PRIVACY STATEMENT REGARDING THE PROCESSING OF PERSONAL DATA OF THE PATIENTS IN THE STUDY ENTITLED: An International Web-Based Database For Longitudinal Data Registry Of Children With Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Dear participant,
As sponsor of the study, UZ Leuven is pleased to provide you with information about how your personal information will be managed, stored and used in the context of the study in which you are participating.
In order to be able to conduct the study to which you are participating, your personal data will be processed, such as information about your age and your gender, but also “special categories” of personal data will be processed. Examples of these include:
your ethnic background and race;
your state of health and medical condition, including your medical history;
your treatments and your response to treatments;
your biological samples, e.g. blood samples, tissue, and the results of their analysis;
your medical imaging material, e.g. scans, X-rays, and the results of their review;
The processing of your personal data is necessary to achieve the scientific research purposes. The conduct of scientific research is one of the core missions of UZ Leuven as defined by law. As a university hospital, part of KU Leuven, UZ Leuven is indeed required to support research and education in the public interest. We would therefore like to inform you that the necessity of the processing for the conduct of scientific research as a task of public interest constitutes the lawful basis on which we process your information in the context of the study in which you are participating. UZ Leuven is also subject to specific legal requirements which require the processing of your personal in the context of safety reporting (such as for example the notification of adverse events to the regulatory authorities).
As sponsor of the study, UZ Leuven is responsible for your personal information that is being processed in the context of the study. This means that UZ Leuven as data controller determines the reason and manner of the processing in the study. However, each participating research site remains the controller of the medical records of its patients. We take the opportunity to clarify that your personal data that are being processed in the context of the present study may also be further processed (either in a pseudonymized or anonymized format) for scientific research, such as for example retrospective studies (which are studies being conducted with existing data that have already been collected), to the extent such studies have been approved by an ethics committee that is amongst others responsible for ensuring appropriate protection of the privacy of study participants.
Furthermore, we would like to inform you that your personal data among other things could be reviewed by the following people:
the investigator and his/her research team (which may include –under certain conditions- a master student or a doctoral student);
study monitors and auditors, possibly employed by the sponsor, its authorized representatives, who will check whether the study is being conducted correctly and whether the information collected about you is accurate;
the ethics committee that approved this study and ensures that your rights and well-being are guaranteed;
national and international competent governmental authorities that are involved in keeping the study safe for participants;
Each of them is subject to obligations of professional secrecy or an undertaking of confidentiality.
It is therefore important to stress that some of these receivers of your information could be located in countries that do not have the same standards of legal data protection as the EU. While UZ Leuven as controller commits to respect the conditions of the European and Belgian legislation regarding privacy protection, a data transfer outside of the European Union could possibly lead to a security risk, as well as to the risk that you will have difficulty exercising some rights, or not be able to at all, regarding these receivers. To the extent possible, the international receivers of your information will sign special agreements to guarantee the safety and protection of your rights (for example, the so-called “EU standard contractual clauses for the transfer of personal data”). In case the safety and protection of your rights cannot be guaranteed for data transfer outside of the European Union, your explicit consent will be requested. In any case, all parties involved in the study are obliged to respect the confidentiality of your personal data.
Furthermore, we would like to inform you that, in accordance with the relevant legislation, UZ Leuven will store(*1) the information that has been collected as part of the study for at least 20 years, or for at least 30 years as far as this information is also part of your medical record.
During this entire term you can always exercise different rights regarding your personal data. The most important ones are the right to information, the right to access, the right to rectification and the right to erasure. Under the current legislation certain rights (such as right to access and right of erasure) are however not -or only partly- applicable when your personal data are being processed for research purposes (including the study to which you are participating). An unrestricted exercise of such rights may indeed render impossible or seriously impair the achievement of the scientific research purposes and therefore be detrimental to the public interest:
Request additional information about the processing of your data.
Request access to your data that is being stored, as long as this does not hinder the scientific integrity of the study. Indeed, to guarantee the scientific integrity of the study, it is possible that you will not have access to certain data before the end of the study.
Request corrections if the data are incorrect or incomplete. During the assessment of this request, you have the right to restrict your data processing.
Request to transfer your data in a common way to yourself or someone else.
Request to erase your data or have your data erased insofar that this does not render the achievement and validity of the scientific research purposes impossible or it does not seriously hinder them.
If you have any questions about how we use your personal information at any other point in time, you can always ask the investigator.
The data protection officer of UZ Leuven is also at your disposal (e-mail: gdpr.research@uzleuven.be).
In order to guarantee the protection of your identity regarding the sponsor, the data protection officer of the hospital will act as intermediary and will contact the s pons or’s data protection officer in the case of questions.
Finally, you also have the right to file a complaint about how your information is being processed, to the Belgian regulatory authority that is responsible for enforcing the data protection law:
Data Protection Authority (DPA)
Drukpersstraat 35
1000 Brussels
Tel. +32 2 274 48 00
email: contact@apd-gba.be
Website: www.gegevensbeschermingsautoriteit.be
(*1) The current legislation obliges to store personal information that is part of this study for 20 years (and - if applicable - the European Regulation regarding clinical drug trials, extends this storage term to 25 years). In case of a study drug for an innovative therapy in which human bodily material is being used, this storage period is at least 30 years and at the most 50 years in accordance with the Belgian law of 19 December 2008 concerning the use of human bodily material and the applicable Royal Decrees.