Rules of use

The Rheinland Studie (hereinafter referred to as “Rhineland Study”) is a prospective cohort study conducted by Population Health Sciences at the German Center for Neurodegenerative Diseases e.V. (DZNE). The primary purpose of the Rhineland Study is to investigate determinants and biomarkers of normal and pathological development of psychological and physical health throughout the adult lifespan, with a special focus on neurodegenerative and other age-related diseases and the ultimate goal to contribute to their prevention.

The data collected within the context of the Rhineland Study is first and foremost meant to be used for own research purposes. Other parties can be given access to the data, generally as part of a scientific collaboration. In individual cases, other options may also be considered. Any data sharing is only possible if covered by the informed consent of the participants.

Data access is granted on the basis of the principles of data minimization and data protection as well as on good scientific practice and scientific value of the proposed research. Applicants can apply for data from the study, image or biomaterial database or from the research database. The study, image and biomaterial databases contain all examination data, either as they were collected during the examinations (“raw data”) or minimally post-processed (i.e., imaging or biomaterial data). These data can be applied for quality control or method development purposes. The research database contains all quality-controlled data that can be used for subsequent (statistical) analyses. This policy defines the corresponding process.

 

§ 1    Definitions

1. Applying Scientist
   The applying scientist is the natural person that submits an application for data use to the data use and access committee of the Rhineland Study. Generally, this is the scientist who is most involved in the execution of the project. This may but need not be the responsible project leader. They prepare the application and obtain the signatures from the responsible project leader (unless it is one and the same person) and, wherever necessary, from other parties involved in the project.
2. Biorepository
   The biorepository is the storage facility for bio-samples gathered as part of the Rhineland Study at the DZNE, including possible backup facilities. Point of contact is lab management of the Rhineland Study.
3. Central Study Databases
   The central study databases of the Rhineland Study include the 1) contact database, 2) the study database including biomaterial and image database, and 3) the research database. All data have been pseudonymized. Personally identifying data and allocations between the different pseudonyms are administered separately by an independent data trustee.
4. Data
   Data is the (processed) raw data and/or the resulting research data after quality control and post-processing. Non-quality controlled and unreleased data must not be used for scientific statistical analysis unless it is absolutely necessary for method development. Personally identifying data (names, addresses, etc.) cannot be used for scientific purposes.
5. Data Management
   Data management in the Rhineland Study is in charge of the entire process ranging from data curation and documentation to the handout of datasets for scientific analysis to the applying scientist(s). Data management is also responsible for the selection of the variables and biomaterial samples and the re-integration of results into the central study data bases.
6. Data Protection Concept
   The data protection concept is the currently valid data protection concept of the Rhineland Study.
7. Data Use
   Data use means the processing and use, in particular the statistical analysis, of all data or a subset thereof for scientific research projects (e.g. for publications or presentations/lectures), method development or quality control purposes.
8. Independent Data Trustee
   The independent (third party) data trustee performs technical tasks in connection with pseudonymization and personally identifying data of the participants of the Rhineland Study. In detail it manages the allocation of pseudonyms, the administration of the information concerning study awareness and consent (consent management) including the documentation of people changing or completely or partially withdrawing their consent over time as well as the central storage of personally identifying data in the participant list. The latter one is technically separated from other study data.
9. Other Parties involved in the Project
   Other parties involved in the project are all persons who, during the preparation or execution of the research project, are given access to the data or samples.
10. Project Data
    Project data is all data that has been handed over to the responsible project leader to carry out a specified research project in accordance with this policy.
11. Project End
    The project end, as far as this policy is concerned, is the day on which, according to the application for data use, the research project comes to an end.
12. Research Project or Project
    A research project is a project that complies with the scientific issues and priorities of the Rhineland Study, has a limited time span and needs  data or samples from the Rhineland Study to be executed.
13. Responsible Project Leader
    The responsible project leader is ultimately responsible for the execution of the project ("senior author"). A project may involve more than one responsible project leader. In such cases all responsible project leaders are fully bound by the same rights and duties.
14. Results
    Results are all information obtained from the project data as well as the derived variables (new variables generated from transferred data such as categories, scores and indices, information gained from samples, markers, etc.).
15. Samples and/or Sample Material
    Samples and/or sample material are all biological materials obtained from participants in the Rhineland Study and stored in the biorepository. These include, for example, blood, serum, plasma, urine, saliva, stool, hair and any material derived from those such as blood components, DNA or RNA.
     

