Data Ethics

Organization Institutes Data Ethics
Institute for Medical and Data Ethics

At the heart of the Data Ethics division at IMDE lies the question of how medical data can be used responsibly to facilitate scientific progress and improve patient care, without compromising the rights and interests of patients. We address ethical issues relating to informed consent, data protection and fair rules governing access to and use of research data. Another key focus is the development of transparent governance structures for large-scale data infrastructures and international data collaborations. We also analyse the ethical challenges of data-driven medicine, such as the handling of incidental findings, the responsibilities of various stakeholders, and issues of trust and transparency within the data ecosystem. Our research combines normative analyses with empirical studies to develop viable and socially acceptable solutions for the handling of medical data.

Projects

The Importance of Data for Medical Research


The success and quality of medical research in the healthcare sector depend crucially on the ability to use personal data for research purposes, in particular personal health data, genomic data and biomaterials collected in clinical settings. To date, all efforts to find a legally sound, ethically justifiable and effective method for handling and making the data available have not yet led to a breakthrough. One promising concept that offers both practicality and the protection of data subjects’ rights is that of the data fiduciary.

The DAFIDUMER Project

The DFG-funded project ‘DAta FIDUciaries in MEdical Research’ (DAFIDUMER), which is divided into a legal and an ethical component, aims to establish the ethical and legal foundations for the concept of the data trustee in medical research and to jointly put forward concrete proposals for its implementation.

Criteria for Data Stewards

In this context, it is crucial to identify clear criteria that enable an individual to qualify as a data trustee. At present, a wide variety of concepts and models – with diverse functions – are grouped under the term ‘data trustee’. Funded by the German Research Foundation (DFG), project number: 528528062, project duration: 1 November 2023 – 31 December 2026

 

Publications

  • Geibel SJ, Kiefer L, Maier AC, Winkler EC. Data trusteeship for medical research. MedR. 2026;44:507–515. https://doi.org/10.1007/s00350-026-7356-z
  • Kiefer L, Maier A-C, Tavakoli S, Sulzbach N, Geibel SJ, Winkler EC. Applying Fiduciary Concepts to Health RDM – Mapping and Evaluation. In: 2nd Conference on Research Data Infrastructure (CoRDI); 2025; Aachen, Germany. Zenodo. doi.org/10.5281/zenodo.16736366
  • Geibel SJ. The data trust for research and other public-interest purposes within the multi-level system of EU law. In: Geibel SJ, Heinze C, Verse DA, eds. Internal Market Law as a Multi-Level System. Baden-Baden: Nomos Verlagsgesellschaft; 2023:233–281. https://doi.org/10.5771/9783748937814-233 

Presentations

  • Kiefer L, Winkler EC. Translating ethical fiduciary concepts into health research: How can data fiduciaries contribute to a trust architecture for the research use of health data? Presented at: EACME 2024 Annual Conference; 12–14 September 2024; Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
  • Kiefer L, Maier A-C, Tavakoli S, Sulzbach N, Geibel SJ, Winkler EC. Applying Fiduciary Concepts to Health RDM: Mapping and Evaluation. Presented at: 2nd Conference on Research Data Infrastructure (CoRDI); 26–28 August 2025; RWTH Aachen University, Aachen, Germany.
  • Kiefer L, Sulzbach N, Winkler EC. Trust me, I’m a data fiduciary. Presented at: EACME 2025 Annual Conference; 11–13 September 2025; University of Zurich, Zurich, Switzerland.
  • Geibel SJ. The Legal Concept of Fiduciary Relationships with Experts. Presented at: Why Trust Matters—And How It Fails: Trust in Technology, Institutions, Communities, and Professions; 6 October 2025; Camilla and Georg Jellinek Centre for Medical Ethics, Heidelberg University, Heidelberg, Germany.
  • Kiefer L. Trustees as Trusted Parties: Data Trustees for Medical Research. Presented at: Research Network “Trust in the Context of Healthcare Technologies”; 26 November 2025; Heidelberg University, Heidelberg, Germany.

