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Institutional Review Board

Institutional Review Board 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.

IRB Submissions:

  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 Expedited or Full Review application form in IRBNet if you a filing IRB for a new project.
  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 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 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.

Summer/Winter Reviews

The Institutional Review Board does not fully function during the Summer Session and Winter Break. Applications will be reviewed on an as available basis.

Fall 2018 Submission Deadlines

  • Full Reviews: 11/9/18
  • Expedited and all other reviews: 11/30/18

UPDATE: As of 9/7/18, CSUSM’s IRB office is implementing a revised Common Rule guideline that eliminates the need to submit a continuing review for expedited applications. Continuing expedited reviews submitted on or after July 19, 2018 will be retroatively closed in IRBNet. Please email irb@csusm.edu with your IRBNet submission number and consent/assent forms to be updated with a new stamp.

The U.S. Department of Health and Human Services (HHS) has announced that the Common Rule changes that were set to go in effect on July 19, 2018 will be delayed by six months, changing the effective date to January 20, 2019. The submission process and application forms will remain the unchanged from 2017. More information on the delay can be found Federal Register.

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.