Session 4: Protection of Human Subjects

Although DBS specimens are not traditionally considered human subjects, proposals have been made for broader protection of human research. This webinar covers federal regulations regarding research done with human subjects, how to identify this research, how to determine if the research is exempt from review, and what it means for an institution to be engaged in research. Michigan is used as an example demonstrating their consideration of these processes, and the formation of the Michigan BioTrust for Health. The Michigan BioTrust declared that residual DBS could be used for research, that this research was not human subject research, and established the importance of an informed consent process for research with samples.