During the course of a research project, a need may arise for the investigator to submit to the IACUC an amendment to the animal research protocol for that project. This may occur when there is a significant change in the original protocol, to include but not be limited to the number of animals used, personnel changes and additional procedures or tests. According to the IACUC Guidebook1, “significant changes to an IACUC-approved protocol must be reviewed and approved before they occur (PHS Policy IV.C.1; and AWR §2.31[d][1])” or are implemented. The review can be done by the full committee or by a designated member.
White was questioning whether the submission of an amendment warrants a complete re-review of an already approved protocol. In response to this, the Public Health Service Policy on Humane Care and Use of Laboratory Animals2 (PHS Policy) requires that a complete IACUC review of PHS-supported protocols be conducted at least once every three years beginning on the date of IACUC approval. The triennial review can be done by the full committee or by a designated member. On the other hand, the Animal Welfare Regulations (AWRs) require an annual review3. In either case, we know that all research activities must conform to the statutes of the Animal Welfare Act3 and the guidelines of the PHS as described in the Guide for the Care and Use of Laboratory Animals4 (the Guide). Depending on when White's original protocol was approved by the Great Eastern University IACUC, and whether the approval was to comply with both the PHS Policy and the AWRs, it might be necessary to completely re-review her protocol.
The designated reviewer chosen by the IACUC thought it was necessary to review White's entire protocol. Covelli understood the prerogative of a designated reviewer and the authority granted to him or her by the IACUC to make sound judgment for the benefit of animal welfare and good research. Therefore, in our opinion, it is fitting to re-review the entire protocol in addition to the submitted amendment if the entire IACUC or the designated reviewer determines that it will conform to the statutes of the Animal Welfare Act and the guidelines of the PHS as issued in the Guide.
References
ARENA/OLAW. Institutional Animal Care and Use Committee Guidebook 2nd edn. (National Institutes of Health, Bethesda, MD, 2002).
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington DC, 1986; amended 2002).
Animal Welfare Act and Animal Welfare Regulations. 9 CFR Ch.1 §2.31[d][1].
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011).
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Srivastava, K., Datiri, B. Response to Protocol Review Scenario: Amendment necessitates re-review. Lab Anim 41, 308 (2012). https://doi.org/10.1038/laban.184
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DOI: https://doi.org/10.1038/laban.184