§ 2    Policy purpose

1. The purpose of this data use and access policy is to ensure that the data and the samples handled as part of the Rhineland Study are used as transparently and wisely as possible. This applies to all persons within and outside the Rhineland Study who want to access the data of the Rhineland Study. The data collected within the context of the Rhineland Study is first and foremost meant to be used for own research purposes. Other parties can be given access to the data, generally as part of a scientific collaboration, and if covered by the informed consent of the participants. In individual cases, other options may also be considered but as they are exceptions, they are not separately referred to in this context.
2. Apart from this data use and access policy, the following other provisions in their respective valid version must also be taken into consideration:
   a) German Federal Data Protection Act and the EU General Data Protection Regulation in their respective valid versions
   b) Guidelines of Good Scientific Practice in their respective valid version^[1]
   c) Guidelines of Good Epidemiological Practice in their respective valid version^[2]
   d) Data Protection Concept of the Rhineland Study
   e) Decision of the ethics committee for the Rhineland Study
    

§ 3    Legal basis of data use

1. The collection, processing and use of data as well as the removal, further processing, analysis and evaluation of data and/or sample material requires the informed consent of the participant concerned. For each participant, a  written declaration of consent has been obtained.
2. If participants withdraw their consent, the data and/or samples are no longer made available for new research project datasets.
3. Further details are provided in the vote of the ethics committee and the data protection concept of the Rhineland Study.
    

§ 4    Rights of ownership and use

1. Data and samples are owned by the Rhineland Study of the DZNE as long as the participants have handed over the data and the samples to the DZNE. This applies irrespective of any rights that may have been conceded to third parties.
2. The Rhineland Study of the DZNE shall, upon request, grant rights to use the data.
3. Sample material may, outside the DZNE, only be used/analyzed as part of a data processing agreement. Analyses of sample material that have been applied for and approved are arranged directly by the DZNE.
4. Any analysis data gained from third parties on the basis of data or sample material from the Rhineland Study is transferred to the central study database including biomaterial and image database of the Rhineland Study and owned by the Rhineland Study. Data use can be applied for according to the guidelines of this data use and access policy.
5. Without the express written approval of the DZNE, the commercial use of data and/or sample material shall be prohibited as shall be the registration of patents or other industrial property rights that refer to or are based on the data or sample material.
    

§ 5    Data Use and Access Committee

1. The Data Use and Access Committee (DUAC) consists of three to five permanent members (Scientific Director of the Rhineland Study, Head of Research Management Population Health Sciences, a member of data management, additional scientists). If required, the DUAC may, depending on the application, ask specialists in certain fields (e.g., statisticians, data protection officials of the DZNE, scientists) for assistance. If there is a request for data from ongoing collaborative projects, the responsible project leader involved in the collaboration may also be included as an ad-hoc member, who is eligible to vote.
2. The DUAC performs its tasks in line with the provisions set out in this data use and access policy.
3. The DUAC members consult with one another as often as necessary to fulfill their tasks. The Committee is chaired by the scientific director of the Rhineland Study. The chairperson calls the meetings of the DUAC. A quorum is established as long as the chairperson and at least two other members are present. Proxies are permitted following approval by the chairperson. Given that all formal and technical requirements have been met, the DUAC decides with a simple majority of members present. The scientific director of the Rhineland Study has a right of veto.
    

§ 6    Principles of data use and sample material

1. Wherever possible, analysis of the data takes place within the DZNE and the data do not leave the servers of the DZNE. Exceptions may be granted in justified cases.
2. When handing out data for research projects, the confidentiality of the participants' data and samples will be protected by pseudonymisation as well as by the principles, which are outlined in each data usage application: For each data usage application, the applying scientists have to agree to refrain from attempting to re-identify persons whose data they have received, and to not publish or pass on data to third parties that could enable such parties to re-identify individuals. In principle, the provision of data can only take place on the basis of the existing informed consent. If the involved Scientist has access to multiple project datasets, it is prohibited to join datasets from different research projects, e.g. based on certain attributes.
3. If an analysis of biomaterial is required to carry out the project for which an application has been made, the following applies: All results of the biomaterial analyses (raw data + analysis results) must be passed on to data management before they can be used for further research purposes (separate application for data use necessary). Any sample material that has not been used must be returned to the Rhineland Study immediately after completion of the analyses. This must take place after consultation with the biorepository in a way that ensures the further processing of the remaining sample material. If this is not possible, the sample material that has not been used must be destroyed after consultation with the biorepository. Data management must be informed in writing of the return/destruction of the remaining material.
    

