Dr. Eduardo Morales' research on the maturation of the immune system included the subcutaneous implantation of an osmotic pump between the scapulae. Thin tubing exited the pump and entered the external jugular vein. Morales performed this protocol in hamsters, aseptically, under general anesthesia and with the use of postprocedural analgesia.

As part of its IACUC application process, Great Eastern University required investigators to perform a literature search for possible alternatives to pain, distress, or animal usage. Morales had always done so without question, and as is common with many investigators, he searched the Medline database from 1966 to the present. The key words he used, in various combinations, included 'hamster', 'alternative', 'in vitro', 'immunity', 'immune system', and the name of the particular compound that he was using. He also listed any pertinent scientific meetings he had attended. Invariably, he told the IACUC that there were no viable alternatives to the use of animals or to the procedures he had used. Also invariably, the IACUC did not question this.

Paula Stone, the University's librarian, received an appointment to the IACUC to “help investigators do a more rapid literature search”. Soon, there was a hint of conflict in the air. Stone, who had been trained by the staff of the National Agricultural Library, made it clear that she truly wanted to help the investigators and would gladly work with them to develop general search strategies, but she did not have the resources to do all the searches for them. In the few instances when she would actually do a search for an investigator, it would be on a fee-for-service basis. This was not what many people wanted to hear. Stone turned to the Morales protocol. She said that Medline is simply not a good database to use for seeking alternatives, that one should not use it as the only database, and that the search terms Morales had used, though seemingly reasonable, were unlikely to uncover alternatives. Rather than have a prolonged discussion during the meeting, the Chairwoman thanked Stone for her insights and said that she would speak privately with her about her concerns.

The following week Stone presented a search scenario that the Chair, who was a scientist, knew was far more complicated and lengthy than any researcher at Great Eastern would accept even if additional databases became available. The Chair emphasized that the key words used by Morales included all of the main terms for an alternatives search that was performed at most other universities, and, in any case, searches (in her experience) never turned up any viable alternatives. Furthermore, she said that researchers were very aware of new developments in their field and would know about any nonanimal alternatives. She suggested that Stone perform her own search on any or all of the 12 protocols reviewed at the last meeting, and if she could find any reasonable alternatives to the procedures that the IACUC had approved, she would personally ask the Vice President for Research to provide funding for a librarian to be assigned specifically to IACUC functions. Stone could not afford the time that such a challenge would entail, and she also felt that the Chair was denigrating her purpose for being on the IACUC.

Did Morales perform an adequate literature search that met the word and spirit of the USDA regulations, or is Stone correct in implying that a better search was needed? If improved searches are necessary, how can the Great Eastern IACUC and its investigators accomplish this within the constraints of a busy research schedule?

Response to Protocol Review Scenario: Perception of an Adequate Literature Search

Response to Protocol Review Scenario: Stepping on Stone