Alternative Methodologies Used in Animal Research
The Animal Welfare Act (AWA) regulations require Principal Investigators (PIs) to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and provide a written narrative of the methods used and sources consulted to determine the availability of alternatives, including refinements, reductions, and replacements. If potentially painful / distressful procedures are proposed on the protocol form (e.g., any Category D or E procedures), the PI is required to document that there are no less painful / distressful procedures to accomplish the goals of the project. Further, if there are less painful / distressful procedures to accomplish the aims of the project, the PI must provide a scientific justification for not using the less painful approach.
The documentation process can be reasonably accomplished with a literature search that includes at least one database search. Before you begin your search:
- Consider other possible animal or non-animal models (e.g., tissue culture, cell culture, fish, rats, etc.)
- Consider your objectives and endpoints
- Note any drugs or compounds used in procedures (e.g., anesthetics, analgesics, test compounds, etc.)
- Note methods and procedures using animals, paying particular attention to those procedures that may cause pain or distress to the animal.
- List any potential alternatives (all 3 Rs) of which you are aware. (e.g., alternate models, modified techniques, housing modifications, modified restraint, in vitro methods, computer simulations, etc.)
- Develop a conceptual search strategy using the keywords and concepts you noted above. A search strategy is necessarily flexible, dependent both on the topic and on the database selected. If too many records are retrieved, additional relevant terms may make the results fewer and more useful; if too little is retrieved, fewer terms and a more conceptual approach may identify the relevant material. Use these terms and concepts as needed when searching.
- Database selection: Choose those that are appropriate for the area of study, keeping in mind type of protocol (research, teaching, or testing protocol)
As per the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA/APHIS/AC) Policy 12 (Consideration of Alternatives to Painful/Distressful Procedures), when a database search is provided the narrative must, at a minimum, include:
- the names of the databases searched;
- the date the search was performed;
- the period covered by the search; and
- the keywords and/or the search strategy used.
Once the search has been performed, the PI should provide the number of hits obtained from the search and describe the search results. In other words, how did the results of the search lead the PI to conclude that there is no alternative to further reduce, replace or refine this potentially painful/distressful procedure?
This page was created from materials obtained from the UCDavis Center for Animal Alternatives Information and the University of Miami College of Medicine’s Office of the Animal Care and Use Committee.