What are examples of research involving coded human specimens, cells, cell lines, or data that is not human subjects research?
Research that involves only coded human biological specimens or coded private information/data from living individuals is not human subjects research under the HHS human subjects regulations (45 CFR Part 46) if: (1) the specimens, cells, cell lines or private information/data were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and (2) the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example: (a) the key to decipher the code is destroyed before the research begins; (b) the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement); (c) there are IRB-approved written policies and operating pr
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?
