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Institutional Review Board

The purpose of Concordia University Irvine’s Institutional Review Board (IRB) is to protect the rights and the welfare of human participants in research or related activities. The federal government has established regulations regarding the protection of human subjects participating in research projects in the Code of Federal Regulations, Title 45, Part 46.

Your project will need IRB review if the following both apply to your project:

  1. If you plan to collect data that you intend to publish or present publicly (including dissertations and theses)
  2. The research methods involve direct and/or indirect interaction with participants via interviews, assessments, surveys, or observation or access to identifiable private information about individuals (e.g. information that is not in the public domain)

Submit an IRB Application or Inquiry

If you are submitting an IRB application or have an inquiry, please submit a request.

Submit Request

Categories and Time Frame

Projects fall into one of three categories, exempt, expedited, and full board review. Projects can take typically around 30 days to review for exempt and expedited and around 90 days for full board review. Data cannot be collected until the researcher has received the IRB approval letter.

 

Classroom Projects Involving Human Participants

Guidelines for Classroom Projects

 

Non-CUI Researchers

Outside researchers can collect data at CUI but first need to find a CUI sponsor and then obtain IRB approval. The IRB approval letter from the home institution must be submitted with the CUI IRB application.

 

IRB Handbook and Forms

The CUI IRB Handbook and Forms are available in a compressed Zip file. These files will need to be extracted and saved in another location on your computer after they are downloaded.

Instructions:

  1. Click on the link below these instructions to download the file.
  2. Do not open the file from your browser, instead go to the Downloads folder on your computer.
  3. Find the file and double-click to open it.
  4. Click extract at the top of the Zip folder’s window, then extract all, and designate where you want the files to be saved.
  5. Go to that location to open the files.

IRB Forms Zip File

 

Definitions

Research: Federal regulations (CFR Title 45, Part 46, 2009) define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This definition excludes instructional activities that are not designed to contribute in any way (e.g., through presentation or publication) to generalizable knowledge. Also excluded are activities related to routine course or program development/evaluation. Research includes all theses, dissertations, publications, and/or data-related external presentations. If results of a study are publicly disseminated in any way or will contribute to generalizable knowledge, then the study probably constitutes research and is within the IRB purview. If no dissemination is planned at the time the data is gathered but the possibility of future dissemination exists, the researcher is advised to submit the project for IRB review/approval before initiating the (research) project.

Generalizable Knowledge: Conclusions or insights which may be extended to populations outside the subset which is the focus of inquiry. Other characteristics of generalizable knowledge include, but are not limited to, the potential for replication and the potential to contribute to the knowledge base of the field of inquiry.

Human Participant or Human Subject: Federal regulations (CFR Title 45, Part 46, 2009) define a human participant as “a living individual from whom a researcher (whether a professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

Sensitive Topics: Topics relating to sexual attitudes, preferences or practices; the use of alcohol, drugs or other addictive products; pertaining to illegal conduct; that if released could reasonably damage an individual’s financial standing, employability, or reputation within the community; that would normally be recorded in a patient’s medical record and the disclosure could reasonably lead to social stigmatization or discrimination; pertaining to an individual’s psychological well-being or mental health.

Vulnerable Population: Minors (under eighteen years of age); fetuses or products of labor and delivery; pregnant women (in studies that may influence maternal health); prisoners; individuals with a diminished capacity to give informed consent; individuals with special needs.

Additional definitions can be found in the IRB handbook.

 
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