A key aspect of the project is the processing of my data in an exclusively pseudonymised manner. What does that mean and how is it carried out?

During your first visit, your clinician will enter certain data about you into the computer. From these personal data a unique code name (pseudonym) is calculated, consisting of a series of 9 digits.

The following personal data are used: first name, birth name (surname), date of birth, place of birth and mother’s maiden name.

Example:
Mary Miller nee Smith, born 10.11.1964 in London, mother’s maiden name Taylor.

This information generates the code (pseudonym): 465-230-024.

Importantly, the pseudonym is created on the basis of a hash-algorithm. This is where an explicit unique value is assigned during a complicated mathematical procedure. The mathematical algorithm ensures that this can only take place in one direction, i.e. the resulting value (the pseudonym) cannot be traced back to your person by anybody (not even the system programmer).

Which data do I have to reveal apart from the registration data in the course of the Registry study and subsequent studies?

During the course of the Registry study, some medical data will be recorded as well as your personal details (see Participant Information Sheet for further details). If you are participating in any subsequent studies, your clinician will give you detailed information about the study and the data required for it accordingly. Each subsequent study requires separate patient consent.

Who can see and use my data?

You
If you wish, you can gain access rights with which you can call up your data. If you don’t have access to your stored data, you can view the data stored about you through the clinician treating you.

The clinician treating you
The clinician treating you locally, who is also your contact person with the European HD Network, is the only person apart from you who can link your pseudonym and personal details.
After the initial registration, however, data entry and viewing by your treating clinicians is carried out via the pseudonym assigned to your person. Your clinician can use your personal information to contact you as and when future studies arise for which you are a suitable candidate.

European HD staff
Euro-HD staff analyses your stored data in order to

• contact the treating clinician and
• co-ordinate projects and trials with the data.

For the purpose of data control, investigators of the European HD Network (monitors and auditors) are allowed to check with clinicians treating you that the data entered onto the network matches with the data found in your medical records. Naturally, monitors/auditors are bound by confidentiality during this, and no personal data will be recorded outside the documentation belonging to clinicians treating you.

Scientists
This only includes scientists who are involved in Huntington’s disease research. The scientists have to apply to the Board of Directors (a group of eight experienced clinicians and scientists) for authorisation to use the data. These scientists can only view and use the pseudonymised data. They are also required to ensure that any further use of the data and any publications will be carried out in an anonymised form (i.e. not even using the pseudonym).

System administrators
In order to administrate and to safeguard the Euro-HD Network central database, a small number of authorised system administrators can view pseudonymised data.

Other individuals and groups
Nobody other than the groups and individuals stated above can access or receive your data. This applies for both identifying and pseudonymised data.

What reassurance do I have that unauthorised individuals cannot gain access to my data via the internet?

During data entry, data processing is encrypted. The server where the database is stored is located behind a firewall. This sophisticated security system ensures that only authorised computers and individuals can access the database. Furthermore, the central database holds no record of your personal identity as it is pseudonymised.

How long is my data stored for?

All data will remain stored for the foreseeable future. A complete deletion of data is impossible because the data is likely to have become part of a scientific study. The reason for this is because the responsible researchers have to be able to prove that the relevant study was carried out in accordance with regulations, even years after the research was completed. Alternatively, complete anonymisation can be carried out in the following cases:

• If you withdraw from participation in REGISTRY and request anonymisation of past data relating to that study.
• If you request complete anonymisation of your data.