IRBNet FAQs

Frequently Asked Questions About IRBNet

Functions and Terms

Forms

CITI Training

Sharing, Signing, and Submitting

IRB Liaisons

 


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

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 has decided that revisions must be made to a project. By unlocking, the IRB has stopped their review until the edits are complete.
“Locked – Revisions Complete”
Green
The investigators have addressed the requested modifications and the IRB can continue their review.

 


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

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 are Messages & Alerts in IRBNet? Back to Top

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? Back to Top

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 documet on your computer. Once the documents has been revised, save it to your computer. Click the pencil icon to upload the new, revised form.

 


Glossary of terms in IRBNet Back to Top

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 of the Principal Investigator.
Package
Each project submitted to IRBNet is a package. Each package has its own unique package number. Each time a new submission is made, you submit it under the same package number, but the submission number will change For example “123456-1” is an Initial Application. If you submitted an Amendment, the number would change to “123456-2”.
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, this will be your previous IRB approval number. This will help the IRB Office link your IRBNet submission with your previously approved transactions.
Amendment
This is the new term for Addendum.
Continuing Review/Progress Report
This is the new term for Renewal.
Department Representative
This is the new term for IRB Liaison.

 


What documents are needed in each package? Back to Top

Application Type
IRB Application Part 1
Applications (i.e. Initial, Renewal, Addenda)
Consent Form or Waiver of Consent
Principal Investigator Signature
IRB Liaison Signature
Initial
Yes
Yes
Yes
Yes
Yes
Amendment
No
Yes
If changes to consent form, yes
Yes
No
Continuing Review
No
Yes
Yes
Yes
No
Human Subjects Research Determination
No
Yes
No
Yes
No

 


Where can I find IRB Initial Application Part 1? Back to Top

You can find IRB Initial Application Part 1 under the “Designer” section of IRBNet. NOTE: To access the Designer page, you must be within your project on IRBNet (click the title of the project under My Projects) for the Project Administration menu to appear on the left side of your screen. Once in the Designer section, click "Start a Wizard" at the bottom of the page. Under the second box titled "On-Line Document," select IRB Application Part 1 and click “add” and follow the prompts to complete the form.

 


What is a Waiver of Consent and where do I find this in IRBNet? Back to Top

A Waiver of Consent is a request to waive/alter some or all of the informed consent elements. If you wish to do this, please address the following four points found here.

 


My project has been approved in IRBNet. How do I get my consent forms? Back to Top

To obtain consent forms, 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. When creating or editing your consent form, please provide the most recent IRBNet package number at the bottom, right corner of the consent form. This ensures you are using the most “up-to-date” version of the form.
 
To find your IRBNet package number, go to the MY PROJECTS tab and click on the title of your project. In the PROJECT OVERVIEW page, your IRBNet package number will be listed at the top, next to your project title.

 


How do I submit an amendment or a continuing review application? Back to Top

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.

For step by step instructions on how to submit an amendment or contrinuing review application, please click here.

 


How do I complete the CITI training and what CITI certification is required? Back to Top

To complete the CITI training, please register at www.citiprogram.org and affiliate with the University of Maryland, College Park.

The required course is under Question 1 – Human Subjects Research. Please choose the course titled Biomedical Research Investigators or Social & Behavioral Research Investigators. Both of these courses will provide you with the CITI Basic/Refresher course.

For step by step instructions please click here.

 


Where do I find my CITI certificate? Back to Top

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.

*Please NOTE: Your CITI Username and Password are not linked to your UMD ID.

 


Who is required to link their CITI certificate to a project? Back to Top

All investigators and co-investigators listed on Application Part 1 must link their CITI training to the project. This includes faculty advisors when a graduate student is listed as the Principal Investigator. Department Liaisons are not required to link their CITI certification to the project.

*Please 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? Back to Top

For step-by-step instructions on how to link your CITI certificate, please click here

 


What does it mean to Share a Project? How do I share my projects with other investigators? Back to Top

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 Maryland – College Park (UMCP) 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? Back to Top

If you cannot find someone within IRBNet, this means that they have not yet registered with IRBNet. Every member at the University of Maryland – College Park MUST have their own unique username and password. The IRB Office will not create a username/password for any member of our research community.

 


How do I Sign a Project within IRBNet? Back to Top

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.

 


How do I submit a project in IRBNet? Back to Top

To submit a project on IRB Net, find the Project Administration menu and click “Submit This Package.” Then, under Search for Organization, find the University of Maryland – College Park. Now, you should see two different options for University of Maryland – College Park. Please select “University of Maryland College Park (UMCP) IRB.” Then, select your Submission Type (i.e., new project, amendment, continuing review) and any comments you wish to include. Finally, click “submit.” NOTE: Please be careful when selecting where to submit your project to as there are two review boards at the University of Maryland, the IRB (human subjects only) and the IACUC (animal research only). 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.

 


When is a project ready to submit in IRBNet? Back to Top

A project is ready to submit in IRBNet when the following has been completed:

(1) All application forms have been completed.

(2) All appendices have been uploaded to IRBNet.

(3) All signatures have been obtained (PI and IRB Liaison for Initial Applications, PI for Continuing Review and Amendments).

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 stalled until you address the modifications and mark your revisions complete. Turning in an incomplete application will slow down the review process.

 


When does my IRB Liaison need to sign my project? Back to Top

The initial application is the only application that needs to be signed by your IRB Liaison.

 


How do I find out who my IRB liaison is? Back to Top

To find your IRB liaison, please click here to search our list of IRB liaisons. If your department does not have a designated liaison, please contact your Department Chair to act in this role for your submission.

 

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