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.

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.

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.

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.

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.

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.