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Animal Research Alternatives: Laws, Regulations, Guidelines

To support research scientists in searching the literature in order to comply with the Animal Welfare Act (7USC 2131-2156)

Literature Searches - Best Way to Comply with USDA Documentation Requirements


The Animal Welfare Act was signed into law in 1966. It is the only Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and by dealers.

The legislation indicates that the investigator must provide a written narrative which demonstrates to the IACUC that alternatives, useful or not, were at least considered in the experimental design. The literature search is suggested as the best way to demonstrate this. The written narrative is to be reproducible by IACUC staff and the public alike.

The documentation "Policy #12: Consideration of Alternatives to Painful/Distressful Procedures"   defines animal alternatives and goes on to say:

"Alternatives should be considered in the planning phase of the animal use proposal. As indicated when these regulations were finalized in 1989, APHIS continues to recommend a database search as the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives to painful/distressful procedures. However, in some circumstances (as in highly specialized fields of study), conferences, colloquia, subject expert consultants, or other sources may provide relevant and up-to-date information regarding alternatives in lieu of, or in addition to, a database search. Sufficient documentation, such as the consultant’s name and qualifications and the date and content of the consult, should be provided to the IACUC to demonstrate the expert’s knowledge of the availability of alternatives in the specific field of study. For example, an immunologist cited as a subject expert may or may not possess expertise concerning alternatives to in vivo antibody production.

When a database search is the primary means of meeting this requirement, the narrative should include:the name(s) of the databases searched (due to the variation in subject coverage and sources used, one database is seldom adequate);

  • the name(s) of the databases searched (due to the variation in subject coverage and sources used, one database is seldom adequate); 
  • the date the search was performed;
  • the time period covered by the search; and
  • the search strategy (including scientifically relevant terminology) used."

[From Why Conduct Literature Searches for Alternatives?]

3 Rs of Animal Alternatives

Animal alternatives should be considered for regulatory, social, human, economic reasons.
These options are often referred to as the 3Rs of Animal Alternatives.


Reduction -Minimize the number of animals used

  • Consider pilot studies, sharing animals, tissues or organs, and new methods in testing (e.g. limit test local lymph nodes assay, etc.)

Refinement - Employ techniques that reduce pain and distress

  • Consider enhanced use of anesthetics and analgesics, modifications in restraining, handling, blood collection, increased sensitivity of monitoring devices and chemical assays

Replacement- Substitute animal with non-animal or lower organisms

  • Consider relative replacement (isolated cell and nerve preparations, use of tissues from slaughter house or grocer, computer simulations based on in vivo data)
  • Consider no animal involvement (endoparasites, plants, microorganisms, computer automated structure evaluation systems, human tissue culture 

From slides 34-48 of Meeting the Information Requirements of the Animal Welfare Act [2012?]