Introduction
This data protection concept describes data protection measures for research endeavors of the Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), a non-profit research foundation, undertaken as sponsor.
RC2NB was founded in 2019 by the University Hospital Basel with the participation of the University of Basel to continue and enhance the long-standing commitment and internationally renowned, clinically oriented research for patients with multiple sclerosis and other neuroimmunological diseases.
RC2NB coordinates and supports several competitively funded research groups, dedicated to improving the clinical, imaging, biochemical, molecular, and cellular characterization of the disease process and understanding the benefits and side effects of newly developed therapies.
The current version of this data protection concept is available on the homepage of RC2NB.
The means and purpose of data collection and data processing are covered in general for all clinical trials and research projects (further referred to as «RC2NB projects») where RC2NB acts as the sponsor.
Details on data collection and data processing for each RC2NB project are covered in the respective RC2NB project descriptions (corresponding to the study protocol for clinical trials). Data collection for study personnel is generally covered in this document.
The Information and Data Protection Act of the Canton Basel-City (IDG BS), its corresponding ordinance, the Swiss Human Research Act (HRA) and its corresponding ordinances (a.o. the Human Research Ordinance [HRO] and the Clinical Trials Ordinance [ClinO]) apply to the data protection procedures at RC2NB as well as the Data Protection and Data Security Regulation («Datenschutz- und Datensicherheitsreglement USB») of the University Hospital Basel (USB). Additionally, any clinical trials within RC2NB are being conducted in compliance with the current version of the Declaration of Helsinki.
In case of RC2NB projects which are conducted (also) in the EU, Regulation (EU) 2016/679 («GDPR») applies additionally (as appropriate) for the sites being situated in the EU.
Participation in RC2NB projects is based on voluntary informed consent in accordance with the legal bases mentioned above (e.g. Clauses 16-18, 32, and 33 HRA), especially regarding compliance with the recognized ethical standards.
Participants receive information about the advantages and disadvantages of participation as well as data protection as described in detail in the respective study protocol/participant information.
Consent can be revoked at any time without giving reasons (Clause 7 (2) HRA). Only the participants themselves or their legal representatives can issue an effective revocation. The declaration of revocation can be sent as detailed in the respective study protocol/participant information.
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Unless prohibited by law, in the event of a participant’s death, his/her data will continue to be used. The informational self-determination of living relatives is safeguarded by the fact that living relatives can object to the data processing.
RC2NB is responsible for compliance with the applicable data protection regulations.
The participating medical facilities are responsible for processing personal data, for which access to original participant records (patient records) is required. Details about participating medical facilities are to be found in the respective RC2NB project description.
Data Protection Contact:
Universitätsspital Basel
Hebelstrasse 32 CH-4031 Basel
RC2NB Contact:
RC2NB Research Center
Spitalstrasse 2 CH-4031 Basel
Personal data of the study personnel (e.g. doctors, study nurses, administrative personnel etc.)
Personal data of study personnel may only be collected if and as far as necessary for the respective RC2NB research project and shall only be kept as long as needed within the RC2NB research project.
Personal data of the participants
Processing of health information as well as of further personal data are described in detail in the respective study protocol/participant information.
By the applicable law, the participants have the following rights:
The duty to provide information for the collection and processing of personal data for the RC2NB projects lies with RC2NB.
As a rule, this is done by informing all parties involved (e.g., through participant information/declaration of consent or information on data processing and storage for study personnel).
For RC2NB research projects, the collected data of the participants is stored and processed in pseudonymized form unless stated otherwise in the study protocol/participant information.
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The number of persons who become aware of these pseudonyms is limited and is obliged to secrecy. Clause 26 (2) HRO is applicable.
The assignment of the pseudonym to identifiable data (e.g., name, age, year/date of birth of the participant) is only possible at the participants’ place of treatment (participating medical institution).
The respective center-specific local PI is responsible for the application and maintenance of appropriate technical and organizational protective measures concerning the collection, storage, and encrypted transfer of the collected and pseudonymized personal data (Clause 5 (1) HRO).
The scientific evaluation of the collected data will be carried out in the context of the respective RC2NB research project by authorized study personnel.
For this purpose, only the data required for the respective research question, with special consideration of the re-identification risk that may arise from it, will be compiled into a project-related evaluation dataset and made available to the authorized study personnel.
Data transfer to non-participants in the respective RC2NB research project will only take place in anonymised form unless covered by a Data Transfer and Use Agreement.
RC2NB research project data, including study personnel data, may only be stored on those IT systems that require authentication of users (access protection), and access to the personal data may only be possible for appropriately authenticated users (according to the authorization system).
Details, including data security about systems used in the respective RC2NB research project, may be found in the RC2NB project description or a separate security whitepaper in case of a technically more complex setup.
When entering personal data (e.g., email address), an active confirmation of participant consent must be made in any case. Before a participant’s personal data is entered into a system used by an RC2NB research project, the study personnel must have a signed declaration of consent from the participant.
Personal data of study personnel must be erased when the data is no longer necessary for the purposes for which it was collected or otherwise processed (§ 16 IDG BS).
All RC2NB research project data will be archived for a minimum of 10 years after RC2NB project termination or premature termination of the clinical trial unless specified otherwise in the RC2NB project description (Clause 45 ClinO by analogy).
After the 10-year period, RC2NB verifies if the data needs to be kept in a pseudonymized format or if the data can be anonymized/deleted unless specified otherwise in the study protocol.
If a participant revokes his/her consent to the use of his/her data, the data will, unless prohibited by law, either be deleted or anonymized. However, the data is not deleted from evaluation records that have already been created. However, evaluation data sets are anonymized as far as possible after creation.
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The involvement of processors/sub-processors and their review must be mutually informed and consensus established between RC2NB and the respective PI as well as the participating medical centres. § 7 IDG BS will be followed.
The following parties provide services for RC2NB in various RC2NB projects:
Departement Klinische Forschung (DKF)
Universität Basel c/o Universitätsspital Basel
Spitalstrasse 8/12, Neubau 2. Stock CH-4031
Basel, Schweiz
Healios AG (DBA Indivi)
Healios AG,
Postfach,
CH-4001, Basel, Switzerland,
Any additional processors mainly commissioned for one RC2NB research project are listed in the respective RC2NB project description.
If technically or organizationally necessary, this data protection concept can be updated or amended. The aim must be to achieve the same or higher level of data protection than before.
RC2NB - Research Center for Clinical Neuroimmunology and Neuroscience Basel
Spitalstrasse 2, CH-4031 Basel, Switzerland
rc2nb@usb.ch+41 61 328 43 47