Application of the Biosafety RAM and eProtocol Software Programs to Streamline Institutional Biosafety Committee Processes at the USDA-National Animal Disease Center

Abstract

The National Animal Disease Center (NADC) conducts basic and applied research on endemic animal diseases of high priority that adversely affect US livestock production or trade. Experiments conducted at this center vary in range and scope with a subset involving synthetic or recombinant nucleic acids (DNA), microorganisms, and/or animals. Historically, the NADC used hard copy paper and filing systems to catalog and monitor these types of experiments, but to improve communication, tracking, searching, reporting, and documentation of Institutional Biosafety Committee (IBC) actions, this institution has transitioned to using a commercially available software tool to digitally manage protocols in our ongoing efforts to maintain excellence in regulatory compliance. In addition, similar to many other research institutions and universities, the scope of the IBC has expanded to include risk assessments on all work conducted at the center. This process has been streamlined using the Biosafety RAM open source software, developed by Sandia National Laboratories, and has stimulated productive discussions on best practices to safely conduct animal and microbiological experiments at the center. Although some initial challenges arose, successful implementation of these two software tools at the NADC has simplified the management of IBC compliance requirements and facilitated review processes at a high-containment government research facility