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

Lock Status	Color of Lock	What does it mean?
“Locked”	Grey	A project has been submitted and is currently under review by the IRB.
“Unlocked – Revisions Pending”	Red	The IRB office has determined that the package is incomplete. By unlocking, the IRB office has unlocked the package to allow the PI or other team members to make the requested updates.  Only once edits are complete and a study team member selects, 'Mark Revisions Complete" can the application continue to be processed and shared with the board for review.
“Locked – Revisions Complete”	Green	The investigators have addressed the missing elements and the IRB office can continue processing.

I have completed the requested changes from the initial administrative review. How do I lock my submission ("Mark Revision Complete")?

Once you have addressed the missing items noted by the IRB office, you must select "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 does it mean to share a project? How do I share my projects with other investigators?

Sharing a project in IRBNet gives others access to your research. There are three levels of access when sharing:

Signature Only (Read): Users whose ONLY role is to sign off on project documentation should be granted "Read" access. Users with Read access can view project documentation, communicate with the project team and add their signature. NOTE: Read access should be provided to ALL IRB Liaisons.

Write: Users that are granted "Write" access can view and edit project documents, collaborate with other users and add their signature, but MAY NOT grant access to other users, submit packages for review or perform any other administrative functions.

Full: Users that are granted "Full" access can perform all functions without restriction. This includes editing project documents, sharing the project with other users, submitting document packages for review and deleting document packages. NOTE: ONLY Project Owners with day-to-day responsibility for the project should be granted Full access. Users with Full access will receive automatic email copies of all project notifications and alerts that are sent to the Project Owners.

To share your project, find “Share My Project” under the Project Administration menu. Then, click the first blue link titled “share.” Select the University of West Florida as the organization. Then, at the bottom of the page you will see a search box to search for users by last name. If you cannot find a researcher, please see the next question.

I want to share my project with someone and cannot find them when I search for them. What do I do?

If you cannot find someone within IRBNet, this means that they have not yet registered with IRBNet. Every member at the University of West Florida MUST have their own unique username and password. The IRB Office will not create a username/password for any member of our research community.  If you have a co-investigator that is not part of the UWF system and their institution does not have access to IRBNet, they may create an account with IRBNet and select UWF as their institution as UWF is not charged any additional fees.

How do I sign a project within IRBNet?

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, Department Representative) 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.

Who needs to sign this package?

New Projects (Initial package):  All members of the research team including the PI, faculty advisors, co-investigators and additional personnel.

Amendments: The principal investigator and any newly added or removed staff, if applicable.  For significant changes, the faculty advisor will need to sign. 

Extensions/ Continuing Reviews:  The Principal Investigator

Final Report: The Principal Investigator

Who is my faculty advisor?

All students who are listed as principal investigators, must have a faculty advisor.  You will list your faculty advisor as "additional personnel" in your application wizard and share your project with them so that they may review and sign your package.  Your faculty advisor will be the UWF professor that will be guiding you through your human participant research and shares the responsibility for your participants' protection.  If you are conducting a study as a part of your dissertation, it would be the chair of your committee.  If your project was in relation to a course assignment, it is more than likely your course instructor is your faculty advisor.  Faculty advisors are required to review and sign all packages their students submit.  Unless otherwise unavailable for teaching, faculty advisors are strongly encouraged to attend any IRB meetings where their student's project will be reviewed.

How do I submit a package in IRBNet?

To submit a package on IRBNet, find the Project Administration menu and click “Submit This Package.” Then, under Search for Organization, find the University of West Florida.  Then, select your Submission Type (i.e., new project, amendment, continuing review) and any comments you wish to include. Finally, click “submit.” If your project still says "Work in Progress (Not Submitted)", that means your project has not been submitted to the IRB and the IRB office does not have access to it.

How do I know my package has been submitted successfully?

