scholarly journals IACUC and Veterinary Considerations for Review of ABSL3 and ABSL4 Research Protocols

ILAR Journal ◽  
2021 ◽  
Author(s):  
Curtis Klages

Abstract With the recent upswing of infectious disease outbreaks (coronavirus, influenza, Ebola, etc), there is an ever-increasing need for biocontainment animal use protocols to better address the research of emerging diseases and to increase the health of both animals and humans. It is imperative that we as a research community ensure these protocols are conducted with the utmost scrutiny and regulatory compliance for the welfare of the animals as well as the health and safety concerns of the individual conducting these studies. Both the welfare of the animals and the health and safety of the research staff must be balanced with the integrity of the science being studied. Even prior to reviewing biocontainment protocols, the research stakeholders should have professional and collegial interactions across all levels of the proposed project. These stakeholders should include the attending veterinarian, the principal investigator, the sponsor, and any organic institutional health and safety assets (environmental health and safety, occupational health, biosafety personnel, medical personnel, facilities operations and maintenance, etc). At most institutions, these stakeholders are members of the Institutional Animal Care and Use Committee and may not possess the necessary tools to properly assess an Animal Biosafety Level 3 and 4 animal use protocol. It is the goal of this article to review some basic concepts of biocontainment, discuss critical communications and preapprovals, clinical observations, medical interventions and supportive care, scientific and study endpoints, euthanasia criteria, animal manipulations, documentation, training, emergency response and contingency plans, security, and decontamination and provide a scenario-based and informative thought-provoking process Institutional Animal Care and Use Committee members and veterinary staff may consider during Animal Biosafety Level 3 and 4 protocol review. These topics will enhance the ability of all stakeholders to balance the protection of the people with the integrity of the science and ultimately the welfare of the animal.

ILAR Journal ◽  
2019 ◽  
Author(s):  
Jessica McCormick-Ell ◽  
Nancy Connell

AbstractResearch with animals presents a wide array of hazards, some of which overlap those in the in vitro research laboratory. The challenge for environmental health and safety professionals when making their recommendations and performing the risk assessment is to balance worker safety with animal safety/welfare. The care and husbandry of animals require procedures and tasks that create aerosols and involve metabolized chemicals and a variety of physical hazards that must be assessed in addition to the research related risks, all while balancing the biosecurity of the facility and NIH animal care requirements. Detailed communication between health and safety, research, and animal care teams is essential to understand how to mitigate the risks that are present and if modifications need to be made as the experiments and processes progress and change over time. Additionally, the backgrounds and education levels of the persons involved in animal research and husbandry can be quite broad; the training programs created need to reflect this. Active learning and hands-on training are extremely beneficial for all staff involved in this field. Certain areas of research, such as infectious disease research in high- and maximum-containment (biosafety level 3 and 4) facilities, present challenges that are not seen in lower containment or chemical exposure experiments. This paper reviews potential hazards and mitigation strategies and discusses unique challenges for safety at all biosafety levels.


2020 ◽  
Vol 36 (9) ◽  
pp. 607-618
Author(s):  
Rachel E Zisook ◽  
Andrew Monnot ◽  
Justine Parker ◽  
Shannon Gaffney ◽  
Scott Dotson ◽  
...  

As businesses attempt to reopen to varying degrees amid the current coronavirus disease (COVID-19) pandemic, industrial hygiene (IH) and occupational and environmental health and safety (OEHS) professionals have been challenged with assessing and managing the risks of COVID-19 in the workplace. In general, the available IH/OEHS tools were designed to control hazards originating in the workplace; however, attempts to tailor them specifically to the control of infectious disease outbreaks have been limited. This analysis evaluated the IH decision-making framework (Anticipate, Recognize, Evaluate, Control, and Confirm (“ARECC”)) as it relates to biological hazards, in general, and to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), specifically. Available IH/OEHS risk assessment and risk management tools (e.g. control banding and the hierarchy of controls) are important components of the ARECC framework. These conceptual models, however, were primarily developed for controlling chemical hazards and must be adapted to the unique characteristics of highly infectious and virulent pathogens, such as SARS-CoV-2. This assessment provides an overview of the key considerations for developing occupational infection control plans, selecting the best available controls, and applying other emerging tools (e.g. quantitative microbial risk assessment), with the ultimate goal of facilitating risk management decisions during the current global pandemic.


