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Response to Protocol Review Scenario: Departure from approved procedures

Lab Animal volume 42, pages 119–120 (2013)Cite this article

The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy; section IV.C)1 requires the IACUC of any institution where animal activities are carried out to assure that the approved research projects will be done in accordance with the Animal Welfare Act and Regulations (section 2.31)2. The PHS Policy also requires research proposals to be consistent with the Guide for the Care and Use of Laboratory Animals (the Guide)3 unless a departure is justified and approved by the IACUC. The IACUC should also determine whether the research projects conform to the institution's Assurance and meet various requirements, such as methods of euthanasia.

New Antigen Inc. has violated its agreement with Great Eastern University by not following the protocol approved by the Great Eastern IACUC, which indicated that the entire study would be done at Great Eastern University; this certainly would include disposition of the animals at the end of the study. New Antigen employees transported mice and used an external procedure location without the approval of the Great Eastern IACUC. Changing the disposition of animals at the protocol's conclusion constitutes a deviation from the approved protocol, regardless of any protocol approved by the New Antigen IACUC.

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References

  1. Public Health Services. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).

  2. Animal Welfare Act and Regulations. 9 CFR, Chapter 1, Subchapter A, Part 2.

  3. Institute of Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011).

  4. Office of Laboratory Animal Welfare. Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals. Notice NOT-OD-05-034. (National Institutes of Health, Washington, DC, 24 February 2005, updated 21 February 2013). http://grants.nih.gov/grants/guide/notice-files/not-od-05-034.html

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  1. Cannon is the Director of the Institutional Animal Care and Use Committee at The University of Alabama at Birmingham, Birmingham, AL.,

    David Cannon

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Cannon, D. Response to Protocol Review Scenario: Departure from approved procedures. Lab Anim 42, 119–120 (2013). https://doi.org/10.1038/laban.259

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