To submit new IRB application, minor changes, or continuing review (also known as "renewal") to a currently approved IRB application, access to online CSUSM IRB system: IRBNet. Each research project submitted to IRBNet is referred as a "package". Each package has its own unique package number. IRB Office will be using this number to refer to your research project.
Please read this IRBNet Picture Guide before submitting any IRB Applications. If you have further questions, please refer to the training resources below.
Below are list of resources for instructions on how to register, how to submit a new package, and other additional IRBNet assistance.
Once you upload all the documents (e.g. application form, consent forms, CITI certificate, etc.) to your package and ready to submit your package, you will click on "Sign this Package" (see the left sidebar). Once you sign the package, then you need to click on "Submit this Package" to actually submit the package to the IRB Office. If you are a student, you must click "Share this Project" and find your advisor's name from the list and share the package with him or her so that she or he can sign the project as well. Your package will not be assigned to a reviewer until your package is signed by your advisor.
All communications regarding your package and letters will be issued electronically through IRBNet. You will receive an e-mail notification every time a letter/communication is issued to your package. It is your responsibility to login to the IRBNet and check what is posted on your package. Below is the list of communications/letters you will receive from the IRB Office:
|IRB Office Letters||Description|
|Acknowledgement Letter||A letter posted by IRB Office within 1-3 business day to acknowledge the submission of the package. At this time, your package is assigned to an IRB reviewer and is waiting to be reviewed. You do not need to do anything until further notification.|
|Modification Required Letter||A letter posted by the IRB reviewer to request clarifications and modifications from the researcher about the documents she or he submitted under the package. The IRB reviewer will "unlock" the package for the researcher to make modifications. The researcher is responsible for making revisions to their documents, uploading new version of the documents, and deleting the old versions. To respond to the modification required letter, the researcher must create a separate document with his or her responses to the reviewer's request and upload this document along with the changes she or he made to other documents. The researcher must "lock" the package when she or he is done. The IRB reviewer can issue as many modification required letter as she or he sees fit.|
|Recommendation Letter||If the IRB reviewer is satisfied with the researcher's responses to the request for modifications and there are no further changes necessary, she or he will assign a recommendation letter to let the IRB Office know that the package is ready for approval. IRB Reviewers do not approve applications; they can only recommend for approval.|
|Approval Letter||The IRB Office will assign an Approval Letter in 1-3 business day to approve the package along with stamped consent document(s). At this time, the researcher can begin his or her study. He or she must use the stamped consent forms provided by the IRB Office.|
The Institutional Review Board does not fully function during the Summer Session and Winter Break. Applications will be reviewed on an as available basis.
Full Reviews: 11/9/18
Expedited and all other reviews:
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 firstname.lastname@example.org 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 at Federal Register.