Incorporation of the OLAW Guidance on Significant Changes to Animal Activities


Problem statement: On August 26, 2014, OLAW released Guidance on Significant Changes to Animal Activities (NOT-OD-14-126).  The guidance clarified that a veterinarian could serve as a subject matter expert and could approve the following  types of changes: (a) anesthesia, analgesia, sedation, or experimental substances; (b) euthanasia to any method approved in the American Veterinary Medical Association Guidelines for the Euthanasia of Animals; and (c) duration, frequency, type, or number of procedures performed on an animal. The Guidance states the veterinarian review must be documented and allows the IACUC to determine the best documentation process for the committee and the institution.

Description of research: The Jackson Laboratory’s (JAX) Animal Welfare & Compliance Office developed a review process that reduces regulator burden and adheres to the new OLAW Guidance.  As in most organizations, Principal Investigators (PI) look to identify ways to reduce review cycle timelines so they can make changes to protocols and continue their work seamlessly. The Animal Welfare & Compliance Office wanted to ensure the new process clearly documented changes, reduced regulatory burden, provided the animal end users with clear instructions, kept the IACUC informed, and provided a thorough review.  Easy to accomplish, right? JAX found that implementing the new veterinary review process yielded the following benefits: (a) Reduces the number of IACUC members required to review significant changes from three to one member (the veterinarian); (b) Reduces the number of amendment change requests the Environmental Health and Safety Services (EHSS) representative is required to review. Previously, the EHSS representative was required to review all changes even if there were no safety related concerns; (c) Allows for significant changes to be approved immediately after the veterinarian has provided approval.  Previously, minor and major change amendments required a 24-hour approval hold period from the time they were distributed to the IACUC, even if all Designated Member Reviewers approved. This time was designated to allow other IACUC members time to comment on the requested change; (d) Allows the PIs to remain competitive in the market and accommodate last minute change requested by their clients/customers; (e) Strengthens the relationship between the IACUC and the PI; and (f) On average, the amendment approval period dropped from two business days down to 0.25 business days.

Additional information: The Animal Welfare & Compliance Office has tracked IACUC submissions and timelines since the integration of the new process.  This poster will include statistical information, along with the JAX process.  Our hope is that this information will be useful for others in the field to assist with decreasing regulatory burden and demonstrating one successful way of implementing the new OLAW Guidance.