Alternatives Search Guidelines
The PHS Policy and the USDA animal welfare regulations require 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(1). Federal regulations require(2):
- Investigators consider alternatives to procedures that may cause more than momentary or slight pain or distress (category D and E procedures);
- A written narrative description of the methods and sources used to determine alternatives were not available;
- 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" originally articulated by Russell and Burch in 1959 (The Principles of Humane Experimental Technique). These include :
- Replacement: Utilizing non-animal models. These may include living systems utilizing organ, tissue or cell culture techniques; non-living systems such as chemical techniques and mechanical models for training; and computer simulations. Wherever possible, use of invertebrates or vertebrate species lower on the phylogenic scale may be considered as a replacement alternative.
- Reduction: Determining the number of animals used in a study by experimental design and/or statistical analysis to minimize the number of animals required to obtain meaningful data.
- Refinement: Reducing or eliminating pain or distress in animals. Some refinement opportunities can include the use of pain relieving drugs (e.g. anesthetics, analgesics, anti-inflammatory agents, antibiotics, or sedatives), non-pharmacologic techniques, new diagnostic and therapeutic techniques (e.g. reduce invasiveness of data collection).
Alternative searches should be performed during the planning phase of the animal protocol and appropriate information provided to allow the IACUC to assess that a reasonable and good faith effort was made to determine the availability of alternatives or alternate methods.
Additional alternative searches should be performed when a protocol is changed significantly by modification, and are required when the modification involves use of a new or more-invasive technique or procedure that would be classified as a Category D or E procedure.
For assistance in searching for alternatives please review the following:
- http://www.nal.usda.gov/awic/alternatives/Altbrochure.pdf
- http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=1&tax_subject=183
References:
USDA Policies 11 (Painful Procedures) and 12 (Consideration of Alternatives to Painful/Distressful Procedures):
- http://www.aphis.usda.gov/animal_welfare/downloads/policy/policy11.pdf
- http://www.aphis.usda.gov/animal_welfare/downloads/policy/policy12.pdf
Footnotes:
(1) IACUC Guidebook, 2nd Ed, 2002 http://grants.nih.gov/grants/olaw/guideBook.pdf
(2) Code of Federal Regulations 9CFR Chapter 1, Subchapter A, Part 2, Subpart C, Section 2.31(d)(1)ii and iii. http://www.aphis.usda.gov/animal_welfare/publications_and_reports.shtml
Last Updated: November 10, 2009 (jp).
