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  • Protocol Review
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Response to Protocol Review Scenario: Compliant but not complete

Lab Animal volume 44, pages 339–340 (2015)Cite this article

As members of a large institution with an IACUC that reviews over 1,000 protocols and protocol amendments a year, we understand the motivation behind Great Eastern University's decision. In theory, we think it could be an appropriate and efficient solution. The original reviewers or presenter of a protocol were likely chosen by the IACUC chairperson because they were qualified to carry out the review1, so it stands to reason that the same individuals would be among the best qualified to review the protocols again in the future if they were subject to significant change. But we think that Great Eastern's policy should include statements indicating that the chairperson can deviate from this policy as he or she deems appropriate, that a full committee review (FCR) can be called by any designated reviewer and that all IACUC members will still have the opportunity to call for a full review should they see fit1. It is not clear from the scenario whether these concepts are implied in the new policy.

The additional language would allow flexibility in instances where the policy would be inappropriate, inefficient or cumbersome. For example, the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) states, “No member may participate in IACUC review or approval of a project in which the member has a conflicting interest...except to provide information...”2. We can envision a situation in which conflict of interest did not exist during the approval process but developed later owing to a new collaboration. It is also conceivable that extenuating circumstances like extended medical leave could prevent the original member from reviewing a protocol modification in a timely manner. Flexibility in this policy would also allow equitable distribution of protocol review responsibilities and prevent any member from becoming overburdened. Finally, significant change requiring protocol review can encompass many modifications such as a change in species, experimental manipulations or procedures that could affect personnel safety3. It is therefore possible that the original reviewer or presenter is no longer the best person on the committee to carry out the designated member review (DMR) or present the change for FCR.

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References

  1. Silverman, J., Suckow, M.A. & Murthy, S. The IACUC Handbook 2nd edn. 121–124 (CRC Press, Boca Raton, FL, 2007).

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  2. Public Health Service. Policy on Humane Care and Use of Laboratory Animals IV, C, 2 (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).

  3. National Institutes of Health. Guidance on significant changes to animal activities. Notice NOT-OD-14-126. (National Institutes of Health, Washington, DC, 26 August 2014).

  4. National Institutes of Health. Guidance to IACUCs regarding use of designated member review (DMR) for animal study proposal review subsequent to full committee review (FCR). Notice NOT-OD-09-035. (National Institutes of Health, Washington, DC, 8 January 2009).

  5. Animal Welfare Act regulations. 7 U.S.C. 2131-2159. §2.31, d, 2.

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  1. Collins, Lofgren and Lester are in the Unit for Laboratory Animal Medicine at University of Michigan, Ann Arbor MI.,

    Dalis Collins,  Jennifer Lofgren &  Patrick Lester

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  1. Dalis Collins
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  2. Jennifer Lofgren
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  3. Patrick Lester
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Collins, D., Lofgren, J. & Lester, P. Response to Protocol Review Scenario: Compliant but not complete. Lab Anim 44, 339–340 (2015). https://doi.org/10.1038/laban.841

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