Comparative Assessment of Genome and Epigenome Editing in Medicine: Ethical, Legal and Social Implications (COMPASS-ELSI)

Funded by the German Research Foundation (Deutsche Forschungsgemeinschaft)
Project duration: 2019 – 2023 (45 months)

Since the development of CRISPR/Cas genome editing tools, the ethical and legal debate on genome modifications, especially germline, has been emerging quickly. COMPASS-ELSI broadens the scope of this discussion, on both the somatic and the germline level, as regards a comparative analysis of scenarios of epigenome editing and applications of genome editing in humans. The interdisciplinary team also includes a cooperation with scientific experts (Grimm lab) who work with CRISPR/Cas applications. The comparative analysis aims at assessing whether the current legal framework fits those applications in medicine, and intends to develop sound and valid ethical and legal criteria of and for a discussion of germline and somatic (epi)genome modifications. It will be complemented by an examination of those concepts from the perspective of philosophy of language, investigating whether the language aligns with normatively relevant aspects of these technologies.

Close cooperation with researchers from Heidelberg as well as within an international advisory board allows for an adequate representation of the necessary biological knowledge and an empirically informed ethical as well as legal analysis that facilitates applicable and realistic results. The advisory board will also foster communication and discussions of the ethical and legal recommendations developed during this project with experts and regulatory bodies in Germany and the EU.

Second funding period:

The ethical and legal debate of epigenome editing and of a comparison of epigenome and genome editing is still very small and apart from the research conducted within this project almost non-existent. Therefore, within an additional funding period of 12 months, the goal of COMPASS-ELSI is to consolidate open issues as regards the ethical, legal, and regulatory evaluation of genome and epigenome editing of somatic and germline cells.
The following objectives, which have been detected as particularly relevant for the ethical and legal debate on genome and epigenome editing during the project’s first funding period, will be further evaluated during the second funding period of COMPASS-ELSI:

(1) Legal analysis

  • Closing the current research gap on the question of regulation of genome and epigenome editing, both on the somatic as well as on the germline level.
  • Evaluation of germline interventions according to European primary and secondary law and in the light of other international regulations.
  • Legal analysis of the concept of “disease.”
  • Evaluation of approaches for the introduction of a reproductive medicine law in Germany.

(2) Ethical analysis

  • Addressing the current research gap on the ethical evaluation of epigenome editing.
  • Evaluation of types of arguments that are used in the current ethical debate on (epi-) genome editing, such as safety arguments, and arguments from non-identity.
  • Reflection on the language used in current discourse on genome / epigenome editing, and on whether the language adequately reflects the technologies and possible applications in an ethically sensitive manner.
  • Ethical evaluation of regulatory proposals resulting from the legal analysis, especially for the regulation of germline genome editing.

(3) Recommendations

  • Preparation of ethical-legal recommendations for the regulation of genome and epigenome editing.
  • Dissemination of the project’s results.

Ethical Analysis

Heidelberg University
Medical Faculty
Heidelberg University Hospital
National Center for Tumor Diseases

Prof. Dr. med. Dr. phil. Eva Winkler
Research Associate: Karla Alex

Legal Analysis

University of Mannheim
Department of Law
Chair of Public Law, Law of Economic Regulation and Media

Prof. Dr. Ralf Müller-Terpitz
Research Associate: Ali Günes


Term: 2019–2023
Project number: 409799774
Project duration: 45 months

Prof. Dr. Emmanuelle Charpentier
Scientific and Managing Director, Founding Director Max Planck Unit for the Science of Pathogens
Max Planck Unit for the Science of Pathogens, Berlin

Prof. Dr. Hans-Georg Dederer
Chair for Constitutional and Administrative Law, Public International Law, European and International Economic Law
University of Passau, Passau

Prof. Dr. Rosario Isasi
Genome Quebec Innovation Centre
McGill University, Montreal

