It seems that Burbank overlooked proper procedures as he got caught up in the rush of the deadline for grant application submission. After all, the dogs were not 'research animals', and taking an extra milliliter of blood surely would not affect the well-being of the animals. Even though the dogs reside at the local humane society, they are covered under the AWA. Great Eastern receives funding from NIH and therefore must follow the Public Health Service (PHS) Policy. The Animal Welfare Regulations state the following as one of the responsibilities of the IACUC: “IACUC review of activities involving animals1.” Additionally, the PHS Policy states that “[t]his policy is applicable to all PHS-conducted or supported activities involving animals, whether the activities are performed at a PHS agency, an awardee institution or any other institution and conducted in the United States...2” A recent comment from the Office of Protection from Research Risks (OPRR)/NIH (now the Office of Laboratory Animal Welfare, OLAW) regarding activities using animals, whether only to obtain blood or blood products, states that “PHS Policy applicability is not limited to research. It also includes all activities involving animals including testing and teaching3.” Burbank obtained this blood specifically to analyze and collect data related to his proposed research project. OPRR/NIH states that, although these activities are not part of specific research protocols, “their use for these purposes contributes significantly to the institutional research program and constitutes activities involving animals3.” Finally, the statement says, “[t]he IACUC must receive and approve of protocols and appropriate systems to monitor the use of animals prior to the commencement of such activities3.” The IACUC Handbook also uses this point to answer a similar question about the necessity of IACUC approval for sentinel animals or blood donors4. Burbank is not in an unfamiliar situation. Rules on blood donor animals often lie in gray areas. The IACUC Handbook recommends that each institution develop a written policy on the procedures to follow when using donated blood5. Whereas a full protocol may not be necessary, this leads to some form of paperwork that the IACUC needs to generate and review for approval to remain consistent with federal guidelines5.

In our opinion, Madela was correct to cite Great Eastern for having performed research without an IACUC protocol. The IACUC Chairperson needs to address the development of an institutional policy to deal with blood donors and similar animal-related activities. Many institutions have developed policies that allow for a “shortened” protocol form that goes through an expedited review. One may argue that requiring an IACUC-approved protocol to use donated blood is yet another way that the burden of paperwork hinders the advancement of science. Because of the diversity of the IACUC members, it is important for a protocol to be reviewed so that the Committee will be able to address the ethical concerns in using humane society animals for research purposes. Did Burbank fail to submit a proposal to the IACUC because he was 'out of time'? This certainly is not a justifiable reason, at least not from the perspective of the law.