Expansion of Northwell Health's Biosafety Program into the Clinical Setting. (December 2017)

• Record Type: Journal Article
• Authors: Jarrett, Mark; Armellino, Donna; Dolojan, Michelle; Lowe, William; Maffeo, Victoria; Nelson, Karen; Smith, David; Woolforde, Launette
• Is Part Of: Applied biosafety. Volume 22:Number 4(2017)
• Page Start: 156
• Page End: 163
• Publication Date: 2017-12
• Subjects: Biosafety Steering Committee -- Institutional Biosafety Committee -- therapeutic biological agents -- gene therapy vectors -- biological agent drug trials; Industrial hygiene -- Periodicals; Public health -- Periodicals; Laboratories -- Safety measures -- Periodicals; Biosecurity -- Periodicals; Biological laboratories -- Safety measures -- Periodicals; Biological laboratories -- Security measures -- Periodicals; 613.62
• DOI: 10.1177/1535676017742134
• Languages: English
• ISSNs: 1535-6760

Abstract

Background: The utilization of live biological agents as vectors for gene delivery systems is becoming more prevalent in clinical research. Often, these agents are handled in patient care environments, such as hospitals and ambulatory sites. While expanding the use of these agents from nonclinical to clinical research, Northwell Health first established a robust process to standardize biological agent research and protect patients, employees, and visitors. Methods: A collaborative, multidisciplinary approach was employed to develop an organizational-wide approach to using live biological agents in clinical research. The needs of both investigators and patient subjects were addressed while outlining a process to safely conduct clinical research, which was rapidly established with project management support and methodologies. Results: An organizational-wide Institutional Biosafety Committee (IBC) was established within 6 months. In addition, a comprehensive Biosafety Program standardized Northwell Health's approach to biological agent research, including agent handling and containment, training and education of providers and subjects, and an audit process for compliance. Conclusion: During clinical research involving biological agents, potential risks must be assessed throughout the agent's chain of custody. Northwell Health successfully implemented a robust process in a large organization that other health systems can replicate to safely conduct research in this rapidly expanding area.