Prof. Dr. Nicole C. Karafyllis
Chair at the Philosophy Institute (Philosophy of Science and Technology)
Technische Universität Braunschweig, Braunschweig

Prof. Dr. Bartha M. Knoppers
Director of the Centre of Genomics and Policy, Faculty of Medicine, Human Genetics
McGill University, Montreal

Prof. Dr. Dirk Lanzerath
Executive Manager of the German Reference Centre for Ethics in the Life Sciences (DRZE)
University of Bonn, Bonn

Dr. Sebastian Schuol
Center for Applied Philosophy of Science and Key Qualifications
University of Erlangen-Nuremberg, Erlangen

Prof. Dr. Dr. Tade M. Spranger
Attorney-at-law and adjunct professor at the Faculty of Law with focus on Regulation of biomedicine and gene technology
University of Bonn, Bonn

Prof. Dr. Jörn Walter
Head of the EpiGenetics working group
Saarland University, Saarbrücken

Prof. Dr. Christiane Woopen
Head of the Cologne Center for Ethics, Rights, Economics and Social Sciences of Health
University of Cologne, Cologne

Epigenome Editing in medicine – preferable to Genome Editing? Scientific foundations, legal and ethical analysis, and international perspectives Public workshop of the project COMPASS-ELSI: “COMParative ASSessment of genome and epigenome editing in medicine: Ethical, Legal and Social implications”

Date & Time: Wednesday, 14 April, 2021, 1 pm – 6.15 pm (CEST/GMT+2)

Place: Zoom meeting & Marsilius-Kolleg Heidelberg, Germany, Im Neuenheimer Feld 130.1, 69120 Heidelberg. The workshop takes place as a hybrid meeting in-person and simultaneously online (as a zoom meeting). The online meeting is open to the public. Prior registration by a short email to karla.alex@med.uni-heidelberg.de and guenes@uni-mannheim.de is kindly requested. You will then receive the flyer with the zoom link.

Description: In contrast to the vigorous debate on ethical and regulatory aspects of genome editing, epigenome editing has rarely been discussed from an ethical or legal perspective. The project COMPASS-ELSI broadens the scope of this discussion. Within an ethical and a legal subproject, novel applications of gene editing tools such as CRISPR/Cas on the germline as well as on the somatic level are evaluated. The leading research question of COMPASS-ELSI is whether epigenome editing needs to be evaluated differently from genome editing. Furthermore, the project’s goal lies in initiating an ethical and legal debate on epigenome editing.  In this workshop, we will present results of our project and discuss them with experts from our international advisory board.

The workshop is organized by the project group at the Section Translational Medical Ethics, National Center for Tumor Diseases at Heidelberg University Hospital (Prof. Dr. Dr. Eva Winkler; Karla Alex), and at the Department of Law at University of Mannheim (Prof. Dr. Ralf Müller-Terpitz, Ass. jur. Ali Güneş).

We cordially invite everyone who is interested in discussing the implications of these novel gene technologies in natural sciences, in ethics and in law to join the event!


I. Introduction and Welcoming
1.00 – 1.10 pm: Eva Winkler, Heidelberg & Ralf Müller-Terpitz, Mannheim

II. Scientific Background (moderated by Dirk Grimm, Heidelberg)
1.10 – 1.30 pm: Genome Editing (Michael Boutros, Heidelberg)
1.30 – 1.50 pm: Epigenome Editing (Albert Jeltsch, Stuttgart)
1.50 – 2.10 pm: Time for questions & discussion
2.10 – 2.30 pm: Break

III. Legal Analysis (moderated by Ralf Müller-Terpitz, Mannheim)
2.30 – 3.00 pm: Regulatory aspects of genome and epigenome editing (Ali Güneş, Mannheim)
3.00 – 3.10 pm: Commentary (Hans-Georg Dederer, Passau)
3.10 – 3.30 pm: Time for questions & discussion
3.30 – 4.00 pm: Break

