Skip to Knowledge Base content

WVU+kc IRB Protocol Module FAQ

Overview:

The IRB Protocol module of the Kuali Coeus electronic research administration tool, known as WVU+kc, allows for the creation and submission of human subject research protocols and review by the WVU Institutional Review Board (IRB). WVU implemented this module of Kuali Coeus in March 2012. For more information about the IRB protocol submission and review process, see the Office of Research Integrity & Compliance website.

Are there any help documents or training guides available for submitting IRB protocols in WVU+kc?

Yes, there is an overview video as well as training documents located on the ITS Training WVU+kc IRB Protocol module resource page.

How do I gain access to WVU+kc in order to submit an IRB protocol?

Training is required before you will be able to create an IRB protocol in WVU+kc. Submit a request for IRB protocol creator access. Upon submitting your request, you will be provided with a link to this training video that explains how to submit a protocol, create and submit amendments/renewals, search for protocols, and other various functions of the IRB Protocol module.

How do I create an IRB protocol?

A protocol is created by clicking on the Create IRB Protocol link located in the IRB section of the menu bar.

Will my protocol data be secure?

Yes, the data will be protected and only the users with proper security will be able to view and maintain their own data.

How do I find a saved protocol that I have not submitted?

Navigate to the Lists section at the bottom of the dashboard and click on the IRB module on the left hand side. The Submitted to IRB section will have all of your protocols that are pending/in progress. Click on the pencil to continue editing your protocol.

Additionally, you can search for a protocol via the Search Protocols link located in the IRB section of the menu bar.

The IRB Protocol Simple Search can be used to identify protocols by number, title, and/or investigator (including aggregators). If you do not know the protocol number, enter your last name (e.g., Griffith) in the Search Terms field to initiate a search that will find all of the IRB protocols with which you are associated. Protocols that have not been submitted will have the status of Pending/In Progress. Once the appropriate protocol has been located in the search results, click the edit link to continue edits.

My IRB protocol says that it is locked for editing. How do I unlock it?

Only one person is able to edit an IRB protocol at a time. If you login to your protocol and see a message that it is locked for editing by someone, that person may currently be in the protocol editing it. For information about unlocking an IRB Protocol, see the IRB Protocol Document Locked for Editing article. 

What is a Disclosure of Interest in Research form?

All conflicts of interest in research must be reported to the Office of Research Integrity and Compliance via a Disclosure of Interest in Research form which can be completed online. A confirmation email received from the WVU COIR Office can be uploaded and attached to a protocol's personnel but this attachment is not required. For more information about conflict of interest in research, see the ORIC website.

What information do I need to provide in the PI Qualifications statement?

PI qualifications must be provided for all principal investigators. Describe your current position at WVU, indicate how many years of experience you have, and provide any previous experience you have in the field of research proposed in the protocol. This information should be a brief statement, no longer than a paragraph and should be entered in the Person Details section for the PI on the Personnel page. A full CV or resume may be attached in the Attachments section for each person but that attachment is not required.  

I am supervising a doctoral student's research, how should the student and I be added as personnel on an IRB protocol?

Only faculty or staff with organization-paid appointments at WVU may serve as principal investigators or as faculty sponsors on a research project involving human subjects. Students may not serve as PIs; however, a student can initiate an IRB protocol document within WVU+kc. When adding personnel to such a protocol, the faculty advisor should be added as the PI. The student should be added as both the Co-I and Primary Study Contact.

Note: When a student submits an IRB protocol, the faculty advisor (PI), will need to approve the protocol before it will route to the ORIC. 

I can't find my lead unit/department number.

When searching for a department, enter a particular word from the department. For example, if searching for Curriculum and Instruction, enter "curriculum" or "instruction" in the field and click search. All departments in WVU+kc whose name contains curriculum or instruction will populate.

If my funding is pending, do I need to list it in my IRB protocol submission?

Funding information can be added to IRB protocols in two places. First, in the Funding Sources section located on the main Protocol page. Select if the funding is pending (Development Proposal) or has been awarded (Award). You will be able to search for and select either a submitted proposal or award within the WVU+kc to attach to your IRB protocol. Additionally, if working with a private/non-profit funding source, be sure to provide the contact name and billing address for the sponsor on the Questionnaire page in the Funding Sources section.

How do I approve an IRB protocol?

If you are a PI or department approver and need to approve a protocol, navigate to the Protocol Actions page and click the approve button. If disapproving the protocol (or returning it to the PI for revisions), enter the reason for disapproval and the protocol will be sent back to the PI to make the requested revisions For more information, see the Approving an IRB Protocol article.

I am a unit administrator/department chair, do I need to approve my own IRB protocol submission?

If a department chair/unit administrator submits an IRB protocol as a PI, the protocol will automatically route to the ORIC for review without an additional approval needed.

