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CIBSS - Responsible Science and Technology

The Legal and Ethical Framework of Control-of-Function Research Technology

 

 

About

'Responsible Science and Technology - The Legal and Ethical Framework of Control-of-Function Research Technology' is a project under the auspices of the Centre for Integrative Biological Signalling Studies (CIBSS) at the University of Freiburg dealing with legal and ethical implications of control-of-function approaches.

The legal and ethical implications of control-of-function approaches at CIBSS differ according to the relevant field of research. They depend on the types of new technique and where the research is conducted. With regard to the legal framework of control-of-function approaches in plants and other living organisms it is not entirely clear whether and to what extent these are governed by existing rules of public international, European or national law. There are no specific rules of customary international law that regulate genome editing or genetic engineering. However, the European Court of Justice (Court of Justice of the European Union, Case C-528/16 - Confédération paysanne et al./. Premier ministre et al., Judgement of 25 July 2018) held that organisms whose genetic material has been modified by targeted mutagenesis are subject to the EU Release Directive 2001/18.

 

Aims

The aim of the project is - as a first step - to look closer at the legal basis, the normative frameworks, and the governance regimes that are applicable today to the different areas of control-of-function approaches pursued by researchers at CIBSS. This includes the critical reflection of current legal and ethical principles and approaches, as - inter alia - the so-called precautionary principle and the process-oriented EU-regulation. Besides, existing ethical standards and codes of conduct will be taken into account as important parts of control-of-function governance regime ( e.g. DFG and Leopoldina have enshrined principles of responsible research in a code of conduct since 2014 that are adopted by Universities in Germany, see Deutsche Forschungsgemeinschaft, Leopoldina - Nationale Akademie der Wissenschaften, Scientific Freedom and Scientific Responsibility, Recommendations for Handling Security-Relevant Research, 2014). Additionally, some experiments of the CIBSS control-of-function research might be covered by international and national rules concerning dual-use activities. It will be explored whether the international, the European and national legal framework are adequate to protect against relevant risks and what criteria may define "relevant" risks. 

After analyzing the advantages and shortcomings of the current legal and ethical regimes, the project shall - as a second step - develop guidelines that could form the basis of a future governance regime of responsible research with regard to the control-of-function approaches. As a precondition, these rules must not violate the freedom of science as a part of the German Basic Law (Art. 5 (3) Grundgesetz (GG)). However, the linkage to this constitutional right with other legal principles, as the precautionary principle, that forms the basis of European law and some international law treaties is not entirely clear and must be examined. Besides, (ethical) duties to carefully weigh the potential risks and the benefits of a research program must be linked to the freedom of science and other constitutional rights.

To achieve these aims, the risks and benefits of control-of-function approaches have to be taken into account, including their probabilities. Moreover, concepts of "responsible scientific research", as spelled out - inter alia - in current codes of conduct (mentioned above) and approaches of effective and legitimate governance - and their implementation - will be explored.

By looking for (new) guidelines and norms for a legitimate governance regime of control-of-function approaches different options will be discussed, as for instance the ways to encourage researchers to reconsider the potential benefits and risks of their research. Considering efficiency and the internationalization of research there should be an exchange whether and how rules should be adopted on a broader basis, be it regional or universal.

Additionally, the research project will form a basis to offer advice on the incorporation of ethical and legal aspects of biotechnology with regard to biosafety and biosecurity concerns into the curricula of graduate and undergraduate degree programmes, and to provide a platform to connect with the interested and engaged public in Freiburg.

