University
of Illinois at Urbana-Champaign
DIVISION OF ANIMAL RESOURCES and
AGRICULTURAL ANIMAL CARE AND USE PROGRAM
Section 9
Alternatives to Painful Procedures:
Overview
The regulations of the Animal Welfare Act (AWA) require that the principal
investigator consider alternatives to procedures that may cause more than
momentary or slight pain or distress to animals. These may include, but
are not limited to such procedures as surgery (even under anesthesia), prolonged
restraint, food deprivation, and chemical immobilization of a conscious animal.
If a protocol includes such activities, the investigator is required to demonstrate
that no alternatives exist, or that existing alternatives are inadequate for
that protocol. The meaning of alternatives, in this case, includes not only
looking for a different, less stressful procedure (refinement), but also looking
into using other, lower order species or non-animal models (replacement), and
(not or!) using fewer animals (reduction).
PIs must provide a written narrative of the sources consulted to determine whether or not alternatives exist to procedures which cause pain or distress. The USDA, which is charged with enforcing the AWA, has promulgated two policies (Policy #11 and #12) that assist investigators in understanding how to comply with this regulation. Policy #11 provides the definition of what is considered a painful or distressful procedure, and provides examples of both. In general, any procedure that would be expected to cause more than slight or momentary and and/or distress in a human to which the procedure is applied is considered to be painful and/or distressful in animals. Policy #12 provides guidance in what the minimal written narrative should include. In general, this requires a narrative describing a specific literature search for alternatives, including databases searched, key words used, and the date of the search. If alternatives are described but will not be used, the principal investigator must describe why these are not adequate for the project described.
Guidelines for Searches to
Alternatives for Animal Use
Introduction
The Animal Welfare Act Regulations, Section 2.31 and USDA (Policy #11
and #12 ) require
that a written narrative be provided by the Principle Investigator (PI) to determine
whether or not alternatives exist to procedures which may cause pain or distress
in animals used for teaching or research. In addition, if alternatives exist
but are not used, the PI must justify why this is the case. Although searching
for animal alternatives may seem to be an overwhelming task, it is hoped that
the information in this document will assist animal users with this federally
mandated task.
Definition of Alternatives
Alternatives refer to methods or approaches which result in refinement of procedures
which lessen pain and/or distress; reduction in numbers of animals required;
or replacement of animals with non-whole-animal systems or replacement of one
animal species with another, particularly if the substituted species is non-mammalian
or invertebrate.
Animal Welfare Act Regulations
The AWA regulations require the Institutional Animal Care and Use Committee
(IACUC) to determine that "the principle investigator has considered alternatives
to procedures that may cause more than momentary or slight pain or distress
to the animals and has provided a written narrative description of the methods
and sources used to determine that alternatives were not available." The
PI must provide scientific justification to the IACUC if alternatives are available
but not used.
Types of Studies Requiring an
Alternatives Search
Not all animal use protocols require an alternatives search. Only studies utilizing
procedures which result in more than momentary or slight pain or distress require
a search. Examples include: toxicity and infectious diseases research, tumor
induction or transplantation studies, survival and non-survival surgical procedures,
pain research, in vivo monoclonal or polyclonal antibody production procedures,
fluid and/or food restriction, and prolonged restraint. This list is not exhaustive.
If you are unsure whether a search is required, please consult the IACUC office
or the Division of Animal Resources (DAR) veterinary staff.
Alternatives Narrative
The written narrative for the search for alternatives must include the following
minimum: methods of searching, databases searched, the date of the search and
years covered, and key words and/or search strategy used. If alternatives exist
to the proposed animal procedures in the protocol, the investigator must scientifically
justify why these alternatives are not used. This information must be updated
with each three-year renewal of the animal use protocol. DO NOT simply provide
a bibliography! It is the investigator’s responsibility to review the
literature and summarize the findings. Examples of narratives are listed below.
Database and Web Site Searching
Computerized storage of scientific information makes database searching relatively
easy. Databases frequently used, and available on-line at UIUC, for alternatives
searches include TOXLINE, GRATEFUL MED, Cancerlit, Bioethics, and AIDSLINE (National
Library of Medicine), and CAB Abstracts and AGRICOLA. Depending on the subject,
searching several of these databases for alternatives is considered adequate
by the IACUC.
Problems often arise in choosing keywords and search strategies that will yield the most pertinent information. Appropriate search terms or keywords include animal testing alternatives, alternatives, tissue culture, cell culture, simulation, in vitro, and model. Additional keywords can be found on the UC Center for Animal Alternatives web page (see below). These terms are useful, but are not the only terminology possible. The following websites provide additional information investigators may find helpful in completing an alternatives search:
The regulations of the Animal Welfare Act (AWA) require that the principal investigator consider alternatives to procedures that may cause more than momentary or slight pain or distress to animals. PI's must provide a written narrative of the sources consulted to determine whether or not alternatives exist to procedures which cause pain or distress. The USDA, which is charged with enforcing the AWA, has promulgated two policies (Policy #11 and #12) that assist investigators in understanding how to comply with this regulation. Policy #11 provides the definition of what is considered a painful or distressful procedure, and provides examples of both. In general, any procedure that would be expected to cause more than slight or momentary and and/or distress in a human to which the procedure is applied is considered to be painful and/or distressful in animals. Policy #12 provides guidance in what the minimal written narrative should include. In general, this requires a narrative describing a specific literature search for alternatives, including databases searched, key words used, and the date of the search. If alternatives are described but will not be used, the principal investigator must describe why these are not adequate for the project described.
Searchable Databases and Web Resources:
Below are several examples of alternatives searches.
Example #1: Intestinal Xenograft Model for Human Enterocytozoon bieneusi infection (infectious diseases study)
Example #2: Monoclonal Antibody Production (in vivo antibody production)
Example
#3: Polyclonal Antibody Production (in vivo
antibody production)
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last updated: February 16, 2006