Rapid Review of Therapy Protocols for Public Health Emergencies.

How research during a public health emergency is conducted is recognized as essential to the public health response to that emergency. Such research needs to undergo substantive and meaningful ethical review in a timely manner. Rapid ethical review may be accomplished through a number of mechanisms, including use of local rapid-response institutional review boards (IRBs). We describe use of such a model in the setting of the 2014 Ebola virus disease epidemic and the Rapid-Response IRB's subsequent transition to a multisite single IRB model during the current Covid-19 pandemic. The rapid-response review model is characterized by a small IRB with extensive use of alternate members with specific expertise and by close collaboration with the investigator in an iterative process.

The cardinal rules: Principles of personal protective equipment for high-consequence infectious disease events.

In recognition of an increasing number of high-consequence infectious disease events, a group of subject-matter experts identified core safety principles that can be applied across all donning and doffing protocols for personal protective equipment.

Challenges and Approaches to High-Level Isolation Unit Staffing and Just-in-Time Training: A Meeting Report.

In November 2022, the National Emerging Special Pathogens Training and Education Center hosted a virtual session with global high-level isolation unit (HLIU) representatives to discuss HLIU staffing challenges and approaches. Takeaways are relevant to healthcare institutions seeking solutions to recruit and retain their healthcare workforce amid unprecedented global staffing shortages.

How Should Biocontainment Balance Infection Control With Practice Sustainability?

This case and commentary canvasses clinical, ethical, and public health considerations about integrated infection control and sustainability efforts of biocontainment units (BCUs). BCUs protect the public's health during infectious disease outbreaks, including accounting for downstream health costs of byproducts of patient care that leave a system as waste. However, environmental costs of BCUs' operations tend to get less attention than BCUs' specialized design to contain and control highly infectious pathogens. Human health promotion and environmental protection are values that sometimes complement each other but sometimes conflict in BCU management. When these values conflict, stakeholders must mediate and balance their implications in terms of individuals' immediate short' and long'term needs for health care, public interest in pathogen control and containment, and environmental impact.

Access, socioeconomic environment, and death from COVID-19 in Nebraska.

Our study assesses whether factors related to healthcare access in the first year of the pandemic affect mortality and length of stay (LOS). Our cohort study examined hospitalized patients at Nebraska Medicine between April and October 2020 who were tested for SARS-CoV-2 and had a charted sepsis related diagnostic code. Multivariate logistic was used to analyze the odds of mortality and linear regression was used to calculate the parameter estimates of LOS associated with COVID-19 status, age, gender, race/ethnicity, median household income, admission month, and residential distance from definitive care. Among 475 admissions, the odds of mortality is greater among those with older age (OR: 1.04, 95% CI: 1.02-1.07) and residence in an area with low median household income (OR: 2.11, 95% CI: 0.52-8.57), however, the relationship between mortality and wealth was not statistically significant. Those with non-COVID-19 sepsis had longer LOS (Parameter Estimate: -5.11, adjusted 95% CI: -7.92 to -2.30). Distance from definitive care had trends toward worse outcomes (Parameter Estimate: 0.164, adjusted 95% CI: -1.39 to 1.97). Physical and social aspects of access to care are linked to poorer COVID-19 outcomes. Non-COVID-19 healthcare outcomes may be negatively impacted in the pandemic. Strategies to advance patient-centered outcomes in vulnerable populations should account for varied aspects (socioeconomic, residential setting, rural populations, racial, and ethnic factors). Indirect impacts of the pandemic on non-COVID-19 health outcomes require further study.

How Should Health Care Organizations Protect Personnel in Environmental Services and Related Fields?

This commentary on a case discusses oft-overlooked roles of health care organizations' personnel in environmental services and related fields, such as waste management. Such personnel are not protected in the same ways frontline clinicians are, although their risk of exposure to pathogens in the course of their work can be high. This article describes why such personnel should be included in planning personal protective equipment access and in administrative and engineering operations concerning infectious disease emergence, containment, and management.

Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency.

Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate-a luxury that is rarely available during a public health emergency. The University of Nebraska Medical Center (UNMC) developed a single institutional review board (IRB), with a vision to establish a rapid review resource for a network focused on clinical research of emerging pathogens in the United States. A core aspect of successful initiation of research during a pandemic or epidemic is the ability to operationalize an approach for rapid ethical review of human subject research and conduct those reviews at multiple sites-without losing any of the substantive aspects of ethics review. This process must be cultivated in anticipation of a public health emergency. US guidance for operationalizing IRB review for multisite research in a public health emergency is not well studied and processes are not well established. UNMC sought to address operational gaps and identify the unique procedural needs of rapid response single IRB (RR-sIRB) review of multisite research by conducting a series of preparedness exercises to develop and test the RR-sIRB model. For decades, emergency responder, healthcare, and public health organizations have conducted emergency preparedness exercises to test requirements for emergency response. In this article, we describe 2 types of simulation exercises conducted by UNMC: workshops and tabletops. This effort represents a unique use of emergency preparedness exercises to develop, refine, and test rapid review functions for an sIRB and to validate readiness of regulatory research processes. Such processes are crucial for conducting rapid, ethical, and sound clinical research in public health emergencies.