Under your "My Projects" view, the submission type of your package should list the package type you selected (New Package, Amendment, etc.) and the Board Action would be listed as "Pending Review".  If the submission type reads "Work in Progress- Not Submitted", this means that it has not been submitted to the IRB office and the IRB administrator cannot see your submission. 

I got a "Modifications Required" letter. What do I do now?

In the letter, it will have a bulleted list of items that you will need to address for approval.  To make these changes, you will need to create a subsequent package in IRBNet (see "How to Respond to a Modifications Required Letter" ).  You will go into your current project and select, "Create a New Package".  From there you will edit your files using the pencil icon, highlight the changes in yellow,  and then sign and submit your package.  For full board review projects that were "approved with conditions", with a modifications letter attached, your modifications can be reviewed in an expedited format and you will not have to attend the next IRB meeting.

How do I get an 'extension'?

If your project is expiring and you need more time to collect data or analyze identifiable data, you will want to create a subsequent package (see How to Request an Extension).  You will go into your current approved project and select, "Create a New Package".  From there you will download the "Continuing Review Form" from the dropdown document library in the Designer section of IRBNet.  You will complete this form, attach your informed consent in use, and then sign and submit your package.  Please note, if your project was originally reviewed via a full board meeting, you will want to submit your extension at least two weeks before the next IRB Meeting. The schedule of IRB meetings can be found at the UWF IRB website.

How do I submit an amendment?

If you would like to make a change from your originally approved project, you will need to submit an amendment by submitting a subsequent package in IRBNet (see How to Submit an Amendment).  You will go into your current approved project and select, "Create a New Package".  From there you will download the "Amendment Form" from the dropdown document library in the Designer section of IRBNet.  You will complete this form, update any of your files that will be affected, highlight the changes in yellow, and then sign and submit your package.  Please note, if your project was originally reviewed via a full board meeting, you will want to submit your amendment at least two weeks before the next IRB Meeting. The schedule of IRB meetings can be found at the UWF IRB website.

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.

Glossary of Terms in IRBNet

IRBNet Term	Meaning
Approved with Conditions	The board agrees to approve your package on the condition that the modifications listed in your "modifications required" letter are confirmed and approved by the board.  You will need to create a subsequent package within your project to submit these revisions.  Once your package status is, "Approved" and have an approval letter listed in your board documents, you may commence with research.
Designer	Section of IRBNet where you will "design" your package.  In the left side blue menu, under Project Administration, there is a button for "Designer".  In this area you can attach your documents, can find the document library with our sample forms, and complete the application wizard (Application part 1).
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.
Local Board Reference Number	If you are submitting an Amendment or Continuing Review for a project that was reviewed prior to the implementation of IRBNet, this will be your previous IRB approval number. This will help the IRB Office link your IRBNet submission with your previously approved transactions.
Mark "Revisions Complete"	Term used when making updates to a protocol that is currently going through the initial administrative review by the IRB coordinator. This link can be found next to the Lock Status on the Designer Page.  If a package has been unlocked for you during an initial administrative review, you must select, "Mark Revisions Complete" so the IRB office is notified that your package is ready to be reviewed again.
Package	Each submission submitted to IRBNet for a study is in a package.  The ID# is represented as the  "Project ID- Package #.  Each time a new package submission is made within a study, you submit it under the same main project ID number, but the package number will change. For example “123456-1” is an Initial Application. If the board requests a modification, you would create a new package within your current project, the number would change to “123456-2”.     For example, if you are submitting an amendment or final report, you would go into your current approved project and select, "Create a new package".  You would NOT select, "Create a new project".
Project	Refers to an entire study within IRBNet. Do NOT create a new project when submitting an amendment, revision, or final report.
"Read Me First" Document	The first file in the drop down menu of the document library that will have step by step instructions for creating a new project.
Submission is Locked	Refers to the Lock Status function. When your submission is locked, you cannot make any edits to your package 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 to allow for changes based on the initial administrative review.  Once a package is officially submitted to the board for review or a decision has been made, no more edits may be made to your package.  Any changes needed afterwards would require an amendment.