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Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards

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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 the communal turn to IC procedures, community advisory boards (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 added values and challenges of relying on CABs as a supplement to 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 the communal turn to IC processes. Three main features of the landscape include (1) new supportive stances that some regulatory bodies have adopted toward 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, some points to consider will be discussed to contextualize relying on CABs within this landscape.

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Acknowledgments

This study has been developed in the context of Erasmus Mundus Master of Bioethics (EMMB), a joint collaborative program between Katholieke Universiteit Leuven, Radboud University Nijmegen and University of Padua. HS is very grateful for being awarded Erasmus Mundus Fellowship by European Commission to participate in the program. The authors also thank two anonymous reviewers for their considerations and insightful suggestions.

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  1. Student of Erasmus Mundus Master of Bioethics (KU Leuven et al), Nijmegen, The Netherlands

    Hojjat Soofi

  2. Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands

    Evert van Leeuwen

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  1. Hojjat Soofi
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Correspondence to Hojjat Soofi.

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Soofi, H., van Leeuwen, E. Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards. J Community Genet 7, 261–270 (2016). https://doi.org/10.1007/s12687-016-0274-4

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