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From exclusion to inclusion : improving clinical research in vulnerable populations ; memorandum
(2014)
Therapeutic care for vulnerable populations – meaning patient groups such as underage children and the mentally ill that have limited or no capacity for giving informed consent – is severely lacking. Thus, for example, a great portion of pharmaceuticals used in the treatment of children and youth have not been specifically designed for these groups, which often results in side effects that are disproportionate to those associated with such medicines when used by adults. Moreover, vulnerable populations are at times faced with having no therapies at all for some of their ailments, such that children and dementia sufferers, for example, are often considered to be “therapeutic orphans”. It is therefore urgent that clinical research be carried out among vulnerable populations in order to improve their therapeutic possibilities. The Clinical Research on Vulnerable Populations Research Group – a cooperative effort between the Berlin-Brandenburg Academy of Sciences and Humanities (Berlin, Germany) and the European Academy of Technology Assessment (Bad Neuenahr, Germany) – has set itself the task of analyzing the state of clinical research on vulnerable populations so as to be able to develop suggestions for improving future research of this kind. The results of this work are presented in the following memorandum, which seeks to portray the state-of-the-art in this domain while also assessing the strengths and weaknesses of contemporary ethical and medical perspectives related to it. The memorandum is primarily oriented towards those in the relevant scientific disciplines who can benefit from obtaining an informed consensus regarding the current state of the discussions taking place around this topic.
New, precise genetic engineering methods for genome alteration in living cells, which can be classed together under the generic heading “genome surgery”,are currently sparking a revolution in biomedical research. The Interdisciplinary Research Group Gene Technology Report is, in principle, in favour of research on these promising new methods for the medical sector. However, for the time being, it has clearly spoken out against gene surgery experiments on the human germ line, which could also enter the realm of possibility thanks to these methods.The research group, therefore, supports the call, which has already been discussed at length in scientific and public circles, for a moratorium for germ line experiments. The period of the moratorium should be used to debate the experimental,
ethical and legal aspects of germ line therapy in an open, transparent
and critical manner with a view to more clearly defining the opportunities and
risks of these technologies for man and nature, and to elaborating recommendations for future regulations. The goal of this analysis is to promote a discourse of this kind.
Single-cell analyses comprise a multitude of analytical methods that share a common feature, namely the focus on individual cells. This is in contrast to previous methods that provided summarized data for cell clusters, groups of cells, tissues and organs. The new field offers huge potential not only for basic research, but also for medical and biotechnological applications, as it opens up new levels in the context-related and personal interpretation of biological interconnections. This brochure on single-cell analysis provides an overview on the new possibilities from the viewpoint of developmental biology, biomedicine and bioinformatics, but also addresses possible social im-plications and consequences.