IV. Ethical Analysis (moderated by Eva Winkler, Heidelberg)
4.00 – 4.30 pm: Ethical aspects of genome and epigenome editing (Karla Alex, Heidelberg)
4.30 – 4.40 pm: Commentary (Christoph Rehmann-Sutter, Lübeck)
4.40 – 5.00 pm: Time for questions & discussion
5.00 – 5.15 pm: Break

V. Panel discussion on international aspects (moderated by Eva Winkler, Heidelberg & Ralf Müller-Terpitz, Mannheim)
5.15 – 6.15 pm
International view on the regulation and ethics of genome and epigenome editing
(Rosario Isasi, Miami; Yann Joly, Montréal; Dirk Lanzerath, Bonn; Jörn Walter, Saarbrücken)

Funding: German Research Foundation (DFG)


(Further information and abstracts upon request)


Alex K, Winkler EC (forthcoming): “Evaluating Human Epigenome Editing: Methods for Risk Assessment and Methodological Challenges for Bioethics.” 35th European Conference on Philosophy of Medicine & Health Care: Methods in Bioethics and Philosophy of Medicine, Riga (Latvia), 23. – 26.08.2023. https://www.espmh.org/

Alex K (01.03. + 05.07.2023): „Ethische Bewertung des genome editing am Menschen – Chancen und Risiken“ / Ethical evaluation of genome editing in humans – opportunities and risks. Talk at Regional teacher training course Gymnasium Baden-Württemberg, Biology, “Bewertungskompetenz am Beispiel der Genomeditierung der Keimbahn [mit Hilfe des CRISPR-Cas Systems]“ (Assessment competence using the example of genome editing of the germline [with the aid of the CRISPR-Cas system]), Heidelberg, BioQuant – also contribution to the conception of this course of continuing education for teachers in cooperation with Dr. Michaela Bollen (Zentrum für Schulqualität und Lehrerbildung Baden-Württemberg).

Winkler EC, Alex K, Herrmann M (12.01.2023): “Did He Jiankui harm Lulu and Nana and do stem cell researchers violate human dignity – bioethical debates.” Lecture as part of Core Competencies Week 2022 for M.Sc. Molecular Biosciences, Heidelberg University.


Alex K, Winkler EC (22.09.2022): “Vergleichende ethische Bewertung von Genom- und Epigenomeditierung als experimentelle reproduktionsmedizinische Technologien: Natürlichkeit, Personenbezogenheit, Vererbbarkeit“ / Comparative ethical evaluation of genome and epigenome editing as experimental reproductive technologies: naturalness, person affecting character, inheritability. Research retreat for early career researchers (BMBF): In-vitro-Gametogenese (IVG) und artifizieller Uterus (AU)  – Problemauslöser oder Problemlöser? – Ethische, soziale und rechtliche Aspekte zukünftiger reproduktionsmedizinischer Verfahren, Regensburg (Germany), 19. – 23.09.2022. Preprint of Abstract, see: http://dx.doi.org/10.13140/RG.2.2.30303.53928 (pp.1-3)

Alex K, Winkler EC (13.09.2022): “Does epigenome editing deserve similar consideration as genome editing within bioethics?” GAP.11 Philosophie & Öffentlichkeit (International conference of the German Society for Analytic Philosophy and Institute for Philosophy at HU Berlin), Berlin (Germany), 12. – 15.09.2022. https://gap11.de/en/programme.html#D

Alex K (08.09.2022): “Non-human primates, human embryos and genome editing research – A case study defining tasks for risk-benefit assessment in international animal research ethics.” Interdisciplinary European research retreat for young scholars (BMBF): Animal research ethics as interaction of research ethics, animal ethics and (animal protection) law. International perspectives on theoretical and cultural differences, Hannover (Germany), 05. – 09.09.2022.

