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Institutional Review Board

Institutional Review Board (IRB) Overview

The role of the Institutional Review Board (IRB) is to review all proposed research by CSUSM faculty, students, and staff involving human subjects to ensure that subjects (meaning research participants) are treated ethically and that their rights and welfare are adequately protected.

A "human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. “Research” in the context of IRB is considered to be a systematic investigation designed to develop or contribute to generalizable knowledge.

The IRB committee is composed primarily of faculty members from various disciplines  and members from the community. The role of the IRB committee is to assure that research with human subjects is conducted in accordance with legal requirements and ethical principles of Respect for Persons, Beneficence and Justice. These principles require the balancing of risks to subjects against the scientific knowledge to be gained and the potential benefits to subjects and society.

All research activities involving the use of human subjects must be reviewed and approved by the IRB before data collection can begin. Investigators may not solicit subject participation or begin data collection until they have IRB approval. We recommend that you submit your IRB application at least 3 months before you plan to collect data.

**COVID-19 Human Subjects Update - October 2020**

As of October 9, 2020, CSUSM is allowing faculty, staff and students to apply for approval for face-to-face human subjects research that cannot be done remotely. 

Human subjects researchers who seek to reactivate face-to-face research that was put on hold due to COVID-19 should first apply to the Reactivating Research Committee (RRC) and then contact the CSUSM Institutional Review Board (IRB) to seek approval for COVID-19-related modifications. These modifications should include a modified participant consent form that recognizes COVID-19 associated risks and safeguards.

Human subjects researchers who seek to begin new face-to-face research should submit applications to the CSUSM Institutional Review Board. IRB applications and supporting materials should explicitly address specific COVID-19 risks and safeguards (see updated application and consent form templates for guidance). Upon recommendation for approval by the IRB, researchers are required to apply to the Reactivating Research Committee for research protocol approval. Researchers must create a subsequent package and submit a completed minor modification form to the IRB. They should add proof of RRC approval to their IRB packages as the last step in the process.

Please note that researchers may still continue to collect data through online surveys or interviews that do not require researchers and subjects to be physically present together. This decision is taken out of an abundance of caution for our research subjects, our faculty, staff, and student researchers, and the community at large. 

If you have any questions or concerns related to this policy please contact Dr. Richelle Swan, IRB Chair, or Dr. Charles De Leone, Dean of Graduate Studies & Research.

IRB Submission Process:

  1. To submit new IRB application, access the online CSUSM IRB System IRBNet If you are a new user, you need to create username and password to be able to log into the system. All your communication with the IRB Office will be through this system. 
  2. All researchers engaged in Human Subjects research need to complete online CITI training, which is good for three years. If you are a new user, you need to create username and password to be able to log into the system. Upload your CITI completion certificate to IRBNet for every package submitted, including continuing reviews and modifications.
  3. Complete and upload either the Exempt Review application form OR Limited/Expedited/ Full Review application form in IRBNet if you a filing IRB for a new project. See Application and Other-Related Forms page. 
  4. When appropriate, upload the following documents to the IRBNet:
    1. Consent Forms (for anyone who is 18 or older)
    2. Assent Forms (for anyone who is younger than 18)
    3. Letter of Support (if you are collecting data off campus, you need to provide a letter of support from that research site)
    4. Recruitment Script
    5. Measures (e.g. interview questions, surveys)
    6. CSUSM/UCSD Application Cover Sheet (only if you are a graduate student in the Joint Doctoral Program)
    7. Verification of Translation Form (This form must be uploaded after the English version of the consent form has been reviewed and approved by the IRB Office for a language other than Spanish.) 
  5. When the researcher (also referred to as “Principal Investigator”) is ready to submit the IRBNet package, she or he will need to click the “submit” button. Students who are doing research as part of their masters thesis or dissertation are considered as researcher (or principal investigator), and need to submit their own IRBNet package. However, students must share their IRBNet package with their faculty advisor and get their advisor’s virtual signature through IRBNet before submiting their application to the IRB Office.

Fall 2021 Submission Deadlines

  • Full Reviews:
    November 15th
  • Limited/Expedited and all other reviews: November 30th

*Please submit full reviews at least FIVE business days before a scheduled IRB meeting. Otherwise, your full review will be reviewed at the following IRB meeting.

IMPORTANT:
IRB reviews over summer & winter break will be reviewed in a limited capacity on an as-available basis, as the full committee is not in session. Please submit your application prior to the semester deadlines in order to get your research reviewed in a timely manner.

IRB Review Process

The IRB review process can take from one to six weeks or more before the researcher receives final approval. The review time depends on what kind of application is submitted, the IRB committee meeting schedule, and the timeliness of responses to requests for clarification.

IRB Trainings

Faculty, would you like IRB training for your research methods class, or at a department meeting? Contact irb@csusm.edu to schedule a training.