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.
journal_name
J Med Ethicsjournal_title
Journal of medical ethicsauthors
Jansen MO,Angelos P,Schrantz SJ,Donington JS,Madariaga MLL,Zakrison TLdoi
10.1136/medethics-2020-106590subject
Has Abstractpub_date
2021-01-01 00:00:00pages
7-11issue
1eissn
0306-6800issn
1473-4257pii
medethics-2020-106590journal_volume
47pub_type
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pub_type: 传,历史文章,杂志文章
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