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Comments on the Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal

Comments on the Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal The featured case discussion on the role of consent and individual autonomy in the PIP breast implant scandal raises interesting and important questions regarding the right of patients (and individuals in general) to decide whether to have their personal data included in medical registries and used for research. The fate of the National Breast Implant Registry, following the introduction of a policy that demanded formally recorded informed consent, is particularly enlightening. Combined with the (ex post) fact that reliable and comprehensive data would have been useful in this specific case, it clearly illustrates the dangers of overemphasizing individual autonomy in observational research. The issue is timely, as the European Commission has recently proposed a new Data Protection Regulation (European Commission, 2012) that may have serious implications for registry based research. In this commentary, I will first discuss two aspects of the regulatory framework that arguably contribute to the problematic situation and then offer an alternative view on why requiring consent should not be the default position in this kind of research. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Public Health Ethics Oxford University Press

Comments on the Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal

Stjernschantz Forsberg, Joanna
Public Health Ethics , Volume 6 (2) – Jul 15, 2013
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References (4)

Publisher
Oxford University Press
Copyright
The Author 2013. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org
ISSN
1754-9973
eISSN
1754-9981
DOI
10.1093/phe/pht020
Publisher site
See Article on Publisher Site

Abstract

The featured case discussion on the role of consent and individual autonomy in the PIP breast implant scandal raises interesting and important questions regarding the right of patients (and individuals in general) to decide whether to have their personal data included in medical registries and used for research. The fate of the National Breast Implant Registry, following the introduction of a policy that demanded formally recorded informed consent, is particularly enlightening. Combined with the (ex post) fact that reliable and comprehensive data would have been useful in this specific case, it clearly illustrates the dangers of overemphasizing individual autonomy in observational research. The issue is timely, as the European Commission has recently proposed a new Data Protection Regulation (European Commission, 2012) that may have serious implications for registry based research. In this commentary, I will first discuss two aspects of the regulatory framework that arguably contribute to the problematic situation and then offer an alternative view on why requiring consent should not be the default position in this kind of research.

Journal

Public Health Ethics – Oxford University Press

Published: Jul 15, 2013

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