Race, Place, and The Federal Exception from Informed Consent (EFIC): A Semiotic Approach [DISSERTATION]

Race, Place, and The Federal Exception from Informed Consent (EFIC): A Semiotic Approach [DISSERTATION]
Samantha Whitney Stein
UCLA, 2021
Abstract
The Exception from Informed Consent (EFIC) regulatory mechanism can be used to waive federal informed consent requirements for emergency medical research, pending satisfaction of pre-trial requirements. EFIC’s most notoriously challenging pre-trial requirement is ‘community consultation,’ a process through which EFIC researchers solicit public feedback on their trials. Using a Peircean semiotic framework, this thesis unpacks the presuppositions undergirding the idea that community consultation can reduce friction between emergency clinical trials carried out without informed consent and the values of patients enrolled in them. I introduce a semiotics of prediction, showing how assumptions about race figure prominently in the commensuration-based tasks of selecting community consultation respondents and subsequently generalizing findings from these respondents to broader populations. I suggest that in practice the content and / or generalizability of feedback collected through community consultation has very limited utility for reducing friction. Rather, community consultation’s primary function—as it is currently operationalized—is one of public relations, whereby the discursive processes through which community feedback is solicited have more bearing on EFIC trials’ public acceptability than the content of community feedback and the ability of biomedical research actors to transpose this content across contexts. By examining who participates in / is affected by the discursive processes through which community feedback is solicited, I help explain otherwise untheorized yet nonetheless troubling disparities between the acceptability of EFIC as determined by community consultation respondents and the acceptability of EFIC as determined by EFIC trial participants and their surrogates.

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