During the semiannual IACUC facility inspection at Great Eastern University, the inspection team visited the laboratory of Greg Morrison, DVM. As part of his IACUC-approved research, Morrison had implanted skull electrodes in rats. The procedure was relatively standard. Under general anesthesia and using aseptic technique, he made a small skin incision and then used a fine drill and bit to make holes in the cranium near the bregma. Then he inserted the electrodes and secured them with bone cement. The protocol stated that analgesia would be given if needed. The inspection team found the animals to be in good health and simply asked to see the operative and postoperative records. Morrison's lab technician produced the anesthesia records but said that there were no records of postoperative observations or analgesics used because all of the animals did fine postoperatively and he didn't have to use any analgesics. According to Morrison's instructions to him, the technician said that no medical record entries were required unless an animal had a specific problem or required analgesia.

The site visit team didn't know what to do, so it deferred to the full Committee. The Attending Veterinarian (AV) felt strongly that monitoring data should be part of an animal's postoperative care record. He said that not only was it common sense, but such records were required under the Animal Welfare Act Regulations (AWRs), USDA Policy #3, the Guide for the Care and Use of Laboratory Animals (Guide), and a 25 October 2004 'white paper' from the American College of Laboratory Animal Medicine (ACLAM) entitled Medical Records for Animals Used in Research, Teaching and Testing. The AV finished by saying that it would be impossible for the IACUC to determine whether proper postoperative care was provided if there were no records for review. There were some IACUC members who disagreed with the AV, saying that if they had to maintain health or postoperative monitoring records for every mouse or rat in their colony, they could never complete their work. After the discussion, the Committee voted to support the AV and require Morrison to maintain postoperative monitoring and care records. When the decision was presented to Morrison, he was incensed. He could not believe that the IACUC would not trust a veterinarian to provide proper postoperative care; more importantly, however, he countered that the AWRs do not apply to his research because he used rats. Furthermore, the other documents cited by the AV and IACUC were guidelines, not requirements. He had no objection to the IACUC or the AV observing any of his procedures or examining his animals, but he steadfastly refused to record normal findings, saying that it was unnecessary, not legally required, and a waste of his time.

Does the AV or the IACUC have the authority to compel Morrison to keep the medical records they believe to be appropriate? What can the IACUC do to prevent such problems in the future?

Response to Protocol Review Scenario: Compromise is in order

Response to Protocol Review Scenario: Consider analgesia for all

Response to Protocol Review Scenario: Proof is in the records