de Melo-Martín, Inmaculada
(2006)
FDA Evidentiary Standards and the need to Attend to Stakeholders’ Values.
[Preprint]
Abstract
Although it seems both ethically and epistemically appropriate to engage with publics to ensure that values used in research consider the interests of relevant stakeholders, doing so successfully faces serious challenges. Because values play central roles in drug and medical device research, using the USA Food and Drug Administration’s (FDA) attempts to incorporate stakeholders’ values can offer insights into these problems. I point out challenges regarding the incorporation of what are arguably legitimate but conflicting values from relevant stakeholders. Identifying these challenges is necessary to determine what strategies might be more likely to address them.
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