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

Prof. Dr. Silja Voeneky (CIBSS-AI), Institute for Public Law, Dep. 2 – International Law, Comparative Law and Ethics of Law, University of Freiburg

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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 the new technique and where the research is conducted. With regard to the legal framework for control-of-function approaches in plants and in 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., Judgment 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.

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 conducts will be taken into account as important parts of a 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, Deutsche Forschungsgemeinschaft, Leopoldina – Nationale Akademie der Wissenschaften, Scientific Freedom and Scientific Responsibility, Recommendatons for Handling Security-Relevant Research, 2014). Additionally, some experiments of the CIBBS 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 or 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 of 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 conducts (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 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.