USC booklet provides answers about human subjects research

The University of Southern California’s Office for the Protection of Research Subjects provides tips on how to identify human research studies in its booklet, “Is Your Project Human Subjects Research? A Guide for Investigators.” The booklet can be found on the university’s web site at www.usc.edu in the research section. Here is an excerpt from the booklet, reprinted with permission:

Studies that are not human subjects research

Studies that fit any of these categories below do not need IRB review.

  1. Data collection for internal departmental, school, or other university administrative purposes. Examples: teaching evaluations, customer service surveys.
  2. Service surveys issued or completed by university personnel for the intent and purposes of improving services and programs of the university or for developing new services or programs for students, employees, or alumni, as long as the privacy of the subjects is protected, the confidentiality of individual responses are maintained, and survey participation is voluntary. This would include surveys by professional societies or university consortia.
  3. Information-gathering interviews where questions focus on things, products, or policies rather than on 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.
  5. Biography or oral history research involving a living individual that is not generalizable beyond that individual.
  6. Independent contract for procedures carried out for an external agency. Examples: personnel studies, cost-benefit analyses, customer satisfaction studies, biological sample processing (for a fee and not authorship or credit), public park usage, IT usage.
  7. Research involving cadavers, autopsy material, or other bio-specimens from deceased individuals, do not require IRB review and approval.
  8. Innovative therapies do not require IRB review and approval except when they involve “research” as defined by the above criteria.
  9. Quality improvement projects are generally not considered research unless there is a clear intent to contribute to generalizable knowledge and use the data derived from the project to improve or alter the quality of care or the efficiency of an institutional practice.
  10. Case histories which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a single patient and do not contribute to generalizable knowledge.
  11. Publicly available data to analyze public figures does not require IRB review.
  12. Specimens and data sets (Secondary Data Analysis) that were not collected specifically for the currently proposed research study and the subjects are not identifiable do not require IRB review and approval. If the data set contains identifiers (either direct or link code numbers) but the investigator will not/does not have the code, then the study is not human subjects research.