Although the outcome of this specific situation was acceptable, there are some potential consequences.

Because the TMPF has its own protocol for generating and holding genetically engineered mice, its personnel can safely make mice for any purpose. But if a specific piece of DNA was needed for the production of Peskin's mouse line, then he needed to have his own protocol and other regulatory approvals in place before submitting a request to the TMPF. Anyone using DNA must have proper registration documents and approvals, and this information should be included in the submission request to the TMPF. The TMPF protocol presumably has this registration for its own purposes.

When the mice were generated for Peskin, he did not have an approved protocol; therefore, they could not officially be transferred to him. Having a 'holding' protocol approved properly by the IACUC is acceptable, as long as the investigator does not carry out any breeding or research on the mice under the holding protocol. If the IACUC reviews the submitted protocol appropriately, then the 'holding' protocol is a valid means of generating and transferring mice from the TMPF to the investigator.

The TMPF, however, should take steps to close this potential loophole. As part of the submission process, the investigator should indicate the current approved protocol number (or other identification as provided by the IACUC); this provides a spot-check that the mice will be properly held on a protocol. If an investigator does not provide this information, then the TMPF has the option of waiting before proceeding with the generation of the requested mice. In addition, without this information, generated mice should not be released to the investigator until the required information is provided. The TMPF's own protocol would cover the generation and holding of these mice, so it would not be at fault for proceeding. The TMPF would be at fault only for releasing mice without an approved protocol for the investigator.

In addition, it would be the responsibility of the IACUC coordinator to ensure that all animals housed under a 'holding' protocol are not used for breeding or research, unless they are officially transferred to an appropriate research or breeding protocol. The TMPF personnel should coordinate this information with the IACUC personnel, to ensure that all requests come from IACUC-approved personnel on approved protocols.

The facility that houses the mice should also have some communication with both the IACUC and TMPF personnel. Animals without an approved protocol should not be allowed to enter the facility or to be transferred from the TMPF to an investigator.

Having this spot-check in place will prevent the accidental production of mice for an investigator without an approved protocol. Otherwise, the next time a mouse line is generated for an investigator who has no protocol, that investigator might not be as careful about getting IACUC approval for a 'holding' protocol, and the facility could potentially have an investigator doing unapproved research on uncounted animals.

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