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In the late 1970s, while working in my laboratory at the American Health Foundation, I received a phone call from Henry Spira. Not one for small talk, he did not even bother introducing himself beyond his name. He immediately began questioning me about my studies using the protozoan Tetrahymena thermophila , which I hoped would serve as an alternative to the Draize ocular irritation test. While flattered that someone cared about my work, I was soon lost in confusion and skepticism about the true purpose of his call. Who was Henry Spira? Why did he want to visit my animal facility and why did he want to bring a physician colleague with him? Not only was I naive about the budding opposition to the Draize test, I was equally naive that it was Spira, an ardent animal protectionist, who was leading the fight. This seminal interaction began a friendship that spanned nearly twenty years; a friendship that indelibly changed my perception of nonhuman animals and how I relate to them.

Although nonhuman primates often have their canine teeth cut or removed for safe handling, osteomyelitis of the mandible or maxilla has rarely been reported in laboratory animal literature. In the case reported here, a young adult squirrel monkey had a draining skin lesion on the left mandible. The monkey was treated with trimethoprim/sulfamethoxazole. The lesion resolved, but recurred. Culture of a specimen from the deep portion of the lesion yielded Staphylococcus aureus and a Proteus sp. Radiographic findings were consistent with osteomyelitis. A sequestrum was removed intra-orally and oral administration of ciprofloxacin for 60 days led to resolution of the problem. It is assumed that infection of the left molar led to the osteomyelitis, but the definitive etiologic agent was not determined.

Dr. Larry Covelli was proud of the IACUC he chaired at Great Eastern University. There was a culture of thorough but reasonable protocol reviews, open discussions at meetings and an honest effort to balance animal welfare with research requirements. Why, then, was he morose and bitter after talking to the IACUC Administrator? Unknown to the IACUC, an investigator without an IACUC protocol was given a single-needle biopsy sample taken from the liver of a sheep that was being used in a survival abdominal surgical procedure for an unrelated purpose. The sheep study did have IACUC approval, but the approval did not include the biopsy. The Principal Investigator (PI) of the sheep study thought he was just doing a favor for a colleague who needed a small sample of liver tissue. In fact, as was later learned, the PI thought he was reducing animal usage because his colleague would not have to use an entirely separate animal for the biopsy. As for the sheep, she recovered uneventfully. All of this occurred on a Monday, and by the next morning, Covelli knew of the incident. He quickly contacted both investigators, told them why they were noncompliant with NIH/OLAW policy and USDA/Animal Care regulations, and stated that no further biopsies were to be done without an approved protocol amendment or a new protocol. Coincidentally, the monthly IACUC meeting took place that Wednesday, and at the meeting, Covelli dutifully reported what had transpired. After a discussion, the committee concluded that the actions taken by Covelli were appropriate and voted to send a letter of explanation and reprimand to both investigators. Although the incident was a protocol noncompliance, the discussion and vote indicated it was not serious enough to inform NIH/OLAW of the incident and its resolution. Some months later, during a routine USDA/Animal Care inspection, the inspecting veterinarian read the minutes of the IACUC meeting during which the sheep

The Great Eastern University IACUC always informed the federal Office of Laboratory Animal Welfare (OLAW) about significant animal welfare concerns that the IACUC was investigating. After an investigation was complete, it would inform OLAW of its findings and any subsequent actions taken by the committee. On occasion, the IACUC deemed it appropriate to suspend all or part of a protocol. When this happened, the IACUC would also inform the USDA and appropriate federal funding agencies if the involved species was covered by the Animal Welfare Act (AWA) and its regulations. Dr. Hillary Banks used hamsters as part of her photoperiodicity studies. She had a well-deserved reputation as an outstanding researcher and an equally well-deserved reputation as a difficult customer of the IACUC. The IACUC previously had issued a warning to Banks about her blatant disregard for following her protocol. The warning contained an ultimatum that all or part of her study would be suspended if any additional study-related problems were verified by the IACUC. True to form, another significant protocol violation occurred, and Banks was called in front of the full IACUC. She readily admitted to the infraction, blaming one of her technicians for the incident, and said that she had suspended the technician without pay for one week and had also voluntarily suspended any further animal work on the protocol. The IACUC thanked her for her cooperation and said that it would get back to her with the committee’s decision. After Banks left the room,Larry Covelli, the IACUC chairman, turned to the committee and announced that because another protocol violation had occurred, he would inform OLAW of the problem and of Banks’ remedial actions, if the committee was in agreement with what she had done.However, he added that there was no need to inform

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?

