Introduction
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Research Activities That Require IRB Review
The term "human subject research" covers a broad range of activities. The following list provides a few examples of research that requires IRB review.
- The use of human beings as subjects to test devices, products or specimens developed through research. Activities might include hardware (human-machine interface) or software usability evaluation where privacy or job performance might be impacted or assessed, or evaluation of medical devices or experimental or licensed pharmaceuticals.
- Private information that can be readily identified with individuals or their families, even if the information was not collected for the study in question, such as employment, radiation exposure, medical, or legal records or biological specimens. Information is considered "private" if the individual can reasonably expect it not to be made public or if the information concerns behavior that the individual can reasonably expect not to be observed or recorded.
- Studies conducted to gain knowledge that can be generalized about categories or classes of human beings, such as oral history projects, DOE workers, or culturally diverse populations.
- Human beings to evaluate environmental or ergonomic alterations such as the effects of lighting options on productivity.
- Data collected through intervention or interaction with human beings such as drawing blood, breath analysis, or X-rays; interviews or web-based surveys, video or audio taping (for the purpose of research and generalizable scientific knowledge where the results will be published).
- Traditional biomedical and clinical studies, including genetic research or analysis of private data or human specimens provided by other researchers or institutions.
- Biological Specimens Derived from Humans, including organs, tissues, biofluids, (e.g., urine, blood, blood products) specimens, (e.g., skin, hair, teeth) cells or cell lines (e.g., primary or established cell cultures); sub-cellular (e.g., organelles) or molecular (e.g., DNA, RNA, protein) constituents.
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October 2007