Alex K, Winkler EC (02.07.2022): “Does epigenome editing deserve similar ethical consideration as genome editing?” Society for Applied Philosophy Annual Conference 2022, Edinburgh (UK), 01. – 03.07.2022. Abstract: https://www.appliedphil.org/wp-content/uploads/2021/09/SAP-Annual-Conference-2022_abstracts_final.pdf

Alex K, Winkler EC (16.06.2022): “Interdisciplinary Uncertainties: Comparative Ethical Analysis of Genome and Epigenome Editing.” Futures Ahead – Translations and collaborations between medicine, social science and the humanities, Conference at the Centre for Medical Humanities and Bioethics, Linköping University, Linköping (Sweden), 15. – 17.06.2022. Abstract: https://liu.se/dfsmedia/dd35e243dfb7406993c1815aaf88a675/58471-source/abstract-booklet-futures-ahead-2022

Alex K (23.05.2022): „Ausgewählte ethische Herausforderungen des Einsatzes der Genomeditierung am Menschen – mit einem Seitenblick auf das Recht der Reproduktionsmedizin“ talk at Regional teacher training course Gymnasium Baden-Württemberg, Biology,  “CRISPR-Cas – ein neues Zeitalter der gezielten Genomveränderung“ (CRISPR-Cas – a new era of targeted genome modification), Heidelberg, BioQuant.

Müller-Terpitz R (13.05.2022): “Fortpflanzungsmedizinrecht – quo vadis? Verfassungsrechtliche Anmerkung zu aktuellen Reformdiskussionen” Medizinrecht zwischen Unter- und Überregulierung: Tagung der deutschsprachigen Medizinrechtlerinnen und Medizinrechtler. München. Program: https://www.jura.uni-muenchen.de/fakultaet/lehrstuehle/spickhoff/medizinrechts-tagung/index.html

Alex K (26.03.2022): “Das Sterben überzähliger Embryonen – Überlegungen zu aktuellen Entwicklungen aus Sicht der Philosophie”/ The death of supernumerary embryos – thoughts on current developments from a philosophical viewpoint. Transmortale XI: Neue Forschungen zum Thema Tod. Program and registration: https://www.sepulkralmuseum.de/forschung/forschung-zur-sepulkralkultur/transmortale--neue-forschungen-zum-thema-tod:transmortale-xi.

Two presentations at a working group meeting of the German Academy of Ethics in Medicine (AEM), (AG Ethische Fragen am Lebensanfang):

Müller-Terpitz R (10.03.2022): „Aktuelle Entwicklungen im Recht der Reproduktionsmedizin“/ Current developments in reproductive medicine law

and: Alex K (10.03.2022): “Nicht-Identität und die Unsicherheit, wie Keimbahneingriffe ethisch und rechtlich zu bewerten sind oder Was kann aus dem nicht-personenbezogenen Verständnis der Keimbahn-Genom-Editierung für den ethisch-rechtlichen Diskurs abgeleitet werden und was nicht?“/ Non identity and the uncertainty how to evaluate germline genome editing ethically and legally or What can and cannot be concluded from the non-person affecting understanding of germline genome editing for ethical-legal discourse?


Mansuy I, Walter J, Winkler E (18.11.2021), Panel discussion: „Epigenetik – Die Sprache der Gene. Mit neuem Wissen gegen Erkrankung und Trauma?“/ Epicenetics – the language of genes. With new knowledge against disease and trauma? Berlin, Futurium. Recording available at: https://www.youtube.com/watch?v=TPsu9V14D20.

Alex K, Winkler EC (07.10.2021): „Vorschlag eines Modells zur ethischen Analyse von Epigenome Editing im Vergleich mit Genome Editing: Kernfragen und erste Antworten“/ Draft of a model for the ethical analysis of epigenome editing: guiding questions and first answers. Leopoldina-Symposium Geschichte, Theorie und Ethik der Humangenetik, Universität Düsseldorf. Program: https://www.uniklinik-duesseldorf.de/patienten-besucher/klinikeninstitutezentren/institut-fuer-geschichte-theorie-und-ethik-der-medizin/veranstaltungen/leopoldina-symposium-gte-humangenetik.

