IRBNet @ RiceI 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.
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:
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:
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.
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.
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:
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?
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.
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.
Transitioning to IRBNet has enabled Rice University to have a completely electronic application process for Compliance. All of the forms you need to complete your Compliance Submission Package are in IRBNet. With the exception of the compliance committee applications, all templates are located in the IRBNet document library. Be sure to select the right committee (IACUC, IBC or IRB) to access the appropriate forms for that committee.
The actual application can only be access from the Document Wizard within IRBNet after a New Project or Subsequent Package has been created.
To access the electronic application form select Designer from the Project administration screen then click on Add New Document. From there access the On-line Document at the bottom of the screen and select the appropriate form from the dropdown menu.
Use Rice University IRB Protocol for IRB submissions and Rice University IACUC/IBC Applications for submission to the IACUC or IBC.
Questions? Contact the eRA Help Desk
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:
Submission Coordinators will receive an email when:
Committee Members will receive an email when:
Email notifications are NOT sent when:
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.
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.
Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants participation in the research, whether or not considered related to the participant’s participation in the research. Adverse events can be both physical and psychological harms and however they occur most commonly in the context of biomedical research, occasionally, they can occur in the context of social and behavioral research.
These can be anticipated or unanticipated.To determine whether an adverse event is an unanticipated problem, the following questions should be asked:
If the answer to all three questions is yes, then the adverse event is an unanticipated problem and must be reported to appropriate entities under the HHS regulations at 45 CFR 46.103(a) and 46.103(b)(5).
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