Riya Ramos, an animal husbandry professor at Great Eastern University, bred hybrids of domestic cattle and American bison. Her goal was to develop rapid growing, well-marbled cattle that also would produce low fat milk, rather than the typically sweet-tasting high fat milk of the hybrids. She began a search to identify a genetic sequence that might be indicative of a low-fat producing cow. As her studies progressed she discovered that in the very few low milk fat producing cows she was able to identify, there was a linked genetic sequence previously reported as being a variant of the prion protein gene. Nevertheless, not one of her animals ever exhibited bovine spongiform encephalopathy, a prion-associated disease. Intrigued, yet preferring to remain focused on her area of expertise, Ramos brought her finding to Jack Mason, a neurologist in the university's veterinary college, and they tentatively agreed to develop a collaborative pilot study looking at additional genetic sequences from high and low milk fat producing animals.

When Mason told Ramos that an IACUC protocol would have to be submitted for approval before any work on prion disease could progress, Ramos balked. Although she had heard of IACUCs, she never had interacted with one and did not want a committee approving what she could or could not do with her animals. In Ramos's mind she was doing agricultural research, not biomedical research. She said that she would be glad to give Mason any extra blood, milk, or tissue samples from those she collected for her own research, but that was as much as she was willing to do. Mason thought that if the IACUC would approve a protocol that listed only him as a biomedical research participant, he could certainly get sufficient preliminary data from those samples. When he broached the issue with the IACUC chair, the chair said he didn't think IACUC approval was even necessary because he would be using extra samples that Ramos was not going to use for her own research.

What is your opinion? Is IACUC approval needed for the pilot study to progress? If it is, what conditions might the IACUC establish so that Ramos could do her agricultural work and Mason could use the same animals for his biomedical research?

Response to Protocol Review Scenario: No IACUC approval necessary, but inspect potential risks

Response to Protocol Review Scenario: IACUC approval for the sake of prudence, not welfare

Response to Protocol Review Scenario: Sample Sharing

Response to Protocol Review Scenario: A Word from the USDA