» Institutional Review Board (IRB)

The Institutional Review Board (IRB) at Chapman University is the authority that reviews, approves, denies, and provides ongoing oversight of research involving human subjects in accordance with federal regulations.

The IRB is composed of full board members, alternate members, and a community member, who represent the Chapman University faculty and administration and the community. With backgrounds in the physical, medical, and social sciences, IRB board members are guided by regulations and standards of practice formulated and enforced by various government departments, including the Department of Health and Human Services.

Human Subjects Research

Research is a component of many courses at Chapman, including in-class exercises, out-of-class assignments, term papers, and capstone projects. While these often include some measure of research methodology, they may not constitute research that warrant oversight by the IRB. All faculty, staff, and students at Chapman University conducting research involving human subjects as defined in 45 CFR 46.102 must submit their research protocol to the IRB for review and approval prior to beginning the project. To help investigators determine whether a planned activity constitutes research involving human subjects, below are federal definitions of research and human subject.

  • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
    • (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
      or
    • (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

 If you are unsure whether your project requires IRB approval, you can:

If your project requires IRB approval, please begin your application in Cayuse IRB.

If your project does NOT require IRB approval, you are not required to submit an application for determination. However, please be aware, IRB approval may not be granted if the research has already started or been conducted and the determination of IRB applicability was made incorrectly by the investigator.

How do I know if my research falls under Exempt, Expedited, or Full Categories?

Exempt

For research to qualify as "Exempt" from the Code of Federal Regulations pertaining to the Protection of Human Subjects (45 CFR 46 full text), the research must be considered minimal risk. Additionally, human subject involvement must fall within one of eight categories listed in 45 CFR 46.104. Read descriptions of the eight exempt research categories.

Expedited

For research to qualify for "Expedited" review, the research must present no more than minimal privacy, psychological, and/or physical risk to human subjects, and involve only procedures listed in one or more of the nine expedited categories. Read descriptions of the nine expedited research categories, as defined by the Office for Human Research Protections (OHRP).

NOTE: The expedited categories describe research that is eligible for expedited review. However, full committee review may be required if determined by the IRB.

Full

If the research does not qualify as Exempt or Expedited based on the above research category descriptions, the research will require full committee review.