The Office of Laboratory Animal Welfare (OLAW) provides the following recommendations on ways the IACUC could streamline the protocol review process when additional approval(s) is required in a way that reduces burden on the investigator while maintaining compliance with PHS Policy requirements.

In research using animals, occupational health and safety considerations require coordination between the investigator, the IACUC, and the safety office1. It is incumbent on all involved to obtain the necessary review and approvals before the work can begin. The IACUC at Great Eastern has chosen to employ a burdensome process that delays the investigator's work. Numerous approaches could mitigate this burden. One option is for the IACUC to delay notification of approval to the investigator until after the safety review is complete2. The approval date of the protocol should be on or after the date of the safety approval as determined by the individual IACUC's operating procedures3. An equally effective option is to submit the work that requires safety approval as an amendment to the protocol after the safety office has cleared the activities and provided any instruction or training2. Many IACUCs conduct protocol review in parallel with the safety review. This practice expedites the process as long as the outcome of both reviews are effectively communicated. If the safety office approves the work without modifications, the IACUC may document this approval administratively without further IACUC review by, for example, a check box, an approval number or a safety representative's signature2. Any of these methods are acceptable for documentation of the safety approval.

Another consideration in avoiding misconceptions by investigators about the status of a submitted animal use protocol is to avoid the phrase “conditional approval”. As stated in OLAW guidance, the PHS Policy does not allow IACUCs to grant conditional approval for animal use protocols2. Committees may only approve, require modification (to secure approval) or withhold approval of a protocol4.

Return to Protocol Review