Getting around late protocol renewals

As always, time was running out for Ray Romansky. It was almost a game for him to wait until the eleventh hour before submit­ ting his protocol renewal to the Great Eastern University IACUC. On some occasions he even had to secure a brief extension of time from the IACUC after the protocol had tech­ nically expired. So, true to form, he submitted his protocol the day it was due to expire, with a request to keep it active until the IACUC had time to review and approve it. Naomi Gates was new to the IACUC office and was unaware of Romansky’s history. She had been told that every protocol had an expiration date. Beginning 90 days before the expiration date, she sent monthly notic­ es to investigators, reminding them to sub­ mit their protocols for renewal well before that date. Once a protocol expired, Gates’s instructions were to inform the investigator that no further animal activities could occur until the protocol had been approved. The following day after Romansky’s pro­ tocol expired, Gates sent him a perfunctory ‘cease and desist’ notice, copying the animal facility to ensure that no additional animals could be ordered. Apparently, nobody had told Gates that the committee often flouted federal regulations and policy and allowed investigators to have some additional time before suspending animal activities on a protocol. When Romansky received the notice from Gates he became livid and immediately called the often-hassled Larry Covelli, the IACUC Chairman. Covelli was apologetic, but asked for Romansky’s understanding. “The damage is done,” Covelli told him,“and there’s nothing I can really do.” Then Romansky got an idea. Because all of his protocols used the same basic methodol­ ogy, he would transfer about 50 mice from his newly expired protocol to one of his active protocols. The 50 animals were less than 5% of the approved number on the active pro­ tocol, so he believed it could be submitted as a minor amendment under Great Eastern’s IACUC policy. He would just add them as an additional drug group to those already approved. Then he could continue his drug studies until the suspended protocol was approved, at which time he would transfer the animals back to that protocol. Covelli wanted to redeem himself, so he gave serious thought to Romansky’s idea and concluded that he didn’t know whether or not he had the authority to grant the request. By not following federal regulations, the Great Eastern University IACUC seems to have boxed itself into a corner with Romansky. If not ethical, is Romansky’s request even legal? If the request is approved by the IACUC as a minor amendment, is it compliant with federal policies to move animals out of a suspended protocol into an active one?