 

Members of the Research Group

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Prof. Dr. Silja Vöneky 

Director Institute of Public International Law and Ethics of Law,

University of Freiburg

Phone: +49.761.203-2206

                     

 

 

Research Assistants

Elisabeth Andersen  Phone: +49.761.203-2243
Katharina Schreiber  Phone: +49.761.203-2243  
Gabriella Kinefss  Phone: +49.761.203-2243  

 

Current Research/PhD Projects

Andersen, Elisabeth: The EU regulation of gen-edited plants in light of WTO law (University of Freiburg)

Schreiber, Katharina: The applicability of the precautionary principle on new plant breeding techniques according to the ECJ judgement C-528/16 Confédération paysanne (University of Freiburg)

 

Third Party Funded Projects

Gutachten für den Deutschen Bundestag (TAB): Mögliche Anwendungen von Gene Drives im Vergleich mit alternativen Herangehensweisen, Prof. Dr. Silja Vöneky zusammen mit Dr. Guy Reeves (MPI für Evolutionsbiologie, Plön) et al., seit 06/2020

 

Presentations/Interviews

  • K. Schreiber, The current discussion on gen-edited crops in the EU, Lecture "Environmental and Energy Transition Law", Freiburg University, 12.01.2021
  • E. Andersen, A possible reform of the legal framework for genetically modified organisms in the EU, Work in Progress CIBSS, 30.11.2020
  • S. Vöneky, Ethics and Law I: Law and Molecular Biotechnologies, CIBSS Seminar, Freiburg University, 06.10.2020
  • S. Vöneky, Ein globaler Verhaltenskodex zur Biosicherheit - Grundprinzipien und Kernelemente, Dialogforum zum Biowaffenübereinkommen, Auswärtiges Amt, tba
  • E. Andersen, K. Schreiber, By Razor or by Chance: What a Court Decision Means for the Future of Plant Breeding, Interview about the CIBSS project, March 2020
  • E. Andersen, K. Schreiber, The CJEU's ruling on genome editing, Work in Progress CIBSS, 27.01.2020
  • S. Vöneky, Biotechnology, Biosecurity and the Global Order, Freiburg Institute for Advanced Studies, 08.01.2020
  • E. Andersen, K. Schreiber, Regulation of Genome Editing in the European Union, International Summer School - Universities of Freiburg, Nagoya, Straßburg, 18.09.2019
  • S. Vöneky, International Standards Setting in Biomedicine, Symposium: International law and Human Health, Kiel University, 27.09.2018
  • S. Vöneky, Evaluation and Impact of Existential Risk according to Public International Law, Cambridge Conference: Challenges of Existential Risk Research, 17.-18.04.2018, CSER, University of Cambridge/UK (Video)
  • S. Vöneky, Legitimate Governance of Existential Risk, Symposium: Human Rights, Democracy, and Legitimacy in the 21st Century, Harvard Law School, Cambridge/US, 04.05.2016

 

Selected Publications

  • S. Vöneky, International Standard Setting in Biomedicine - Foundations and New Challenges, GYIL 61 (2018), 131-151
  • S. Vöneky, F. Beck, Umweltschutz und Menschenrechte, in Proelß (ed.), Internationales Umweltrecht, 2017, 133-182
  • S. Vöneky, Das Recht der Biomedizin auf dem Prüfstand des EGMR - Grundrechtseingriffe und die Lehre vom weiten Beurteilungsspielraum des nationalen Gesetzgebers, MedR 32, 2014, 704-711
  • S. Vöneky, Recht, Moral und Ethik, in Puhl et al. (eds.), Leitgedanken des Rechts: Paul Kirchhof zum 70. Geburtstag, Heidelberg 2013, 333-350
  • S. Vöneky, Ethisches Expertentum und moralischer Autoritarismus, in Vöneky/Hagedorn/Clados/von Achenbach (eds.), Legitimation ethischer Entscheidungen im Recht - Interdisziplinäre Untersuchungen, Heidelberg 2009, 85-97

 

Contact

Institute of Public Law
Department 2 (Public International Law and Comparative Law) - Prof. Dr. Silja Vöneky
Werthmannstr. 4 
79098 Freiburg im Breisgau
Germany

Phone: +49.761.203-2206
Fax: +49.761.203-67683