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Dissertation
Within and Beyond Communal Turn to Informed Consent in Industry-Sponsored Pharmacogenetics Research: Pros and Cons of Community Advisory Boards
Authors: --- ---
Year: 2016 Publisher: Leuven KU Leuven. Faculteit Geneeskunde

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Abstract

The one-size-fits-all paradigm of drug development fails to address inter-individual variability in drug response. Pharmacogenetics research aims at studying the role of genotypic differences in drug response. Recently, the pharmaceutical industry has shown interest to embed pharmacogenetics studies in the process of drug development. Nevertheless, population-based and commercial aspects of such future-oriented studies pose challenges for individually based informed consent (IC). As an exemplar of communal turn to IC procedures, community advisory board (CABs) have been integrated into different types of medical research. CABs hold the promise of organizing the relationship between participants and researchers in a more reciprocal and participatory way, offering possible means of overcoming the lapses of individualistic IC. However, the involvement of CABs with pharmacogenetics research might be rife with difficulties, uncertainties and challenges. The current study first reviews the existing literature to discuss the pros and cons of CABs compared with individually based IC. Then, the particular moral and regulatory landscape of pharmacogenetics research will be delineated to argue that community engagement is both necessary and promising beyond a communal turn to IC processes. Three main features of the landscape include 1) new supportive stances that some regulatory bodies have adopted towards pharmacogenetics research, 2) the motivation of the industry to draw reception and trust from the subpopulations, and 3) the important role of the society in generating and embedding pharmacogenetics knowledge. Finally, a set of suggested elements of cooperation will be discussed to situate existing or future CABs within this landscape.

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