Regulating the Secondary Use of Data for Research: Arguments Against Genetic Exceptionalism

Abstract

As accessing, collecting, and storing personal information become increasingly easier, the secondary use of data has the potential to make healthcare research more cost and time effective. The widespread reuse of data, however, raises important ethical and policy issues, especially because of the sensitive nature of genetic and health-related information. Regulation is thus crucial to determine the conditions upon which data can be reused. In this respect, the question emerges whether it is appropriate to endorse genetic exceptionalism and grant genetic data an exceptional status with respect to secondary use requirements. Using Swiss law as a case study, it is argued that genetic exceptionalism in secondary use regulation is not justified for three reasons. First, although genetic data have particular features, also other non-genetic data can be extremely sensitive. Second, having different regulatory requirements depending on the nature of data hinders the creation of comprehensible consent forms. Third, empirical evidence about public preferences concerning data reuse suggests that exceptional protection for genetic data alone is not justified. In this sense, it is claimed that regulation concerning data reuse should treat genetic data as important, but not exceptional.

Keywords: data protection; genetic data; genetic exceptionalism; research policy; secondary use.

Figure 1

Legal consequences of data subjects’ replies on consent forms in Switzerland. This decision-tree illustrates what are the consequences of the different choices that data subjects can take when compiling the consent form. Under the current national policy, patients that enter a care facility (ambulatory or hospital) should be provided with a consent form that explains them how their data collected during clinical care might be reused for research and then asks them whether they would consent to the secondary use of their data.