Abstract
In prospective interventional research, a treatment may provide an advantage for the recipient over other people who do not receive it. If the intervention proves successful, the treated are better able to compete for such things as a scarce ventilator, a class grade, or a litigation outcome, potentially risking the deaths, jobs, or incomes of nontreated persons. Discussions of ethical concerns related to “bystanders” have typically focused on direct harms (such as infecting them with a virus), rather than the competition for a rivalrous good (such as a ventilator or clinical outcome). After broadly scoping this problem of advantage, this article reveals several reasons that such interventional research is typically permissible, notwithstanding the potential setbacks to nonparticipants. I consider the almost-dispositive concept of clinical equipoise and then glean insights from the harm principle, status quo bias, the leveling-down problem, and a potential bias against prospective interventional research versus program interventions with retrospective study. My consideration of institutional relationships does not change the analysis that such research is permissible.
Original language | English (US) |
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Pages (from-to) | 2-16 |
Number of pages | 15 |
Journal | IRB |
Volume | 43 |
Issue number | 1 |
DOIs | |
State | Published - Jan 1 2021 |
Keywords
- bystander risk
- human research ethics
- human subjects research
- institutional review boards
- interventional field research
- research risks and benefits
ASJC Scopus subject areas
- Health(social science)