Institutions as an Ethical Locus of Research Prioritisation image

Journal of Medical Ethics, April 11, 2017 (Online)
Luke Gelinas (Fellow in Clinical Research Ethics), Holly Fernandez Lynch (Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director)

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Introduction

Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in real time at the institutional or site level, where complex decisions must be made about how to manage overlapping trials in ways that balance different considerations, including the risk of non-completion. We sought to explore what research institutions in particular might ethically do to mitigate the risk that competition between trials will contribute to recruitment shortfalls.

Against this backdrop, we appreciate the thoughtful replies to our article and are especially encouraged that all three respondents acknowledge the importance and indeed necessity of setting research priorities in ways that respect the rights and interests of various parties. The key question raised by the commentaries primarily concerns not whether research prioritisation should take place but rather how it is best accomplished. In what follows, we clarify our argument in the original article, and then focus on several points raised in the commentaries regarding the role of institutions in research priority-setting.

Our approach is animated by the risk that competition between clinical trials for the same population of participants can be a cause of underenrolment when there are insufficient participants to meet the statistical needs of all open studies. In such situations, one or more of the competing studies will fail to meet recruitment targets, reducing their statistical ability to answer the research question. There are strong ethical reasons to avoid this outcome, including unjustified risks and burdens to participants and waste of research resources and funding. It is worth emphasising that ethical concerns over participant exposure to risk in non-completing studies are far from hypothetical or trivial. A recent study by Carlisle et al2 estimates that, as of 2011, over 48 000 subjects were exposed to risks and burdens in underpowered phase II and III clinical trials registered as ‘closed’ on clinicaltrials.gov. These data should impress upon us the urgency of taking steps to decrease the risk of non-completion at every possible juncture. [...]

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bioethics health law policy holly fernandez lynch human subjects research i. glenn cohen luke gelinas regulation research