Studies That Are Not Human Subjects Research

Studies that fit any of the categories below typically 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. Note: If at a future date, an opportunity arose to contribute previously collected identifiable or coded survey data to a new study producing generalizable knowledge; IRB review may be required before the data could be released to the new project.
  3. Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Examples: canvassing librarians about their libraries’ inter-library loan policies or periodical purchases or interviews with company engineers or managers about how a product is made.
  4. Course-related activities4  designed specifically for educational or teaching purposes, where data are collected as part of a class exercise or course requirement, but are not intended for use outside of the classroom. Note: Review the Guide for Human Subjects Research under Chapter 9, Course Related Student Projects for the seven criteria that must be met for this condition to be applicable.    If you have any question as to whether or not your project meets this definition, contact the HSO at prior to beginning the project.      
  5. Biography research involving a living individual that is not generalizable beyond that individual. 
  6. Research involving cadavers, autopsy material or biospecimens from now deceased individuals. Note: Some research in this category, such as genetic studies providing private or medical information about live relatives, may need IRB review. Please contact the IRB for further information.
  7. Innovative therapies except when they involve "research" as defined by the above criteria. (An innovative clinical practice is an intervention designed solely to enhance the well being of an individual patient or client. The purpose of an innovative clinical practice is to provide diagnosis, preventative treatment, or therapy to particular individuals, or when the innovative therapy is investigational.) Note: When innovative therapies differ significantly from routine practice it should be viewed and treated as such with appropriate safeguards in place to protect the rights and welfare of the patients.
  8. 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. Any individual who is unsure whether or not a proposed quality improvement project should be classified as research should contact the IRB for guidance. If the data are re-examined or re-analyzed and new information surfaces that would contribute to generalizable knowledge, an application must be submitted to the IRB.
  9. 9. Case history or Case Study 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 three or fewer patients and do not contribute to generalizable knowledge.  Note: Investigators should contact the IRB if they are uncertain as to whether or not they are contributing to generalizable knowledge.
  10. Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
  11. Coded private information or biological specimens that were not collected for the currently proposed projects do not need IRB review as long as the investigator cannot link the coded data/specimens back to individual subjects. If the data/specimen provider has access to the identity of the subjects (e.g. subjects’ names, addresses, etc.), the investigator must enter into an agreement with the data/specimen provider that states under no circumstances will the identity of the subjects be released to the investigator. Note: Investigators can not independently make this determination. These projects require verification from the IRB Chair or their designee. (
  12. Some examples of Non-Engagement in Research include: when an institution’s employees or agents act as consultants on research but at no time obtain, receive, or possess identifiable private information, perform commercial services for the investigators, or inform prospective subjects about the availability of research. Note: the examples above are not an all inclusive listing.(

Course work as part of a Master’s Theses, Dissertation, or other Honor’s Program would not fall under this category.