IACUC

PROBLEM: You are an animal testing facility.

PROBLEM: This means you have to deal with the federal government, as well as foreign regulatory bodies.

PROBLEM: This also means you are exposed to various animal rights groups, be they fringe lunatics or understanding yet wary.

PROBLEM: But, on the other hand, you may have principal investigators who want to do questionable experiments.

SOLUTION: You put together an Institutional Animal Care and Use Committee, the IACUC.

Functions

The IACUC is a team of people charged with three primary responsibilites:

• Review and approval or rejection of study protocols involving the use of animals. All such studies must be approved by the IACUC to be carried out.
• Routine inspection of animal facilities, including testing suites, animal housing, and ancillary areas such as feed and bedding preparation and storage sites, for compliance with guidelines, regulations, and laws.
• If in the United States, reporting to the USDA the number of animals from defined species (more on this later) used in studies.

In short, these responsibilities add into the chief goal of the IACUC, namely: to maintain humane animal care and use. This means that the IACUC is charged with making sure the following practices are being carried out:

• Testing is done using the 3 R's:
  • Refinement: Testing causes minimal pain in the animals, and humane end points (when euthanasia should be used) are clearly defined. Refinement generally refers to constantly reworking experiments so that the impact on the animals is reduced.
  • Reduction: Testing is only performed on animals if absolutely necessary, and experiments are constantly examined to see if the number of animals used can be reduced without jeopardizing the outcome or the statistical viability of the experiment.
  • Replacement: Alternative experiments are reviewed to see if non in vivo test systems, such as modelling or in vitro testing, can be used.
• Testing and animal care facilities are well-maintained and maximize the physical and psychological wellness of an animal. The latter is particularly important among more intelligent animals such as dogs or non-human primates, which need to be provided with a social and interactive environment. Recent work has also shown that animals such as guinea pigs, rats, and mice also benefit from manipulanda and mazes. This is known as animal enrichment.
• Part of maintaining animal health is making sure that their housing and husbandry practices are clean and humane, and that each animal is given sufficient space, air, food, and water. If an animal model has special needs (for example the diabetic mouse model), then those needs are consistently met.

Composition of the IACUC

Each institution (which is the IACUC-speak term for any research organization, such as a university, a life sciences company, or a government lab that conducts animal testing) appoints an Institutional Official (IO) who is held accountable for animal welfare. If the institution breaks a law (and the Animal Welfare Act is a law), the IO is the one who will go to jail. Thus, it is the IO's job to make sure the IACUC functions properly. The IO may be the CEO of the institution, or they may be the Chairman of the IACUC. They are typically one or the other, and are always an authority on animal care. They are commonly DVMs.

The CEO and/or IO is charged with appointing the IACUC. Different regulatory bodies have different requirements for the composition of an IACUC, but the following rules typically apply:

• The IACUC has at least 3-5 members.
• The IACUC has at least one DVM.
• The IACUC has at least one person not affiliated in any other way with the institution. This person is typically a layperson, and ideally someone like a government employee or member of an SPCA-type organization, who can remain judicious and impartial.
• The IACUC has a non-voting administrator who can record minutes and maintain protocols and approval notes.
• Often an individual from a regulatory affairs or quality assurance department is a member, especially if the testing facility is GLP-compliant.

Activities

As mentioned previously, the IACUC has three primary functions. Let's review these in greater depth:

• Review and Approval/Rejection of Study Protocols: before any study can be performed, a study protocol must be written by the principal investigator (PI) that captures the following information:
  • The purpose and objective of the study
  • The justification of the study: how the study benefits human- or animalkind
  • The number, sex, and species of the animals to be used
  • The study methods: what exactly is going to be done in the study
  • The animal facility conditions and animal husbandry practices that will be performed
  • The USDA pain category of the procedure
  • The humane end points of the procedure
  Based on these things, the IACUC may approve or reject the procedure. If rejected, the procedure can NOT be performed by the PI.
• Inspection of Animal Facilities: IACUC members are charged with periodically inspecting animal facilities, looking for the following items:
  • Animals are housed and cared for humanely
  • Animal well-being is maximized; facilities are sanitary
  • Animals are clearly identified; the protocol is clearly identified on animals being studied
• Reporting the Numbers of Animals Used to the USDA: Every year, the IACUC must draft and issue a report to the USDA showing the number of animals used on study. The USDA wants to make sure that animals are not being used needlessly, and an animal census is one way this is accomplished.

