Application & Other Related Forms
Prior to submitting a study application to the IRB office through IRBNet, you will need to consider what type of review is appropriate for your study, as this will determine the application form you will need to submit. The types of IRB review are based on the level of risk to participants. There are three types of IRB reviews: (1) Exempt, (2) Limited/Expedited, and (3) Full. Ultimately, the IRB Office has the final decision in verifying the type of review for a study.
IMPORTANT: The U.S. Department of Health and Human Services (HHS) made changes to federal regulations around human subject research. We revised our forms as of January 14th, 2019. Please use the latest forms in your submission. Old forms will not be accepted by our office.
Exempt Review Application Form
Please fill out this form, if your research study is no more than "minimal risk" and fits one of the federally designated exempt review categories. Please review the Exempt Categories to determine if your study qualifies for exempt review.
Limited/Expedited or Full Review Application Form
The IRB Office uses one form for both limited/expedited and full reviews. A research study can be approved as "limited/expedited" if it is "minimal risk". Research that presents "more than minimal risk(s)" to participants will receive Full Review.
*Note, this form has been updated to reflect COVID-19.
Minor Revisions Form
Please use this form if you are making minor revisions to an existing IRB approved
study. You must submit this form along with other documents (e.g. revised consent
forms) if applicable. All minor changes must be reviewed and approved by the IRB Office
before they can be initiated by the researcher. Please submit all required documents (including CITI training, consent forms, surveys,
etc.) from the previous package along with the application.
Minor modifications need to be submitted as a subsequent package - please do not create a new package.
Continuing Review Form
Please use this form if you would like to extend the time period of an approved full review study. Research studies that have gone through Exempt or Limited/Expedited IRB reviews do not have expiration dates and therefore researchers do not need to submit a continuing review form. This form is submitted through IRBNet at least once a year 30 days before the expiration date of the original approval as shown on the approval letter. Please submit all documents to be used in your research (including CITI training, consent forms, surveys, etc.) along with the application, even if they have not changed. Continuing reviews need to be submitted as a subsequent package - please do not create a new package.
Course Work & Instructional Review Form
Please fill out this form if you a CSUSM faculty who teaches a course where students engage in research. Please review the Course and Intructional IRB Review Guidelines to determine if what your students are doing as part of a course qualifies for this review type of review.
Unaffiliated Investigator Form
Please use this form if you are an investigator outside of CSUSM system (meaning if you are not a faculty, staff, or student at CSUSM) who has an approved IRB study at your home instituition and would like to use a CSUSM population in your study.
IMPORTANT: If you are conducting a survey, you must also contact the University Survey Committee and get their approval (after having gone through CSUSM IRB review and approval) before administering the survey to CSUSM faculty, staff, or student.
Joint CSUSM/UCSD Ed.D. Program Cover Sheet
Please fill out and submit this cover sheet along with your application form if you are a Ed.D. graduate student in the joint CSUSM/UCSD EDD program. Please review the CSUSM/UCSD Ed.D. Agreement for IRB that describes a cooperative review process that allows the UCSD and CSUSM Institutional Review Boards (IRB) to rely upon each other to avoid duplication of effort and reduce burden for investigators, IRB members and staff.
Verification of Translation Form
If a consent form is provided in another language, you first have your IRB application and English-language consent form approved by the IRB. Then upload this form along with your application for verification of the translation of consent forms for languages other than Spanish. Because most translations will be to Spanish, we provide a translator to verify translations instead of requesting the Verification of Translation form. Alternatively, the Spanish translation verifier can translate the document for a fee. For other languages, the form must be signed by any CSUSM instructor who is reading and writing fluent in that language. They are only verifying that the translation you provide is accurate. Please review the Consent Form Requirements for Languages Other than English page.