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