Dr. Larry Chen was the Principal Investigator (PI) on an IACUC protocol which involved performing an orthopedic surgical procedure using a rabbit model. Chen's colleague, Dr. Riva Rosen, was the PI on a study involving long bone fracture healing, using a mouse model. About two years earlier, when Chen's protocol was first approved, Rosen had worked with Chen and she had performed the same orthopedic surgery on rabbits that was now being performed only by Chen. Both researchers were board-certified orthopedic surgeons and their research was funded through NIH grants. Over time it became clear to Rosen that she would need to use an animal much larger than a mouse for a proof-of-concept study that she wanted to perform, and the procedure used by Chen on rabbits precisely met her research needs. So Rosen 'borrowed' two of Chen's rabbits and performed the exact same procedure used by Chen, without any complications.
Neither Rosen nor Chen thought they were doing anything wrong until the IACUC found out what had happened and told Rosen that she did not have IACUC approval to use Chen's animals or perform the surgical procedure. Chen was told that he did not have IACUC approval to give the rabbits to Rosen. In her own defense, Rosen said that the surgery she performed on the rabbits was already approved by the IACUC and that she herself was approved by the IACUC to do the surgery. Chen said nearly the same thing but added that after the IACUC contacted him he looked at the PHS Policy on Humane Care and Use of Laboratory Animals1 and at the Animal Welfare Act regulations2, and both documents said that the IACUC had to approve activities related to the care and use of animals. Chen's point, like Rosen's, was that the use of rabbits for the surgery had been reviewed and approved by the IACUC.
Chen and Rosen have argued that Rosen's so-called unapproved surgical work was actually approved by the IACUC. Chen did not find anything in the documents he consulted to indicate that the surgery had to be performed under a single IACUC approved protocol. The two researchers believed that as long as all the component parts of a study were approved, the research could go forward without additional approvals. Do you agree with Chen and Rosen? How would you approach this problem?
References
Public Health Service. Policy on Humane Care and Use of Laboratory Animals. (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
Animal Welfare Act Regulations. 9 CFR. Chapter 1, Subchapter A, Part 2, Subpart C.
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Silverman, J. Sharing animals across protocols. Lab Anim 45, 209 (2016). https://doi.org/10.1038/laban.1019
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DOI: https://doi.org/10.1038/laban.1019
