Systematic Investigation: Utilization of specific methods of inquiry or data collection that are repeated with multiple participants. Methodology alone does not determine the need for IRB review.

Designed to Develop or Contribute: The investigator intends to disseminate results to those outside of the University via the web, poster presentations, conferences, library placement, or publication. Pilot studies require IRB review because the intent is to "develop" a subsequent study that is designed to contribute to generalizable knowledge.

Generalizable Knowledge: Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions. Knowledge gained may be applied to populations outside of the specific study population, used to inform policy, or be analyzed for predictive value.

About: In order for research to involve a human subject, data collected must be about them. Data is about an individual whenever it includes information based in behavior, opinion, attitude, or perception.

Intervention: Includes physical procedures by which data are gathered and manipulations of the subjects or the subjects’ environment that are performed for research purposes.

Interaction: Includes communication or interpersonal contact between investigator and subjects. The interaction may be as remote as an anonymous, online survey.

Individually Identifiable: The identity of the subjects is or may be readily ascertained by the investigator or associated with the information.

Private information: Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects. Identifiable individuals may include third parties.