IACUC

IRBNet

As of 7/28/09 the IACUC is using IRBNet (a web-based electronic protocol submission and management system) for all committee business including applications.  All UAF faculty, staff, and students planning to work on an IACUC protocol must create an IRBNet account.  To create your account, go to the IRBNet website and follow the "New User Registration" link in the upper right hand corner of your screen (just below the log-in fields).  Once you've created your account, the IRBNet system will send you an activation email.  You must go to the link provided in the email to activate your account. 

The first thing you should do once you've activated your accoung is submit your Personnel Information Form (PIF) through IRBNet.  You can do this by following the step-by-step instructions for creating new project in IRBNet.  The PIF is available in the IRBNet Forms Library.  Your PIF must be submitted as an independent project in IRBNet, you may attach training certifcates or other documentation if you wish but it is not required.  Do NOT submit any protocol documents with your PIF. 

If you would like to receive training on IRBNet, please contact the Office of Research Integrity at x7800 or x7832.
 

IACUC Forms and Procedures

Instructions & Forms

There are several types of documents and forms available in the IRBNet Forms Library:

  • Instructions - these are the first three documents in the IRBNet Forms Library; the first was created specifically for UAF, the other two are generic instructions created by IRBNet.
  • Research Forms - should be used for any research and testing activities that are inquiry-based or hypothesis driven.  The goal of these activities is to generate new knowledge.  The research forms are 100 series and their names all start with "Research".
    • Protocol
    • Personnel List
    • Progress Report
  • Teaching Forms - should be used for classes, courses and workshops that use live vertebrates.  The goal of these activities should be to demonstrate techniques or train individuals.  The teaching forms are all 200 series and their names all start with "Teaching".
    • Protocol
    • Personnel & Class List
    • Student Project
    • Progress Report
  • Standard Operating Procedures (SOP) - these forms may be submitted independently or as part of a Research or Teaching application.
    • Surgery - required for all major and minor surgical procedures.
    • Capture & Transport - required for all wildlife capture activities except kill trapping, which may be described in the Animal Use Procedures, section # , of the Protocol form.
    • Husbandry - required for all species of animals held and maintained in UAF animal facilities or at non-UAF facilities for UAF purposes.  The IACUC has approved Husbandry SOPs for all species currently maintained by the animal facility staff. These SOPs are available from the Office of Research Integrity.  Any deviation from the approved SOPs must be specified in a Research or Teaching Protocol.
  • Miscellaneous
    • Personnel Information Form - must be submitted from each individual as a separate project in IRBNet.
    • Satellite Facility Designation - may only be submitted with a research or teaching application.

Review Process (New Protocol Applications)

Most IACUC protocols must be reviewed at a convened IACUC meeting with a majority of members present and be approved by the majority of members attending. The IACUC holds monthly meetings to review new protocols and conduct other business. In some cases, e.g. strictly observational research, new protocols can be handled by one or two designated members on behalf of the full committee.

The IACUC review of new protocols consists of four primary areas: scientific merit, method appropriateness, sample size appropriateness, and personnel qualifications. Sample size is often an issue in the IACUC review process, and is discussed in more detail below.

The principal investigator (PI) is responsible for all aspects of the IACUC protocol and must electronically sign the protocol before it is submitted through IRBNet or it will be returned by the IACUC. However, that does not mean that the PI must be the one to write every section. The PI may ask collaborators, students or staff to complete the form, but by signing the submission the PI is certifying that the application materials are accurate and complete as of the date signed.

Some things to remember when writing or proofreading an IACUC protocol:

  • The abstract/summary must be written in lay language
  • The IACUC members come from diverse backgrounds and specialties.
  • Avoid the use of jargon and acronyms whenever possible; if you must use it - DEFINE IT!
  • The IACUC will review and vote on the protocol, but final approval cannot be issued until all personnel have completed the following requirements:
    • created IRBNet accounts,
    • have at least "Read" access to the protocol in IRBNet,
    • have completed the required training modules,
    • submitted their Personnel Information Forms; and, if required,
    • been cleared for animal related duties by the University's contract health care provider before the Protocol can receive final approval.
    • Note:  The Office of Research Integrity will consider PI requests to exempt non-UAF personnel from the IRBNet account requirement on a case-by-case basis.

