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New technological developments surrounding CRISPR-Cas9 have increased hopes that many illnesses might be prevented or cured successfully in the future using genome editing (GEEN) procedures. CRISPR-Cas9 allows to deactivate certain DNA-sections and thereby change the functioning of (possibly defect) genes at less costs and with less complications than any preceding GEEN technology. Moratoria have so far prohibited most germline interventions of GEEN technology as resulting changes might be passed down to the next generation. However, these moratoria do not include applications of GEEN technologies to somatic human cells who are not relevant for procreation. It is therefore to be expected that genome editing of somatic cells will be increasingly deployed and examined in clinical studies and so called “Heilversuchen”. Existing ethical and legal frameworks will have to interpreted for the specificities of these applications.

Accordingly, in subproject 1, we will develop a tool for risk-benefit assessment of somatic cell applications of GEEN technology based on conceptual-normative and practice-oriented analyses. The tool will be evaluated and possibly refined based on expert interviews. The tool should be able to support relevant actors in assessing the risks and benefits of studies in the GEEN context in a structured and systematic way.

In subproject 2, we focus on how valid informed consent of patients and participants can be ensured in these kinds of applications of GEEN technology. This is complicated by the high degree of uncertainty that characterises these types of intervention. Specifically, we want to develop recommendations and possibly templates for informed consent documents for studies involving genome editing of somatic human cells. To arrive at recommendations, we plan to employ Delphi-methods.

Subproject 3 is dedicated to evaluating from a conceptual-legal perspective existing regulatory institutions and governance structures relevant to genome editing in Germany. It is planned to analyse the interdependency of various regulatory regimes (e.g. governmental and non-governmental actors like legislating bodies, ministries and ethics commissions) and assess whether GEEN technology applications to somatic human cells are adequately captured by existing national law.

This research project is conducted jointly with researchers from Hannover Medical School and Leibniz University Hannover. The project receives financial support from the Federal Ministry of Education and Research.


  • Prof. Dr. Dr. Daniel Strech

    Head of research group | Deputy Director QUEST Center

    Contact information
    Phone:+49 30 450 543 068