IRB: Human Subjects in Research

The Institutional Review Board (IRB) conducts review and approval of research that involves human participants. A project is considered Human Subject Research if it meets the below criteria:

  • The project meets the definition of research as defined by the common rule: “Research” as defined by DHHS is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
  • The project involves Human Participants: A human subject is defined by DHHS as a living individual about whom a research investigator (whether a professional or a student) obtains data through intervention or interaction with the individual or from individually identifiable information.
  • “Intervention” as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. [45 CFR 46.102(f)]
  • “Interaction” as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
  • “Private information” as defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]
  • “Identifiable information” as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

NOTE: Research meeting exempt criteria will need to submit their research for an Exempt Determination from the IRB.

If the above criteria is met, then you will need submit and IRB application via Cayuse IRB and obtain IRB approval to conduct research. Please contact the IRB Compliance Administrator if you have any questions.