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Office of Research Compliance and Assurance


Alternatives to Animal Models

The PHS Policy and the USDA animal welfare regulations require research institutions to ensure that investigators have appropriately considered alternatives to procedures that can cause more than slight or momentary pain or distress in animals, consistent with sound research design. Federal regulations require:

  1. A written detailed description of the methods and sources used to search for alternatives to procedures that may cause more than slight or momentary pain or distress (category D and E procedures).
  2. A written assurance that the animal activities proposed do not unnecessarily duplicate previous experiments.
Alternatives are framed within the context of the "3 R's": Replace, Reduce, & Refine.
Alternative searches are required in the planning phase of the animal use protocol and are given equal consideration along with the overall experimental design and the appropriateness of the animal model to be used.
The IACUC must review and assess the information provided in the protocol application in order to ensure that the PI has made a good faith effort to determine the availability of alternatives and consider their applicability to the specific research project.
An animal use protocol will be returned to the PI without approval if the application:
  1. Does not include appropriate search terms for the refinement, reduction and replacement of live animal subjects.
  2. Does not use at least 2 appropriate literature data bases.
  3. Does not provide a narrative description of the methods, sources and results of the literature search.
  4. Does not include a written assurance that the use of animal subjects does not unnecessarily duplicate previous experiments.
  5. Does not clearly indicate that the researcher has considered all alternatives to the use of live animals and to procedures that may produce pain, distress or discomfort.
Procedures:
The USDA considers the performance of a computerized search of scientific literature databases to be the best method for demonstrating compliance with the requirement to consider alternatives and avoid unintended duplication. With that in mind, the IACUC requires that at least two legitimate scientific databases be searched. The PI must provide the following as part of the written protocol application:
The USA Library staff can assist you in the successful performance and documentation of literature database searches alternatives.
Sources:
Institutional Animal Care and Use Committee Guidebook, 2nd edition, 2002
United States Code Title 7, Chapter 54, Section 2143(d) and (e)
Code of Federal Regulations 9CFR Chapter 1, Subchapter A, Part 2, Subpart C, Section 2.31(d)(1)ii and iii.
USDA Policies 11 (Painful Procedures) and 12 (Consideration of Alternatives to Painful/Distressful Procedures): http://www.aphis.usda.gov/ac/polmanpdf.html
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