Covelli's opposition to conditional or limited approval of protocols is valid. But there are other options available that will not place unnecessary restrictions on the investigators and the IACUC process. Therefore, we do not completely agree with Covelli that the IACUC could not let Francis begin any work on her protocol until the IBC approval was received.
IACUCs can approve, require modifications (to secure approval) or withhold approval of proposed activities related to the care and use of animals1,2. If the IACUC determines that a protocol is approvable contingent upon receipt of a very specific administrative modification or clarification, then it may handle the issue as an administrative detail that is verifiable. IACUCs should avoid using the term 'conditional approval' of a protocol, even when they determine that no major revisions or clarifications are required, because use of the term may cause confusion3. Because IBC approval may not be considered a major revision or clarification, the IACUC can approve Francis' protocol with the contingency that the IBC must review and approve the biocontainment work on the rats. This modification is an administrative detail that an individual, such as the IACUC Chair or IACUC Administrator can verify3. Once the IBC approves Francis' biocontainment work and she updates her protocol to reflect the approval, the contingency can be lifted and she can begin the biocontainment research on rats. No substantive information (e.g., justification for withholding analgesics in a painful procedure), as required in the PHS Policy on Humane Care and Use of Laboratory Animals1 or the Guide for the Care and Use of Laboratory Animals4, is missing from Francis' protocol; therefore, the IACUC can make a judgment on the animal work. We disagree with Covelli's viewpoint that the IBC approval is a substantive piece of information missing from her protocol. The protocol contains all the required information and should be accepted and approved by the IACUC.
This is a preview of subscription content, access via your institution