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Frequently Asked Questions

How Do I Add/Remove A New Associate?

To add a new associate to an approved Proposal, please visit the "Forms" section of this web page and complete the electronic form for the Addition of a New Associate.  Once the reviewers have approved the form, the associate will then be added to the requested IACUC Proposal(s).

To remove an associate from a Proposal simply email the IACUC Service Account at iacuc@louisville.edu and request that the individual be removed.  Please remember to include the individual's first and last name as well as each Proposal number.

 

How Do I Modify My Proposal?

All request to modify an IACUC-approved Proposal, with the exception of adding/removing Project Participants (see the following question), should be submitted electronically to the IACUC Service Account at iacuc@louisville.edu and should consist of the following two items:  

1) An explanatory cover letter that describes and justifies proposed protocol changes. 

2) A complete, revised Proposal with the changes highlighted in yellow  . (Track Changes is not acceptable and will be returned.) If the modification includes a significant increase in the number of animals used (over 25%), change in laboratory location, or a change in project pain/distress classification, then a new hard copy signature page must also be forwarded to the IACUC office. 

For complete modification information please refer to the IACUC policy "Modification of an Approved Proposal".

 

May I Include Several Methods That May Or May Not Be Used In Experimental Groups?

Yes and no.  Yes, it is certainly appropriate to describe, for example, two different methods of euthanasia that may be used in different experimental groups. It is also likely acceptable to state that one of several methods may be employed for the same outcome (for example, modes of anesthesia, euthanasia, different post-procedural analgesia) as long as the IACUC understands the rationale behind the various means.

It might even be appropriate to describe invasive procedcures that may or may not be employed.  This becomes a bit stickier; however, because the use of such procedures may increase the potential for distress.  As long as the committee is congizant of what will (even potentially) occur, then approval is likely.

It would not be appropriate to simply provide a laundry list of potential procedures.  Again, the IACUC must not only be aware of what will happen to experimental animals, by why.  The IACUC Propsoals must describe and justify the experiments themselves and be able to reasonably agree that the designed experiments will produce useful data.  An incomplete, poorly planned, or open-ended study should not be approved.

 

Is There A Maximum Number Of Animals That Will Be Approved By The IACUC?

No.  The number of animals needed is driven by the goals of the experiments.  The use of each animal should be accounted in the Proposal; for some studies, this may be a very large number.  In fact, it is just as likely that the committee will question a small number of animals - it would be wasteful to attempt an experiment and not produce enough data for meanigful analysis.

 

I Will Be Submitting A Grant and the Proposed Use Of The Animals Involves Procedures For Which I Already Have IACUC Approval.  Could I Consider/Attest That I Have IACUC Approval For The Proposed Grant?

If the studies (not just procdures) you have described in the grant application are the same as in your approved protocol, then you are approved.  If there are differneces in the grant application and what is described in your approval IACUC, then you are not (yet) IACUC approved, and you should state "approveal pending" if that is an acceptable option for the granting agency.  This is true for the rationale, animal numbers, etc., and not solely for the procedures that will be performed.

 

Must There Be A One-To-One Relationship Between IACUC Proposal And Grant/Contract Application/Award?

No. It may be perfectly reasonable to include the studies of several related grants in a single "master" IACUC Proposal.  There are also examples of individual Proposals, such as for breeding colony maintenance, that are associated with  several experimental Proposals, each of which may be linked to other grants; therefore more than one Proposal with a single grant award. While the committee is happy to provide advice, we generally leave that decision with the PI.

 

May I temporarily Extend My Proposal's Approval After 3 Years?

No, federal regulation strictly forbid an institution or IACUC from extending approval once the IACUC approval has expired.  The only way to continue studies described in a Proposal that has surpassed its 3-year expiration date is to submit a renewal, which receives IACUC review identical to a new Proposal. We recognize your frustration if a project only requires a few more months or even days, but the federal rules on this are crystal clear with absolutely no wiggle-room.  Once a protocol is expired - it's expired.  Animals remaining must be: 1) transferred to an active, approved IACUC Proposal (preferably to your renewal), 2) transferred to the RRF "holding protocol," under which NO experimental procedures may occur, or 3) euthanatized. IACUC Policy - Proposal Expiration.pdf

 

Sigma Sells A Ketamine/Xylazine Combination For Rodent Anesthesia. Is Use Of This For Anesthesia Or Euthanasia Acceptable?

