Leader: Europäische Akademie GmbH
The driving force behind the ELSI-group of NanoDiaRA is the insight that though nanoparticles are endowed with enormous potential for medical innovation and economic revenue this technology bears also potential risks that may cause considerable social, ethical and legal problems. Questions related to research involving humans and animals, risks towards the environment, and possible moral boundaries of introducing nanotechnology to our life-world need in-depth discussion parallel to the basic research going on in the ﬁeld of nanoparticles.
The work package lead by the Europäische Akademie and consisting of eight members representing the major working areas of the consortium will draft an interdisciplinary memorandum on the social, ethical and legal aspects of applying nanotechnology for medical purposes. The experts will prepare a report on “the opportunities and risks of nanoparticles in diagnosis and therapy” based on their knowledge and expertise including the information from consumer groups and health departments. The report will then be published, giving recommendations to decision makers from governmental departments, industry and academia. Special attention will be paid to the ethical concerns of consumers and the way to handle and improve regulatory affairs in the companies. The consortium is well aware of the potential effect of functionalised nanoparticles on the human health but possible environmental consequences also have to be considered.
Further aspects of investigation deal with the determination of social acceptance of nanotechnological applications in medicine, the moral boundaries of introducing nanotechnology to our life-world, and the question of balanced legal regulation of research and application of nanotechnology. Though public concern about these issues cannot be overlooked, the scientiﬁc study of these risks is still in its infancy. Currently speciﬁc regulations governing the development, production and application of nanotechnology on humans do not exist and research institutes and companies have to adjust with regulations for chemical and/or pharmaceutical production. Therefore the consortium pays special attention to the possible impact of nanoparticles on humans and their environment both in the research phase as well as in the different in-vitro and pre-clinical applications. Special focus lies on the patient’s right to be informed of possible side effects. The ELSI-group will develop recommendations to politicians and decision makers in industry, research, education and to consumers about the consequences of the use and dissemination of nanoparticles in medical contexts. This aim includes developing acceptable and socially accepted recommendations for a long term reliable science and technology-policy for medical research and application of nanotechnology.