“I'm really sorry, Connie, but I don't have the authority to extend your protocol's expiration date. The NIH/OLAW policy is pretty clear about that. The IACUC sent you three notices that it was nearing its expiration date, but a renewal application was never received. In the meantime, you can work on your other protocols, but this one is now a holding protocol. You have to stop all work on this protocol until you get it renewed.”
“You must be kidding, Larry,” was the response from Dr. Connie Linder. “We're talking about a week, maybe less, and you're making me jump through bureaucratic hoops and stop funded research?”
“I understand why you're upset,” answered Larry Covelli, the IACUC Chair, “but you're the one who stopped it. The IACUC has no choice in this. The IACUC office will send you a letter saying you have 30 days to submit a new protocol, and during that time, Lab Animal Resources will care for your animals, but no research or breeding can be done, and you're going to have to pay for the care of the animals.”
“And what happens if I don't submit one in 30 days?” queried Linder.
The answer came slowly but clearly: “The animals are now under a holding protocol, with the IACUC as the investigator. Nothing will be done other than providing husbandry and any needed medical care. The IACUC will determine their fate, which can include euthanasia, donation to other investigators, etc.”
Hearing that, Linder hung up her phone and complained, to no avail, to all of her colleagues.
Thirty days later, there still was no protocol renewal from Linder. Covelli was unsure what to do, because in similar past instances, the investigators had always submitted their protocol renewals as quickly as possible. Covelli decided to send an ultimatum to Linder, in which he warned her that if a protocol renewal application was not received within 30 days, the 172 mice that were on the holding protocol would be euthanized. Thirty days passed again with no renewal submission. Covelli finally discussed the issue with the IACUC, and the committee's decision was to euthanize the animals if other investigators could not use them. That was not what Covelli wanted to hear, although he didn't know what he did want to hear.
Do you think that the IACUC's initial action and Covelli's subsequent actions were ethical and permissible under policies of the National Institutes of Health and Office of Laboratory Animal Welfare? How would you approach the problems faced by Covelli?
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Silverman, J. Refusal to renew an expiring protocol. Lab Anim 39, 335 (2010). https://doi.org/10.1038/laban1110-335a
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DOI: https://doi.org/10.1038/laban1110-335a
