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: 2019–2021

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.

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: 2019–2021
Project duration: 31 months
Project number: 409799774

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)

Alex K, Winkler EC. “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, 16.–20.09.2019, Nuremberg/Fürth.

Dingermann T, Dederer G, Fehse F, Flügge UI, Winkler EC. „Panel-Diskussion: Ethische und rechtliche Fragen der Forscher und Kliniker zum Genom-Editing bei Menschen, Tieren und Pflanzen.“ 9. Seminar Medizin auf dem Österberg: Ärztliche Entscheidungen in Grenzsituationen – Nutzen und Risiken der Gentechnik. Nahrungsmittel, Medikamente, Menschen (“Panel discussion: Ethical and legal questions by researchers and clinicians concerning genome editing in humans, non-human animals and plants.” 9. Seminar auf dem Österberg: Medical decision making in difficult situations – Benefits and risks of gene technology. Food, pharmaceuticals, persons), 19.10.2019, Tübingen.

Schleidgen S, Müller-Terpitz R, Cantz T, Ott M. „Verantwortbarkeit der (Ein-Generation)Keimbahntherapie?“ (Re)Produktion und (Re)Kombination: Humane artifizielle Gameten und Genomeditierung in Ethik und Recht. Interdisziplinäres Symposium (“Justifiability of (one-generation) germline therapy?“ (Re)Production and (Re)Combination: Human artificial gametes and genome editing in ethics and law. Interdisciplinary symposium), Federal Ministry of Education and Research (BMBF), 30.10.2019, Berlin.

Alex K, Fischer L, Müller-Terpitz W, Wittbrodt J. Panel discussion following the film “Human Nature: Die CRISPR Revolution,” 10.11.2019, Heidelberg, Gloria.

Winkler EC, Wiesemann C, Schleissing S, Wildermuth V. „Wie werden wir in 10 Jahren über Genom-Editierung denken?“ Genom-Editierung – (fast) natürlich? Dialogkonferenz: Die Genschere im gesellschaftlichen Diskurs (“How will we think about genome editing in 10 years?” Genome editing – (almost) natural? Dialogue Conference: Gene scissors in societal discourse), Federal Ministry of Education and Research (BMBF), 19.11.2019, Berlin.

Alex K, Winkler EC. "Ethische Fragen der Epigenom-Editierung: Kein Designerbaby, aber eine neu zu 'designende' ethische Debatte." Jahrestagung der Akademie für Ethik in der Medizin, 24.-25.09.2020, online.

Alex K. "Ethical conceptualization of a sustainable right to health(care)." Understandning Value IX: Sheffield Postgraduate Philosophy Conference, 09.-11.12.2020, online.

Alex K. “Ethical aspects of genome and epigenome editing.” DFG-Workshop Epigenome Editing in medicine – preferable to Genome Editing?, 14.04.2021 (Heidelberg), online.

Güneş A. “Regulatory aspects of genome and epigenome editing.” DFG-Workshop Epigenome Editing in medicine – preferable to Genome Editing?, 14.04.2021 (Heidelberg), online.

Alex K. “Ethische Konzeptualisierung eines nachhaltigen Rechts auf Gesundheit und Gesundheitsversorgung.” Jahrestagung der Akademie für Ethik in der Medizin, 22.-25.09.2021 (Erlangen, Nürnberg), online. Abstract: https://www.aem-online.de/index.php?id=167#c812 .

Güneş A, Müller-Terpitz R, Winkler EC, Alex K. “Genet(h)ik - ohne ‚Strangbruch kein Dammbruch‘? Eine vergleichende Bewertung der Genom- und Epigenom-Editierung aus naturwissenschaftlicher, ethischer und juristischer Sicht.” Jahrestagung der Akademie für Ethik in der Medizin, 22.-25.09.2021 (Erlangen, Nürnberg), online. Abstract: https://www.aem-online.de/index.php?id=167#c813 .

Alex K, Winkler EC. “Vorschlag eines Modells zur ethischen Analyse von Epigenome Editing im Vergleich mit Genome Editing: Kernfragen und erste Antworten” Leopoldina-Symposium Geschichte, Theorie und Ethik der Humangenetik, 07.10.2021, Universität Düsseldorf. https://www.uniklinik-duesseldorf.de/patienten-besucher/klinikeninstitutezentren/institut-fuer-geschichte-theorie-und-ethik-der-medizin/veranstaltungen/leopoldina-symposium-gte-humangenetik.

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, Winkler EC (forthcoming). "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: Berlin-Brandenburg Academy of Sciences and Humanities, Interdisciplinary Research Group Gene Technology Report (ed.), Fünfter Gentechnologiebericht [Fifth Gene Technology Report]. Baden-Baden, Nomos.

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, 2021, pp. 28-48. Abstract: https://philpapers.org/rec/ALEECO-5 .