No, unless the IACUC has reviewed and approved a specific request to use this product based on scientific necessity.  According to "Use of Pharmaceutical-Grade Medications and Outdated Drugs/Supplies", the Guide, PHS Policy, and USDA Animal Welfare Regulations, pharmaceutical-grade medications must be used whenever they are available, including for non-survival procedures or euthanasia.  Exceptions may be approved by the IACUC if based on scientific requirements;  cost-savings alone is not an adequate justification.  Even though a Sigma-Aldrich Product (e.g., K113 or K4138) may be described as "an anesthetic that produces rapid and reversible anesthesia in experimental animals," they are considered chemical-grade by the IACUC, OLAW, and the USDA.

 

Is It Acceptable To Include "extra" Animals?

Sure, as long as their use is described and justified.  Two likely examples include:

-Training.   A few animals (remember to justify why you chose that number) are often required for you and your staff to learn or finalize a new procedure.  In fact, the IACUC may insist on performing at least terminal (non-survival) procedures on a few to maximize the potential for success in experimental animals.

-Anticipated adverse events.  It is usually not considered acceptable to "pad" the numbers just-in-case, i.e. for unexpected events.  In these cases, a modification to add back numbers of animals that succumbed to a watering mishap, identification error, or some such will be readily reviewed and approved.  However, it is reasonable to predict some animal loss, either from mortality or otherwise rendered "unusable," for some procedures or models.  In these cases, an estimate of loss can be used to justify additional animals - remember to include a description of how such loss will be minimized. 

 

Surgical Definitions:

Major Survival Surgery - Any surgical intervention that penetrates and exposes a body cavity; any procedure that has the potential for inducing permanent physical or physiologic impairment; and/or any procedure associated with orthopedics or extensive tissue dissection or transection.

Minor Survival Surgery - Any surgical intervention that does not expose a body cavity and causes little or no physical impairment.  Examples include laproscopy; wound suturing; peripheral vessel cannulation; percutaneous biopsy; routine farm-animal procedures such as dehorning, castration; prolapse repair; and most procedures done on an “outpatient” basis in veterinary clinical practice.

Multiple Survival Surgery - Animal recovers from initial surgery (major and/or minor) and is subsequently reanesthetized for one or more survival surgical procedures (major and/or minor) related to this study.  NOTE:  No animal may be used in more than one MAJOR operative procedure from which it is allowed to recover, unless, 1) justified for scientific reasons, 2) required as routine veterinary procedure or to protect the health or well-being of the animal, or 3) other special circumstances as determined by the Administrator, APHIS, USDA.

 

The 6 Problem Areas In IACUC Proposals

The IACUC has been planning a “Frequently Asked Questions” (FAQ) section for its ever-developing web site. One of the most frequently-asked questions (FAQ) relates to completing the IACUC’s Proposal to Use Laboratory Animals in Research and Teaching (Proposal) form. With that in mind, I have compiled what I believe are (at least some of) the most common sources of reviewer query, at least in hopes of stimulating deliberation and discussion from our research staff.

Disclaimer: The following article is used with permission from the Research Integrity Program – published in Volume II, Winter 2008 of the Compliance Companion.  The information in this article represents solely the opinion of the author and does not necessarily portray the opinion of the entire Institutional Animal Care and Use Committee. In fact, it probably doesn't portray that opinion! With that in mind,…

 

