IRB review is required for regulated non-exempt human subjects RESEARCH

QUESTION 2 – Is this activity “research”?

There are many activities that use research type techniques (interviews, for example) that are not defined as research by regulation. Evaluators may do both research and quality assessment but only one may need IRB review.  

Activity not defined as research by regulation may be quite valuable, usable, publishable and honorable but it does not meet the definition of research that puts it into the regulated arena.

“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

  • Systematic Investigation:  The approach to the activity is designed; that is, it is well thought out in advance.  The design should be an approach recognized and given a name within your discipline.

  • Designed to develop or contribute to:  The intent is to learn something or take something to the next step. This is the intentional aspect – the study is started with the intent is to do some activity to advance some aspect of your field.

  • “Generalizable knowledge”What is learned can be applied outside or beyond the specific situation being studied.  These two words are critical to distinguish quality improvement or internal evaluation from research.  Knowledge gained that is useful only to your client may use research techniques and may be designed to develop knowledge but it cannot be generalized.

  • Including research development, testing and evaluation:  Activities that should be considered include “research development”, evaluation projects (especially those included in grants) and testing.   Although this increases the number of projects to be tested by this definition, most won’t meet all the above elements and will not turn out to be “research”.

Each of these concepts are constantly debated in IRB circles.  Research is NOT defined in terms of risk or intent to publish; however, if an activity that was not research results in something interesting, it can be published as a case study or with an IRB supported determination that it is not research with human subjects.  This determination can be retroactive but if it is denied and the research is already done, it is too late.  The activity cannot be retroactively approved.

FDA defines a “clinical investigation.”  This definition is very different and involves use of an investigational product.  A clinical investigation can be minimal risk as can be the case with in vitro diagnostic devices.

CONTINUE if you are doing “Research” and may have human subjects