§ 7    Data use only after application and approval

1. Any data that has been made available must only be used for the purpose and within the period of time for which the application has been made and approval has been granted. Furthermore, samples must only be utilized in the laboratory stipulated in the data processing agreement. Where possible, material-saving procedures must be used for the analysis. Any specifications and conditions stipulated in the data processing agreement and approved data application  must be adhered to. For any further (intended) use of data or samples exceeding the application – even a use of data beyond the time frame that was originally requested – an amendment or new application must be submitted.
2. Copying and passing on data and/or sample material to third parties is prohibited. Data may only be passed on by data management and samples may only be sent by the biorepository.
3. The responsible project leader may allow other parties involved in the project access to the sample material and the data only, if they have confirmed in writing to comply with the regulations set out in this data use and access policy.
    

§ 8    Notification, administration and further use of the results

1. All results and publications resulting from data of the Rhineland Study must, as soon as possible but at the latest two months after the end of the period specified in the application, be reported to the Rhineland Study (to the attention of data management) by the applying scientist in full and in the appropriate electronic format.
2. There must be a sufficient self-explanatory documentation of the results and the analysis programs that have been used for generating all results. The format of the electronically transmitted results must be agreed on with data management. The format should be imported using a commonly used type of software. The information must be divided into the smallest meaningful units and be easily accessible. Generally, this means the results are reported per participant.
3. For all publications for which data or sample material or results of the Rhineland Study are used, the rules of Good Scientific Practice shall apply. Further details may be set out in separate agreements.
4. In written publications that are fully or partially based on data or sample material or results from the Rhineland Study, a notice must be included, informing the readers that these data have been collected/made available by the Rhineland Study of the German Center of Neurodegenerative Diseases (DZNE).
5. The funding bodies/sponsors of the Rhineland Study or of individual projects must be mentioned in the publications. The names of the funding bodies relevant for the data will be made available by data management together with the data.
    

§ 9    Erasure of data  

1. All applying scientists and other parties involved in the project are obliged to erase all data of the Rhineland Study at the latest two months after the end of the period specified in the application. Data management must immediately and in writing be informed of the erasure.
2. In case of withdrawal of consent by participants, data management will send a request for deletion. This must be followed immediately. A confirmation of the deletion must be sent to data management.
    

§ 10    Responsibility and liability of the responsible project leader

1. Applying scientists are responsible and liable for any sample material and data that has been handed over to them.
2. If an applying scientist or responsible project leader leaves the project, they must immediately and in writing inform the DUAC of a successor, who will take on that responsibility. Any applications and contracts associated with the project must be signed anew.  For Rhineland Study internal projects, amendments may be filed which carry the respective signatures.
3. In the event of paragraph 2 above, the Rhineland Study shall have the right to ask the applying scientist and/or responsible project leader for the immediate return of the sample material and for the erasure of all data that has been handed over.
4. Applying scientists and responsible project leaders shall be liable for any damage/loss caused by them during their use of the data and sample material, in particular such damage/loss that has arisen due to the unauthorized use or passing on of data, sample material and/or results.

§ 14    Handover of data

After the application for use has been approved, data management will provide data access in accordance with the data protection concept of the Rhineland Study.
 

§ 15    Handover of samples

1. The biorepository is tasked with the handover of the sample material. In the case of researchers and guest scientists at the DZNE, the sample material is handed over to a responsible scientist as specified by the responsible project leader. If the analyses are undertaken outside the DZNE, the recipient will be specified in the data processing contract.
2. Sample material will be handed over with as little metadata as possible.
    

§ 16    Costs and fees

1. The provision of data and samples may result in fees that are charged by the DZNE.
2. In the case of commercial use, as long as it has been approved by the provider of the data and samples as well as the DZNE, the recipient must pay a license fee. Further details must be set out in a separate agreement.

§ 18    Entering into force and transitory provisions

The data use and access policy shall enter into force following the decision of the DUAC and approval by the board of the DZNE.

 

 

---

^[1] Recommendations of the Commission on "Self-regulation in Science“ – Proposals to ensure Good Scientific Practice, German Research Foundation, in their respective valid version

^[2] Guidelines and recommendations to ensure Good Epidemiological Practice (GEP) issued by the German Society for Epidemiology (DGEpi) in their respective valid version