One of the IACUC’s responsibilities is to help ensure that researchers use the least possible number of animals compatible with research requirements. Therefore, it seemed like a good idea to Patty Bergman to use the same animals for her own research that her colleague Yancy Wycroft was using for his research. His work involved behavioral testing of rabbits after exposure to different chemical scents, and hers required a weekly blood sample of 0.5 ml per rabbit. On the surface, this sounded like a fine idea to Craig Miller, the IACUC Chairman. Then Bergman clarified things. She wanted to have her own IACUC protocol, but do her experiments concurrently with those of her colleague, using the same animals he was using. This was a new twist for Miller. He had thought that Bergman planned on using the animals after Yancy was done with them. “You know, Patty,” Miller said, “since all you’re planning on doing is taking a little blood once a week from each of the rab­ bits, wouldn’t it just be easier to amend Yancy’s protocol by adding you as one of the research personnel and indicating you will just be taking the blood?” “I thought of that,” said Bergman, “but Yancy said he wasn’t comfortable with that arrangement. He’s very confident that my taking a little blood won’t affect his own research in any way, but his NIH [National Institutes of Health] grant doesn’t say any­ thing about the kind of work I’m doing or about taking any blood. He’s afraid that if I add my work onto his protocol, there might be questions at NIH about a change in the direction of the work.” “I understand what you mean,” Miller said, “but he’s not changing the direction or scope of the work under his grant; he’s just letting you use his rabbits for an unre­ lated purpose that doesn’t affect his own research.” “Thanks,” said Bergman, “but I already tried that argument and it didn’t get me anywhere. As a practical matter, I’d rather have my own protocol anyway and not have to worry if Yancy put in his protocol renew­ al on time or did anything else that might affect my research. My work is NIH-funded so if it’s a real problem for the IACUC, I’ll just purchase rabbits for bleeding rather than use Yancy’s animals. I’m only making this request because I’m trying to save ani­ mals and save money. It seems like a winwin deal all around.” “It is a good idea,” said Miller,“but I really have to think about the consequences and legality of doing this. Let me get back to you.” Can Patty Bergman have her own IACUC protocol but use Yancy Wycroft’s rabbits for blood draws at the same time he is using them for an unrelated research purpose? What IACUC problems, if any, can you foresee?

There had been rumors for some time that the Board of Trustees was about to replace Edna Gordon as president of Great Eastern University. It wasn’t that Gordon did any-thing wrong; it was more that she didn’t do much of anything at all. The university had languished under her presidency and some board members had been hinting that new blood was needed. Then, unexpectedly, Gordon announced her resignation, saying that she would be leaving in six months to become the president of another academic institution.None of this raised any eyebrows on Great Eastern’s IACUC; the Committee members had seen presidents come and go over the years. For the IACUC, it seemed like busi-ness as usual, until one of the newer mem-bers raised an unusual issue. Doug Daniels, who considered himself well-versed in the federal regulations governing IACUCs, asked if there would be any change to the Committee’s membership.“No, I haven’t heard anything—but why are you asking?” said Dave Hammill, the IACUC Chairman.“Well,” said Daniels, “the Animal Welfare Act Regulations (AWRs) say that the Chief Executive Officer (CEO) appoints the IACUC, and since the new president will also be our CEO, doesn’t the new president have to reappoint the IACUC?”“I’ve never heard of anything like that,” said Hammill. “In any case, President Gordon appointed Vice-President for Research John O’Connor as the Institutional Official (IO) and you may recall that under the Public Health Service

Lila Schope, the Attending Veterinarian (AV) at Great Eastern University, was also the Director of the animal care program. As such, she was always looking for ways to bring in new revenue to help keep down the per diem animal care charges. For over three years she had been receiving requests from local startup companies to house mice and guinea pigs. Because animal housing space was available at Great Eastern, she began the process of entering into contractual agreements for animal housing. The com­ panies would provide any technical person­ nel needed for research procedures. After all legal and National Institutes of Health requirements were in place, the universi­ ty’s attorneys and the Vice President for Research approved the contracts. Great Eastern had a policy that only a university employee could be a Principal Investigator (PI) on an IACUC protocol, so Schope listed herself as the PI on each indi­ vidual research protocol that involved work with the contracted companies. Schope felt that this was appropriate because as the AV she had general oversight responsibility for all the animal research performed on cam­ pus. The IACUC agreed and it approved her protocols. At first there was no problem, but after two years the IACUC, led by a new Chairperson, told her that she could no lon­ ger be PI unless she was “intimately involved with the research.” Of course, Schope was upset because the Committee was changing its decision in the middle of work on 12 con­ tract protocols from four different compa­ nies. She was trying to help the university and she had no desire to be any more involved in the research than she originally stated to the IACUC. The IACUC said that it was simply complying with federal regulations about the responsibilities of a PI. Schope said that the only regulation that even vaguely touched upon the current issue was the definition of a PI in the Animal Welfare Act regulations (AWRs). Nevertheless, she contended that there was no appropriate regulatory guidance that the IACUC could use to justify replac­ ing her as PI. She also wanted to know what would happen to the research if her PI status was revoked. The Vice President for Research sided with the IACUC.