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University of Kentucky E-IRB Information

To jump to a topic, click on your choice in the menu below:

Introduction
Frequently Asked Questions
Video Tutorials
Known Issues for Researchers/IRB

Online Training Schedule

News and Updates
E-IRB Features
Tips and Recommendations

Introduction: Vice President for Research Statement

Consistent with the University of Kentucky’s (UK) mission, vision, and values, the Office of the Vice President for Research (VPR) provides programs and services to facilitate research, as well as support UK faculty, staff and students in research development and submission. 

The VPR has invested available resources for Research Information Services (RIS) and the Office of Research Integrity (ORI) to develop a Link Blue-secure, customized, web-based system aimed at giving the human research community a paperless experience without compromising the university's high standards for compliance with federal regulations and institutional policies for human research protections.  This platform has formed into what is now called “E-IRB”, use of which will be mandatory for submission of human research activity proposals falling under the purview of the UK Institutional Review Board (IRB) once the system has been finalized for full production.

This web-based system will provide users with robust reporting capabilities as well as increase the efficiency of internal transactions that require authorization (UKIT Business Procedure Manual, Q-1-6), and reduce the environmental impact of paper use.

We appreciate everyone’s support in this endeavor.

Lisa A. Cassis, PhD,
Vice President for Research
=====================

For updates and information about the UK E-IRB system, please bookmark this web page and come back and visit, and/or contact Billy Clark, Director of RIS, at billy.clark@uky.edu or Judi Kuhl, E-IRB System Administrator, at Judi.Kuhl@uky.edu .

 

Video Tutorials - to aid in the navigation and use of the E-IRB system

Log-in to the private E-IRB Video Library using your Link Blue ID and password to see video tutorials on how to:

  • Create a new application
  • Change Principal Investigator
  • Complete assurance statement as a Dept. Authorization or signee
  • Manage attachments
  • Add Non-UK Personnel
  • and more!

News and Updates

  • October 23, 2017: The E-IRB Pilot Phase has been expanded to include mandatory participation for Initial Full and Initial Expedited reviews for the College of Dentistry and the Markey Cancer Center. Participation in the Pilot phase for importing existing applications begins Nov. 1 for the units who started piloting in June 2017. Of course, anyone with patience, cooperation, and interest in participating in the pilot on a volunteer basis is welcome!
  • June 22, 2017: All new Exemption applications are required to be submitted in E-IRB while the E-IRB Pilot Phase continues for Initial Full and Initial Expedited reviews with mandatory participation as agreed by the Departments of Surgery, Neurology, and the College of Communication and Information.
  • May/June 2017: Link to the live E-IRB system will become available to the UK research community for mandatory submission of Exemption Applications effective June 21, 2017.  Initial Full and Initial Expedited review applications will continue in the Pilot Phase until further notice. Trainings are being offered for those participating in the pilot phase and for those who will be submitting exemption applications; see online training schedule below.
    • E-IRB Pilot Phase details in a nutshell:
      • Purpose: Allows the system to be used in a live environment by select users from submission to approval.
      • Method: This is live data and there is no longer a separate paper/email backup for the users.
      • Timeline: In progress. Completion will be based on the success level of users participating in the Pilot Phase, and when Research Information Services (RIS) implements the remaining components needed to round out the system.

  • March/April 2017: E-IRB is currently in the pilot phase. This means the system is live for a handful of trained researchers, and initial review applications are being accepted while RIS continues to work on other components of the E-IRB system.

  • 2016: The Office of Research Integrity (ORI) has been conducting extensive internal testing for the last several months, and RIS is on a schedule for responding to that feedback. Meanwhile ORI staff will be branching out to test E-IRB with a handful of IRB members at the end of October 2016. Further external testing will then be scheduled based on RIS's ability to implement necessary changes.

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Features of the E-IRB system

E-IRB Slideshow [PPT]

Known Issues

These documents summarize issues users may encounter and what workarounds are available to minimize or avoid problems. The lists are a work in progress so periodic review is recommended.

Known Issues for Researchers [PDF]

Known Issues for IRB members [PDF]

Frequently Asked Questions (FAQs)

Basic system questions:

When will I be able to use the E-IRB system to enter and submit my IRB application?
How do I access the E-IRB system?
How and when will my current IRB approved protocol(s) get into the E-IRB system?
Will I be able to access E-IRB when I am out of town or off-campus?
Will I be able to print my application?
What web browsers and/or platforms will I be able to use to get to E-IRB?
Who will have access to my protocol information in E-IRB?
Will my Human Research Protections (HRP) Training information be tracked in E-IRB?
Why isn't there a link to the E-IRB system in the notification e-mails I receive?
How do I change my name and/or contact information in E-IRB?

Navigation and procedural questions:

How do I know when my submission has been approved, or when revisions have been requested?
Will I be able to insert photos or diagrams, or use standard formatting like bold, italics, underline,super/sub scripts in the Research Description text boxes?
How do I see all my currently approved study documents (e.g., approval letter, stamped informed consent documents, attachments, etc...)?
What do I do if my study personnel does not have a Link Blue account?
 


