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Searching for Alternatives to Painful or Distressful Procedures

A search for alternatives to all procedures that in USDA pain and distress categories D or E must be conducted, and the search strategy documented in the animal use protocol. The IACUC may request written description of the outcome of the search for alternatives from a PI. If a search for alternatives identifies a bona fide alternative method, a written narrative must be included to explain why this alternative was not used.

USDA Policies #11 and #12 include guidance for what kinds of procedures are classified D or E (#11, pp. 11.1 – 11.2), as well as requirements for conducting the search for alternatives (#12, pp. 12.1 – 12.3). Both USDA Policies are linked from http://www.aphis.usda.gov/ac/polmanpdf.html. The IACUC strongly recommends you review the USDA pain and distress categories and these USDA Policies before conducting the search for alternatives.

Both NIH and USDA have tip sheets that encapsulate their guidelines for searches for alternatives to painful or distressing procedures, suggestions for key words, lists of suggested databases, tips for working with the databases, and the USDA tip sheet includes some dialog commands and web links to many of the databases listed.

IACUC review of protocols that include painful and/or distressful procedures the IACUC must include a check that the requirements outlined in the USDA policies and USDA and NIH tip sheets have been satisfied.

Some USDA tips for PIs include:

    • Check terminology, strategy, database sources, and dates of search.
    • Conduct the search before completing the protocol.
    • Assess and evaluate the alternative possibilities.
    • Be prepared to support the use or non-use of any alternatives in writing.
    • Keep on file a copy of strategy, databases searched, and years of search for future reference.

And, for the IACUC reviewers, both USDA and NIH tip sheets have a list of “search evaluation red flags”:

    • Only one database searched.
    • Terms used only for painful aspects.
    • Using the term “alternative” used alone with no other alternative terms.
    • Keywords listed not relevant to the protocol.
    • Keywords and concepts linked in an incorrect manner.
    • Search does not cover an adequate time period (5-10 years).

 

 

 

 

Search for alternatives. UMass IACUC December 2005