appropriately sized for the species/age of rodent. Proper placement of the tag is required to ensure it does not cause irritation or trauma to the ear. RAR staff is available to demonstrate and train personnel on proper placement location.

Microchip Transponders: Microchips are available for use in rodents and have the ability to transmit body temperature, activity, etc... in addition to providing a unique identification number. The chips are placed subcutaneously or intraperitoneally using aseptic technique. When microchips are used, scanners should be readily available to confirm animal identity.

Tattoo (ink injection): Rodent tattoo devices are available through RAR and can be used to permanently mark the skin on the tail, toes, or other sites as needed. RAR staff should be consulted for training on this method of identification. Tattooing may be best accomplished under anesthesia. Improper technique will result in fading of the tattoo.

Toe-clipping: Toe-clipping must be described and justified in the Animal Care and Use Protocol and approved by the IACUC. Toe-clipping should be used only when no other individual identification method is feasible and only on altricial pre-weaning rodents (mice and rats, but not guinea pigs) after the toes are no longer webbed and before they reach 8 days of age. If possible, it is preferable to remove toes from a hind paw rather than a forepaw. In neonatal mice before 8 days of age it appears to have few adverse effects on behavior and well-being. When possible toe clipping and genotyping should be combined. Under all circumstances aseptic practices should be followed.

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What records do I need to maintain for animals on a protocol?

A post-operative record should be kept in the room where the animals are housed. Having the record in the room accomplishes several functions. 1) It explains the condition of the animals to animal care staff (a sedated animal may otherwise be thought to be ill), 2) It assures animal care staff and federal inspectors that the animal is being cared for, and 3) It informs animal care staff how recently the investigator has seen the animal; this knowledge helps them decide whether or not there is a need to contact the investigator to inform him or her of the present condition of the animal.

Although individual records are desirable, a composite post-operative record may be used for a group of rodents. Download an example of a Post-Operative Care Record here, this example may be copied or modified as needed. Important information to include in the post-operative record is the animal's identification, surgical procedure summary, any therapeutics given including drugs, doses, and routes of administration, and the observation date and findings. After all wounds have healed and all sutures/wound clips have been removed, the post-operative record requires no further entries. When the study is completed and the animals are euthanized, the record may either be kept by the investigator or discarded.

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I am new to the University. How can I have my animal colony imported while I am waiting for IACUC approval of my protocol?

Contact RAR at 612-624-9100 and view rodent quarantine information at http://www.ahc.umn.edu/rar/rodentquarantine.html

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