In yesterday's post, I mentioned USC's booklet, "Is Your Project Human Subjects Research? A Guide for Investigators.
The bad news about this booklet is that it makes the false claim that "Federal regulations do not allow investigators to make this determination [of whether they are conducting human subjects research] themselves."
The booklet does so in an odd context. The full passage reads:
Certain studies may have the characteristics of human subjects research but may not meet the regulatory definition. Studies which meet the definition require IRB review. There are three categories to be considered:
Any investigator who is unsure of whether his/her proposal constitutes "human subjects research" should contact the IRB office or submit an online "Request for Human Subjects Research Determination" through iStar (http://istar- chla.usc.edu). The IRB staff, Chair and/or designee will determine if the study is human subjects research. Federal regulations do not allow investigators to make this determination themselves.
- studies that are human subjects research
- studies that may be considered human subjects
research (gray area)
- studies that do not qualify as human subjects research
This passage not only ends with a falsehood; it is internally inconsistent. If USC really believes that regulations forbid researchers from determining if their projects constitute human subjects research, it is not "any investigator who is unsure" who should contact the IRB office, but rather any investigator, period, even those who will never conduct human subjects research.
The good news about the USC booklet is that it lists several categories that do not need IRB review. Among them:
3. Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Example: canvassing librarians about inter-library loan policies or rising journal costs.
4. Course-related activities designed specifically for educational or teaching purposes, where data is collected from and about human subjects as part of a class exercise or assignment, but are not intended for use outside of the classroom. Example: instruction on research methods and techniques. Note: The IRB is only required to review studies that meet the Federal definitions of research and human subject, or "engaged in research".
5. Biography or oral history research involving a living individual that is not generalizable beyond that individual.
Unfortunately, while the University of Iowa decided to copy almost all the text of the USC document for its booklet, "Do I need IRB Review? Is This Human Subjects Research? A Guide for Investigators," the Iowa version deletes "or oral history."
So oral history and biography are both free of IRB constraints at USC, but only biography at Iowa.