Two presentations at the Annual meeting of the German Academy for Ethics in Medicine (AEM) 2021: Die Zukunft der Menschlichkeit im Gesundheitswesen. Both abstracts and power point presentations available at: https://www.aem-online.de/index.php?id=50:

Alex K (24.09.2021): “Ethische Konzeptualisierung eines nachhaltigen Rechts auf Gesundheit und Gesundheitsversorgung”/ Ethical conceptualization of a sustainable right to health and to healthcare

and: Güneş A, Müller-Terpitz R, Winkler EC, Alex K (24.09.2021): „Genet(h)ik - ohne „Strangbruch kein Dammbruch“? Eine vergleichende Bewertung der Genom- und Epigenom-Editierung aus naturwissenschaftlicher, ethischer und juristischer Sicht“/ Genet(h)ics – without DNA break no slippery slope? Comparative assessment of genome and epigenome editing from a scientific, ethical and legal perspective.

Güneş A (14.04.2021): “Regulatory aspects of genome and epigenome editing.” DFG-Workshop Epigenome Editing in medicine – preferable to Genome Editing? (further information above under “Public Adivsory Board Workshop”).

Alex K (14.04.2021): “Ethical aspects of genome and epigenome editing.” DFG-Workshop Epigenome Editing in medicine – preferable to Genome Editing?” (further information above under “Public Adivsory Board Workshop”).

Alex K (08.03.2021): “Normative Methodik der Medizin- und Forschungsethik“/ Normative methods of medical ethics and of research ethics. Mini-presentation during a meeting of the Junge Medizinethik (JMED) of the German Academy of Ethics in Medicine (AEM).


Alex K (09.12.2020): “Ethical conceptualization of a sustainable right to health(care).” Understanding Value IX: Sheffield Postgraduate Philosophy Conference. Book of abstracts: https://understandingvalue.weebly.com/uploads/2/4/3/6/24368826/book_of_abstracts_website.pdf.

Alex K, Winkler EC (25.09.2020): “Ethische Fragen der Epigenom-Editierung: Kein Designerbaby, aber eine neu zu 'designende' ethische Debatte”/ Ethical issues of epigenome editing: no designer baby but a new ethical debate to be designed. Annual meeting of the German Academy for Ethics in Medicine (AEM) 2020: Ethische Fragen zu COID-19/Lebensqualität. Program available at: https://www.aem-online.de/index.php?id=50.


Alex K, Fischer L, Müller-Terpitz W, Wittbrodt J (10.11.2019), Panel discussion following the film “Human Nature: Die CRISPR Revolution.” Heidelberg, Gloria. Further information: https://www.gloria-kamera-kinos.de/film_show.php?flm_id=1948.

Winkler EC, Wiesemann C, Schleissing S, Wildermuth V (19.11.2019), Panel discussion: „Wie werden wir in 10 Jahren über Genom-Editierung denken?“/ How will we think about genome editing in 10 years? at “Genom-Editierung – (fast) natürlich? Dialogkonferenz: Die Genschere im gesellschaftlichen Diskurs.“ Federal Ministry of Education and Research (BMBF), Berlin. Further information: https://www.gesundheitsforschung-bmbf.de/de/Dialogkonferenz2019.php.

Schleidgen S, Müller-Terpitz R, Cantz T, Ott M (30.10.2019): „Verantwortbarkeit der (Ein-Generation)Keimbahntherapie?“/ Justifiability of (one-generation) germline therapy? At „(Re)Produktion und (Re)Kombination: Humane artifizielle Gameten und Genomeditierung in Ethik und Recht.“ Interdisciplinary Symposium of the German Federal Ministry of Education and Research (BMBF), Berlin.