What do the IRB protocol statuses mean?

  • Active-Closed to Enrollment indicates the protocol has been approved by the IRB, is currently active, but is closed to accrual of subjects.

  • Active-Open to Enrollment indicates the protocol has been approved by the IRB, is currently active, and is accruing subjects.

  • Amendment in Progress or Renewal in Progress indicates that an amendment or renewal has been created and is currently being edited but has not been submitted to the IRB for review.

  • Closed Administratively or Closed by Investigator indicates that the protocol has been closed and is no longer active.

  • Exempt – Acknowledged indicates an exempt protocol has been approved by the IRB.

  • Expired indicates that the protocol has expired and is no longer active.

  • IRB Review Not Required indicates that the protocol is a non-human subject research project and does not require review by the IRB.

  • Pending/In Progress indicates a protocol that is currently under development and has not been submitted to the IRB for review.

  • Recalled in Routing indicates that a protocol was submitted and was in the process of obtaining approvals before reaching the ORIC but was withdrawn by the PI or an aggregator for additional revisions.  If a protocol is recalled in routing for edits, it will have to receive all appropriate approvals again once resubmitted.

  • Routing Protocol indicates the protocol has been submitted but may be pending approval from a PI, department, or location approver and has not been reviewed by ORIC or IRB.

  • Specific Minor Revisions Required or Substantive Revisions Required indicates the protocol was submitted to the IRB, reviewed, and returned to the PI to make specific revisions.

I submitted my protocol but have not heard back from the ORIC or IRB. What is the status of my submission?

Once an IRB protocol has been submitted, it will enter into routing and depending on who submitted the protocol, there will be several approvals that need to take place before the protocol will reach the ORIC including departmental, biosafety, or radiation. To check the status of your protocol, navigate to the Route Log located on the Protocol Actions page of your protocol. The Pending Action Requests section will indicate who needs to take action on the protocol. Once submitted to the ORIC, the Pending Action section will display the names of the staff of the ORIC.

How do I find my approved protocols?

Navigate to the Lists section at the bottom of the dashboard and click on the IRB module on the left hand side. The Active Protocols tab will display all of your active, approved protocols.

Additionally, you can search for a protocol via the Search Protocols link located in the IRB section of the menu bar.

The IRB Protocol Simple Search can be used to identify protocols by number, title, and/or investigator (including aggregators). If you do not know the protocol number, enter your last name (e.g., Griffith) in the Search Terms field to initiate a search that will find all of the IRB protocols with which you are associated. Protocols that are approved will have one of these statuses: Active-Open to Enrollment, Active-Closed to Enrollment, IRB Review Not Required, or Exempt-Acknowledged. Once the appropriate protocol has been located in the search results, click the View link to view the protocol or the Edit link to submit a renewal/amendment.

My IRB protocol is approved. Where do I find the approval letter?

When you receive email notification that your IRB protocol has been approved, there is a link within the email that will take you directly to your approval letter. If you misplace your email, log into WVU+kc, search for, and open your protocol. After opening your protocol, navigate to the Protocol Actions page and open the Correspondence section to see all correspondence associated with your protocol, including approval letters and revision requests.

How do I create an amendment or renewal for an approved IRB protocol?

Navigate to the Lists section at the bottom of the dashboard and click on the IRB module on the left hand side. The Amend or Renew tab will display all of your protocols that are eligible to have an amendment or renewal submitted. Please remember that only one amendment or renewal can be submitted at a time per protocol, so if an active protocol is missing from this list it is most likely because you already have an amendment or renewal pending for it.

How do I cancel/delete/close the amendment on which I am working?

Navigate to the Protocol Actions page and in the Request an Action section, select Delete Protocol, Amendment, or Renewal. Provide a description for the reason you want to delete the amendment and click the submit button. WVU+kc will confirm if you want to delete the amendment. Click yes. This action only deletes the amendment, not the entire IRB protocol. The number that is displayed should have an A suffix such as A002 to indicate that you are deleting an amendment and not the original protocol.

How do I add a non-employee to an IRB protocol?

If you are working on an IRB protocol and need to add a non-employee to the Personnel page, there are two options. First, if the employee will need access to WVU+kc to make edits to the protocol, a special WVU Login account must be requested. Second, if the person does not need access to WVU+kc, search for the person in the Non-WVU Person Search. If the person needs added to the database of non-employees, click on the link to add a new Rolodex entry into the Address Book. For more information, see Non-Employee Needs Added to IRB Protocol.

For additional information, check these categories in the Knowledge Base:

Human Subject Research Articles

Research Articles

Need assistance? See the following related services:

Research Requests

Research Administration Requests

 

 

Details

Article ID: 10626
Created
Fri 1/8/16 12:05 PM
Modified
Fri 10/13/17 10:51 AM

Files (1)