ECRA Member Christin Doehla


"Data stewardship can be helpful as a concept for individuals and society in handling personal health data"

With regard to research and the use of health data, consent forms from subjects and patients are of particular interest. In written consent declarations, there is always a passage that includes consent to the disclosure of personal data for medical research purposes. These purposes according to Article 89 of the GDPR are of a scientific, historical and statistical nature and require appropriate safeguards, i.e. technical and organizational measures, to ensure the rights and freedoms of the data subjects. Personal (health) data is defined as individual information about personal or factual circumstances of identified or identifiable natural persons. This includes, for example, addresses, income and, above all, data relating to personal health. When dealing with this sensitive, personal data, data stewardship can provide ethical and legal support in addition to technical support. At the beginning of a study, in addition to the allocation of third-party funds, the preparation of the study protocols and the application to the ethics committee are existential steps.
Only after these have been approved can a data management plan, which is now expected by many sponsors, structure the research work and diverse data processes. The data management plan contains information about the objectives, data (sources), documentation, type of storage, costs, and legal and ethical aspects of a research project. In addition to the data management plan, sponsors increasingly expect data sharing as a component of new quality of work in research. Here, researchers need support, as the value of that expectation for researchers is also tied to monetary infrastructures on the part of the university. However, scientific exchange, the sustainable use of data and the promotion of interdisciplinary collaboration across national borders can only succeed if this is approached conceptually and as holistically as possible. In addition to the high scientific requirements, the technical relevance of the topic of data management and migration, the well-being of the data donors also plays a significant role.
The personal data should be used for health promotion and prevention. Therefore, exploring the concept of data stewardship from a health and humanities perspective is urgent. To date, although many workers with digital skills in the sense of Data Steward:dess or Data Scientist are sought, there is a lack of clear definitions and clear ideas about the role and tasks of this job description. Thus, these new occupations are associated with a variety of tasks and responsibilities. However, some of these tasks are already performed by other professions. Data stewardship should therefore encompass much more in its consulting services than the technical, statistical issues and administrative services that have been the focus so far, because personal data require sensitivity as well as accountability in the complexity of the whole.
Data stewardship can be understood as a complex intervention in the health science approach because the concept is characterized by the following features:

  1. Complex interventions include multiple, synergistic components such that their sum is greater than their parts
  2. Complex interventions use a "multi-level" approach; they often address social and environmental determinants as well as individual competencies and behaviors
  3. Complex interventions interact with their context
  4. Complex interventions can be complex themselves; likewise, they can be made complex by the context in which they are applied. Interactions between intervention and context can further increase complexity; and
  5. Complex interventions involve spontaneous, unpredictable, and nonlinear relationships between components involved and outcomes.
The concept of data stewardship can be understood as a complex intervention in view of this and the applicable code of science, within which data are understood as an asset that should also be available to posterity.
For the more detailed treatment of this intervention, the Medical Research Council can be used. Thus, in the first step of the PhD project (Development), a comprehensive deductive (starting from the rule) and inductive (starting from the case) inventory will be conducted. For this purpose, currently active Data Steward:dess will be analyzed, networked and examined by the PhD Student on his/her background, professions and professional understanding as a Data Steward:dess. In addition, the focus of the survey is on the Data Steward:dess's own continuing education as well as continuing education in the sense of a curriculum that he/she intends to implement within his/her site. The results of this survey are to promote a standardization of the job description of a Data Steward:dess, in order to be able to describe above all researchers the performance of Data Stewardship independently of persons and institutions Germany-wide uniformly. In the second step (Feasibility and Piloting), the establishment of data stewardship is to be accompanied in the sense of a close-meshed process control. For this purpose, concrete cases will be processed in a pilot project as study support. The resulting legal and ethical conflicts and questions will be examined in more detail. A possible core conflict could be located between the data donor (patient, subject) and the researcher (also in the role conflict as physician). The third step (evaluation) will analyze the costs and benefits of data stewardship for the research, the researchers and the research institutions and assess the success of the proposed change process. This will show whether data stewardship can establish itself as a concept and or as an independent entity in the sense of a data stewards:dess among the professions in health care, or whether parts of the concept will be found in the already existing, divergent professions in research data management as an additional qualification or secondary task.

Contact Details

Dipl.-Soz.Arb. Christin Döhla, MScPH
Research Assistant and Data Stewardess
Department 6 Research and Publication Support
University of Cologne, University and City Library
Universitätsstr. 33, 50931 Cologne
E-mail: doehla@ub.uni-koeln.de

Websites:
https://www.ub.uni-koeln.de/about_us/contact/research/index_eng.html
https://www.nfdi4health.de/about/
https://fdm.uni-koeln.de/en/c3rdm-team

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