Remnant Blood Quantification: Informing the Definition of Minimal Risk in Clinical Research.

Guidelines from the Office for Human Research Protections regarding categories of research that institutional review boards (IRBs) may review through expedited procedures limit the volume of blood that can be obtained from research participants for minimal risk research purposes. As defined by the Common Rule, minimal risk research is research in which the probability and magnitude of harm or discomfort anticipated are not greater than the probability and magnitude of harm or discomfort encountered from routine clinical tests. For this study, we considered the volume of remnant blood following routine clinical tests in light of the current definition of minimal risk in research.