Animal Research has contributed to major scientific advances in biomedical, veterinary, and environmental sciences and in public health. However, these efforts often pose significant risks to the health and safety of research and facility staff due to the wide range of species, complex experimental procedures and equipment, and facility hazards that are involved. Balancing optimal worker safety and animal welfare with research objectives yields the best results but requires a solid understanding of how animal programs are managed and an ability to identify and mitigate inherent risks. This course provides a thorough introduction to routine hazards commonly encountered in animal programs that utilize rodents, small animals, nonhuman primates, aquatics, and agricultural species, with a primary focus on identifying and managing biological, chemical, radiological, and physical hazards. Topics include assessment and management of animal program hazards; universal regulations, guidelines, and quality standards that apply to animal research; duties and responsibilities of key program personnel; local oversight systems; best practices that enhance the quality of animal care; and strategies for biosafety professionals to develop and maintain effective partnerships with program staff and institutional animal care and use committee members. Opportunities will be provided to apply new knowledge and skills through interactive group activities and problem-solving sessions. The instructors are experienced laboratory animal veterinarians who are actively involved in the management, oversight, and evaluation of animal care and use programs. The primary target audience for this course are biosafety and general safety professionals with limited experience in the animal research environment.

The clinical setting poses a different environment than research laboratories. This course provides foundations for applying biosafety concepts in the clinical setting. Course topics include common issues and lessons learned pertaining to clinical facilities including pharmacies, laboratories, clinics, infusion areas, ORs, and waste disposal facilities; PPE, disinfection, risk assessments, and safety practices in the clinical setting; speaking biosafety to doctors, nursing staff, pharmacy staff, infection prevention and control, diagnostic microbiology lab personnel, and hospital EHS staff; applying NIH Guidelines and the BMBL to the clinical setting; gaps in oversight of research safety for clinical trials, and risk assessments for unconventional or highly specialized delivery mechanisms for biologics. The course will conclude with a focus on clinical trials including the role of an IRB and how it can overlap with an IBC; the process for investigational products to obtain FDA approval to be deemed as safe and effective therapeutics; and the evolving regulatory environment in the U.S. for biologics such as vaccines, regenerative medicines, and gene therapy. The course is designed to be highly interactive with discussions, surveys, and group exercises.

The anticipated implementation of United States Pharmacopeia (USP) 800 in healthcare created a new resolve to conduct thorough risk assessments of healthcare formularies. The role of this assessment was to identify the hazards posed by these drugs, to evaluate the exposure risks associated with these hazards, and to determine the potential health consequences of both acute and chronic exposure. Most healthcare facilities that conducted these risk assessments utilized a risk matrix that incorporated criteria commonly used in toxicology to evaluate exposure to chemicals. As the pharmaceutical industry quickly turns to novel biologics to treat and/or correct disease, a risk assessment of the biological hazards associated with these novel biologics is warranted. This course will provide information on these biologics; explore the known and anticipated biological properties of each; discuss the potential these biologics have to cause infections, to be shed, to contaminate the environment, and to be transmitted to others; and will cover the pertinent controls needed to contain these biologics, to prevent inadvertent exposure to these materials, to remove them from the environment, and to ensure staff and patients are appropriately educated.

IBC Basics is an introductory course on the function and administration of Institutional Biosafety Committees (IBCs) delivered by expert staff from the National Institutes of Health (NIH) Office of Science Policy (OSP). IBC Basics will promote the professional development of those associated with IBCs by providing an opportunity to learn about the role of NIH OSP, the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules, and understand the range of biosafety oversight responsibilities that IBCs have under the NIH Guidelines. This course provides an overview and may be helpful for those new to the field.

The use of recombinant and synthetic nucleic acid molecules in clinical trials is growing at an explosive pace. This course is intended to introduce biosafety professionals to the science and biosafety of gene-based investigational products in clinical trials including gene-based vaccines, gene modified cellular products, gene therapy and gene editing. This course will provide an overview of molecular biology, virology and viral vectors. Participants will discuss risk assessments and best practices for dealing with risks associated with diverse types of biological hazards.

Plant research is the backbone of both genetically modified, disease resistance, and breeding of both academic and biotechnology research. Attendees will discover what is needed to design a greenhouse and lab that will contain genetically modified material and insects as well as an overview of Arthropod Containment Levels. This course will feature a diverse array of advanced scenarios and interactive exercises showcasing the spectrum of biological, genetically modified, arthropod, and other risks and hazards commonly encountered in greenhouses, fields, and laboratories supporting plant research. Attendees will be guided through strategies for identifying potential hazards, assessing the magnitude and extent of induced risks and cost, and developing effective control measures to protect the safety of workers, plants, and the environment. The course employs “real world” examples to improve understanding of greenhouse and field operations.

This course is tailored for individuals responsible for establishing and overseeing infectious substance shipping programs within their facilities. This webinar series aims to assist institutions in developing robust shipping programs tailored to their needs. Course elements include: training; written policies; written descriptions of program plans; transport and shipping specific SOPs; safety and security plans; emergency response plans; logistics and supplies; carrier selection and support; MOUs and authorizations; access control and personnel assurance. The instructor will provide a detailed and comprehensive shipping program assessment and implementation guidance document. Attendees will receive an introduction to this document and step-by-step guidance on its completion. By completing the assessment document, attendees will conduct a thorough review to identify areas for improving existing shipping programs. This interactive, instructor led, web-based training will invite attendees to share examples of how these elements are addressed at their own institution.

This course will focus on research-based, unique scenarios presented with animals in research and diagnostic environments. Course topics include: composting, incineration, rendering challenges, carcass movement, unique agent requirements, complex variety of animal species (large, small, wildlife, companion, research, diagnostic), mixed hazard waste issues. The attendees will see strategies to assess risk and apply best practices and regulatory requirements to common and diverse situations. Course will be interactive, with breakout sessions and real-world examples.