The PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy)1 allows an IACUC to review protocols with three possible outcomes: approval, requiring modifications in (to secure approval) and withholding approval. Covelli's initial point that there is no option for conditional or limited approval is consistent with the PHS Policy. In our opinion, the IBC approval is an administrative approval as long as the IBC approves the protocol without modifications. Francis, the Principal Investigator (PI), cannot start to work on animals until the administrative approval from the IBC is provided and the protocol is officially approved by the IACUC. Allowing Francis to start her mouse work without an IACUC protocol approval, as suggested by Gordon, is an apparent violation of the PHS Policy1 and the Guide for the Care and Use of Laboratory Animals2.
The compromise suggested by Covelli is a more practical approach. The IACUC can require the PI to remove the rat segment to secure the approval of mouse work. Then the PI can start her mouse work under the approved IACUC protocol. Once the IBC approval is provided, the PI can submit the rat work as an amendment to the approved protocol. We believe that such an amendment should be considered a major amendment, not a minor one, and must be reviewed by the IACUC again. The IACUC can decide whether this amendment will receive Full Committee Review or Designated Member Review (DMR). The DMR method may allow the amendment to be approved more quickly, because it does not require a convened meeting of a quorum of the IACUC members.
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