Informed consent and registry-based research - the case of the Danish circumcision registry

Abstract

Background Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The main purpose of the register was to enable future research into the consequences of ritual circumcision.

Discussion This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual.

Summary Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised.