When does research with human specimens, cells, cell lines, or data involve human subjects?
In order for research with human specimens, cells, cell lines, or data to involve human subjects, 1. The specimens, cells, or data: • Must be or must have been obtained from individuals who are alive; AND • Must be or must have been obtained by an investigator conducting research AND 2. The investigator EITHER: • Must be obtaining or must have obtained specimens, cells, or data through interaction or intervention with living individuals; OR • Must be obtaining or have obtained individually identifiable private information. IF providers of coded human specimen, cells, cell lines or data: • Obtained or will obtain the specimens or data, AND • Can link the specimens or data to living individuals, AND • Will also collaborate on other activities related to the conduct of a proposed research project with the investigators who obtain the specimens or data; THEN both the providers and recipients will be considered to be involved in the conduct of the research and are conducting human subjects
Related Questions
- What are examples of research involving human specimens, cells, cell lines, or data that would not be considered human subjects research under HHS regulations at 45 CFR Part 46?
- What are examples of research involving coded human specimens, cells, cell lines, or data that is not human subjects research?
- When does research with human specimens, cells, cell lines, or data involve human subjects?