The following are some of the most common errors in IACUC protocol applications:

  • Not completing one or more applicable sections.
  • Failure to attach required forms or documentation.
  • Methods or Animal Use Procedure sections that lack detail/specifics.
  • Insufficient justification of sample size.
  • Failure to designate satellite facilities (locations outside of a designated animal facility where animals will be kept or housed for >12 hours) and have them approved.
  • Incomplete or no literature search conducted.
  • Specific duties of project personnel not listed.
  • Not submitting the application at least one week before the IACUC meeting.
  • Assuming a new protocol application will be approved the first time it is reviewed. Often the IACUC has to table an application because it lacks essential information. When an application is tabled it must be modified and resubmitted, and then reviewed at the next IACUC meeting.
  • Required permits must be obtained prior to starting animal work. The UAF IACUC prefers that permits be obtained by the PI or an agency collaborator, rather than a student or staff person. You do not need to submit copies of permits at the time of review or to receive IACUC approval, but we do ask that you submit them as an amendment through IRBNet once they have been approved/issued. It is the PI's responsibility to insure that all necessary permits have been obtained prior to beginning work with live animals.
     

Satellite Facilities

When animals will be kept or housed outside of an animal facility for >12 hours the location must become a designated satellite facility. All satellite facilities must be specified in an IACUC Protocol and/or Husbandry SOP.  Animals may not be moved into the satellite facility until the attending veterinarian has inspected and approved the location and animal housing, and the IACUC has approved the Protocol or SOP.

Designation as a satellite facility is Protocol specific and ends when the Protocol is closed or expires.

Animal care in satellite facilities must meet the same standards as required in the animal facilities.

All personnel working in designated satellite facilities, regardless of whether or not they will be handling live vertebrates, are required to complete this online training program. This requirement exists because they are technically working in an animal facility and should understand the basic requirements for animal welfare and know where to go for help with any problems or questions.
 

Research SOPs (not the Husbandry, Surgery and Capture & Transport SOPs described above)

Although not required by the IACUC, researchers are encouraged to develop and use SOPs for all regular or recurring activities involving live vertebrates. This is a "best practice" that can significantly improve research outcomes by insuring consistency between researchers, animals, experiments, etc. SOPs are also extremely useful in preventing protocol drift (small gradual changes in how things are done that, over time, can result in significantly different procedures and therefore outcomes).

If you plan to use the same SOP in multiple assurances, e.g. collecting blood via cardiac puncture in arctic ground squirrels, the IACUC can approve the SOP once and you can reference it in each assurance. From a purely management perspective, the main advantage to using SOPs for common procedures and activitiesis that the IACUC approved SOP exists as a seperate submission (file) in IRBNet so modifications only need to be requested once and when approved apply to all Assurances referencing that SOP.

A well written SOP should read something like a recipe; there should be a list of supplies and then detailed step-by-step instructions on how to complete the procedure or activity. Enough detail must be provided so that someone generally familiar with the procedure could follow the SOP and conduct the activity without additional instruction or assistance.
 

Modification Requests

When it comes to activities involving live animals the main thing to remember is the following: 

IF IT'S NOT IN YOUR APPROVED PROTOCOL - YOU CANNOT DO IT!

To request a Modification you simply need to update the relevent IACUC document(s), making sure it is on the IRBNet Forms, and submit the revised documents (do not attach revisions as new documents) through IRBNet in a new package, (NOT as a new study/project).  Remember all protocol modifications, like the initial assurance, must be signed by the PI before they are submitted for review. 

Most modifications are minor and are handled by designated review (i.e. reviewed by one or two members). This means that they can be finalized relatively quickly, usually in a few days. However, some changes, because of their scope, complexity or potential for complications, are considered major modifications. Major modifications must be reviewed, discussed and approved at a convened IACUC meeting with a quorum of members present.

Changes in personnel are a modification and must be approved by the IACUC. Addition of new personnel to an Assurance will not be approved until they have completed the following:

  • created IRBNet accounts,
  • have at least read access to the protocol in IRBNet,
  • have completed the required training modules,
  • submitted their Personnel Information Forms; and, if required,
  • been cleared for animal related duties by the University's contract health care provider before the Protocol can receive final approval.
  • Note:  The Office of Research Integrity will consider PI requests to exempt non-UAF personnel from the IRBNet account requirement on a case-by-case basis.
     

Progress Reports

IACUC approval is valid for one year.  If the work will continur into year two or three (after the initial approval or subsequent to a three-year renewal) the PI can request that the protocol be renewed by submitting a Progress Report, with General Information and Section 1 completed.  The IRBNet system will send expiration notices at 60, 30 and 7 days prior to the expiration date.  If the renewal has not been approved by the expiration date, IRBNet will issue an notice that the protocol has been closed and that all work with live vertebrates must stop.  It is the PI's responsibility to ensure that they've signed and submitted the Progress Report through IRBNet at least one week prior to the expiration date listed on the Approval Letter; this will reduce the chances that the renewal will not be approved prior to the expiration date.

