» 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 definitions of research and human subject as prescribed by the Office of Human Research Protections.

  • 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

Research Excluded Under the OHRP Definition

The following activities are not considered to be “research” under the OHRP definition: 

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted supported, requested, ordered, required, or authorized by a public health authority (as defined under federal regulation).
  • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized optional activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Does my data use agreement (DUA) require IRB approval?

Secondary analysis of research data is a common method of research at Chapman. Contact Lawrence Lau at lalau@chapman.edu regarding DUAs with an external party.

Research projects that use data accessible to the public, that are not restricted to researchers, and where the data are not individually identifiable (stripped of identifiers) do not require IRB approval.

IRB approval may be required where the dataset/DUA includes:

  • Identified data
  • Restricted and de-identified data, and where the team holds the code to the identifiers
  • Security or confidentiality provisions that apply to the data provided under the DUA, or
  • Where two or more data sets are merged such that individuals may be identified.


When there is a question about where IRB approval must be given, researchers should submit a Non-Research Determination Form to irb@chapman.edu for official review. The IRB will assess the request and provide a determination as to whether the research requires IRB approval and what type of approval is appropriate (Exempt or Expedited).

Many studies using secondary data for research are Exempt under Category 4. See the criteria for Exempt and Expedited studies below for more information.

If IRB approval is required, submit your IRB request for approval through Cayuse. This can be done concurrently with the negotiation of the DUA by the Office of Research. The IRB study may be approved before the DUA is finalized, but the DUA will not be finalized until the IRB approves the study.

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 exempt research categories, with examples. 

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. 

How long will IRB review take?

IRB review times vary, as they are based on review categories and submission completeness. Exempt and expedited studies are typically reviewed by one or two IRB members, so they may be processed relatively quickly. Full studies are reviewed by all of the IRB members, so they take longer to process. The IRB meets once a month and reviews submissions that were received at least two weeks prior to a meeting. See the submission deadlines and corresponding meeting dates to allow sufficient time for full committee review.

Submission deadline due by Noon
Meeting dates
November 28, 2022 December 12, 2022
December 26, 2022 January 9, 2023
January 30, 2023 February 13, 2023
February 27, 2023 March 13, 2023
March 27, 2023 April 10, 2023
April 24, 2023 May 8, 2023
May 22, 2023 June 12, 2023
June 26, 2023 July 10, 2023
July 24, 2023 August 14, 2023
August 28, 2023 September 11, 2023
September 25, 2023 October 9, 2023
October 23, 2023 November 13, 2023
November 27, 2023 December 11, 2023
December 25, 2023 January 8, 2024

 

*To ensure submission completeness prior to IRB review, the IRB office may request revisions and supplemental materials. Supplemental materials include but are not limited to consent/assent forms, surveys/questionnaires, interview questions, recruitment advertisements, HIPAA authorization or waivers of authorization, certification of human subjects protection training, etc.