Application Review

I am a reviewer, where do I go to review protocols?
As a committee member, it is important to pay attention to the symbols on the Submission Manager page of IRB Net. They all help guide member to efficiently address items which need their attention.

ROLES & PERMISSIONS

If I am both a PI and Committee   Member are my User ID and Password the same?
Yes. You will have tabs/buttons for both Submission Manager (Committee   Member) and My Projects (PI) to navigate once you login.

Forms and Templates

Where can I find the Application Forms?
You can find the Application Forms for each committee under the “Designer” section of a specific project. Once in the Designer section, click “Add New Document” at the bottom of the page. Under the second box titled “On-Line Document,” select the “Rice Application Form” for the specific committee that you are applying to and click “add” and follow the prompts to complete the form.

When do I need to complete the Online Application Form?
You need to complete and submit “IBC Application” when:

  • You are submitting a new Initial Application to the IBC.
  • If your project existed before the switch to IRB Net, you will need to complete and include the Online Application Form when you submit a Protocol Amendment Form or Continuing Review in IRB Net for the first time ONLY.
  • Any time you make a change to your research that requires a change to the Online Application Form Responses (i.e., change in personnel, study participants or species).

For more information on application forms, please view the IBC Readme Document. For assistance with completing forms contact your compliance administrator.

You need to complete and submit “IACUC Application” when:

  • You are submitting a new Initial Application to the IACUC.
  • If your project existed before the switch to IRB Net, you will need to complete and include the Online Application Form when you submit a Modification Form or Continuing Review in IRB Net for the first time ONLY.
  • Any time you make a change to your research that requires a change to the Online Application Form Responses (i.e., change in personnel, study participants or species).

For more information on application forms, please view the IACUC Readme Document.

IRBNet has created duplicate Online Application Forms within my package Designer, what do I do?

Duplicate application forms are created when the user clicks back in the browser bar instead of using the previous and next buttons within the IRBNet document wizard. If you happen to duplicate the application form, delete all forms that are designated as incomplete. If you are not sure which one to delete, usually the application with the oldest chronological date is the most complete. However, it is important that user reviews each duplicate and select Save & Exit to return to the designer. By selecting Save and Exit this will designate which forms have been completed making it easier to determine which duplicated forms need to be deleted.

Messages and Notifications

What are Messages and 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.

How do I notify the Compliance Administrator the I have made the necessary modifications?
Once you have completed the modifications requested by the Committee, you must Mark Revisions Complete to notify the Committee that they may continue the review of your application. To do this, select the appropriate project from the “My Projects” list then go to the Designer page, located on the left hand side. At the top of the designer page view, you will see “This package is” followed by the lock status: 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.”

When will I receive expiration notices on my protocols?
60, 30, 15, and 1 days prior to and the day of the expiration date, IRBNet will send automated messages informing the PI of the upcoming expiration of their Expedited or Full Board protocols. The expiration date is 1 year following the issued approval date. At that point, any expired protocol must have a continuation request approved by the compliance committee or the research must stop.
If you feel you are receiving these notices in error, please contact the Research Compliance Administrator.

Where are my research protocols that were submitted before IRBNet?
Any research protocols that were submitted prior to the implementation of IRBNet are recorded in within the IRBNet system under my projects. However, the completed application is stored in archives. To access these protocols you can search within your project dashboard by the protocol title, PI Name or by the previously assigned protocol number. During this transition period, protocols that were approved prior to the launch of IRB Net will be listed but no supporting documents (i.e., appendices, forms and paper application forms) will be included in the project. If you need to amend a current project or submit a renewal application you must click “Create New Project” and complete the submission process. We do not need any of your previously approved documents as they are stored in our archives.

Project Submission and Status

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 project team members including student researchers, so please be sure that all team members are registered in IRBNet before submitting the application for review.

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. NOTE: Write access should also be given to your compliance administrator who may need to access some of the project documents before it is submitted for review.

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.

First, make sure the staff member has created a user profile in IRBNet. Go into My Projects and select the study you wish to add staff to. Select “Share This Project” from the Project Administration menu on the left. On the next screen ensure that Rice University is highlighted and then click on the “Select Organization” tab. Then, at the bottom of the page you will see a search box to search for users by last name. Type in the first letter of the individual’s last name, any letter of their full name, or * to list all users and click on the

“Search” icon. Place a mark in the appropriate level of access next to the research team member’s name and click on the “Save” icon. Continue these steps until all members of the research team are given shared access.

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 Rice University MUST have their own unique username and password.

