ABSTRACT
Protocol review was mandated by federal law for most institutions using animals in research, teaching, and testing by the passage in 1985 of an amendment to the AWA known as the Improved Standards for Laboratory Animals Act (Public Law 99-198) and by a component of the legislative reauthorization for the NIH, known as the Health Research Extension Act of 1985 (Public Law 99-158). In advance of this requirement, and as early as 1980, several academic institutions already had begun to implement the basic concepts of protocol review. The veterinarians in these institutions had made a compelling case for needing some information about the nature of the ongoing animal use to be able to sign their institutional APHIS/AC annual report in good conscience. In the context of the contemporary standards for protocol review in most institutions, the forms used were rudimentary. The information retrieved in these pioneering efforts was extremely scant and generally would now be insufcient for the issuance of an IACUC approval. Nevertheless, these initial efforts were important because they introduced the setting, players, and ethos of an evolving process that eventually would be adapted and embellished at diverse institutions across the country as the federal mandates for protocol review took effect.
