Johnson, BarbaraByers, KarenPatlovich, Scott J.Gillum, David...
2页原文链接:
NSTL
Mary Ann Liebert, Inc
Emery, Robert J.Patlovich, Scott J.King, Kristin G.Rios, Janelle...
8页查看更多>>摘要：Introduction: With the onset of the COVID-19 pandemic, a rapid adjustment of work tasks was necessary for many biosafety programs (and other safety programs) to address drastic shifts in workload demands amid pandemic-related shutdowns and subsequent needs for supporting COVID-19-related safe work protocols, diagnostic testing, research, vaccine development, and so forth. From a program management standpoint, evaluating and understanding these tasks were critically important to ensure that appropriate support and resources were in place, especially during such unprecedented times of rapid change and significant impact to normal life and routine.Methods: Described here are examples of how the biosafety program at The University of Texas Health Science Center at Houston (UTHealth Houston) addressed these challenges.Results: As part of this required pivot, key services and tasks emerged into three distinct categories: (1) those that were temporarily diminished, (2) those that had to continue despite COVID-19 and the associated shutdowns for safety or compliance purposes, and (3) those that dramatically increased in volume, frequency, and novelty.Conclusion: Although the adjustments described were made in situ as the pandemic evolved, the cataloging of these tasks throughout the experience can serve as a template for biosafety programs to plan and prepare for the next pandemic, which will inevitably occur.
原文链接:- NSTL
- Mary Ann Liebert, Inc
Gillum, DavidWyneken, HenryFletcher, JenniferNubbe, Karl...
17页查看更多>>摘要：Introduction: Biosafety professionals were called to action during the COVID-19 pandemic. They were tasked with prescribing measures to keep workers and the community safe while often not having accurate information at their fingertips. Understanding biosafety professionals' experiences may help shape new approaches that could further advance preparedness and resilience goals for future pandemics. This article discusses the overall response efforts of the biosafety community.Objectives: The main objective of this article is to quantitatively and qualitatively interrogate the responses to an email survey sent to individuals with biosafety responsibilities during the COVID-19 pandemic. This article catalogues those responses and the different aspects in how biosafety professionals were involved in the pandemic. The focus of this research was on aggregate data and summarized results.Results: A total of 609 out of 654 respondents fully completed the survey, equating to a 93.1% completion rate. Respondents were individuals with varying levels of COVID-19-related responsibilities participating in emergency preparedness and planning, developing laboratory diagnostic capabilities, reviewing clinical trials, developing safety guidelines, writing return-to-work and quarantine procedures, and participating in press releases and communications.Conclusions: Biosafety professionals played important roles during the COVID-19 pandemic, from developing safety protocols for laboratories to resourcing personal protective equipment during a global shortage. They experienced challenges when balancing their home/work lives. Some biosafety professionals were very involved in clinical trials and vaccination efforts, but most were not. Overall, there were significant differences in how biosafety professionals were involved in pandemic response efforts.
原文链接:- NSTL
- Mary Ann Liebert, Inc
Gentry-Weeks, ClaudiaCiaravola, Dell RaeBarker, MarcLong, Kelly...
16页查看更多>>摘要：Introduction: Universities were challenged during the COVID-19 pandemic to continue providing quality education for their students while navigating the uncertainties of the SARS-CoV-2 virus. Objectives: The goal of this article is to describe strategies used by Colorado State University (CSU) to mitigate SARS-CoV-2 transmission among faculty, staff, and students and to describe procedures used in microbiology teaching laboratories. Methods: Information concerning CSU's pandemic response was gathered via email communications to the CSU community, town hall meetings, and interviews with leaders, researchers, and staff who spearheaded public health initiatives. Results: To date, there have been no known cases of transmission of SARS-CoV-2 in the classroom. Early strategies that contributed to this success included social norming of safe public health behaviors, development of low-cost, rapid screening and surveillance methods, an online COVID-19 reporting system, contact tracing and quarantine, rearranging classrooms to reduce the capacity by 50%, increasing air flow, enhanced cleaning and production of sanitizer, and flexible instructors who quickly changed their courses for remote delivery or launched extra risk management procedures for face-to-face delivery of laboratory, performance, or studio classes. Conclusion: Intense collaboration among the CSU community, open and frequent communication, coordination of efforts, flexible instructors, and the willingness to follow safe public health behaviors allowed CSU to continue face-to-face teaching in courses that required hands-on learning or demanded in-person instruction. It is the hope of the authors that this information can provide both a historical account and useful information for others dealing with the COVID-19 pandemic.
原文链接:- NSTL
- Mary Ann Liebert, Inc
Aguilar-Setien, AlvaroArechiga-Ceballos, NidiaBalsamo, Gary A.Behrman, Amy J....
22页查看更多>>摘要：Introduction: Field work with bats is an important contribution to many areas of research in environmental biology and ecology, as well as microbiology. Work with bats poses hazards such as bites and scratches, and the potential for exposure to infectious pathogens such as rabies virus. It also exposes researchers to many other potential hazards inherent to field work, such as environmental conditions, delayed emergency responses, or challenging work conditions. Methods: This article discusses the considerations for a thorough risk assessment process around field work with bats, pre- and post-occupational health considerations, and delves into specific considerations for areas related to biosafety concerns-training, personal protective equipment, safety consideration in field methods, decontamination, and waste. It also touches on related legal and ethical issues that sit outside the realm of biosafety, but which must be addressed during the planning process. Discussion: Although the focal point of this article is bat field work located in northern and central America, the principles and practices discussed here are applicable to bat work elsewhere, as well as to field work with other animal species, and should promote careful considerations of how to safely conduct field work to protect both researchers and animals.
原文链接:- NSTL
- Mary Ann Liebert, Inc
Eisenman, DanielSwindle, Scott
7页查看更多>>摘要：Introduction: The US regulatory environment is evolving to accommodate a boom in gene therapy research. The 2019 version of the National Institutes of Health (NIH) Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) lacks an appendix providing specific guidance for Institutional Biosafety Committee (IBC) review of clinical trials. Discussion: As the field matures, the burden of Federal oversight for clinical trials of investigational products containing recombinant or synthetic nucleic acid molecules is shifting toward the Food and Drug Administration (FDA). This report summarizes recent FDA guidance documents on shedding and considerations for environmental impact assessments highlighting key points pertinent to IBC review. Conclusion: This report helps biosafety professionals understand the evolving regulatory framework for gene therapy products. Knowledge of the guidance documents discussed in this report will assist biosafety professionals in addressing issues pertaining to shedding and environmental impact during IBC review of clinical trials.
原文链接:- NSTL
- Mary Ann Liebert, Inc
