Institutional Review Boards (IRBs)

Institutional Review Boards

If you are working with people (especially vulnerable populations such as children), your work could be considered research (it contributes to general knowledge and the results are generalizable), and you should consult an Institutional Review Board (IRB) for guidance before starting data collection.

IRBs are groups of individuals who monitor research projects that involve human subjects.  IRBs must have at least five members from different professional backgrounds who have diverse experience. IRBs are regulated by Health and Human Services (HHS) and the Food and Drug Administration (FDA).  Institutions, such as universities or hospitals, that conduct research on human subjects, must have internal IRBs. Other entities, such as non-profits, may work with a commercial IRB in their community. The information that follows applies primarily to non-biomedical, behavioral research.
 

 

Frequently Asked Questions About IRB's :

What is research?

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

What are human subjects? 

 HHS defines human subjects as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

How do I know if the study I am going to conduct is human subject research?

You can check with your institution or a local IRB in your community to verify whether or not your study is research. Your study may constitute research if it
  • Is a systematic investigation designed to contribute to generalizable knowledge.
  • Systematic: having or involving a system, method or plan.
  • Investigation: a searching inquiry for ascertaining facts; detailed or careful examination.
  • Generalizable: universally applicable – including use for a thesis, dissertation, publication, or poster presentation.
  • Involves an interaction or intervention with living human subjects
  • Collects identifiable or private information

 

Your institution may also have a checklist to help you determine if the work you plan to do constitutes research with human subjects. The University of Arizona Human Subjects Protection Program has an example.

If you have verified that you are, in fact, doing human subjects research, the next step is to determine if your research must undergo review and approval through the IRB process.  Check with your institution to determine their IRB guidelines.

Here is an example of the IRB guidelines from the University of Arizona Human Subjects Protection Program Application for a New Social/Behavioral Project.

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