How do I Sign a Project within IRBNet?
To Sign a Project, after selecting the appropriate protocol from the “My Projects” list then click “Sign This Package” under the Project Administration menu on the left hand side. Then, in the drop down box next to your name, select your affiliation with the project (i.e. Principal Investigator, Lab Manager, for student researchers use Other Signatory) and click “sign” at the bottom of the screen. Please remember to sign the package you must use the Password that you created at the time of registration not your Rice NETID password. NOTE: The project must have been shared with you in order for you be able to view and sign.

How do I know if a project is ready to submit to the committee for review?
Before submitting your research protocol all of the following must occur:

  • Completed Application Form using the Online Document
  • Supplementary Documentation has been uploaded to the project. This includes all appropriate forms and appendices.
  • Project has been shared with the necessary users (Please share your project with all personnel listed so they can submit electronic signatures)
  • Project signed by all personnel listed on the protocol
  • Necessary training and credentials are linked to the protocol. ATTENTION: Incomplete protocols will not be reviewed by the compliance committee. If an incomplete protocol is submitted, further information will be requested by the Compliance Administrator, the project will be unlocked and can not move forward in the process until all modifications have been satisfied and revisions are marked complete in the project.

How do I submit a project on IRBNet?
To submit a project on IRBNet, find the Project Administration from the Project overview screen and click “Submit This Package on the left navigation pane.” Then, under Search for Organization, find Rice University. Now, you should see three different options. Please select the option that applies to you (i.e. for human subject research, select “Rice University IRB).” Then select your Submission Type (i.e., new project, amendment, continuing review) and any enter any comments you wish to include. Finally, click “submit.” Projects cannot be deleted after they are submitted for review and are automatically locked from editing upon submission.

NOTE: Please be careful when selecting where to submit your project to as there are three review boards at the Rice University, the IRB  (human subjects only), the IACUC (animal research only), and the IBC (this is research involving recombinant DNA and hazardous materials). 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 and APPROVAL.

What is the Lock Status? What does Locked and Unlocked mean?

  • Locked: A project has been submitted and is currently under review by the Committee.
  • Unlocked – Revisions Pending: The Committee decided that revisions must be made to a project. By unlocking, the Committee has stopped their review until the appropriate edits are made.
  • Locked – Revisions Complete: The investigators have addressed the requested modifications so the Committee can continue their review.

Can you Unlock my package?
Packages may only be unlocked for editing prior to being provided to the committee member(s) for review. Packages automatically Lock upon submission. To request a package be unlocked you must “Send Project Mail” to the administrative staff, indicating why you are requesting the Lock to be removed.

Training

How can I get training on IRBNet?
To sign up for training please visit the IRBNet Training  page on the IRBNet Blog, you can also contact the eRA training Specialist to schedule 1-on-1 or group training sessions. Also, there are several training resources and videos available on the IRBNet website to access these documents or view these videos visit the IRBNet Resources, click on Resources and use the following information to login:

User: rice
Password: training

Does IRBNet have the ability to track my CITI and EHS training?
Currently, the only staff training that is automatically tracked by IRBNet is CITI. You can link your Citi Training to your IRBNet Profile by entering your CITI ID Number. Any other training and credentials including EHS Lab Safety Training you will be responsible for uploading the training certificates to your IRBNet User profile. Contact the Environmental Health & Safety Office for more information about EHS training certification.

Does each individual need to upload their own training certificates?
In the past, it was possible for a coordinator to collect and send a stack of training certificates to the office for several individuals at one time. It is now the responsibility of each researcher, faculty or staff, to load their own training certificates into their own profile.

When will research staff be expected to have their training certificates on their IRBNet profile?
Each research staff should load a copy of their training certificate onto their user profile as soon as the training is completed.

Who reviews the training and credential documents once they are submitted?
The Rice University Compliance Administrator receives and reviews all submitted documents.

Email notification, when does it happen?

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All users receive an activation email when they register for the National Research Network.

A researcher with any level of access will receive an email when they are granted project access.

A researcher with Full Access (also known as Project Owners) will receive an email when:

  • The package status is changed to reflect a committee decision
  • A Board Document is published within a package
  • A fellow researcher signs the package
  • The package is unlocked (committee administrators can choose not to send this email)
  • The Project Expiration date is upcoming (this is a committee specific configuration)

Submission Coordinators will receive an email when:

  • A package is submitted to their committee
  • An unlocked package is marked “Revisions Complete” by the research team
  • Reviewers mark their personal review complete (if the Reviews Complete alert tool is used)
  • Another committee records a decision on a package also submitted to their committee (this feature may be turned off for particular committees)
  • The Project Expiration date is upcoming for a project submitted to their committee (this is a committee specific configuration)
  • A Training & Credential Record is submitted (only Training & Credential administrators will receive this email, and only if the submitter chooses to send a message)

Committee Members will receive an email when:

  • They are given access to a submission through sharing (committee administrators can choose not to send this email)
  • Access to a submission is taken away (committee administrators can choose not to send this email)

Email notifications are NOT sent when:

  • A researcher’s existing access level on a project is changed or removed
  • A Board Document is drafted.
  • The Submission Coordinator publishes a meeting agenda.
  • The Submission Coordinator publishes meeting minutes.

