Research Ethics and Research Ethics Committees in Europe

Abstract

In Europe, the topics of “research ethics” and “ethics committees” are becoming increasingly present in publications, university seminars, public debate, but also in connection with codes of conduct of companies or non-governmental organisations. The reasons for this are to be found in particular in the fact that technological developments are dramatically changing society and nature. This is because natural boundaries are being shifted or overcome, which raises the question of new moral boundaries in order to control or minimise the negative consequences or risks of the application of technologies. Morality thus becomes the “price of modernity” that societies have to pay through increasing dissolution of boundaries in the form of self-limitations. Ethical reflections structure this field of possible normative reorganisations and can contribute to opening up the attitudes of actors in order to articulate ethical self-obligations independently of legal regulations. For the field of science and research, an ethos of researchers would ideally emerge as a common scientific ethos before state-imposed legal regulations intervene to regulate. Currently, in addition to new methods, for example in genetic engineering (e.g., genome editing through Cripr-Cas9), the challenge posed by the coronavirus pandemic (e.g., development of drugs and vaccines against COVID-19), the focus is particularly on information technology research and innovations. Data collection, automation as well as robotic and autonomous systems based on AI are significantly changing not only biomedical research, but also medical practice and healthcare systems. Moreover, these developments are not selective or regionally limited, but rather encounter internationally linked societies. With a global view of the ethical debates, however, one also recognises different views of values and norms, which can vary in detail even within Europe despite many moral commonalities. This is already the case, for example, with the ideas about the appropriate handling of personal data. In addition to the ethical debates on new fields of research and their applications, a system of ethical consultation by ethics committees has been established worldwide within the scientific community for medical research. Against the background of abusive medical research, not only under the Nazi regime in Germany, the involvement of ethics committees is intended to ensure compliance with ethical standards. The importance of the work of ethics committees is not exhausted in the review of the protection of human participants who make themselves available for research purposes, but also represents a genuine contribution to stabilising the moral credibility of research. Ethics committees are therefore often also addressed as “intermediary institutions” between science and society, which contribute to social trust in research and contribute to the ethical infrastructure of a research institution. The procedures of ethical evaluations of research projects in Europe are increasingly expanding to other disciplines, guided by the example of ethics committees in medicine. In particular, when personal data are processed, for example in social science or psychological projects, funding organisations or publication bodies often consider ethical consultation to be appropriate. Nevertheless, the procedures for this are only uniformly regulated in a few European countries. In contrast, the instrument of the new EU regulation for clinical trials intends to standardise the work of medical research ethics committees in Europe through clear deadlines and a central electronic EU portal. However, since the European legislator has left the member states freedom of implementation with regard to the competence of the ethics committee, there will probably be differences between the procedures in the member states, especially with regard to the scope of the ethical review. The chapter gives an overview about this recent European debate in a global context.