Avoiding Crisis Conditions in the Healthcare Infrastructure: 2 Case Studies in Statewide Collaboration.

In fall 2020, COVID-19 infections accelerated across the United States. For many states, a surge in COVID-19 cases meant planning for the allocation of scarce resources. Crisis standards of care planning focuses on maintaining high-quality clinical care amid extreme operating conditions. One of the primary goals of crisis standards of care planning is to use all preventive measures available to avoid reaching crisis conditions and the complex triage decisionmaking involved therein. Strategies to stay out of crisis must respond to the actual experience of people on the frontlines, or the "ground truth," to ensure efforts to increase critical care bed numbers and augment staff, equipment, supplies, and medications to provide an effective response to a public health emergency. Successful management of a surge event where healthcare needs exceed capacity requires coordinated strategies for scarce resource allocation. In this article, we examine the ground truth challenges encountered in response efforts during the fall surge of 2020 for 2 states-Nebraska and California-and the strategies each state used to enable healthcare facilities to stay out of crisis standards of care. Through these 2 cases, we identify key tools deployed to reduce surge and barriers to coordinated statewide support of the healthcare infrastructure. Finally, we offer considerations for operationalizing key tools to alleviate surge and recommendations for stronger statewide coordination in future public health emergencies.

Prepared to Act: Lessons Learned by the Special Pathogens Research Network, Based on Collaborations with the NIAID-Led Adaptive COVID-19 Treatment Trial.

The need for well-controlled clinical trials is fundamental to advancing medicine. Care should be taken to maintain high standards in trial design and conduct even during emergency medical events such as an infectious disease outbreak. In 2020, SARS-CoV-2 emerged and rapidly impacted populations around the globe. The need for effective therapeutics was immediately evident, prompting the National Institutes of Health to initiate the Adaptive COVID-19 Treatment Trial. The Special Pathogens Research Network, made up of 10 Regional Emerging Special Pathogens Treatment Centers, was approached to participate in this trial and readily joined the trial on short notice. By trial closure, the Special Pathogens Research Network sites, making up 19% of all study sites, enrolled 26% of the total participants. The initial resources available and experience in running clinical trials at each treatment center varied from minimal experience and few staff to extensive experience and a large staff. Based on experiences during the first phase of this trial, the Special Pathogens Research Network members provided feedback regarding operational lessons learned and recommendations for conducting future studies during a pandemic. Communication, collaboration, information technology, regulatory processes, and access to resources were identified as important topics to address. Key stakeholders including institutions, institutional review boards, and study personnel must maintain routine communication to efficiently and effectively activate when future research needs arise. Regular and standardized training for new personnel will aid in transitions and project continuity, especially in a rapidly evolving environment. Trainings should include local just-in-time training for new staff and sponsor-designed modules to refresh current staff knowledge. We offer recommendations that can be used by institutions and sponsors to determine goals and needs when preparing to set up this type of trial for critical, short-notice needs.

Structural Discrimination in Pandemic Policy: Essential Protections for Essential Workers.

An inordinate number of low wage workers in essential industries are Black, Hispanic, or Latino, immigrants or refugees - groups beset by centuries of discrimination and burdened with disproportionate but preventable harms during the COVID-19 pandemic.

Uncertainty, scarcity and transparency: Public health ethics and risk communication in a pandemic.

Communicating public health guidance is key to mitigating risk during disasters and outbreaks, and ethical guidance on communication emphasizes being fully transparent. Yet, communication during the pandemic has sometimes been fraught, due in part to practical and conceptual challenges around being transparent. A particular challenge has arisen when there was both evolving scientific knowledge on COVID-19 and reticence to acknowledge that resource scarcity concerns were influencing public health recommendations. This essay uses the example of communicating public health guidance on masking in the United States to illustrate ethical challenges of developing and conveying public health guidance under twin conditions of uncertainty and resource scarcity. Such situations require balancing two key principles in public health ethics: the precautionary principle and harm reduction. Transparency remains a bedrock value to guide risk communication, but optimizing transparency requires consideration of additional ethical values in developing and implementing risk communication strategies.

Invisible No More: The Impact of COVID-19 on Essential Food Production Workers.

From the farms to the packing plants, essential workers in critical food production industries keep food on our tables while risking their and their families' health and well-being to bring home a paycheck. They work in essential industries but are often invisible. The disparities illuminated by COVID-19 are not new. Instead, they are the result of years of inequities built into practices, policies, and systems that reinforce societal power structures. As a society, we are now at an antagonizing moment where we can change our collective trajectory to focus forward and promote equity and justice for workers in agriculture and food-related industries. To that end, we describe our experience and approach in addressing COVID-19 outbreaks in meat processing facilities, which included three pillars of action based on public health ethics and international human rights: (1) worksite prevention and control, (2) community-based prevention and control, and (3) treatment. Our approach can be translated to promote the health, safety, and well-being of the broader agricultural workforce.