Does My Project Constitute Human Subjects Research?

Please review the below information to help you determine if your project meets the definition of human subjects research and therefore needs ERB approval. Please see the Project Determination Form for full details on human subjects research and appropriate review levels.

Definition: Research is a systematic investigation designed to develop or contribute to generalizable knowledge. In order to be considered research, the project must meet each of the three components of the definition.

Systematic: The implementation or utilization of specific methods of inquiry or data collection that is repeated with multiple participants. Methodology alone does not determine the need for ERB review. More often than not, methods used in research (such as interviews or blood draws) are employed for reasons having nothing to do with research.

Designed to develop or contribute: Intent to disseminate results to those outside of the College via the web, poster presentations, conferences, library placement, or publication. Examples that would not be seen as dissemination outside of the College include: presentation to a department in fulfillment of a college requirement; sharing results with the sponsor or a collaborator; or student presentations to a class or campus organization.

Generalizable knowledge: Examples of generalizable knowledge include: conclusions are drawn from the data; results are analyzed for predictive value; results can be applied to a larger population (i.e., applicability is not limited to the participants).

If your project meets each of these three definitional components, then your study constitutes research. Now, you must determine if your study also constitutes research with human subjects. If your project meets all three components of the definition below, then your study also constitutes human subjects research.

Definition: Human subject means a living individual about whom an investigator conducting research obtains: (1) Data through intervention or interaction with the individual, OR (2) Identifiable private information.

Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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 (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. Identifiable individuals may include third parties.

Please contact the ERB via the MCU messaging system (preferred) or via email at erb@midwifery.edu if you need clarification or assistance.

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