Data processing and data security at iPSYCH

Genetics play a major role in the development of mental disorders, just as environmental factors can also be important. To find the causes of schizophrenia, bipolar disorder, depression, autism and ADHD, we examine the genes from 80,000 people, of which 25,000 are a healthy control group. The biological data from the blood samples is coupled with the Danish Civil Registration System (CPR) and other registry data on e.g. psychiatric diagnoses, treatment and deaths.

How do we obtain information about people’s genes?
Since 1981, Statens Serum Institut (SSI) has stored the heel prick blood samples that are taken from all newborn babies in Denmark in the Danish Neonatal Screening Biobank, so that they can be screened for congenital metabolic disorders. In connection with the sample taking, parents are given a folder informing them that the samples will be stored in the biobank with a view to using them in health science research. They are also informed that they can at any time demand that the samples be destroyed, or that they are not used for research. A small amount of blood from this heel prick sample is used for the determination of DNA. The regional Scientific Ethical Committee has given us permission to use the samples without having to ask the participants for further consent for a specific study. This is due to factors such as e.g. the distortion of the result if the group of participants is not representative, that there is no inconvenience involved in participating in the study, and that genetic data cannot precisely predict whether a person will develop mental disorders or not. All samples are furnished with a laboratory serial number and therefore do not include civil registration numbers, names and addresses.

How do we examine the genes?
We analyse the DNA we get from the blood samples by determining selected parts of the DNA sequence from the entire genome. These analyses are called genotyping and gene sequencing and are a mechanical determination of the genetic code in the DNA. Hitherto, the DNA has been sent to the Broad Institute at Harvard University in the USA under especially secure conditions; the Broad Institute has then sent data to Aarhus University via an encrypted connection. In future, the DNA analysis will primarily be undertaken in Denmark as we now have the equipment to do this.

How do we store the genetic data?
All data is stored on two supercomputers at Aarhus University and the Technical University of Denmark, respectively. The computers are equipped with a wide range of security measures to prevent unauthorised access. All activities are also monitored and logged, and access to the material requires special permission which only a few researchers have. Similarly, it is not possible to export data without special approval.

How do we couple information about genes with other registers?
With the help of the Danish CPR register, we can extract information on the participants from a range of registers. All information is provided with serial numbers, so that no information about individuals can be traced. The material that contains the coupling between civil registration number (CPR) and serial number is locked and protected and even stored separately, and the researchers who analyse the genetic data do not have access to the coupling. The researchers do not at any time have the opportunity or permission to identify individual persons in the project. And, since the project deals with patterns in groups, this is not something that would interest them anyway.

How do we exchange information with our partners?
Personal data is not given to the partners we collaborate with. We only exchange results for whole groups which other research groups can use in their research.

What happens to the data once the research project is completed?
Once the project is completed, we have to destroy all data and return excess sample material to the Neonatal Screening Biobank. If we wish to continue our research using this data, we require a new authorisation from the Scientific Ethical Committee.

Can a participant be deleted from the project?
All project participants are controlled in the Registry for Use of Tissue and samples are not selected from persons who have indicated that they do not wish to participate in research projects. If you have deregistered after iPSYCH has extracted data, you cannot be deleted because iPSYCH is not authorised to identify individuals. Heel prick blood samples have not been stored for people born before 1981 and these people are therefore not included in the project.

Link to this information in Danish.