1997 ◽  
Vol 2 (4) ◽  
pp. 43-46 ◽  
Author(s):  
Robert J. Emery ◽  
Pek Lee ◽  
James Garman

Heightened interest in pathogens with the potential for aerosol transmission and for which prevention and medical treatment is not readily available has resulted in a need for more work environments that meet Biosafety Level 3 (BSL 3) criteria. Recognizing that the facility-based criteria for BSL 3 cannot be achieved by some existing laboratories, the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) biological safety guidelines provide an option for attaining BSL 3 status through the use of Biosafety Level 2 (BSL 2) facilities and strict adherence to BSL 3 practices (BSL 2/3). Inherent to this provision is a greater emphasis on safe work practices. Since the extent to which this approach is actually used in practice is not known, a nationwide mail survey of medical academic and research institutions was conducted to provide an objective indication of the proportion of BSL 3 operations actually being carried out in the BSL 2/3 mode. The results obtained indicate that 2% of activities designated as BSL 3 in the study population actually achieve this level of protection using the BSL 2/3 approach. The findings quantitatively estimate for the first time the proportion of BSL 3 activities being carried out in this fashion, and can serve as a reference point for future studies to evaluate usage trends. The results also demonstrate the utility of flexible, performance-based health and safety guidelines, as a significant amount of clinical and research work is being accommodated with the BSL 2/3 provision.


2021 ◽  
Vol 5 (1) ◽  
pp. 7-14
Author(s):  
Luh Putu Kirana Pratiwi ◽  
Ni Made Kencana Maharani

A market is a place where sellers and buyers meet in buying and selling transactions. People's market is atraditional market. The people's market is one of the most obvious indicators of the economic activities of thepeople in an area. The implementation of safety and health in the work environment is not only intended forvisitors but also employees (market managers), suppliers, and traders. This is because people's markets canbe the main route for the spread of infectious disease outbreaks. People's markets have an important positionto provide safe food. Public markets are influenced by the existence of upstream producers (suppliers of freshingredients), suppliers, vendors, consumers, managers, health-related officers, and community leaders. Thehealthy market is one of the structures in the development of the people's market.


2021 ◽  
Author(s):  
Joelle Evans ◽  
Susan S. Silbey

The governance of front-line professionals is a persistent organizational problem. Regulations designed to make professional work more legible and responsive to both organizational and public expectations depend on these professionals’ willing implementation. This paper examines the important question of how professional control shapes regulatory compliance. Drawing on a seventeen-month ethnographic study of a bioscience laboratory, we show how professionals deploy their discretionary judgment to assemble environmental, health, and safety regulations with their own expert practices, explaining frequently observed differential rates of regulatory compliance. We find that professional scientists selectively implement and blend formal regulations with expert practice to respond to risks the law acknowledges (to workers’ bodies and the environment) and to risks the law does not acknowledge but professionals recognize as critical (to work tasks and collegiality). Some regulations are followed absolutely, others are adapted on a case-by-case basis; in other instances, new practices are produced to control threats not addressed by regulations. Such selective compliance, adaptation and invention enact professional expertise: interpretations of hazard and risk. The discretionary enactment of regulations, at a distance from formal agents, becomes part of the technical, practical, and tacit assemblage of situated practices. Thus, paradoxically, professional expert control is maintained and sometimes enhanced as professionals blend externally imposed regulations with expert practices. In essence, regulation is co-opted in the service of professional control. This research contributes to studies of professional expertise, the legal governance of professionals in organizations, regulatory compliance, and safety cultures.


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