[The role of biostatistics in institutional review boards].

Research in humans is associated with risks. These risks are only justifiable if an independent institutional review board (IRB) has evaluated the planned research in terms of scientific integrity. Only scientifically sound research can be considered ethical. A biostatistician should be a member of the IRB to assure adequate evaluation of fundamental topics like design, sample size estimation, and statistical analysis of the study.This paper presents core biostatistical concepts following the current guidelines of the International Council of Harmonization (ICH E6 and ICH E9). We discuss important pitfalls based on examples from published clinical trials. Furthermore, we discuss new concepts like estimands and their relevance for biostatisticians working in IRBs. Finally, we discuss the role of biostatisticians in IRBs and present thoughts on the way they should be trained.