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) Expedited, and (3) Full. Ultimately, the IRB Office has the final decision in verifying the type of review for a study.
UPDATE: 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 January 19, 2018 will be delayed by six months, changing the effective date to July 19, 2018. Until that date, the submission process and application forms will remain the unchanged from 2017. More information on the delay can be found Federal Register.
Please fill out this application 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 Activity Guidelines to determine if your study qualifies for exempt review.
The IRB Office uses one form for both expedited and full reviews. A research study can be approved as "expedited" if it is no more than "minimal risk" and fits in one of the federally designated expedited review categories. Research that does not qualify for expedited or exempt review and/or presents more than minimal risks to participants will receive Full Review.
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.
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.
Exempt studies do not have expiration dates and therefore researchers do not need to submit a continuing review form. Please use this form if you would like to extend the time period of an approved expedited or full review study. 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.
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.
Please fill out and submit 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.
Please upload this form along with your application for verification of the translation of consent forms for languages other than Spanish. The form must be signed by any CSUSM instructor who is reading and writing fluent in the other language. They are only verifying that the translation you provide is accurate.
Opening the application
You must use Adobe Reader or Adobe Acrobat Pro to open and fill out the application.