Basic system questions:

When will I be able to use the E-IRB system to enter and submit my IRB application?

Although there currently is not a specific start date for implementation of the new E-IRB system in its entirety (submission of just exemptions became mandatory June 21, 2017), the plan is to have it in full production by the end of the 2017. The pilot phase of E-IRB was launched in March/April 2017. Please re-visit this web page for news and updates.

How do I access the E-IRB system?

Only individuals with a Link Blue account will be able to access the E-IRB system. If an individual not affiliated with UK needs to work in the E-IRB system and he/she does not have a Link Blue account, one will need to be requested. If this is the case, please notify Judi Kuhl at Judi.Kuhl@uky.edu and provide the individual's full name, date of birth (UK HR requires DOB), and why he/she needs access to the E-IRB system. Note, requesting a Link Blue account for the purposes of E-IRB access will not necessarily give the individual access to all UK-secure networks; if access to secure networks University-wide are necessary, a Link Blue account will need to be requested at the individual's departmental level.

Note that only select individuals have access to the pilot version of E-IRB at this time -- when the system is ready for general use the link will be added to this page, the ORI home page, and it will be well publicized.

How and when will my current IRB approved protocol(s) get into the E-IRB system?

How:
For existing studies, the researcher will be responsible for importing some basic information from the 'old' electronic tracking system into E-IRB (via "Import Application" feature on the researcher Dashboard), and fill-in the incomplete application sections in E-IRB. This decision was made with the intent of optimizing accuracy of research records, but with full understanding that the researcher will be sharing some of the burden during the initial transition; other options taken into consideration were deemed even less ideal.

Entering an application in E-IRB may entail scanning and attaching materials that are not already in electronic format (e.g., Sponsor's protocol). Note: the entire history of a protocol will not need to be entered into E-IRB - just the most currently approved version. If the researcher has been prompted by a Continuation Review (CR) request, the completed CR report form will need to be attached to the imported application under the "Additional Information" section (detailed instructions will be available by video tutorial in the private E-IRB video library).

When:
The current line of thinking is to allow researchers the capability to enter their protocol as soon as E-IRB is in production, but there will not be a requirement to submit the application until Continuation Review (CR) is due; if some other event needs to be submitted to the IRB for review prior to the CR deadline (e.g., Modification Request, Protocol Violation, Unanticipated Problem/Adverse Event), researchers will be encouraged to submit the event(s) in the new system then on the imported application.

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Will I be able to access E-IRB when I am out of town or off-campus?

You will be able to access E-IRB if you have a secure connection to the Internet using a supported browser (Chrome or Firefox) and laptop (Mobile and tablet devices like your cell phone and iPad are not yet supported (Surface Pro works)).

Will I be able to print my application?

Yes. If you are PI or study personnel on the application, you can print to a PDF file anytime during or after the creation of the application (using the "Print Protocol" button in the blue application banner).

What web browsers and/or platforms will I be able to use to get to E-IRB?

RIS is recommending using desktop browsers running Chrome and Firefox for optimal user experience. IE 11 or higher may also be used with E-IRB, although during testing some display/formatting issues were noted and it is unclear whether those issues will be resolved before production. Mobile and Tablet devices like your cell phone and iPad are not yet supported (Surface Pro works). The system should function for both PC and Macs.

Who will have access to my protocol information in E-IRB?

When a researcher creates a new application, he/she will be able to add study personnel with specific authorizations (or "roles") on the study. The Principal Investigator will have complete control of the application and is the only one with "submit" capability for Initial Review, Modification Review, and Continuation Review. Other study personnel roles include "Editor" (Read, write/edit), and "Reader" (Read-only of an approved study). Each study personnel role will include an option to be a "contact" and receive E-IRB protocol e-mail notifications (e.g., if minor revisions/additional information is needed; when approval has been issued, etc...).

Others who may have access to your protocol in E-IRB are staff working under the auspices of the Office of the Vice President for Research (e.g., Research Information Services, Office of Research Integrity, IRB members), or officials of federal regulatory bodies (e.g., FDA, NIH).

Research Information Services is taking measures to provide a secure web-based system which prevents unauthorized access, and every effort will be made otherwise to keep confidential all research records maintained in E-IRB to the extent allowed by law. For University of Kentucky expectations on access to and use, see UK Administrative Regulation 10:1.

Will my Human Research Protections (HRP) Training information be tracked in E-IRB?

Yes.

ORI encourages PI's and study personnel to utilize CITI for their mandatory initial and renewal HRP training. See ORI's Mandatory Human Subject Protections Training web page for details.

Why isn't there a link to the E-IRB system in the notification e-mails I receive?

You may receive emails from individual ORI staff or co-workers with the E-IRB system link, but per RIS, for security purposes automated messages issued by the E-IRB system will not contain a link to the E-IRB system. It is recommended that you bookmark the E-IRB log-in page, or add a shortcut to it on your computer, for easy future access.

 

How do I change my name and/or contact information in E-IRB?

