Legal Framework for Research Data Management
Legal considerations play a central role in research data management – both in the collection, processing and publication of research data and in its subsequent reuse. This gives rise to a wide range of challenges, particularly concerning data protection, copyright and conditions for re-use.
1. Data protection issues
- What legal requirements must be observed when collecting and processing personal data?
- How can research data be anonymised or pseudonymised in such a way that it remains scientifically usable without violating personal rights?
- How can informed and legally compliant consent be obtained from the data subjects?
There are a number of useful templates and guidelines available for drawing up informed consent forms:
KonsortSWD – Consent documents for research involving personal data
The Consortium for Social, Behavioural, Educational and Economic Data (KonsortSWD) offers practical templates and guidelines on informed consent in accordance with the requirements of the General Data Protection Regulation (GDPR). These materials support researchers in collecting, documenting and making personal data available for re-use in a legally compliant manner.
https://www.konsortswd.de/themen/best-practice-forschungsethik/einwilligungsunterlagen/
Medical Informatics Initiative (MII) – Sample texts for informed patient consent
The Medical Informatics Initiative provides standardised and ethics-approved templates for informed consent in medical and health-related research. The documents serve as a reference for projects that handle sensitive personal or clinical data.
https://www.medizininformatik-initiative.de/en/template-text-patient-consent-forms
2. Copyright issues
- What types of research data are subject to copyright law?
- Who has the right to decide on the use and publication of protected or unprotected data?
- Who holds the rights to use copyright-protected research data?
3. Reuse of research data and liability issues
- What are the possible licensing conditions for the publication of research data?
- What requirements apply when reusing protected data for scientific purposes?
- Who is liable in the event of legal violations – such as data protection breaches or the unauthorised disclosure of protected content?
You can find a practical guide to legal aspects in research data management here: https://zenodo.org/records/11083303. This guide is provided by FAIRmat, a consortium of the German Research Data Infrastructure NFDI. While their focus is on physics, their guide gives a good first overview of legal aspects in RDM in the German context. Alternatively, Anne Lauber-Rönsberg’s chapter in the Practical Handbook on Research Data Management provides a concise overview of the topics covered, available in German only here:
Lauber‑Rönsberg, Anne (2021): „Rechtliche Aspekte des Forschungsdatenmanagements“. In: Putnings, Markus; Neuroth, Heike; Neumann, Janna (Hrsg.): Praxishandbuch Forschungsdatenmanagement, Berlin, Boston: De Gruyter Saur, S. 89–114.
https://doi.org/10.1515/9783110657807-005
Please feel free to contact us with any questions you may have regarding data protection, copyright or research ethics. You can contact us at: forschungsdaten@ub.uni-frankfurt.de
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