Just-in-time Verification

You are probably aware that NIH changed the PHS Policy on Humane Care and Use of Laboratory Animals to permit institutions with PHS Animal Welfare Assurances to submit verification of IACUC approval for competing applications on a "just-in-time" basis (after peer review, but prior to award). This change takes place for applications submitted for the May-June 2003 Advisory Council dates (October 1 deadline).

The University Committee on Animal Resources has voted to change our current requirement that Animal Use Protocols must be submitted before Vivarium sign-off can be obtained. Beginning with applications due October 1, 2002, we are requiring that all applications proposing use of vertebrate animals (whether to PHS or other agencies) continue to be brought to the UCAR office as part of the sign-off procedure. The office will log the application, briefly review the required Vertebrate Animal section (for NIH grants), and obtain vivarium sign-off. We will no longer require that the Animal Use Protocol accompany the application. However, NIH is clear that no funding will be awarded without notification of approval. It will be up to the investigator to submit the Animal Use Protocol so that the UCAR has at least 60 days to review it before an approval letter is needed by the funding agency. It will be the responsibility of the investigator to determine when approval letters are required, and to send the approval letter to the appropriate office.

At this time, the UCAR has not imposed any restrictions on who may use this process. Based on our experience over the next several months, we may elect to require submission of protocols at the time of sign-off for some submissions. This is particularly likely if the PI does not allow enough time for review of submitted protocols. We highly suggest that protocols proposing recovery surgery, (Section B) receive approval of the surgery from the UCAR veterinarians prior to submission of the protocol. Similarly, protocols using hazardous chemicals or biohazards (Section C) should receive pre-approval from Environmental Health and Safety (EHS). These pre-approvals, sent to the UCAR office, will facilitate our review process.

Not all funding sources accept just-in-time verification of approval (see list following this memo). American Cancer Society, American Heart Association, American Diabetes Association, and the March of Dimes, to name a few, still require verification of approval either with the application or within 60 days of submission. The UCAR office will not require submission of protocols as a condition of vivarium sign-off. However, if we do not receive protocols within a week of grant submission to these agencies, we may not be able to provide verification of approval within the required 60 days.

The UCAR review process is described below:

1. Upon receiving a protocol, the UCAR office staff logs it into the system, and checks that it is appropriately signed, that it matches a specific research application, that any necessary appendices (recovery surgery, EHS review, etc. are appended, and that appropriate contact information for the investigator is included.
2. The protocol is then sent to a designated review team consisting of at least one veterinarian and 4 other UCAR members for review. Each reviewer either approves the application, asks questions of the PI to help clarify the protocol, or provide missing information, or requests that the protocol be reviewed at a convened meeting of the UCAR.
3. A description of each protocol submitted during the week is sent to all UCAR members each Friday. The members have until the following Wednesday to request to be added to the protocol review team.
4. Questions from the reviewers are complied by the UCAR office staff and sent to the PI for response. Failure of the PI to respond to these questions effectively halts the review process.
5. The response of the PI to all questions asked by the reviewers is sent to all members of the review team for further review, and, if necessary, more questions.
6. Once all members of the review team approve the protocol, a letter verifying approval is generated and sent to the PI, who must send it to the appropriate granting agency.

Before a protocol may be activated and animals ordered the following conditions must be met:
· Protocol is reviewed and approved, and an updated version addressing all reviewer concerns and questions is provided to UCAR Office.
· All personnel working on protocol must have attended the Animal Resource Orientation, and obtain any relevant training from DLAM/Vivarium (e.g., micro-isolator training, non-human primate handling, appropriate tours of facilities as required).
· Personnel on the protocol are enrolled in the Occupational Health Program if required (e.g., users of non-human primates, bats, sheep. If you have questions call the UCAR Office, extension 5-1693).
· If you are using hazardous chemicals or biohazards, (e.g., tumor cell lines, recombinant DNA, and viruses -- check the Environmental Health and Safety website (http://www.safety.rochester.edu). Approval from EH&S must be received by the UCAR Office.
· You must be able to provide evidence that your grant was peer reviewed. If it has not gone to an agency that provides peer review or if it has not yet been peer reviewed before you want to start work, you must have the work reviewed and approved by the Deans Research Advisory Committee (DRAC) and approval provided to the Committee.
· When all of these conditions have been met you may call the UCAR Office to activate the protocol. Please allow 24-hours to activate.

In general it is a good idea to contact the Vivarium Supervisor before ordering animals to make sure that they can be adequately housed. This is particularly important if you are a new investigator without animals in house, are ordering an unusually large number, a new species, have special housing requirements (micro-isolators, one rodent per cage), are using hazardous substances, or are acquiring animals from a non-routine vendor.