Minimal Risk and Large-Scale Biobank and Cohort Research

Introduction Minimal risk is a core concept in research ethics, but its proper role in the regulation of large-scale biobank and cohort research is unsettled. By framing a project as posing only minimal risk to research participants, researchers may be afforded a degree of latitude in the design and implementation of consent procedures. In the context of large-scale population biobank and cohort studies, whether and to what degree of specificity one is required to seek informed consent from study participants is a critical issue. (1)