How to Submit to the IRB

The UC Davis IRB uses an electronic database called IRBNet, which provides online submission and protocol management. IRBNet is hosted at a secure, enterprise-class data center that supports and meets the strict requirements of federal regulations. For information on creating an IRBNet account click here.

Submission Process

While each submission type has specific requirements, all submissions will go through the following steps.

Create a New Project or Create a New Package

Create a New Project

When submitting an application for the initial review of a new project you will click Create New Project. The only time you should Create a New Project in IRBNet is at the initial submission of a new project. 

Create a New Package

To submit a modification, continuing review progress report, report of new information, or response for any study that has already gone through the initial review you must click the project title to open the project in IRBNet and click “Create New Package” from the left-hand menu. This will create a new package within the project. Each package is a unique submission. Within the new package, you can edit project details, update the initial review application, and upload new or modified study documents. You should only create a new package when the review of the last package has been completed and a determination has been issued, or when you need to submit a report of new information that requires prompt reporting to the IRB. If you have questions about when to create a new package, contact IRB Administration at 916-703-9158.

Work in Progress

When you create a New Project or a New Package it is a “work in progress” submission. At this time you can build and edit your submission as needed. There is no limit to the number of times you edit project details or upload new versions of documents while the submission is a “work in progress.” During this step, you should complete all required IRB forms, upload supporting documents, share the project with the necessary personnel, and collect required signatures. Each submission type (New Project, Amendment/Modification, Continuing Review Progress Report, Response, and Reportable New Information, has specific submission requirements. Follow the links below for more information.

Uploading documents

The IRBNet Designer page holds all of the documents submitted to the IRB for the life of the study. When submitting a  new project you will use the “Start a Wizard’ button to add the UC Davis Initial Review Application. You will use the “Attach a New Document” button to upload all other study documents from your computer. It is likely you will need to make changes to documents during the initial review. The Initial Review Application is an online document and is edited within IRBNet. All other documents should be edited and saved on your computer, and then uploaded into IRBNet. The pencil icon is used to open the Initial Review Application and make edits. It is also used to upload a new version of a document. If you need to edit or replace a document, you should click the pencil icon. After the first package, the Designer page is broken into two parts: “Documents in this Package” and “Documents from Previous Packages that you can Revise.” The package must be either a work in progress or unlocked when you upload or edit documents. If you have questions about the status of the package contact IRB Administration at 916-703-9158.

When a document appears in the “Documents from Previous Packages that you can Revise” section, click the pencil icon to ADD a new version of the document. The old versions will not be removed; they are part of the permanent record of the study.

When a document appears in the “Documents in this Package” section, click the pencil icon to REPLACE the most current version of the document. You cannot add multiple versions of the same document in a package. The version that was replaced is removed from the system and there is no way to recover it. In addition, if you upload multiple versions of the same document in one package, an IRB analyst will ask you to delete all except the most current version.

Submit this Package

When you are ready to submit the application to IRB Administration you must click “submit this package” button from the left-hand menu. After you click the button, complete the subsequent steps to submit the package.

Pending Review

When you have completed the submission steps the “Board Action” will update to “Pending Review.” At this time the project is locked and no revisions can be made. You will find a black lock indicating that the package is not available for revisions.

 

Click here for an overview of the IRB review process.

Click here for a list of possible IRB determinations.

Submission Types

Initial Review Application (New Project) Process

The initial review application is required for approval of any research utilizing human participants, regardless of risks imposed by the research. Once received, the IRB begins with a screening process to determine whether the proposal qualifies as research and utilizes human participants. In addition, the screening form will assess whether the submission might qualify for exemption or if expedited/committee review is warranted.

Amendment/Modification Submission Process

All amendments/modifications to currently approved research must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects.

Reportable New Information Submission Process

During the course of the research, investigators or others may encounter events which are unexpected in nature, potentially adverse, and/or can affect the potential risks or conduct of the research. Such information must be reported to the IRB in the form of a Reportable New Information (HRP-214) submission.

Continuing Review/Study Closure Submission Process

Except for human research studies that have been granted exempt determination, the IRB is required to continually review ongoing research at intervals appropriate to the potential risk to participants. Study closures follow the same submission process as continuing review and must be submitted prior to study approval expiration.

NOTE: If the continuing review application is not received by the administrative due date requested in the approval letter, you will be required to develop and implement a suitable corrective and preventive action plan (CAPA).

Responses

When the IRB requires clarification, justification or modifications to secure approval you will need to submit a response. Review this information about how to submit a Response and what to include.

Frequent Reasons for Deferral at Initial Review

A list of common reasons why initial review applications to the IRB are delayed or deferred to a later agenda.