Covelli and White are struggling over the meaning of “requires modification (to secure approval)1.” This is demonstrated by White's statement: “It seems to me that having a question for a PI and requiring modifications to secure approval are not one and the same.” They appear to be creating an artificial distinction between “required modifications” and “having questions,” which does not exist within the regulation. PHS Policy1 allows for only three possible responses by the IACUC during a protocol review: “...approve, require modifications in (to secure approval) or withhold approval of those components of PHS-conducted or supported activities related to the care and use of animals as specified in IV.C of this Policy.”
More troubling is Covelli's statement: “If the PI agrees to accept the required modification and revises the protocol to include it, the protocol can be administratively accepted.” As indicated in background section of NOT-OD-035, “PHS Policy does not allow for 'approved pending modification'1 and does not recognize this approval designation.” This is, in essence, what Covelli has described. Additional guidance on acceptable items for administrative review or acceptance can be found on the OLAW website FAQ page2.
In the end, Covelli hits on the true benefit of NOT-OD-35: “Maybe it's just a time-saver.” This notice outlines a process whereby the IACUC can establish a method to send a protocol directly from FCR to DMR without the delay caused by polling members to see if they wish to call for FCR.
References
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Protocol Review, Question No. 9. (US Department of Health and Human Services, Washington, DC, 2006; revised 2009). http://grants.nih.gov/grants/olaw/faqs.htm#proto_9.
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Matu, J., Anderson, R. Response to Protocol Review Scenario: A time-saver. Lab Anim 38, 226 (2009). https://doi.org/10.1038/laban0709-226a
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DOI: https://doi.org/10.1038/laban0709-226a