How can I determine whether research proposed in my application involves human subjects if I will only use human specimens (and/or cell lines, and/or data) for part of the project?
The research described in your application may include more than one research activity. Each research activity should be assessed independently to determine whether it meets the requirements for human subjects research, exempt human subjects research, or research that does not involve human subjects. The involvement of human subjects in your application is determined by the greatest involvement of human subjects in any single research activity. Examples are provided below to help you determine whether your proposed research involves human subjects. Human Subjects Research • If the specimens and/or data were obtained specifically for the currently proposed research project through intervention or interaction with a living individual, then your research is human subjects research. • If you receive or have access to individually identifiable specimens or data from living individuals (e.g., pathology or medical records), your proposed research is human subjects research. Exempt Human Subje
The research described in your application may include more than one research activity. Each research activity should be assessed independently to determine whether it meets the requirements for human subjects research, exempt human subjects research, or research that does not involve human subjects. The involvement of human subjects in your application is determined by the greatest involvement of human subjects in any single research activity. Examples are provided below to help you determine whether your proposed research involves human subjects. Human Subjects Research • If the specimens and/or data were obtained specifically for the currently proposed research project through intervention or interaction with a living individual, then your research is human subjects research. • If you receive or have access to individually identifiable specimens or data from living individuals (e.g., pathology or medical records), your proposed research is human subjects research. Exempt Human Subje
Related Questions
- Who, at my institution, is responsible for determining whether my proposed research involves human subjects but meets the criteria for one or more exemptions (46.101(b)) from regulatory requirements?
- How can I determine whether research proposed in my application involves human subjects if I will only use human specimens (and/or cell lines, and/or data) for part of the project?
- How and who will determine the proposed actrivity is human subjects research?
