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

Maud O. Jansen, Peter Angelos, Stephen J. Schrantz, Jessica S. Donington, Maria Lucia L. Madariaga, Tanya L. Zakrison

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)7-11
Number of pages5
JournalJournal of Medical Ethics
Volume47
Issue number1
DOIs
StatePublished - Jan 1 2021
Externally publishedYes

Keywords

  • clinical trials
  • policy guidelines/inst. review boards/review cttes
  • research ethics

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health(social science)
  • Arts and Humanities (miscellaneous)
  • Health Policy

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