Dingermann T, Dederer G, Fehse F, Flügge UI, Winkler EC (19.10.2019), Panel discussion: “Ethische und rechtliche Fragen der Forscher und Kliniker zum Genom-Editing bei Menschen, Tieren und Pflanzen”/ Ethical and legal questions by researchers and clinicians concerning genome editing in humans, non-human animals and plants at “9. Seminar Medizin auf dem Österberg: Ärztliche Entscheidungen in Grenzsituationen – Nutzen und Risiken der Gentechnik. Nahrungsmittel, Medikamente, Menschen.” Tübingen. Program: http://www.oesterberg-seminare.de/wp-content/uploads/2019/07/Programm_Medizin_2019.pdf.

Alex K, Winkler EC (18.09.2019): “A philosophical analysis of future generations’ impact on the value of healthcare: the case of genome and epigenome modifying therapy.” International conference for young scholars (BMBF): Defining the value of medical interventions. Normative and empirical challenges, Nuremberg/Fürth (Germany).

Alex K, Winkler EC 2022. “The mutual benefit of the integration of philosophy and bioethics – Our experience from an interdisciplinary research project on (epi-)genome editing” The American Journal of Bioethics 2022(12): 61–63. https://doi.org/10.1080/15265161.2022.2134488

Alex K, Rehmann-Sutter C. 2022. “Gibt es einen therapeutischen Imperativ zum genome editing in der menschlichen Keimbahn?” [Is there a therapeutic imperative for editing the human germline genome? / Existe-t-il un impératif thérapeutique à l’édition du génome dans la lignée germinale humaine] URPP Human Reproduction Reloaded | H2R (University of Zurich), Working Paper Series, 05/2022. Zurich and Geneva: Seismo, https://doi.org/10.33058/wpuzh.2022.8676

Alex K, Winkler EC. 2021. “Is Dupras’ and Bunnik’s Framework for Assessing Privacy Risks in Multi-Omic Research and Databases still too exeptionalist?” The American Journal of Bioethics 21(12): 80–82. https://doi.org/10.1080/15265161.2021.1991039

Alex KWinkler EC. 2021. "Ethischer Diskurs zu Epigenetik und Genom-Editierung: Die Gefahr eines (epi-)genetischen Determinismus und naturwissenschaftlich strittiger Grundannahmen." [Ethical discourse on epigenetics and genome editing: The danger of (epi-)genetic determinism and scientifically controversial basic assumptions]. In: B. Fehse, F. Hucho, S. Bartfeld, S. Clemens, T. Erb, H. Fangerau, J. Hampel, M. Korte, L. Marx-Stölting, S. Mundlos, A. Osterheider, A. Pichl, J. Reich, H. Schickl, S.Schicktanz, J. Taupitz, E. Winkler, M. Zenke (eds.), Fünfter Gentechnologiebericht: Sachstand und Perspektiven für Forschung und Anwendung [Fifth gene technology report: State of the art and perspectives for research and application]. Baden-Baden, Nomos, pp. 299-323. https://doi.org/10.5771/9783748927242  . English summary: https://www.gentechnologiebericht.de/fileadmin/user_upload/Webseitendateien/
Dokumente/BBAW_Broschuere_V-Gentechnologiebericht_PDF-A1b.pdf (pp. 69 f.).

Müller-Terpitz R. 2021. "Genforschung und Gentherapie im Zeitalter der Genom- und Epigenom-Editierung – welche rechtlichen Grenzen sind (noch) haltbar?" [Gene research and gene therapy in the age of genome and epigenome editing – which legal boundaries are (still) tenable?]. Wissenschaftsrecht 54 (2), pp.  225–253. https://doi.org/10.1628/wissr-2021-0016  .

Alex K. 2021. "Ethical conceptualization of a sustainable right to health(care)." In: Schildmann J, Buch C, Zerth J (eds.), Defining the value of medical interventions: Normative and empirical challenges. Stuttgart, Kohlhammer, pp. 28-48. Full text: https://www.ncbi.nlm.nih.gov/books/NBK585098/