Dr. David Burbank, an assistant professor at Great Eastern University, was excited about his planned study. However, at the 11th hour, he realized that a small amount of blood taken from four or five dogs would provide important additional preliminary data to support his pending NIH grant submission. Unfortunately, the school's animal facilities were not housing dogs at the time. So, acting on a suggestion from one his technicians, Burbank called the veterinarian at the local humane society and asked him if it was possible to obtain a small amount of freshly drawn blood from a few healthy-looking dogs. The veterinarian said that they routinely took blood samples for clinical purposes, and he saw no real problem in taking one additional milliliter from some of the larger animals to help Burbank's research. This was great news to Burbank, and with the veterinarian's assistance the blood was drawn, the data were gathered and analyzed, and the grant was submitted.

Under the new NIH 'just-in-time' procedures for peer review, Burbank's grant application was reviewed, received a favorable priority score, and was likely to be within the fundable range. He submitted to the Great Eastern IACUC an application that included the use of cats (the primary species of interest) and dogs (based on his supplementary data). The application used the words “based on preliminary data from dogs,” a point missed during the protocol review process because dogs were occasionally housed at Great Eastern. After approval from the IACUC, Burbank began his research, but not everything went as planned. There were a series of small technical problems, and as a result some of the dogs did not appear as healthy as others, although they all eventually did well. Therefore, it was not surprising when Dr. Shana Madela, the USDA Veterinary Officer, asked to see Burbank's protocol after observing some of the dogs during a regular inspection. Madela reviewed the promptly produced protocol, which clearly stated that no health or welfare problems were anticipated. Madela then asked to see the protocol that supported the “preliminary data from dogs,” which, of course, did not exist. Burbank received a call, and he explained exactly what had happened. Madela said she would have to cite Great Eastern for having performed research without an IACUC-approved protocol. In its own defense, Great Eastern's IACUC Chairperson argued that it was just a little extra blood taken from clinical cases that had never needed an IACUC protocol to begin with. Additionally, it came from animals at a private humane organization that did no research at all. Madela was unimpressed. Her opinion was that blood was taken from a USDA-covered species for research purposes, whether it was a just a supplement to a clinical procedure or not.

What do you think? Did Burbank need the approval of the Great Eastern IACUC for the private veterinarian to take a little extra blood, or is Madela wrong in her interpretation?

Response to Protocol Review Scenario: IACUC in a Bind Thanks to Lack of Information

Response to Protocol Review Scenario: Grant Deadline No Excuse

Response to Protocol Review Scenario: Better Safe Than Sorry