Be aware that Title 45 Code of Federal Regulations Part 46; defines a “human subject” as a living individual about whom an investigator obtains:
1. data through intervention or interaction with the individual, (such as, interviews, surveys, clinical testing, or any other physical intervention or personal interaction), or,
2. identifiable private information.
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 fall into this category.
Please visit the Office of Human Subject Research Protection for more information.