Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  Activities which meet all three of the elements of this definition constitute research.  A project requires IRB review if it includes both research and human subjects.

Research is:

 

1. Systematic

 

A systematic investigation is an activity that involves a prospective study plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a study question.  These investigations implement or utilize specific methods of inquiry or data collection that are repeated with multiple participants.  Methodology alone does not determine the need for IRB 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.

 

2. 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.  Examples that would not be seen as dissemination outside of the University include: presentation to a department in fulfillment of a university requirement; sharing results with the sponsor or a collaborator; or student presentations to a class or campus organization. Pilot studies require IRB review because the intent is to "develop".

 

3. 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, inform policy, or be analyzed for predictive value.

A Human subject is A living individual about whom an investigator (whether professional or student) conducting research obtains:

 

• Data through intervention or interaction with the individual, or

• Identifiable private information

 

 

Examples

 

 Examples of projects likely to be viewed as research involving human subjects

• Anonymous, online surveys when the results are intended for dissemination via thesis, dissertation, publication, etc.

• Use of incoming samples or data if individually identifiable and collected for current study

• Studies involving observation and/or recording of public behavior

Examples of projects not likely to be viewed as research involving human subjects

• Case studies (N=1)

• Use of publicly available data sets (e.g. census data)

• Class projects

A project requires IRB review if it includes both research and human subjects. The IRB must make the final determination of whether or not a study requires review.  If you do not think that your study constitutes research involving human subjects, please complete a determination form and submit it to the IRB.