@article{5670f628b0cb4243a387a4950bbb28e1,
title = "Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies",
abstract = "Covid-19 raised many novel ethical issues including regarding the allocation of opportunities to participate in clinical trials during a public health emergency. In this article, we explore how hospitals that have a scarcity of trial opportunities, either overall or in a specific trial, can equitably allocate those opportunities in the context of an urgent medical need with limited therapeutic interventions. We assess the three main approaches to allocating trial opportunities discussed in the literature: patient choice, physician referral, and randomization/lottery. As, we argue, none of the three typical approaches are ethically ideal for allocating trial opportunities in the pandemic context, many hospitals have instead implemented hybrid solutions. We offer practical guidance to support those continuing to face these challenges, and we analyze options for the future.",
keywords = "Covid-19, clinical trials, public health, research ethics, trial recruitment",
author = "Kayte Spector-Bagdady and Lynch, {Holly Fernandez} and Bierer, {Barbara E.} and Luke Gelinas and Hull, {Sara Chandros} and David Magnus and Meyer, {Michelle N.} and Sharp, {Richard R.} and Jeremy Sugarman and Wilfond, {Benjamin S.} and Ruqaiijah Yearby and Seema Mohapatra",
note = "Funding Information: We would like to thank Steven Joffe and the members of the National Institutes of Health{\textquoteright}s Department of Bioethics for their comments on previous versions of this article. This work was funded in part by the National Center for Advancing Translational Sciences of the National Institutes of Health through grants UL1TR002240 for Kayte Spector-Bagdady{\textquoteright}s role as coinvestigator, UL1TR002319 for Benjamin S. Wilfond{\textquoteright}s role as coinvestigator, UL1TR003098 for Jeremy Sugarman{\textquoteright}s role as coinvestigator, and UL1TR002541 for Barbara E. Bierer{\textquoteright}s role as coinvestigator; by the Center for Bioethics & Social Sciences in Medicine of the University of Michigan Medical School for Spector-Bagdady{\textquoteright}s role as associate director; by the National Human Genome Research Institute for Sara Chandros Hull{\textquoteright}s role as director of the Bioethics Core; and by the Greenwall Foundation for Holly Fernandez Lynch as a Faculty Scholar. Funding Information: We would like to thank Steven Joffe and the members of the National Institutes of Health's Department of Bioethics for their comments on previous versions of this article. This work was funded in part by the National Center for Advancing Translational Sciences of the National Institutes of Health through grants UL1TR002240 for Kayte Spector‐Bagdady's role as coinvestigator, UL1TR002319 for Benjamin S. Wilfond's role as coinvestigator, UL1TR003098 for Jeremy Sugarman's role as coinvestigator, and UL1TR002541 for Barbara E. Bierer's role as coinvestigator; by the Center for Bioethics & Social Sciences in Medicine of the University of Michigan Medical School for Spector‐Bagdady's role as associate director; by the National Human Genome Research Institute for Sara Chandros Hull's role as director of the Bioethics Core; and by the Greenwall Foundation for Holly Fernandez Lynch as a Faculty Scholar. Publisher Copyright: {\textcopyright} 2022 The Hastings Center",
year = "2022",
month = jan,
day = "1",
doi = "10.1002/hast.1297",
language = "English (US)",
volume = "52",
pages = "51--58",
journal = "Hastings Center Report",
issn = "0093-0334",
publisher = "Hastings Center",
number = "1",
}