Number 6: Wrong Form

It is not uncommon that Proposals, especially “three-year renewals,” are submitted on outdated forms. While understandably a bit frustrating, there are two primary reasons why the committee cannot accept submissions on old forms. Revised forms have additional information that are necessary for its review. Furthermore, even though the procedures and experimental design may be identical for two different projects, the purpose of the project, which is an extremely important aspect of IACUC review, must be different. Similarly, unless absolutely no work has been performed in the three years of an existing Proposal, some aspects of projects must have been revised, updated, or otherwise changed since a project’s creation three years prior. If nothing else, pertinent literature has likely changed necessitating an updated assurance of non-duplication and lack of alternatives (see also Number 4 below). The IACUC continues to pursue electronic forms and database capacity enabling editing of pre-filled screens; until then we must rely on “cut-n-pasting.” The newest Proposal form can be accessed by clicking on  the "Forms" page.

 

Number 5: Identification of Hazardous Agent

The IACUC serves as the “gatekeeper” for the use of hazardous agents in animals, promoting not only research staff but also Research Resources Facilities (RRF) staff safety. In so doing, the IACUC assists the Principal Investigator (PI), Department of Environmental Health and Safety (DEHS), and RRF in developing and implementing appropriate precautions and procedures before study initiation. As stated in the Proposal Instruction page, “Proposals that include the use of hazardous agents, such as toxic or dangerous chemicals, carcinogens, microbials, or research associated with radiation risks or recombinant DNA will be forwarded and reviewed by the appropriate University safety committee (Institutional Biosafety Committee, Radiation Safety Officer, or Department of Environmental Health and Safety). Following review, the safety committee will issue a clearance statement separate from IACUC approval. IACUC Approval is contingent upon Safety Approval.

 

If hazardous agents are appropriately identified in Section VII, Proposals are routed to the appropriate safety unit upon submission to the IACUC Office. Occasionally, reviewers discover hazardous agents within the body of the Proposal. While the process then remains the same, the reviewer must then instruct the IACUC Office to forward the Proposal, creating potentially unnecessary delays in the approval process. Regardless, PI’s are advised not to wait for the IACUC Office to forward information to the appropriate safety unit, but are encouraged to contact the appropriate representative promptly and  obtain the  necessary approval.

 

Number 4: Search for Alternatives

Two questions in the Proposal form address the consideration of alternatives. Section V.B. pertains to all Proposals and instructs the PI to describe the methods used to verify that the proposed activities do not unnecessarily duplicate previous experiments (reduction from Russell and Birch’s “3 R’s”: reduction, replacement, and refinement). Section X.C. pertains only to those projects that involve more than momentary pain and distress (UofL IACUC Category 2 and 3 procedures), and requires the PI to provide a narrative description of the methods and sources used to determine that inducing the pain/distress in question is necessary and that there are no suitable alternative (less painful or distressful) models. According to the USDA’s Animal Welfare Information Center (AWIC), an alternative is any procedure which results in the reduction in the numbers of animals used, refinement of techniques to minimize pain/distress, or replacement of animals. The narrative should address of all three of these concepts.

 

The IACUC recognizes that considerable thought and planning precludes a PI’s decision to employ animal models, from ethical, practical, and financial perspectives. Animal use necessity for many projects is somewhat intuitive; nonetheless, federal regulations require a written description justifying the model and outlining how the PI determined that alternatives are not available. For both John Chenault Picconsideration of alternatives and assurance of non-duplication, most PI’s wisely use literature databases in their “good faith review of available sources.” The USDA advises the use of at least two different databases, e.g., MEDLINE, AGRICOLA, CAB Abstracts, ToxFile, EMBASE, BIOSIS, Zoological Record, Life Sciences, PSYCHINFO, ASFA, Current Contents, SciSearch, Index Medicus, and Current Research Information Services (CRIS). AWICThe AWIC (http://www.nal.usda.gov/awic), through the National Agricultural Library and National Library of Medicine, offers assistance with literature reviews. AWIC also publishes bibliographies, information resource guides, bulletins, and fact sheets that address alternatives. When using database searches to support their assurances, PI’s are reminded that USDA Policy 12 requires that the narrative includes: a) the database, b) the date the search was performed, c) the keywords used, and d) the years/range included in the search. Federal requirements also state that the “narrative should be such that the IACUC can readily assess whether the search topics were appropriate and whether the search was sufficiently thorough.”   The following information page was created by the IACUC to assist the PI in the consideration of alternatives. 

