Slowly and methodically working his way through the Animal Welfare Act (AWA), Dr. Harry Rosen almost jumped out of his chair with excitement when he found what he was looking for. There it was, clearly stating that “Nothing in this Act. . . shall be construed as authorizing the Secretary to promulgate rules, regulations, or orders with regard to design, outlines, guidelines or performance of actual research or experimentation by a research facility as determined by such research facility.” Then, as if by magic, when he turned his attention to the regulations of the Act, the first thing he found was the wording he was seeking. The regulations stated that the IACUC could not set standards for the design, performance, or conduct of actual research by the research facility. Half giggling and half delirious, he ran down the hall to Dr. Sam Gooding's lab. With a grand flourish, he barged through the door and exclaimed, “Sam. You and your meddling Committee are illegal. You can't stop my research. It says right here that the IACUC can't interfere with the design of my experiments.” Looking up from his desk, Gooding turned and said, “Slow down, Harry. Let me see what you're talking about.” Pulling out his copies of the Act and the regulations, Rosen's quivering finger showed Gooding the sections he underlined. “Read it for yourself,” he said. “You can't tell me how to design my research.” Carefully, Gooding read what Rosen had brought, looked at his friend, and said, “Harry, you're way off base. You've misinterpreted everything. All the IACUC wants to do is make sure that you are going to use the smallest number of animals that can give you scientifically acceptable results.”

The story was simple. As part of his research, Rosen wanted to perform anastomoses of the large intestine of rabbits. In one group of animals he would periodically examine the anastomoses endoscopically, whereas he would euthanize rabbits from another group at specific time points and examine the anastomosis microscopically. Upon review of the study, the IACUC wanted to know what additional knowledge Rosen would gain by having both groups of rabbits, rather than one or the other. Rosen took this question as an affront to his ability to design a study, and he felt that the IACUC should not be interfering with the study design itself. For its part, the IACUC did not see this concern as interfering with the study design; rather, it believed that it was asking a very basic question about animal numbers, and with Rosen refusing to respond to its query, it had no choice but to withhold approval until the issue was resolved.

Was Rosen right, or was the IACUC just doing what it was supposed to do?

Response to Protocol Review Scenario: Understanding is the key

Response to Protocol Review Scenario: The 3Rs of our ways

Response to Protocol Review Scenario: Freedom without accountability