If you are working with people (especially vulnerable populations such as children) and your work could be considered research (in that it contributes to general knowledge and the results are generalizable), you should consult an 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 HHS and the Food and Drug Administration (FDA). Institutions that conduct research on human subjects, such as universities or hospitals, must have internal IRBs. Other entities, such as nonprofits, may work with a commercial IRB in their community. The information that follows applies primarily to nonbiomedical, behavioral research.
IRB FAQ
| 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 a human subject as “a living individual about whom an investigator (whether professional or student) conducting research: Obtains (i) information or biospecimens through intervention or interaction with the individual, and, uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” |
| How Do I Know if My Study Is Human Subject Research? | You can check with your institution or a local IRB to verify whether your study is research. Your study may constitute research if it is a systematic investigation designed to contribute to generalizable knowledge.
Your study may constitute research if it involves an interaction or intervention with living human subjects. Your study may constitute research if it collects identifiable or private information. |
Institutions may also have checklists to help determine if work constitutes research with human subjects.
Once it has been determined that human subjects research is being done, the next step is to determine if the study must undergo review and approval through the IRB process. Check individual institution guidelines for more specific information.
Contact your institution for a set of IRB guidelines.