“…4,5 The formal definition of minimal risk in biomedical research is ''risks ordinarily encountered in daily life.'' 6 Although there are examples of minimal-risk research, the definition is again vague, 7 with local institutional review boards (IRBs) given the ultimate responsibility for interpretation, resulting in substantial disagreement, confusion, and variability in the application of federal guidelines. 1 The IRB Guidebook provides several benchmark examples of minimal research procedures, including venipuncture.…”