What Counts as Research

But is it research? The answer to this question determines whether your activity requires IRB review. Your ordinary understanding of what is human subjects research is a good starting point, but the definition under federal regulations may be both broader and narrower than you think.

"Research" is defined in the federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [45 CFR 46.102(d)]

On the one hand, the criterion of intent to contribute to generalizable knowledge may be broader than your ordinary understanding of research. It means that preparatory work in a research project is included. On the other, it also means that systematic investigations to develop local knowledge would not be considered research, which is perhaps different from how this word, "research," is sometimes used.

And so, the IRB definition of research may include:

  • pilot projects that might be thought of as preparation to do a formal research study
  • exploratory studies
  • independent studies, theses and dissertations
  • systematic studies of demonstration projects (with intent to generalize)
  • systematic studies of programs (with intent to generalize)

But also, generally, research would not include:

  • activities conducted to improve the quality of teaching in a particular classroom or curriculum
  • improvement-oriented or accountability-oriented inquiry in the college (unless denoted as "research" in a publication, which makes it presumptively research).
  • inquiry primarily intended to benefit the very individuals who are the focus of the inquiry.
  • activities confined to the classroom that teach research methods or simulate research activities

At the same time, if there is a component of any systematic investigation that is designed to contribute to generalizable knowledge, then the investigation would be research. Although intent to publish does not define a research intent, thoughts about presenting or publishing findings in an academic venue warrants asking, with due diligence, “is there an associated intent to contribute to generalizable knowledge?”

Resources for determining what activities are research. There are a range of other factors that affect the determination of what is versus is not human subjects research. The Alverno IRB Chair assists in making determinations that conform with the Office of Human Research Protection (OHRP) guidance. The following are often helpful in making correct decisions.

  • OHRP’s regulations decision Chart 1.
  • The SON-RRC Review Committee SON Screening Checklist and review process for determining if a Practitioner Based Inquiry Project in nursing would also be categorized as research.