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Human Subjects Division (HSD)

Quick Tips from HSD

Student Research?

Mar 16, 2012 at 12:00am

In our February issue, Quick Tips discussed student research projects involving human subjects that do not need to go through the HSD/IRB process.  Now we'll talk about student research that DOES need HSD/IRB review.

A student researcher recently visited HSD Quick Tips with a timely request.  She waved around an inch-thick document while she tried to catch her breath.

        "Help! This is my master's thesis proposal.  My best friend is in my department and she told me that she didn't need to go through the HSD/IRB process for her thesis project.  So I thought I didn't have to either.  But my faculty advisor just told me that he thinks I do need IRB review."

      "Now I'm really worried, and I'm so confused!  He told me I have to figure it out before I present my proposal to my thesis committee tomorrow!"

      "Don't worry," Quick Tips replied, "we can figure it our right now.  There are just a few key things involved.  Why don't you start by giving me an overview of your project?"

The student began describing her intent to administer surveys to parents of third grade students at a local school in an effort to show that reading to their children each night raises their overall achievement scores.  Then she started describing the statistical methods she planned to use...

      "That's fine, thanks." Quick Tips interrupted. "The key issue for most student projects is the intent of the project.  Specifically, are the results intended to be generalizable?  Almost all thesis and dissertation projects are intended to be generalizable.  I bet your friend's project was one of the rare exceptions."

The federal and University definition of human subjects research is based on a couple of key concepts.  one of them is that the project is "designed to develop or contribute to generalizable knowledge." This is quite different from what we talked about last month, where the student was practicing skills as apart of a class project, research practicum, or internship.  The student does need to submit an application to HSD for review and approval when a student is not just practicing skills, but is actually designing and implementing a research project with the intent to apply the results more broadly beyond the individuals studies or beyond a specific time and/or location, such as to other settings, circumstances, or categories.  This includes almost all independent undergraduate research projects and honor theses, masters these and doctoral dissertations, because they are almost always intended to contribute to generalizable knowledge.

HSD and/or the IRB will review the application and:

  • Approve it (though some changes may be required first), or
  • Determine that the project is "exempt" from the regulations, or
  • Determine that it is not human subjects research based on the complete definition.

The student researcher was right to come to HSD with her question.  Now let's hope she convinced her committee members about those statistical methods...