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Congruence between grants and protocols

The nonhuman primate (NHP) facility at Great Eastern University had an IACUC-approved protocol to supply blood and certain other tissues (e.g., lymph node biopsies) from live primates to researchers for their studies. Joan Collier, an IACUC member who also was an IACUC office staff employee, was carrying out a third-year renewal review of the NHP facility's protocol. As part of her office duties, Collier helped to assure that animal use procedures listed on research grants were approved by the IACUC on one or more of the principal investigator's protocols. Therefore, it surprised her to find that the use of the NHP facility tissue collection protocol by investigators at Great Eastern seemed to exceed the number of research grants that claimed to require the use of primate tissues. Collier did a little detective work, focusing on grants belonging to Drs. White and Green.

White's grant, which used monkeys in a surgical study, included blood transfusions using blood obtained from other monkeys of her own. However, she had recently begun using the NHP facility protocol to supply additional blood for transfusions. She did not report this to the IACUC, nor was it mentioned on her last non-competing renewal to her funding institute at the National Institutes of Health (NIH). In contrast, Green's research normally used only commercially available mice and mouse cell lines. But in the second year of his study, he realized that he needed to confirm some of his results by using primary cells derived from NHP lymph nodes. Therefore, he amended his IACUC protocol to add the use of the primate lymph node cells obtained from animals at the school's NHP facility, but he never informed his funding source (the NIH) of this change. When questioned by Collier about the use of the NHP facility animals, both White and Green indicated that they had nothing to do with the live monkeys; they simply obtained blood or lymph node tissue using the NHP facility's fee-for-service program. They never notified the NIH because they believed they were not using live monkeys.

Collier said that the monkey tissues obtained from the NHP facility were custom samples and could not be considered 'off-the-shelf' items. In her opinion, the researchers were non-compliant with their NIH grants. Do you think that White and Green were noncompliant with their grants? Should Green's addition of the lymph node tissue have been reviewed for its scientific merit? What role, if any, should the IACUC, NHP facility and Great Eastern University have in addressing the concerns of Collier?

Response to Protocol Review Scenario: Hole in the system

Response to Protocol Review Scenario: Verify congruence

Response to Protocol Review Scenario: Documentation needed

Response to Protocol Review Scenario: A word from OLAW

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Silverman, J. Congruence between grants and protocols. Lab Anim 44, 129 (2015). https://doi.org/10.1038/laban.727

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