Under Section 2.31 (d)(1)(ii) of the Animal Welfare Act, the principal investigator is required to provide a written narrative to his or her Institutional Animal Care and Use Committee stating that alternatives to painful procedures have been explored and are not available.
Animal Care Policy #12 of the USDA Animal Care Resource Guide, "Consideration of Alternatives to Painful/Distressful Procedures" states of this written narrative:
When a database search is the primary means of meeting this requirement, the
narrative should include:
1. the name(s) of the databases searched (due to the variation in subject
coverage and sources used, one database is seldom adequate);
2. the date the search was performed;
3. the time period covered by the search; and
4. the search strategy (including scientifically relevant terminology)
Regardless of the alternatives sources(s) used, the written narrative should
include adequate information for the IACUC to assess that a reasonable and
good faith effort was made to determine the availability of alternatives or
alternative methods. If a database search or other source identifies a bona fide
alternative method (one that could be used to accomplish the goals of the
animal use proposal), the IACUC may and should ask the PI to explain why
an alternative that had been found was not used. The IACUC, in fact, can
withhold approval of the study proposal if the Committee is not satisfied with
the procedures the PI plans to use in his study.
It will help your report to keep a log of the above four points for each search performed. You will be required to report this information anew to the IACUC when submitting a new protocol, amending an existing one, or requesting renewal.
Explanations of why an identified alternative was not used in the experimental procedure (if one is available) must also be included in the appropriate fields in your IACUC applications, as stated above.
In some fields, the development of new procedures in research may not be reported in journal literature, and thus may not be indexed in databases such as PubMed/MEDLINE. In these cases, it is the responsibility of the principal investigator to ensure that a search of appropriate literature sources such as government reports and conference proceedings is performed. When an expert is consulted, a description of his or her credentials and relevant expertise must be included.