Supplementary publications

 

IMDE Contact Partners

Lukas Kiefer

Niamh Sulzbach

A Central Infrastructure for Genomic and Medical Data

Genomic and other medical data are playing an increasingly important role in biomedical research: When aggregated on a large scale, they reveal new patterns and clinically relevant correlations that can improve future treatments. This requires a reliable and secure infrastructure for collecting, analyzing, and sharing this sensitive data. The Human Genome-Phenome Archive (GHGA) is establishing precisely this central data infrastructure—for the long-term storage and reuse of medical data in research. Internationally, GHGA serves as the German node connected to the European Genome-Phenome Archive (EGA), thereby helping to shape common standards for data exchange.

The GHGA Consortium

Since October 2020, the consortium has been funded by the German Research Foundation (DFG) as part of the National Research Data Infrastructure. Experts from over 20 leading institutions in genomic medicine are collaborating—ranging from software development, cloud computing, and bioinformatics to medicine, ethics, and law (ELSI).

Ethical and Legal Questions

In addition to the technical development of the infrastructure, the project also addresses key ethical and legal issues surrounding consent, data sharing, and governance, which are being addressed, among other places, at the Institute for Medical and Data Ethics. The focus is on:

  • The needs and interests of patients regarding the reuse of their data
  • Fostering trust and acceptance among relevant stakeholders in medical research data infrastructures
  • The development of appropriate consent solutions for data use in medical research
  • Ethical principles for data access and use as a basis for decisions by access committees
  • An international governance concept for the GHGA

GHGA Website

IMDE Contact Partners

Dr. Katja Mehlis

Dr. Aline Weis

Precision Oncology in Pediatric Oncology


Despite substantial advances in the treatment of childhood cancer over recent decades, outcomes remain poor for children with high-risk diseases or relapse. As paediatric cancers differ fundamentally from adult malignancies, there is a particular need to identify and prioritize effective therapeutic options for children. Precision oncology offers an important opportunity in this regard by using the molecular characteristics of individual tumours to inform treatment decisions and identify potentially promising targeted therapies. Given the rarity and diversity of paediatric cancers, international collaboration and the systematic integration of genomic and clinical data are essential to generate sufficient evidence and improve the prioritization of new cancer therapies for children. 

International Data Integration in Pediatric Oncology

A global collaborative approach, such as the ITCC Data Integration Platform, is essential for pediatric oncology. The ITCC paediatric cancer data portal enables the analysis of genomic data from more than 6,000 paediatric cancer patients across seven countries. To accommodate different national data-protection regulations, raw data remain locally stored while harmonized analysis algorithms are applied across datasets.

 

Ethics: the ethical work package WP6A

The international linkage, sharing and analysis of clinical and genomic data from children with cancer raises important ethical questions. Genomic data are highly sensitive and the patients are  vulnerable minors. A central focus is safeguarding patients’ informational rights, autonomy and trust and to involve parents’ legal custodians appropriately. 

Information and Consent from Children and Parents

The project develops guidance on the information and consent processes involving children and parents. It particularly focuses on consent for genomic sequencing and data sharing in personalized paediatric oncology, considering children’s evolving capacity for self-determination. We examine whether and under which conditions the use of broad consent for future research purposes can be ethically justified in paediatric oncology.

Responsible Data Use and Governance

We also address the ethical challenges of data use, access and sharing by developing ethical guidelines and governance concepts that support responsible, transparent and fair access to and use of paediatric clinical and genomic data. Finally, the project aims to develop guidance for responsibly managing incidental genomic findings, including whether, when and how clinically relevant findings should be returned to patients and their families.

 

Sponsored by the Dietmar Hopp Foundation

Project Number: 1DH2211091

Project Duration: 01.01.2023 - 31.12.2028 (Ethical Work Package: 01.01.2023 - 31.12.2026)

 
Workshops and Conferences
  • Together with Childhood Cancer Europe: International Meeting on ICF Threshold and Parental Consent for Genomic Data in Childhood Cancer Research, Workshop with in the annual meeting of the Society for pediatric oncology (SIOP), 20.10.2025, Amsterdam
  • 2025 Annual Conference of the Academy for Ethics in Medicine: Ethical Challenges in Developing a Data Infrastructure for Pediatric Next-Generation Sequencing, 10.10.2025, LMU München
Upcoming Events
  • 2026 Annual Conference of the Academy for Ethics in Medicine: Ethical Challenges of the Temporal Perspective of Broad Consent in Pediatrics—Between the Right to an Open, Informed Future and the Benefits of Future Research, 11.09.2026, Carl von Ossietzky Universität Oldenburg 
  • European Association of Centres of Medical Ethics Conference 2026: Ethical Considerations About Broad Consent in Paediatrics, KU Leuven Centre for Biomedical Ethics and Law, 24.09.2026
Publications

