Abstract
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. Abiostatistician should be amember 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 (ICHE6 and ICHE9). 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.
Published Version
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