Additionally, the IACUC may have other functions. Certainly it is in the IACUC's best interests to promote humane animal care, and many IACUCs offer hands-on training to animal technicians and handlers. The IACUC must always maintain the facility in a state of preparedness, should the USDA or AAALAC (more on these below) decide to visit.

Regulatory Guidelines

A veritable alphabet soup of acronyms governs IACUC activity. Essentially, these guidelines may be broken up into three different categories, based on who or what is enforcing the guidelines:

Guidelines from the Federal Government

For this I will note the US government. I'm not sure about EU policy with regard to animal testing.

• The primary law (yes law) that governs animal use is the Animal Welfare Act (AWA), which protects animals from cruelty and ensures that testing labs are accountable to the Animal and Plant Health Inspection Service (APHIS) branch of the USDA. The AWA is enforced on defined species, which are, essentially, every warm-blooded animal with the exception of humans and mice. The reason for the former is self-evident; the reason for the latter is that since mouse studies comprise a large percentage of all animal studies, the USDA lacks the manpower to inspect all of these studies. The number of defined species used in experimentation must be reported to the USDA per the AWA.
• USDA/APHIS also requires compliance with animal welfare regulations (AWRs) , such as 9 CFR A 1-3.
• The US Department of Health and Human Services (HHS) awards grants to animal research labs through the National Institutes of Health (NIH). The NIH issues animal care guidelines through the Public Health Service (PHS) office, which maintains the Policy on Humane Care and Use of Laboratory Animals.
• Additionally, the NIH maintains the Office of Laboratory Animal Welfare (OLAW). OLAW issues the Guide for Care and Use of Laboratory Animals, colloquially referred to as the "Guide". Failure to comply with the Guide may result in withdrawal of public grants.

Guidelines from the Professional Community

Different veterinary councils and animal use organizations issue guidelines for animal care and use, and the conduct of an IACUC. Several organizations offer accreditation for animal research; accreditations are typically very beneficial for a testing facility to have. Accrediting organizations may inspect a testing facility and interview its IACUC; a bad inspection may result in the revocation of accreditation. The following are professional organizations concerned with animal research:

• The Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) is an international body that accredits animal testing facilities and conducts regular inspections.
• The American Association for Laboratory Animal Science (AALAS) also trains IACUCs and accredits individuals with ALAT, LAT, and LAGT certifications.
• The American College of Laboratory Animal Medicine (ACLAM) also offers training and serves as a forum for animal research concerns.
• The American Veterinary Medical Association (AVMA) also functions as a professional forum for DVMs. AVMA is particularly concerned with humane end points.

Guidelines from the General Public

Sometimes there is no higher court than the court of public opinion. Animal research must walk a fine line between getting what needs to be done done, and not overstepping their bounds. Its important for laypeople to understand why animal research is being done, and this has a direct impact on study approval, through the non-professional, unconnected member of the IACUC. This member was specifically designated to prevent overzealous scientists from undertaking potentially unnecessary studies. Most people do not approve of the Draize eye test for example, particularly when used by cosmetics manufacturers. Thus, public opinion offers constant guidlines, informed or no, that must be reckoned with.

Sources:

• The Animal Welfare Act
• SCAW IACUC 101 training binder
• My own LAT certification binder
• OLAW Guide for Care and Use of Laboratory Animals
• Personal experience in biotech field