The global aim of medical ethics committees is to judge the scientific quality and the integrity of the content of medical research projects (studies), thereby assessing the benefit-risk profile. Apart from judging content-related aspects and the legal correctness, the study design and the analysis strategy must also be assessed from a biostatistical point of view. This very sophisticated task is further complicated by the fact that medical research constantly faces new challenges.Within this work, current developments in medical research that directly impact the assessability of ethical proposals will be identified and discussed. The aim is to sensitize researchers to the opportunities and challenges of new developments.The work focusses on the topics of digitalization in the healthcare system and individualized medicine. The authors illustrate some problems resulting from these developments that affect the ethical justification of medical research projects. Problems related to medical as well as biostatistical aspects are presented and their direct implications on the legal justification and ethical and moral conceptual integrity are highlighted.New developments in medical research such as digitalization and individualized medicine offer new perspectives for optimized therapies. These promising developments must be further advanced. A critical view on the so far only poorly investigated consequences of embedding new data sources and study designs must urgently accompany this process. Transparency and clarity in formulating ethical proposals is thereby of utmost importance.
Keywords: Digitalization; Individualized medicine; Medical progress; New data sources; New study designs.