When do I need IRB approval?
IRB review is required when the research involves human subjects. Human subjects can be people, human specimens (such as embryos), or data in which the subject’s identity is known or can be readily ascertained. Examples of human subjects research include:
- Interactions with living individuals, such as discussions with potential gamete donors. These interactions include the transplantation of human cells or test articles, such as differentiated cells derived from human embryos or human fetal tissue, into human recipients;
- Clinical research involving use of cells or test articles regulated by the Food and Drug Administration, such as drugs, devices, and biological products;
- Human cell lines where the donor(s) may be identified, including cells that retain links (such as a code).
If sponsors require verification that the research is not human subjects research, PIs must at the very least complete a Human Subject’s Division (HSD) form called the “Biological Specimens Determination” form. This form allows the HSD to make a formal determination that the project is not research involving human subjects. The Biological Specimens Determination Form is documentation that the researcher can then use for his or her funding source, regulatory bodies, etc.