Haase-Saebel, I., Schickhardt, C. (2025). Ethical challenges of precision medicine: adults and minors/children. A literature overview for ITCC Paediatric Cancer Data Portal. Zenodo, https://doi.org/10.5281/zenodo.17135897

 

IMDE Contact Partners

Dr. Christoph Schickhardt

Isabell Haase-Saebel

Patient Data for Research

Patient data from medical care can provide valuable information for research, for example, on the effectiveness of medications under real-world conditions or on rare diseases (secondary use of patient data for research). Successful secondary use of this data requires the sharing and integration of data from various clinics and hospitals (data sharing). For this reason, the Federal Ministry of Research, Technology, and Space has commissioned the Medical Informatics Initiative (MII) to facilitate such data sharing on a nationwide basis.

Ethical Issues in Secondary Use

As part of HIGHmed and the Consent Working Group, we address ethical issues related to secondary use within the MII, such as the appropriate implementation of data protection—particularly with regard to genetic data—as well as the provision of information and consent (broad consent) for patients in various languages and formats, the conditions under which research projects may access the data, the handling of incidental findings (patients’ right to information and right to remain uninformed), and the handling of withdrawals, the development of additional modules that can expand the Broad Consent, or the question of under what conditions and what types of research with organoids are permitted within the framework of the Broad Consent.

Use and Access Committee (UAC)

As members of the Use and Access Committee of the Data Integration Center in Heidelberg, we also review which research projects are permitted to access patient data.

Publications (selection)

Zenker, S., Strech, D., Jahns, R. et al. Nationally standardised ‘broad consent’ in practice: initial experiences, current developments and critical considerations. Bundesgesundheitsbl 67, 637–647 (2024). https://doi.org/10.1007/s00103-024-03878-6

Zenker, S., Strech, D., Ihrig, K., Jahns, R., Müller, G., Schickhardt, C., Schmidt, G., Speer, R., Winkler, E. C., von Kielmansegg, S. G., Drepper, J. Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio)medical research: Towards a new German national standard. J Biomed Inform. 2022 Jul;131:104096. doi: 10.1016/j.jbi.2022.104096. Epub 2022 May 25. PMID: 35643273.

Vorträge (Auswahl)

Broad Consent in the Medical Informatics Initiative within the scientific discourse (Schickhardt, C., Schweer, J., Winkler, E. C.), 68th GMDS Conference, Heilbronn.

25–26 May 2023: Perspectives from HiGhmed and Heidelberg on incidental findings
11th National Biobank Symposium, theme: Biobanking in challenging times, Technology and Methods Platform for Networked Medical Research (TMF e. V.) in cooperation with the German Biobank Node (GBN), Berlin.

15.03.2023, Collecting and Using (genetic) medical data for research with the Broad Consent of the German Medical Informatics Initiative; Lecture series Advances in data-driven biomedicine des German Human Genome Phenome-Archive (GHGA), online.

29 November 2022, Collaboration between the MII and the NFDI Consortium German Human Genome-Phenome Archive (GHGA), Web conference organised by the Consent Working Group of the Medical Informatics Initiative, genomDE and the German Human Genome-Phenome Archive (GHGA).

21 November 2022, The Broad Consent of the Medical Informatics Initiative – Development and Prospects (Winkler, E. C., Schickhardt, C.). Workshop at the Eberhard Karls University of Tübingen, Medical Clinic, Tübingen.

29 September 2021 Feedback on additional information (‘incidental findings’) from the secondary analysis of patient data in the Medical Informatics Initiative (Rudra, P., Winkler, E. C., Schickhardt, C.), 66th GMDS Annual Conference / 12th TMF Annual Congress, virtual.

IMDE Contact Partners

Dr. Christoph Schickhardt

Niamh Sulzbach

Institute for Medical and Data Ethics
EN