Application of the biosafety RAM and eProtocol software programs to streamline institutional biosafety committee processes at the USDA-National Animal Disease Center

Authors: Bannantine, John; Register, Karen; White, David

Submitted to: Applied Biosafety
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 3/9/2018
Publication Date: 4/22/2018
Citation: Bannantine, J.P., Register, K.B., White, D.M. 2018. Application of the biosafety RAM and eProtocol software programs to streamline institutional biosafety committee processes at the USDA-National Animal Disease Center. Applied Biosafety. 10.1177/1535676018767904.
DOI: https://doi.org/10.1177/1535676018767904

Interpretive Summary: To better handle and streamline the submission and review of recombinant DNA protocols and monitor experiments conducted using recombinant DNA, the NADC's Institutional Biosafety Committee (IBC) explored and implemented eProtocol software tools. In addition, the Biosafety RAM software tool was implemented to help researchers conduct risk assessments for all research projects at NADC. These software tools are described and their strengths and weaknesses are discussed. This manuscript is of primary interest to researchers and safety personal at government labs, universities and private industry.

Technical Abstract: The National Animal Disease Center (NADC) conducts basic and applied research on endemic animal diseases of high priority that adversely affect U.S. 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 in order to improve communication, tracking, and documentation of Institutional Biosafety Committee (IBC) actions, and gain the ability to quickly search protocols and assemble reports, 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.