d. Responsibilities

You, as a researcher, are principally responsible for data stewardship. Your UMC will support you with policies as well as technical and organisational solutions.

As a researcher, you are the principal data steward. In practice, this means that you are responsible for the complete scientific process: from study design to data collection, analysis, storage, and sharing. Protecting the privacy of study subjects is also your responsibility. This may seem a daunting task, but you can use the available expertise and infrastructure at your UMC.

 

In short, the responsibilities of the key players are:

  • Principle Investigator or research leader (=Principal Data Steward): responsible for research, hence for the data stewardship in a particular research project, but can delegate certain data stewardship tasks such as data management and FAIRification to dedicated data stewards (see below).
  • Researcher involved in a project: responsible for the execution of good data stewardship.
  • UMC Board: end responsible for research data stewardship within the institute.
  • UMC: responsible for offering all researchers support in data stewardship, such as policies, training, tools, technical solutions and organisational support, for instance by appointing institutional data stewards and project data stewards.
  • Institutional data stewards and project data stewards: offer advice on good data stewardship and certain data stewardship tasks may be delegated to these data stewards.

Frequently Asked Questions

You:

  • are accountable and responsible for your research data;
  • are in control of the complete research data flow;
  • collaborate with patient organisations throughout your research;
  • reuse existing data when possible;
  • protect research quality and reproducibility;
  • protect the privacy and safety of study subjects;
  • apply the FAIR Principles as much as possible;
  • think ahead about rights of third parties, proprietary data and intellectual property rights;
  • share your data responsibly.

Your institution has a duty of care when it comes to data stewardship. Your UMC is accountable for having adequate policies (e.g., a Data Governance Policy), facilities and expertise around data management and data stewardship. It is your UMC's responsibility that you as a researcher are informed about these policies, facilities and expertise.

 

Your institute has:

  • professionals that provide the procedures and technical systems for data stewardship (e.g., institutional/operational data stewards, data managers, IT-specialists, statisticians, protein sequence experts);
  • institute managers, who govern and facilitate the professionals;
  • supervisory bodies such as medical-ethical review committees and privacy officers;
  • data collections from patients and citizens.

Responsibilities of the managers at your UMC:

  • facilities for data stewardship (e.g., data protection, storage, interoperability);
  • financial means for data stewardship and expert employees;
  • organisation, policy, standard procedures, practical measures, etc.;
  • training the employees who work with data.

Responsibilities of professionals that support data stewardship are

  • to provide, advise and support the use of terminologies, IT-standards and e-infrastructure that promote data sharing, data integration, etc.;
  • data curation and archiving.

The principle of accountability refers to the responsibility of the data controller (i.e., the person or organisation that is collecting and maintaining the data) to ensure that the fundamental principles relating to processing of personal data are respected, as well as the ability to demonstrate compliance.

Clinical researchers that are working at UMCs are obliged to complete the ‘Basiscursus Regelgeving en Organisatie voor Klinisch onderzoekers (BROK®)’. After four years, a re-registration course should be followed. Every UMC organises a centre-specific BROK for employees that perform clinical research. This centre-specific BROK offers information about data management as well as information about local policies, facilities and expertise. Many universities and UMCs organise additional datastewrdship training and/or data management courses that are not obligated, but highly recommended. HANDS’ toolbox can help you find such courses.

Healthcare organisations are increasingly taking a leading role in effectively aggregating data and setting up data science strategies themselves in order to gain insights into wider care processes.