LAUSR

While technically impressive, the study presented in “The iPSYCH2012 case–cohort sample: new directions for unraveling genetic and environmental architectures of severe mental disorders” by Pedersen CB et al. [1], raises ethical concern. In 2012, ~50,000 patients born between 1981 and 2005, and diagnosed with disorders such as ADHD, schizophrenia, mood disorders, and bipolar affective disorder, along with an additional random sample of 30,000 individuals, were identified using Danish population-based registers. Subsequently, dried blood spots from nearly all 80,000 individuals were retrieved from the Danish Neonatal Screening Biobank and processed for genotyping. All 80,000 were genotyped using an arraybased assay, while 20,000 were exome-sequenced. For each subject, longitudinal information on health, prescribed medicine, and socioeconomic information was made available, as was analogous information on relatives. The data concerning iPSYCH2012 are pseudonymized (http://ipsych. au.dk/about-ipsych/data-processing-and-data-security-atipsych/). The re-identification key for coupling the Danish civil registration number (CPR) and pseudonym identifiers is stored separately from genetic profiles. None of the 80,000 individuals included in the study provided their consent to participate in iPSYCH2012, nor were they even informed about the fact that their personal data and genetic footprints were included in the study. Once registered in the genetic profile database, subjects had no right to deregister. Furthermore, if citizens with psychiatric diagnoses who may have been genotyped and profiled seek transparency regarding own data, they are denied any right to know whether they have been included. In Denmark, loose ethical standards, lax data protection legislation, and universal compulsory registers, make it possible to genotype stored samples and link genetic data with data from other registers without consent from the individuals involved. The exemption from the general principle of consent is possible if allowed by The Danish Scientific Ethics Committee (Videnskabsetisk Komité). In the case of iPSYCH2012 the exemption from consent was granted in 2012. Subsequently a total of three changes to protocol were approved, all of which included exemption from consent. The latest change to protocol and exemption from consent was granted in 2018. Our concern is that the study, and thus the excemptions granted by the Danish Scientific Ethics Committee, does not live up to the ethical framework of the WMA declaration of Taipei on ethical considerations regarding health databases and biobanks. The Declaration of Taipei was published in October 2016 well ahead of the latest exemption from consent. Furthermore, the paper at issue was submitted in May 2017. The Declaration of Taipei builds on the Declaration of Helsinki and emphasizes the importance of obtaining informed consent before using personal health data and biologic materials. It also provides hands-on governance instructions in cases when obtaining strict informed consent is impractical. The governance instruction is a multi-step action list. Major steps include securing an initial consent based on limited and general information, conducting an ethical review before establishing a database, and securing third party oversight by an ethics committee for any re-use of the personal health data. Although establishing a database for research purposes requires approval from the Danish Data Protection Agency (Datatilsynet), Danish law does not require initial consent nor does it require oversight from an ethics committee. Danish research such as the iPsych2012 project thus does not comply with the requirements of the Taipei Declaration. Importantly, the Declaration of Taipei takes into consideration that it is most often not possible to identify future scientific research purposes at the time of data collection. Therefore, we suggest, subjects could be allowed to give their consent to future scientific research * Thomas Birk Kristiansen [email protected]