Does Your Study Require IRB Review?

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  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 think that your study does NOT constitutes research involving human subjects, please complete a determination form and submit it to the IRB.

Research is:

 

Systematic Investigation

 

Typically predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory.  A scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or to answer a question.

  • INCLUDES: observational studies, interview or survey studies, group comparison studies, test development and interventional research
  • NOT SYSTEMATIC INVESTIGATIONS:  oral histories, journalism, phenomenological activities
  • GRAY AREA: Program Evaluation – need to assess design and intent

 

Generalizable Knowledge

 

The intent or purpose of the systematic investigation is dissemination of findings (publication or presentation) outside of OSU.

  • Intended to have an impact (theoretical or practical) on others within one’s discipline. 
  • Dissemination with the intent to influence behavior, practice, theory, future research designs, etc. are contributing to generalizable knowledge.[1]
    • CONSIDER: Would this project be conducted as proposed if the PI knew that he or she would never receive any form of academic recognition for the project, including publication of results or presentation of the project at an academic meeting?

If the activity would remain exactly the same, the project is likely NOT research.

A Human subject is:

 

A living individual about whom an investigator conducting research obtains:

  • Data through intervention or interaction with the individual, OR
  • Identifiable private information
    • 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

 

 

 

Additional Guidance:

Scenarios and Examples

Research Versus Program Evaluation Checklist

Engagement in Research decision tree 




[1] Colorado State University. http://ricro.colostate.edu/IRB/Documents/GeneralizableData.pdf. Accessed 01/06/2014.