Fair and equitable subject selection in concurrent COVID-19 clinical trials.

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials.

A Crucial Moment for Reflection on the Importance of Ethical Leadership in Academic Medicine.

The extreme disturbances caused by the COVID -19 pandemic on our academic medical centers compounded by a recurrent surge of violence against people of color have reopened our wounds exposing fragility, inequality, and continued racial disparities in society and health. At the center of this severe institutional disruption, leaders will be compelled to take action to keep their constituents and patients safe and their hospitals and departments afloat during and after a pandemic, all while simultaneously addressing and implementing the cultural changes required to eliminate systemic racism and discrimination. Organizational disruptions of this magnitude will naturally test one's principles, loyalties and responsibilities while challenging the practical burdens of leadership. If the goal of responding to these upheavals is to bring them to resolution and ultimately to bring about organizational change for the better, ethical leadership is critical. Applying ethical principles allows leaders to chart clear paths to solutions both in the short and long term. We review the principles of ethical leadership exemplified by a case illustration and provide a novel resource to help ensure ethical leadership in academic medicine and beyond.

Pediatric Modification of the Medically Necessary, Time-Sensitive Scoring System for Operating Room Procedure Prioritization During the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic forced surgeons to reconsider concepts of "elective" operations. Perceptions about the time sensitivity and medical necessity of a procedure have taken on greater significance during the pandemic. The evolving ethical and clinical environment requires reappraisal of perioperative factors, such as personal protective equipment conservation; limiting the risk of exposure to COVID-19 for patients, families, and healthcare workers; preservation of hospital beds and ICU resources; and minimizing COVID-19-related perioperative risk to patients. STUDY DESIGN: A scaffold for the complex decision-making required for prioritization of medically necessary, time-sensitive (MeNTS) operations was developed for adult patients by colleagues at the University of Chicago. Although adult MeNTS scoring can be applied across adult surgical specialties, some variables were irrelevant in a pediatric population. Pediatric manifestations of chronic diseases and congenital anomalies were not accounted for. To account for the unique challenges children face, we modified the adult MeNTS system for use across pediatric subspecialties. RESULTS: This pediatric MeNTS scoring system was applied to 101 cases both performed and deferred between March 23 and April 19, 2020 at the University of Chicago Comer Children's Hospital. The pediatric MeNTS scores provide a safe, equitable, transparent, and ethical strategy to prioritize children's surgical procedures. CONCLUSIONS: This process is adaptable to individual institutions and we project it will be useful during the acute phase of the pandemic (maximal limitations), as well as the anticipated recovery phase.

Medically Necessary, Time-Sensitive Procedures: Scoring System to Ethically and Efficiently Manage Resource Scarcity and Provider Risk During the COVID-19 Pandemic.

Hospitals have severely curtailed the performance of nonurgent surgical procedures in anticipation of the need to redeploy healthcare resources to meet the projected massive medical needs of patients with coronavirus disease 2019 (COVID-19). Surgical treatment of non-COVID-19 related disease during this period, however, still remains necessary. The decision to proceed with medically necessary, time-sensitive (MeNTS) procedures in the setting of the COVID-19 pandemic requires incorporation of factors (resource limitations, COVID-19 transmission risk to providers and patients) heretofore not overtly considered by surgeons in the already complicated processes of clinical judgment and shared decision-making. We describe a scoring system that systematically integrates these factors to facilitate decision-making and triage for MeNTS procedures, and appropriately weighs individual patient risks with the ethical necessity of optimizing public health concerns. This approach is applicable across a broad range of hospital settings (academic and community, urban and rural) in the midst of the pandemic and may be able to inform case triage as operating room capacity resumes once the acute phase of the pandemic subsides.