1. 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. NOTE: This log-in is NOT RELATED to your DU ID. You may create any username and password that you like; however, we recommend using a simple first name, last name or first initial, last name combination.
2. How will I be able to access existing approved studies from eProtocol in IRBNet?
The transition for each study is "event-based" and may differ somewhat for each Board or Committee. In general, at the time of your next submission "event" - continuing review, amendment, reportable event, etc., your existing study documents will be uploaded to IRBNet and the project will be "shared" with the study PI. Once this has been shared, PI's should remove the Research Compliance Office from the protocol and then share it with any additional study personnel.
For guidance specific to each Board or Committee, please see materials on IRBNet or the Research Compliance website.
3. Where can I receive training on how to use IRBNet?
The Office of Research Compliance will continue to schedule training and orientations sessions across campus and advertise these on the website. In addition, ALL Researchers will be able to self-train using online training materials (videos, read-me documents, and PowerPoints) that will be available on the website and via WebCentral. Step-by-step user guides and other resource materials on how to submit to the IRB and manage project accounts will be available to all researchers.
Please Do Not Request A Demo from the IRBNet Homepage. This is Not a training application and it will not be helpful to you.
4. How can I access my documents that were submitted through eProtocol?
Up until June 30, 2013, you may log into eProtocol, as you have done in the past. After this date, you must contact the firstname.lastname@example.org in the Office of Research Compliance.
The materials on the "Forms and Templates" page and in the Document Library do not appear to apply to me.
All three of DU's research compliance committees submit protocols through IRBNet. Please make sure that you have selected the correct document library from the drop down menu. For example, for human subject research, the drop down should read "University of Denver (DU) IRB – Documents for Researchers"
5. When is a project ready to submit in IRBNet?
A project is ready to submit in IRBNet when the following have been completed:
1) All application forms have been completed (this includes the DU IRB SmartForm checklist)
2) All protocol specific forms and attachments have been uploaded to IRBNet
3) All signatures have been obtained (PI and Faculty Sponsor – when applicable)
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. Naturally, this slows down the review process.
6. What is the Lock Status? What does "locked" and "unlocked" mean?
7. 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.
8. 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 Denver (Colorado Seminary) 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 Question 17.
9. 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 Denver (Colorado Seminary) MUST have their own unique username and password.
10. 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) 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.
11. I am a faculty Sponsor. What level of access should I receive and how should I classify myself when I sign an application?
As a Faculty Sponsor, you must be given "Full" access. This will allow you to view all documents, sign, and get emails about every action taken on each project.
When signing, please select "Advisor" as your affiliation with the project.
10. How do I submit a project on IRBNet?
To submit a project on IRBNet, find the Project Administration menu and click "Submit This Package." Then, under Search for Organization, find the University of Denver (Colorado Seminary). Now, you should see three different options. Please select the option that applies to you (i.e. for human subject research, select "University of Denver IRB (DU 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."
NOTE: Please be careful when selecting where to submit your project to as there are three review boards at the University of Denver, the IRB (human subjects only), the IACUC (animal research only), and the IBC (this is research involving recombinant DNA). 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.
11. Pre-review revisions have been requested by the Research Compliance Office. How do I change documents previously submitted?
When making changes to documents within IRBNet, we request that you remove the old documents and upload and rename the new ones. This will accelerate the process if the changes are clear to our reviewers. For example, you need to make a revision to Section 6 of your Research Narrative. Go to your hard drive, make the necessary changes, and upload the document onto IRBNet. Title the document "Research Narrative REVISED." Remember to delete the original application to avoid confusion.
12. I have completed the pre-review revisions requested by the Research Compliance Office. How do I Mark Revisions Complete?
Once you have completed the modifications requested by the IRB, you must Mark Revisions Complete to notify the Research Compliance Office 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."
13. Glossary of Terms in IRBNet
IRB SPECIFIC FAQs for IRBNet
14. Where can I find the DU IRB Application Form?
You can find the DU IRB Application Form 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 "DU IRB Application Form" and click "add" and follow the prompts to complete the form.
15. When and why do I need IRB Application Form?
You need "DU IRB Application" when:
You are submitting a new Initial Application to the IRBIf your project existed before the switch to IRBNet, you will need to complete and include the DU IRB Application Form when you submit a Protocol Amendment Form or Continuing Review (aka renewal) in IRBNet for the first time ONLY.Any time you make a change to your research that requires a change to the DU IRB Application.
16. What documents are needed in each package?
See detailed information in "Human Subject Researchers - Read me First Document"
¹There may be some exceptions to these requirements; however, and exception to, or alteration of, the consent or assent process requires that you complete the "Informed Consent Waivers and Alterations Form".
²Only needed if your protocol was reviewed by the full board and is now eligible for expedited review under expedited categories 7, 8 or 9.
³Only needed if you are making amendments to the protocol at Continuing Review.
4All approved documents must be submitted with updated package #. Currently approved documents being amended at continuing review should only be submitted in the tracked version.
LIST OF PROTOCOL SPECIFIC FORMS:
- RESEARCH INVOLVING MINORS
- INTERNATIONAL RESEARCH
- RESEARCH USING THE INTERNETWAIVERS AND ALTERATIONS OF INFORMED CONSENT (coming soon)
- RESEARCH INVOLVING PRISONERS (coming soon)
- RESEARCH INVOLVING PREGNANT WOMEN/FETUSES (coming soon)
- RESEARCH INVOLVING NEONATES (coming soon)
- RESEARCH INVOLVING NON-ENGLISH SPEAKERS (coming soon)
- RESEARCH INVOLVING SECONDARY/EXISTING DATA (coming soon)
- RESEARCH INVOLVING DECEPTION (coming soon)
- DEVICE USED IN RESEARCH (coming soon)
- BIOMEDICAL RESEARCH (coming soon)
Please also refer to General IRB FAQ's.