IRBNet FAQs

Frequently Asked Questions About IRBNet

New Project Submission

Post-Submission

CITI Training

Terms and Instructions



How do I register in IRBNet and submit a new (first time) project in IRBNet?
The first time you log onto www.irbnet.org you will need to create a username and password; select LifeBridge Health (LBH) as your affiliation, and continue until you have completed registration.  When you receive an e-mail from activation@irbnet.org, follow the link contained in the email to complete the account activation process.

Once you have an account, log on, choose ‘Create New Project’ (on the left), and fill out all initial required fields (and non-required fields for your own ‘search’ requirements).

A project is ready to submit in IRBNet when the following has been completed:
(1) All checklist/application forms have been completed/uploaded.

(2) All supporting documents have been uploaded to IRBNet.

(3) All package signatures have been obtained (PI and Department Chair).

Please do not submit before each of these items have been satisfied. If you submit an incomplete application, we will unlock your project and the review process will be delayed until you address the modifications and mark your revisions complete. Turning in an incomplete application will slow down the review process.

NOTE: Please be careful when selecting where to submit your project as there are two review Boards at LBH, IRB (A) and IRB (B). Selecting the incorrect Board will require your application to be withdrawn and then will need to be resubmitted to the correct Board. This will delay your review.  To find out which Board you should submit to, look under the IRB’s Frequently Asked Questions, “What is the difference between IRB (A) and IRB (B)”.



How do I sign a Project/Package?

To Sign a Project, go under the Project Administration menu and click “Sign This Package.” Then, in the drop-down box next to your name, select your affiliation with the project (i.e. Principal Investigator, Co-Investigator) and click “sign” at the bottom of the screen. NOTE: You must be shared on the project in order to view the project and sign.



What does it mean to Share a Project? How do I share my Project with other study team members?

All projects should be shared with all personnel on the Personnel List you created so that they can be fully informed about the protocol.  Sharing also allows the IRB Office to contact personnel directly (to discuss training, etc.).

To share your project, find “Share My Project” under the Project Administration menu. Then, click the first blue link titled “share.” Select LifeBridge Health as the organization. Then, at the bottom of the page you will see a search box to search for users by last name.

Personnel must register in IRBNet before you share with them.  If you cannot find someone within IRBNet, this means that they have not yet registered with IRBNet. The IRB Office is unable to create usernames/passwords for you. The training website, CITI, is not linked to IRBNet and therefore personnel must register in both places.

There are 3 different levels of sharing:

  • Full - recommended for co-investigators and research coordinators so that they can help manage the project paperwork and submissions. 
  • Write - if you wish for the person to contribute documents but not change submissions.
  • Read - minimum for all personnel.  All personnel need to be able to read the protocol package so that they can be well informed.  This also allows the administrator to be able to contact all personnel directly about training, etc.


I have completed the modifications requested by the IRB. How do I lock my submission ("Mark Revision Complete")?

Packages can be unlocked prior to review if the researcher needs to add another document or make a change. Please do not create a new package for forgotten documents or pre-meeting revisions.

Once you have completed the modifications requested by the IRB, you must Mark Revisions Complete to notify the IRB that they may continue the review of your application. To do so, go to the Designer page, located under the Project Administration menu on the left-hand side. At the top of the page, you will see “This package is” followed by the lock status; the status will read “Unlocked – Revisions Pending” and the lock will be red. To Mark Revisions Complete, click the second link to the right of the Lock Status, “Mark Revisions Complete.” The lock will then turn green and read “Locked – Revisions Complete.”



What is the Lock Status? What does 'locked' and 'unlocked' mean?

Lock Status

Color of Lock

What does it mean?

“Locked”

Gray

A project has been submitted and is currently under review by the IRB.

“Unlocked – Revisions Pending”

Red

The IRB has decided that revisions must be made to a project. By unlocking, the IRB has stopped their review until the edits are complete. This is for only revisions identified during the pre-review process. Once a study is reviewed by the IRB Board, or Expedited Reviewer, revisions must be submitted in a new package.

“Locked – Revisions Complete”

Green

The investigators have addressed the requested modifications and the IRB can continue their review.



What are Messages & Alerts in IRBNet?

The Messages & Alerts function, located at the bottom of the left side toolbar, presents a complete history for each individual protocol. Any messages that are sent between investigators or between investigators and the IRB office can be found here. If modifications are requested, a copy of the requested adjustments can also be found here. This is a useful tool in projects that have multiple team members to help keep track of the actions taken on your project.



Modifications have been requested by the IRB Office. How do I change documents previously submitted?
When making modifications to documents in IRBNet, please click the paper icon located on the right side of the document, in the Designer page. This will open the previous document on your computer. Once the documents have been revised, save them to your computer. Click the pencil icon to upload the new, revised forms.
 



My application has been approved in IRBNet, how do I access my documents?
To access your approved documents, go to the Designer Page and locate the list of Documents in the package. Click on the “paper icon” next to the consent form to download a copy and print.
The consent forms in your approved IRBNet PACKAGE must be used.  

 



How do I submit an amendment or a continuing review application?
To submit an amendment or a continuing review application you must first create a new package. This new package will be linked to your initial application in IRBNet. To submit a new package, go to the My Projects tab and click on Project History. In this tab, you should see the option to Create a New Package.



Where do I find my CITI certificate?
You can view and access your CITI certificate by logging into your CITI account at www.citiprogram.org.
On the Main Menu, you should see a list of your completed CITI courses.

NOTE: Your CITI Username and Password are not linked to your LBH ID.
 
NOTE: In order for co-investigators to link their CITI certificate to a project, all co-investigators must be granted at least, “Write” access.
 

 


How do I link my CITI certificate to a project?
CITI Training Completion Reports must be linked to your project in order for the IRB to proceed with the approval process. This is a fairly simple process:

(1) Add CITI Completion Report to your IRBNet User Profile. Once you are logged into IRBNet, click USER PROFILE in the upper right corner of the screen. Scroll down to the bottom of the screen and click Add New Record. Follow the instructions to attach the PDF version of your completed CITI Training.

(2) Link your CITI Completion Report. During your Initial Application or next package submission in IRBNet, link your CITI Completion Report to the project. To do this, click Designer and then click Link/Unlink Completion Report near the middle of the page. Follow the instructions. This should be done for each member of the research team.


 


Glossary of terms in IRBNet

IRBNet Term

Meaning

Mark Revisions Complete

Term used when making modifications to a protocol that is currently being reviewed by the IRB. This link can be found next to the Lock Status on the Designer Page.

Submission is Locked

Refers to the Lock Status function. When your submission is locked, you cannot make any edits to your project as it is under review by the IRB.

Submission is Unlocked

Also refers to the Lock Status function. Your submission may be unlocked by the IRB office because modifications are needed or upon request by the Principal Investigator.

Package

Each project submitted to IRBNet is a package. Each has its own unique package number. Each time a new submission is made, you submit it under the same application number, but the package number (the last number) will change. For example “123456-1” is an Initial Application. If you submitted an Amendment, the number would change to “123456-2”, etc.

Internal Reference Number

This function is completely optional. If your department has their own numbering system, separate from the IRB, this is where you could include your own project number. This number cannot be seen by the IRB, only the investigators.

Amendment

Changes to previously approved materials.

Continuing Review/Progress Report

Continuing Reviews are submitted every 364 days and are required; Progress Reports are submitted on an as needed basis.




Detailed, step-by-step instructions
Detailed instructions of how to create, submit, and sign a package are located under the Library Manager tool in IRBNet. The Library Manager can be found on the left-hand side of the screen.