 

Other Resources:

 Searching for Alternatives to Painful Procedures Used on Research Animals.pdf

Alternatives and the Animal Welfare Act.pdf

 

Number 3: Project Participants

As stated in the Guide for the Care and Use of Laboratory Animals (the “Guide”), a fundamental IACUC responsibility is ensuring that personnel performing animal-related procedures are adequately skilled. Training requirements are summarized and can be accessed via the IACUC Policy entitled, “Required Training.pdf”.

There are three levels of training available; minimum training for most research staff consists of attending a Level II Training session. Continued enrollment in the Occupational Health and Safety Program is also required for initial IACUC authorization (within 90 days of request and renewed every three years thereafter) as well as RRF vivarium access.

 

For the IACUC to meaningfully review training and/or experience, PI’s must complete section VI in the Proposal form. A participant’s “Role in Study” should outline expected duties, e.g., observation, handling, anesthesia, test article administration, post-procedural monitoring, and euthanasia. The information provided in “Experience” should include the years’ experience performing each of these tasks. If an individual has little or no relevant experience, the PI should describe how, and by whom, the individual will receive appropriate oversight and training. A new modification to the form also allows PI’s to indicate which Project Participant(s) is/are authorized to request new participants for that study.

 

Number 2: Incomplete description

Another crucial aspect of IACUC oversight is appreciating not just the procedures planned, but the justification, rationale, and purpose of the proposed use of animals. The committee must understand what will happen to each individual animal, when, and why. This information should be presented in “Project Goals,” Section V.A., which requests an account of the “specific aim(s), long-term project objective(s), and a brief description of experimental groups.” Unfortunately, this not uncommonly consists of a 3-5-sentence “cut-n-paste” of a grant application’s specific aims. This may be acceptable if additional information is provided elsewhere in the Proposal; however, outlining all experimental groups, the procedures that will be performed on each group, and the rationale for each set of procedures in V.A. will facilitate the review. Timelines, tables, and graphs are not required but often assist the reviewer in recognizing individual animal disposition and discerning when in the course of the experiment procedures will occur (this is especially important for projects employing multiple survival surgery or other repeat procedures). Take-home-message: the clearer the description, the easier the review.

 

Of course, “incomplete description” applies to essentially any other section of the Proposal -- reading the instructions is always recommended.

 

Number 1: Animal Number Justification.

In my humble opinion, Section V.C., “Justification of animal numbers,” is the most common source of confusion. This may stem from incomplete experimental group description (see Number 2, above); regardless, Proposals must provide adequate information to enable reviewer assurance that projects employ a minimum (yet adequate) number of animals. As stated above, the Proposal must contain a thorough description of the experimental groups and the number of animals assigned to each experimental group (preferably in Section V.A.). Furthermore, the PI must also provide a specific rationale for the selected number of animals per group (“N”). Statistical calculation given a known or expected error rate and difference between groups (i.e., power analysis) is preferred, but extensive experience with the specific model may be accepted.

 

Rarely, if ever, is a number based on a timeline deemed sufficient justification (e.g., “we hope to analyze one sample per month – this requires 3 animals/month, or 36 animals per year, equating to 108 – let’s make that 110 – animals/year”). Such an open-ended justification is based on practical issues rather than the scientific aims of a well-organized and designed project. Agreement between the numbers displayed in the table and those in the narrative is also beneficial!

 

This article admittedly only “scratches the surface” of these important issues. Each could be augmented by “it depends”-type discussion as well as regulatory reference citation. Again, feedback regarding these comments will likely stimulate future items for this publication or the RRF’s “Research Resources,” “Dear Colleagues” letters, and IACUC web-site postings. Keep ‘em coming!

 

 

       ~ William W. King, DVM, PhD

         Assistant Vice President, Research Services

        Director, Research Resources Facilities

 

 

 

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