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The Research Ethics Unit at the IMDE addresses the challenge of reconciling scientific progress in biomedical research with the protection of individuals and society.
A particular focus is the responsible handling of patient data. We investigate innovative concepts such as data trusteeships and develop guidelines for modern informed consent that safeguards informational self-determination even within complex, interconnected infrastructures.
Furthermore, the IMDE addresses specific ethical issues such as the handling of incidental findings in whole-genome sequencing, the development of robust ethical frameworks for translation – that is, the transition from research to clinical application – and the development of governance structures that regulate fair access to data, strengthen patients’ trust and thus create an ethically sound basis for biomedical research.
Projects
EURAT (Ethical and Legal Aspects of Translational Medicine)
The EURAT platform has been in existence since 2011 and was founded as an interdisciplinary and inter-institutional group to provide ethical guidance on ethical and legal issues relating to genome sequencing and the translation of new technologies into clinical practice.
EURAT comprises researchers from Heidelberg University, Heidelberg University Hospital, the German Cancer Research Centre (DKFZ), the National Centre for Tumour Diseases (NCT), and the Hopp Children’s Cancer Centre (KiTZ), who come from both the normative sciences (ethics, law) and the life sciences (biology, medicine, etc.).
EURAT is funded by the German Cancer Research Centre. In the past, funding was provided by the Marsilius Kolleg.
Publications
Statement on the Handling of AI-Assisted Genomic Re-Analyses, Heidelberg 2026, https://doi.org/10.11588/fmk.2026.28.115792
Position paper on the handling of additional genetic findings in minors, Heidelberg 2023
Position paper on the return of additional genetic findings in minors, Heidelberg 2023
On the release of raw genomic data to patients and study participants, Heidelberg 2019
Statement on the release of raw genomic data to patients and study participants, Heidelberg 2019
Cornerstones for an ethically and legally informed practice of whole-genome sequencing, 2nd, updated edition, Heidelberg 2016
Key principles for the Heidelberg practice of whole-genome sequencing, 2nd, updated edition, Heidelberg 2015
Cornerstones for an ethically and legally informed practice of whole-genome sequencing, Heidelberg 2013
Key Principles for a Heidelberg-based Practice of Whole Genome Sequencing, Heidelberg 2013
IMDE Contact Partners
SEEM (Social and Ethical-Legal Challenges of Human Embryo Models)
Human stem cell-based embryo models open up new possibilities for research into early embryonic development and could make important contributions to reproductive medicine and regenerative medicine in the future. At the same time, they raise fundamental ethical, legal and social questions. The interdisciplinary research project SEEM examines these so-called human stem cell-based embryo models (hSCBEMs) from ethical, legal and social science perspectives. The focus is on analysing scientific practices, normative concepts, and the perceptions and assessments of various scientific and societal stakeholders. Through empirical social science research and ethical analyses, the project aims to lay the foundations for the responsible use of this new technology and to develop recommendations for research, policy and science communication.
IMDE Contact Partners
SynthImmune
Combating Serious Diseases with Synthetic Immunology
The “bottom-up” approach to synthetic immunology pursued by the SynthImmune Cluster of Excellence promises significant advantages over conventional “top-down” methods, such as CAR-T cell therapy. The anticipated benefits include, in particular, rational design, improved precision, control, cost-effectiveness, and scalability, as well as increased safety and greater efficacy.
Global Challenges and Therapeutic Prospects
The field of bottom-up synthetic immunology thus aims to address globally relevant challenges posed by diseases such as malaria, HIV/AIDS, and hard-to-treat tumors. Due to their “immune-evasive” or “immune escape” mechanisms, these diseases have so far been associated with significant limitations in therapy development.
Ethical Risks and Challenges
On the other hand, this innovative bottom-up strategy—which is still in its infancy—must also take into account potential risks, such as conceivable adverse (auto)immune reactions and off-target effects, as well as potential risks of misuse. It is also important to address issues of (informed) consent, the selection of study participants, data protection risks, and questions of distributive and access justice.
How promising is the new technology—and what are its limitations?
The goal of the ethical subproject “Normative Assessment of the Risks and Benefits of SynthImmune,” based at the Institute for Medical and Data Ethics, is to first map out the potential risks and anticipated benefits of the bottom-up approach using methods of empirical social research. In a second step, building on this foundation, the risks and benefits will be evaluated from an ethical perspective. The subproject has been involved with the SynthImmune cluster from the very beginning in order to incorporate ethically relevant aspects early on in the project. Ultimately, the goal is to develop recommendations for research and for the scientific communication of its objectives and results, thereby contributing to a socially responsible approach to this new technology.