Accountability and responsibility

Many stakeholders are involved in data stewardship at UMCs:

  • professionals that collect, analyse, or reuse data (e.g., researchers, clinicians, and technicians);
  • professionals that provide the procedures and technical systems for data stewardship (e.g., data managers, IT-specialists, statisticians, protein sequence experts, etc.);
  • institute managers, who govern and facilitate the professionals;
  • supervisory bodies such as medical-ethical review committees, privacy officers, etc.;
  • patients and citizens from whom data is collected.

In short, you as a researcher are responsible for the complete scientific process: from the chosen methodology, to data collection, to the analysis, storage and sharing of reliable data sets. Protecting the privacy of study subjects is also your responsibility.

Your UMC is accountable for having adequate policies, facilities and expertise around data management. It is your UMC's responsibility that you as a researcher are informed about these policies, facilities, and expertise.

Responsibilities of professionals that collect, analyse, or reuse data are
  • privacy of the study subjects (i.e., use anonymised or pseudonymised data);
  • quality of the data registration (e.g., completeness, timeliness, standardised coding for registration);
  • data protection;
  • when reusing data: the interests of the data creator (agree upon collaboration, interpretation of the data, co-authorship of publications, compensation for costs, etc.) ;
  • sharing your data stewardship expertise with your fellow researchers.
Responsibilities of professionals that support data stewardship are
  • to provide, advise, and support the use of terminologies, IT-standards, and e-infrastructure which promote data sharing, data integration, etc.;
  • data curation and archiving.
Responsibilities of the managers at your UMC:
  • facilities for data stewardship (data protection, storage, interoperability, etc.);
  • financial means for data stewardship and expert employees;
  • organisation, policy, standard procedures, practical measures, etc.;
  • training the employees who work with data.

Frequently Asked Questions

WHAT to show:

  • show that your data is FAIR (i.e., Findable, Accessible, Interoperable, and Reusable; including metadata, reference of the data collection in a metadata catalogue, the IT standards and code book, the set of conditions for data sharing);
  • show that your procedures comply with standards (use a certified infrastructure, e.g., NEN or data seal of approval).

HOW to show it:

WHOM to show it:

  • patients and citizens, who may ask questions such as: 'Can I trust researchers and healthcare professionals with my personal data?' 'Is my privacy protected?' 'What are the results and the benefits of research with my data?';
  • monitoring and supervising bodies (e.g., CBP, CCMO, IGZ, UMC management);
  • research funders (e.g., ZonMw, NWO, KNAW, health funds, the European Commission);
  • your research and business partners.
  • reputation damage;
  • liability;
  • losing or having to refund a research grant.

Several legal requirements and codes address the principles of data stewardship:

  • European laws: There is forthcoming new European legislation on data stewardship.
  • Dutch laws and regulations: privacy legislation (WBP) and 'Wet op Geneeskundige Behandelingsovereenkomst' (WBGO).
  • The CCMO has described international legislation in the Medical Research Involving Human Subjects Act (WMO).
  • Dutch codes and guidelines: Federa has described 'gedragscodes' for biomedical research (Gedragscode Gezondheidsonderzoek, Code Goed Gebruik, Code Goed Gedrag).
  • The Vereniging Klinische Genetica Nederland (VKGN) and the European Society for Human Genetics (ESHG) have made guidelines and protocols in the field of genetics.
  • The NFU has established guidelines for research involving humans: 'Kwaliteitsborging van mensgebonden onderzoek 2.0'.
  • The NFU describes guidelines and practical tools for data stewardship in this living handbook.
  • Every UMC has its own formal research policy.

Several ongoing societal and political debates may have a large impact on various aspects of accountability and data stewardship:

  • A new EU regulation for data protection is in preparation. This may require revisiting regulations and measures on data protection and consent provided by study subjects.
  • The PGD (persoonlijk gezondheidsdossier, personal health record) debate is about the right of citizens and patients to manage their own medical data. This will change the hierarchy between the current stakeholders in research, because the patient will join as an important new stakeholder. As a consequence, the (re)use of data may become a more transparent and democratic process.
  • An obligation to report data leaks is expected.

The content of this handbook is therefore subject to change and will be continually improved.