What is meant by a human subject?
• data through intervention or interaction with the individual, or • identifiable private information. (Private information includes information such as medical records, blood, urine, or tissue samples, diagnostic specimens, and DNA samples, even if you did not collect these materials.) Legal requirements to protect human subjects apply to a broader range of research than many investigators realize. Protections are required for research that uses: • Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials. • Residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research. • Private information, such as medical information, that can be readily identified with individuals, even if the information was not specifically collected for the study in question. Research on cell lines or DNA samples that can be associated with individuals falls
