Developing an Ethics Framework for Allocating Remdesivir in the COVID-19 Pandemic.

On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). Remdesivir is an investigational drug studied in clinical trials for COVID-19 and is available to children and pregnant women through compassionate-use access but is not yet FDA approved. In early May, the US Department of Health and Human Services began to distribute remdesivir, donated by Gilead Sciences, Inc., to hospitals and state health departments for emergency use; multiple shipments have since been distributed. This process has raised questions of how remdesivir should be allocated. The Minnesota Department of Health has collaborated with the Minnesota COVID Ethics Collaborative and multiple clinical experts to issue an Ethical Framework for May 2020 Allocation of Remdesivir in the COVID-19 Pandemic. The framework builds on extensive ethical guidance developed for public health emergencies in Minnesota before the COVID-19 crisis. The Minnesota remdesivir allocation framework specifies an ethical approach to distributing the drug to facilities across the state and then among COVID-19 patients within each facility. This article describes the process of developing the framework and adjustments in the framework over time with emergence of new data, analyzes key issues addressed, and suggests next steps. Sharing this framework and the development process can encourage transparency and may be useful to other states formulating and refining their approach to remdesivir EUA allocation.

Partner notification in the context of HIV: an interest-analysis.

Codes of confidentiality play an essential role in the intimate discourses in many learned professions. Codes with various prescriptions exist. The Hippocratic Oath for example, prescribes rewards to the secret keeper, for keeping secret what ought to be kept secret, and punishments for failing. In public health practice, partner notification, arguably is one endeavor that tests the durability of this secret keeping doctrine of the health professional. We present an interest-analysis of partner notification in the context of HIV service rendition. Using principles-based analysis, the interests of the individual, the state/public health, and the bioethicist's are discussed. The public health interests in partner notification, which are usually backed by state statutes and evidence, are premised on the theory that partners are entitled to knowledge. This theory posits that knowledge empowers individuals to avoid continuing risks; knowledge of infection allows for early treatment; and that knowledgeable partners can adapt their behavior to prevent further transmission of infection to others. However, persons infected with HIV often have counter interests. For instance, an infected person may desire to maintain the privacy of their health status from unnecessary disclosure because of the negative impacts of disclosure, or because notification without a matching access to HIV prevention and treatment services is detrimental. The interest of the bioethicist in this matter is to facilitate a resolution of these conflicted interests. Our analysis concludes that governmental interests are not absolute in comparison with the interests of the individual. We reiterate that any effort to morally balance the benefits of partner notification with its burdens ought to first recognize the multivalent nature of the interests at play.

How clinical trials really work rethinking research ethics.

Despite prevalent concerns about the ethical conduct of clinical trials, little is known about the day-to-day work of trials and the ethical challenges arising in them. This paper reports on a study designed to fill this gap and demonstrates a need to refine the oversight system for trials to reflect an understanding of this day-to-day work. It also illuminates ethical challenges that cannot be addressed by the oversight system and so necessitate a rethinking of the ethics of clinical trials.

Attending to social vulnerability when rationing pandemic resources.

Pandemic plans are increasingly attending to groups experiencing health disparities and other social vulnerabilities. Although some pandemic guidance is silent on the issue, guidance that attends to socially vulnerable groups ranges widely, some procedural (often calling for public engagement), and some substantive. Public engagement objectives vary from merely educational to seeking reflective input into the ethical commitments that should guide pandemic planning and response. Some plans that concern rationing during a severe pandemic recommend ways to protect socially vulnerable groups without prioritizing access to scarce resources based on social vulnerability per se. The Minnesota Pandemic Ethics Project (MPEP), a public engagement project on rationing scarce health resources during a severe influenza pandemic, agrees and recommends an integrated set of ways to attend to the needs of socially vulnerable people and avoid exacerbation of health disparities during a severe influenza pandemic. Among other things, MPEP recommends: 1. Engaging socially vulnerable populations to clarify unique needs and effective strategies; 2. Engaging socially vulnerable populations to elicit ethical values and perspectives on rationing; 3. Rejecting rationing based on race, socioeconomic class, citizenship, quality of life, length of life-extension and first-come, first-served; 4. Prioritizing those in the general population for access to resources based on combinations of risk (of death or severe complications from influenza, exposure to influenza, transmitting influenza to vulnerable groups) and the likelihood of responding well to the resource in question. 5. Protecting critical infrastructures on which vulnerable populations and the general public rely; 6. Identifying and removing access barriers during pandemic planning and response; and 7. Collecting and promptly analyzing data during the pandemic to identify groups at disproportionate risk of influenza-related mortality and serious morbidity and to optimize the distribution of resources.

Ethical considerations in pandemic influenza planning.

Although the timing and severity of the next influenza pandemic is impossible to predict, there is broad agreement that one will occur. Preparation is vital to mitigating its effects. A severe influenza pandemic like that which began in 1918 would be unlike other disasters in nature, scale, and duration. It could cripple normal business operations and disrupt global distribution of essential goods and services. It could force ethical decisions that many in a country accustomed to relative abundance are poorly prepared to make. Although sound evidence and clinical and public health expertise are needed to make informed decisions, so is an understanding of our common and diverse values. This article outlines some of the challenges the state would face during a pandemic, especially concerning the rationing of resources and care. It also describes a process currently underway to develop guidelines for how the state should approach the ethical questions that would arise.

Educational approaches to the responsible conduct of clinical research: an exploratory study.

PURPOSE: To identify best practices in education related to the responsible conduct of clinical research (RCCR). METHOD: American Society for Bioethics and Humanities (ASBH) members involved with teaching RCCR were asked to complete an online survey, followed by an in-depth telephone interview. The online survey asked about respondents' RCCR teaching, trainees, and institutional context. The phone interview involved discussions about teaching strategies, institutional context, and needs. The study was conducted between 2003 and 2005. RESULTS: Forty-eight respondents to the online survey indicated a breadth of topics being covered in RCCR curricula; 35 respondents indicated that their RCCR teaching applied toward institutional RCCR requirements. Among the 21 instructors interviewed, many described a wide variety of teaching responsibilities. Recommended teaching strategies included fostering interactive discussion, using skills-based exercises such as designing IRB applications, accommodating students' individual interests in curriculum design, involving experienced researchers, involving trainees early in their careers as well as requiring continuing education, and designing a curriculum with a clear view of educational objectives. Interviewees described the institutional supports they needed, and they noted that insufficient support sometimes undermines RCCR teaching goals. Participants generally agreed that RCCR education should be required. CONCLUSIONS: Strong agreement among participants concerning recommended strategies for teaching RCCR provides useful, if provisional, guidance to instructors and institutions charged with providing such training. The study suggests a need for substantial investments in RCCR training, studying outcomes, and developing mechanisms to ensure the quality of instruction.

Ethics review of social, behavioral, and economic research: where should we go from here?

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examinees 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES--and in particular, behavioral health--research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work.