All emails generated within IRBNet are automatically archived on the system and are always available within the project they are associated with. If the email involves the research team, it can be accessed via the “Messages & Alerts” page. If it is a committee specific email, it can be accessed via the “Committee Messages” page.

 

Project Package?

Q: I cannot create a new package for my project. Why is that?

A: You can create as many packages for your project so long as all of your previous packages were submitted and locked. In other words, if there is any package that is not in “locked” status, you won’t be able to create a new package until the “unlocked” package is complete and submitted.

New User Registration

IRBNet New User Registration guide with screen shots (PDF)

How do I register for IRBNet?
To register, go to www.irbnet.org. At the top right of the screen, under the log-in box, click on the link that says “New User Registration” and fill in the information requested. At the time of registration, use your NETID but do NOT use your Rice password. This should be something that you can easily remember because you will need this password to be able to sign projects electronically. After receiving the confirmation email, you can login using your NETID and password you chose, but the password that you created will always be used to sign IRBNet Application Packages.

How Do I Activate My Account?
When you receive your activation email, click the link in the email. You will be taken to the IRBNet login page.

I registered for IRBNet but it still isn’t allowing me to enter the site. Can the Electronic Research Administration fix this?
Once you have registered for IRBNet, you will be sent a confirmation email. You must click a link that is included in the email to finalize your registration process. Your login information will not work until this step has been completed.

How do I learn more about IRBNet and the protocol submission process?
To learn more about IRBNet please review the IRBNet Resources available on the blog. In addition, training for Students, Staff and Faculty are provided on an ongoing basis. To sign up for training please visit the IRBNet Training Page  you can also contact the eRA training Specialist to schedule 1-on-1 or group training sessions.

I have never used IRBNet before. Is there anyone available to help me with a submission?
The electronic Research Administration has several resources available online at irbnet.rice.edu. You can also register for Classroom or 1-on-1 IRBNet training. Finally, you can contact the eRA Help Desk for assistance with IRBNet or your Compliance Administrator for assistance with protocol or registration application preparation.

When you register for the first time on irbnet.org:
User ID – If possible, please use your Rice Net ID so that we know who you are*.
*This does not apply to committee reviewers. 
Password – NEVER use your Rice account or bank account password. Please use something that you can easily remember.

Review Complete Alert Tools

The tools allow submission coordinators to set up automatic alerts and be notified when individuals or groups of reviewers have marked their personal reviews as complete (on the Reviewer Comments page). Both “Individual” and “Group” alerts can be set up on the Share Submission page (accessible from any Submission Detail page).

  • Review Complete alerts may be set by anyone with administrative access to a specific submission package.
  • Alerts are sent to all submission coordinators and individuals shared with Admin access on the specific submission package.
  • Any reviewer/administrator shared on a submission may either have their “Individual” alert activated, may be part of the “Group” or can have no alert at all.
  • If an “Individual” alert is activated for any user, an alert will be triggered when that individual has marked their personal review complete (check box).
  • If one or more users have been set up under a “Group” alert, then an alert will be triggered only when all of those individuals have marked their personal reviews as complete. Only one “Group” can be set up for a given submission.
  • When an alert is generated, you will immediately see a My Reminders flag on the Submission Manager (with an associated email).
  • Alerts are set up at the submission package level; alerts set up for one submission are completely unrelated to alerts set up for any other submission.

How to use:

  • On the “Share Submission” page, turn alerts on and off for any individual who has access to a submission by simply clicking the individual’s alert icon
  • Click multiple times to toggle between “Individual” and “Group” alerts

Uses might include:

  • Notify administrators when a specific Expedited Reviewer, Attending Veterinarian, or other specialist has completed their review
  • Notify administrators when all Expedited Reviewers have completed their reviews
  • Notify administrators when all Primary and/or Secondary Reviewers have completed their reviews
  • Notify administrators when a particular administrator or staff member has completed their pre-review or administrative review

SOPs:

  • Administrators should silence all My Reminder flags on a given submission at the time it is shared with reviewers or at the time the it is to an agenda date, whichever occurs first. This will ensure there are no lingering reminders so that when a “Review Complete” alert is generated it is immediately evident.
  • Successful use requires reviewer commitment to marking reviews complete. If you find your reviewers are not consistently marking their reviews complete, this may be an opportune time to remind your reviewers of the proper procedure.