Every three years the protocol must undergo a new IACUC review.  To request a three-year renewal, the PI must submit a Progress Report with General Information, Setion 1, and Section 2 completed.  The IRBNet system will send expiration notices at 60, 30 and 7 days prior to the expiration date.  If the renewal has not been approved by the expiration date, IRBNet will issue an notice that the protocol has been closed and that all work with live vertebrates must stop.  It is the PI's responsibility to ensure that the completed form is received by the IACUC in time to be reviewed at the meeting preceding the expiration date (stated on the Approval Letter).  You may not request renewal more than 60 days prior to the expiration date.
 

Sample Size and Statistical Power

Dr. Eric Rexstad, a former faculty member in UAF's Department of Biology and Wildlife, taught this section in the lecture course from 1993 through 1999. His lecture handout (required reading) provides a very nice overview on how to evaluate sample size during the design phase of your research project. From the viewpoint of an IACUC review process, it is important that you address the number of animals used. One of the 3 R's (remember them?) is reduction, so the IACUC wants to be assured that you are not using more animals than are necessary to achieve your stated objectives. However, the IACUC is equally concerned that you use enough animals to achieve your objectives. As painful as it might be, this invariably requires some thought about statistics, sample size, power, and type I and type II errors.

The IACUC does not expect everyone to be a statistician. The committee does expect researchers to be competent enough in statistics to understand basic concepts and to know when to involve statisticians. Dr. Rexstad's lecture handout is intended to cover the basic concepts and formulas used for power analysis and sample size determination. This discussion should help you write the Scientific Methodology / Research Design section of the IACUC Assurance application. A poor explanation of your proposed sample size may result in your Assurance being questioned and possibly tabled or denied. At minimum you must clearly answer the following questions in the context of how you plan to achieve your research objectives:

  1. How many animals will be needed for this project?
  2. How many experimental groups, replications, trials, etc. are required?
  3. How did you determine that the sample size, number of groups, replications, trials, etc. are appropriate?

There is some flexibility in the IACUC review process. For example, if you are conducting a pilot study, evaluating a technique, developing a new procedure, or conducting a training or educational exercise, statistical justification of sample size may not be important. The IACUC considers the purpose/intent of the Assurance in their evaluation and can approve Assurances using small numbers of animals. However, you must be clear about your intent and not overstate the objectives of your Assurance! For example, you cannot model the Prince William Sound ecosystem nor say anything about the effects of contaminants by sampling 5 fish, but you may be able to develop a new technique for assessing contaminant load or train a group of summer research technicians in how to collect the appropriate tissues for your study.
 

Euthanasia

There is a sup rising amount of jargon out there related to ending an animal's life as part of research, teaching or testing activities.  Some of the common terms and euphemisms are kill, perform euthanasia, euthanatize/euthanize, sacrafice, and collect.  However, for most scientific purposes the commonly accepted term is euthanize.

Methods of euthanasia include mechanical, chemical, electrical, and gaseous methods of producing death.  Whatever the method, death is achieved by one of three methods:

  1. Hypoxia, direct or indirect
  2. Depression of the CNS
  3. Physical damage or concussion of the brain

The 2013 American Veterinary Medical Association (AVMA) Guidelines on Euthanasia is the primary reference the UAF IACUC relies on when evaluating proposed methods of killing of animals. UAF personnel are expected to comply with these guidelines or to justify the use of alternative practices in their IACUC applications. Another excellent resource for individuals working with wildlife is the 2006 Guidelines for Euthanasia of Nondomestic Animals published by the American Association of Zoo Veterinarians (copies are available in ORI and Vet Services).

An important part of humane euthanasia is ensuring that it was successful (i.e. that the animal will not revive). This is especially important when animals are killed by an overdose of an anesthetic agent. At high doses most anesthetics greatly reduce breathing and heart rates making them undetectable by visual observation. Therefore it is important to identify a means of ensuring that there is no possibility of recovery. This is a specific question on the IACUC Assurance form, but it is often answered inappropriately. One of the most common answers is "observation of rigor mortis". Rigor mortis is not apparent until several hours after death and is therefore not an acceptable means of ensuring death. The following methods, many of which are part of normal tissue collection procedures, are examples of acceptable means to ensure that animals will not recover:

  • Exsanguination
  • Decapitation
  • Bilateral Pneumothorax - this can be done by opening the thoracic cavity (cutting the rib cage and/or diaphram)
  • Perfusion (replacement of the blood with saline, fixative or other solution)
  • Removal of one or more vital organs (brain, lungs, heart, liver, etc)
  • Rechecking vitals after a set period of time
  • Freezing in liquid nitrogen
  • Pithing or Cervical dislocation (only by trained personnel) - these may be primary methods of euthanasia in some situations.

Researchers should choose the method that best fits their research goals and methodology.