When you log-in to E-IRB and start a new application, your SAP account information will be the default contact information added to the application. If your name or contact information is incorrect, you will need to make changes through one or both of the following sources before E-IRB will reflect the correct information:

  • If your work address is outdated, you may edit your Personal Profile through the UK Employee Self Service web page: MyUK Portal
  • If your name has changed, you will need to submit a 'Name Change Form' to the Human Resources Benefits Office for entering into SAP.


Navigation and procedural questions:

How do I know when my submission has been approved, or when revisions have been requested?

The PI, and any study personnel designated on the application as "Yes" for 'Is Contact', will receive email notification to log-in to E-IRB to view the application in whatever the current status is.


Will I be able to insert photos or diagrams, or use standard formatting like bold, italics, underline, super/sub scripts in the Research Description text boxes?

No. At this time the technology available does not sufficiently accomodate special text in the text boxes. To compensate for this, attachment buttons have been strategically associated with certain Research Description topics so you can attach documents containing information/formatting not recognized by the text boxes. If you have content that applies to a particular topic of the Research Description, but there is not a corresponding attachment button, please attach the document(s) under Additional Information with a document description helpful in associating it with the applicable topic in the Research Description.


How do I see all my currently approved study documents (e.g., approval letter, stamped informed consent documents, attachments, etc...)?

    • On your Dashboard menu on the left hand side, click on the folder "Approved".
    • In the table displayed, click the protocol number for the application on which you wish to retrieve approved study documents.
    • Under the Application Links menu on the left hand side, select "All Attachments". A pop-up window will list all the documents for the currently approved IRB application. Use the blue down arrow to download/open the document you wish to view.

What do I do if my study personnel does not have a Link Blue account?

If study personnel do not have a Link Blue account they are considered "Non-UK" personnel.

Non-UK personnel who need access to the E-IRB application materials will need to acquire a Link Blue account. To acquire a Link Blue account contact Judi Kuhl at judi.kuhl@uky.edu to request one. Note, requesting a Link Blue account for the purposes of E-IRB access will not necessarily give the individual access to all UK-secure networks; if access to secure networks University-wide are necessary, a Link Blue account will need to be requested at the individual's departmental level.

If non-UK study personnel will not need to access the application materials in E-IRB, it will still be necessary to add the individual for tracking human subject protection (HSP) training. Researchers can add non-UK personnel using the Manage Study Personnel menu option on the Dashboard. See the Video Tutorial in the Link Blue-secure E-IRB Video Library on "How to Add Non-UK Study Personnel" for specific instructions.

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Online Training Schedule (for Exemption Application submission and Pilot Initial Review Submissions)

If you would like to be included in our select group of E-IRB pilot researchers for initial review submission, and you have not attended a previous training for the E-IRB testing phase, you (and/or your study coordinator, if applicable) should participate in at least one of the online “E-IRB basics” trainings being offered via Zoom. If you plan on having an exemption application to submit June 21, 2017 or later, an online training session is highly recommended. Alternatively, the online video tutorials and "Known Issues for Researchers" should be reviewed before initiating an E-IRB application (links to both are available on the E-IRB Log-In page).

 

To join the Wednesday, November 1, 10:30-11:30am online training via Zoom
WITH FOCUS ON EXISTING IRB-APPROVED STUDY IMPORTS, use this info:

Join from PC, Mac, Linux, or mobile device: https://uky.zoom.us/j/611403592
Or iPhone one-tap (US Toll):  16699006833,611403592#  or 14086380968,611403592#
Or Telephone:
Dial:
+1 669 900 6833 (US Toll)
+1 408 638 0968 (US Toll)
+1 646 876 9923 (US Toll)
Meeting ID: 611 403 592
International numbers available: https://uky.zoom.us/zoomconference?m=0hszt4YVif3gB-2yuf3jJ9zB4O3DS4Tp

Or Skype for Business (Lync):
SIP:611403592@lync.zoom.us

 

Additional training dates to be announced.

Past online trainings:

5/4/17 2-3pm 7/6/17 2:30-3:30pm 9/19/17 10:30-11:30am
5/10/17 10-11am 7/12/17 2:30-3:30pm 9/27/17 10-11am
5/16/17 10:30-11:30am 7/18/17 10-11am 10/19/17 10-11am
5/25/17 10-11am 7/26/17 10:30-11:30am
6/1/17 2-3pm 8/3/17 10:30-11:30am
6/6/17 2-3pm 8/9/17 2-3pm
6/7/17 10-11am 8/15/17 2:30-3:30pm
6/14/17 2:30-3:30pm 8/23/17 10:30-11:30am
6/20/17 10-11am 9/5/17 2:30-3:30pm
6/28/17 10:30-11:30am 9/14/17 2:30-3:30

 

 

Tips and Recommendations

  • When you log-in to E-IRB and start a new application, your SAP account information will be the default contact information added to the application. If your work contact information is outdated, or you're not sure what information SAP has, please review and edit your Personal Profile through the UK Employee Self Service web page: MyUK Portal. If your name has changed, you will need to submit a 'Name Change Form' to the Human Resources Benefits Office for entering into SAP.

 

 

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