Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and chal
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REVIEW
Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards Hojjat Soofi 1
&
Evert van Leeuwen 2
Received: 2 June 2016 / Accepted: 27 July 2016 # Springer-Verlag Berlin Heidelberg 2016
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 futureoriented 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 * Hojjat Soofi [email protected]; [email protected] Evert van Leeuwen [email protected] 1
Student of Erasmus Mundus Master of Bioethics (KU Leuven et al), Nijmegen, The Netherlands
2
Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
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. Keywords Pharmacogenetics . Informed consent . Community advisory boards . Pharmaceutical industry
Introduction The old one-size-fits-all approach to drug development seems a hindrance to optimized patient care (Giacomini et al. 2012). There is a broad inter-individual variability in response to a particular drug, and some patients might be at a higher risk of developing the adverse effects than others (IngelmanSundberg 2001; Meyer 2000). As an emerging application of genetic knowledge, pharmacogenetics research aims at studying inter-individual genetic polymorphisms associated with drug response (Buchanan et al. 2002). One of the characteristics of pharmacogenetics stu
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