Rahmenbedingungen einer Forschungsethik der datenintensiven medizinischen Forschung

The research and regulatory levels for data-intensive research in medicine are divergent. This results in a heterogeneous global field of regulating institutions with regionally unequal regulations, both in terms of the depth and restrictiveness of regulations. Despite or precisely because of the lack of globally binding regulation, nonbinding or only partially binding normative guidelines can also serve as orientation. But how should such normative regulation be designed in view of data-intensive research in medicine and what should it be based on?

The question of how concrete and in detail such research should be regulated can only be answered on a case-by-case basis for specific situations and institutions. Whether new norms or weightings of norms should be introduced, or whether the norms and their weightings should remain in place, can only be answered with reference to strong normative arguments. So far, there is a lack of compelling arguments in favour of new standards in view of data-intensive medical research. However, it is always necessary to translate norms, whether new or old, and apply them to a new method or technology. As in the past, both established and transparently communicated standards and an independent judgement on the application of these standards are therefore required.

In view of their particular suitability for this task, ethics committees should continue to be required and qualified as a procedural authority in the approval of data-intensive research in medicine; as an independent institution, they should make a judgement appropriate to the individual case on the basis of existing norms and standards. However, the changing practices of data-intensive research projects can also be reflected in new demands on research ethics committees, which should be addressed with reforms of their operating mode.