How is My Information Kept Private?
The information collected for the Enroll-HD study is safeguarded in four ways. These precautions are taken to ensure that the privacy of participants is protected using the highest standards possible, but no method can ever be 100 percent foolproof.
When you go to your Enroll-HD study site, your name is never entered into the study database where all the information is kept. Instead, the staff there helps you generate your own unique “HDID.” This HDID is a 9-digit code that corresponds to some personal information that only you know. (That way, if you forget it, the code can be reconstructed later using that same information.) The data that is entered into the Enroll-HD database isn’t linked to your name or any other type of identification. It’s only associated with that confidential 9-digit code.
The only people who can translate the code—that is to say, link your name to that code—are you, the people at your study site who are directly involved in the study, and the monitors who make sure that data is entered properly and ensure participant privacy and safety. Nobody else, including the scientists running the Enroll-HD study or the researchers working with study data, knows the your name.
The data for the study is entered into a separate database that includes only study information and not any regular medical records. That way, nobody can accidentally connect the information in participants’ health records with the information collected as part of the study.
The data is actually stored on secure servers in the United Kingdom—a system specialized for high-security users such as banks and hospitals. The UK was chosen as the site for the database because it has particularly high standards for data protection.
Before any scientist can access the database to carry out their HD research project, the data are first stripped of any other identifying information, such as study site locations or participants’ birthdates. Then it gets a new, separate code number as a second layer of protection.
In addition, a group of statisticians analyzes the whole database to identify study participants who might possibly be at a slightly higher risk of re-identification because they have an unusual characteristic that would make them stand out—for example, they’re 92 years old, or they have another disease that would make them especially distinctive. Instead of including the actual age, the entry would just indicate that the person was above age 89. Some participants’ data will simply not be available if it is judged that there is a higher risk that they might be identified. As Enroll-HD grows and more people join the study, chances are good that more people over a certain age will also join, or people with a second disease. When there is a critical mass, it won’t be necessary to lump them all together any longer to protect each volunteer’s privacy. But for now, that extra step is taken.
The biosamples (blood draw) that are part of Enroll-HD are also given a new ID number separate from the HDID. They’re then sent to a specialized biorepository in Milan, Italy. If you consent to have your biosamples used for research, they’ll be stored there so that scientists can request access to them for their research studies.
Any researcher who wants to use the data or the biosamples must first sign a legal agreement where they promise to honor the privacy of study volunteers and agree not to try to use the data or biosamples to re-identify any participants.