In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:

Although this scenario involves rodents, which are not USDA-covered species, it is important to consider how the USDA/APHIS/AC requirements would apply to a similar scenario involving USDA-covered species.

There are three questions asked at the conclusion of the scenario that we will address. May the IACUC allow work to start on a protocol while portions of the study are pending IBC approval? The Animal Welfare Act and Regulations and the Public Health Service Policy on Humane Care and Use of Laboratory Animals do not allow IACUCs to grant conditional approval for animal use protocols. Committees may only approve, require modification (to secure approval) or withhold approval of a protocol1,2. We highly recommend using this unambiguous language when communicating with the principal investigator (PI)3,4. The phrase 'approved pending modifications' is confusing, and IACUCs should avoid using it4.

Is the addition of another species to the protocol considered a minor amendment? We consider the addition of a second species of animals to the protocol to be a significant change5. A significant change must be reviewed and approved by the IACUC by either full committee or designated member review.

Is there a different approach for the IACUC to consider? One option is to include the work that requires IBC approval in the protocol and delay notification to the PI of IACUC approval until after the IBC has conducted its review and approval. The approval date of the protocol should be on or after the date of the IBC approval as determined by the IACUC's operating procedures6. Another option is to submit the work that requires IBC approval as an amendment to the protocol after IBC review and approval has been obtained. A third option is for the PI to submit one protocol for the mouse study and another for the rat study. After review and approval by the IACUC, the research on the mouse protocol may then proceed without delay, while the rat protocol awaits IBC approval of the safety issues.

In our experience, many IACUCs conduct protocol review in parallel with IBC review. This expedites the process as long as both committees effectively communicate their actions and decisions. If the safety committee reviews and approves the work without modifications, the IACUC may document this approval administratively without further IACUC review. IBC approval may be indicated by, for example, a check box, an IBC protocol approval number or a safety committee representative's signature. Any of these methods are acceptable for documentation of IBC approval.

Response to Protocol Review Scenario