Not all IACUCs are created equal. At UAF there is a considerable amount of field biology experience on our IACUC; therefore, you may find a different attitude toward certain field activities here compared to other universities. The following are examples of activities that the UAF IACUC will consider but may not be allowed by other IACUCs:

  1. Use of chloroform for euthanasia, although not considered acceptable by the AVMA Panel due to personnel occupational health and safety issues, it is a reasonable euthanasia agent particularly for small mammals and it has the added benefit of killing ectoparasites. However, chloroform is a known hepatotoxin and possible carcinogen so must be handled and used properly. Contact your unit chemical hygiene/safety officer or EHS&RM for assistance in determining the appropriate protective equipment and the proper procedures for transporting it, working with it safely, and disposing of any resulting hazardous wastes.

  2. Use of kill traps such as Museum Specials and Conibears to "collect" wildlife is perfectly acceptable if properly justified and used in an appropriate fashion. The IACUC is generally concerned not about using these tools, but whether the person deploying them knows how to properly set traps to ensure a humane kill and to reduce the likelihood of killing or injuring non-target species.

  3. Use of gunshot is an acceptable means of "collecting" wildlife as long as the appropriate weapon and ammunition is used. Like trapping, the IACUC requires confirmation that the individual doing the shooting can offer a quick, humane kill and is experienced enough to properly identify the target species.

  4. Suffocation is not an acceptable means of killing fish unless it is truly unavoidable or if there is scientific justification to allow a fish to suffocate. As an example, trawling for scientific purposes may not allow the opportunity to ensure a humane kill (i.e. blow to the head) on every fish brought up. When dealing with 100s or 1000s of fish on the deck of a boat there is no feasible means to render each fish unconscious quickly! However, for capture techniques whereby a small number of fish are being caught, the IACUC expects you to include a method for rendering fish unconscious prior to euthanasia or explain why this cannot be done.

  5. Chest/Thoracic compression of small birds and mammals was not considered to be a humane method of euthanasia in earlier editions of the AVMA Guidelines on Euthanasia, partly because the method of death is not known. However, in the most recent edition (link provided above) chest compression is discussed and considered an acceptable method of euthanasia for small birds but not mammals. Despite this recommendation, the UAF IACUC may approve chest compression for small mammals in certain procedures or circumstances if adequate scientific justification is provided.

  6. Death by decapitation is only allowed when the animal is rendered unconscious by an acceptable method or is under deep general anesthesia. The committee may make exceptions for animals under deep hibernation but each project is assessed individually.

Some methods of euthanasia, although humane, may not be allowed in specific circumstances due to other considerations. For example, use of barbiturates to euthanize animals is only acceptable if the carcass will be incinerated or properly disposed of. Under no circumstance may you euthanize animals with barbiturates and leave the carcass in the field. There are numerous reports of scavengers, particularly eagles, dying after feasting on a barbiturate laced carcass. Likewise, although MS-222 is the preferred anesthetic for use in fish, the Alaska Department of Fish and Game and other permitting agencies typically will not approve its use if fish may reasonably be expected to be harvested for human consumption prior to the end of the withdrawal period.
 

Humane Endpoints

Humane endpoints are the earliest "endpoint" that is compatible with the scientific objectives of the research.  The Canadian Council on Animal Care defines an endpoint as "the point at which an experimental animal's pain and/or distress is terminated, minimized, or reduced by taking actions such as killing the animal humanely, terminating a painful procedure, or giving treatment to relieve pain and/or distress."

In 2000 the Institute for Laboratory Animal Research (ILAR) devoted vol. 41 no. 2 to the discussion of humane endpoints.  One article, A Systematic Approach for Establishing Humane Endpoints by David B. Morton, provides good background and an excellent approach for determining humane endpoints.  Another good resource is the Altweb Humane Endpoints Database which provides links to scientific articles involving humane endpoints.

If experiments will produce more than momentary or short duration pain or distress and research considerations prohibit methods to minimize or reduce it, the UAF IACUC requires the identification of a humane endpoint.  Actual selection of a humane endpoint for animal experiments should involve consultation with the laboratory animal veterinarian, animal care staff, researchers, and the animal care and use committee.
 

Death as an Endpoint

“Death as an Endpoint” is a term that is only used in cases where the researchers intend to cause the death of the animal, but are not actively causing the death by euthanasia, i.e. when no humane endpoint will be set.  Although “death as an endpoint” is counter to basic principles of animal welfare, it may be necessary for some types of research, for example when studying the natural progress of a disease or in LD50 studies.  However, in the the vast majority of research projects "death as an endpoint” is neither required nor warranted. 

The use of “death as an endpoint” is strongly discouraged at UAF and will only be authorized by the IACUC when selecting a humane endpoint or euthanasia would compromise the scientific validity of the study.  Researchers must specifically identify in their IACUC Assurance if they plan to use "death as an endpoint" and provide substantial scientific justification for its use.