E-IRB Frequently Asked Questions
Basic System Questions
When will I be able to use the E-IRB system to enter and submit my IRB application?
As of January 22, 2018, new Exempt, Expedited and Full Review Applications (Medical and Nonmedical IRB) must be submitted via "E-IRB".
All full and expedited IRB studies previously approved external to E-IRB will need to be imported and completed in E-IRB at Continuation Review time. For details, see the pertinent FAQ on this page ("How and when will my current IRB approved protocol(s) get into the E-IRB system?).
You are not required to submit a paper copy when submitting through the E-IRB system.
Modifications and Other Reviews (Unanticipated Problem, Protocol Violation, Deviation/Exception) for existing protocols approved external to E-IRB will still be submitted electronically in PDF format to IRBSubmission@uky.edu. Go to the Human Research Forms web page to download applicable forms. Please contact ORI at 859-257-9428 if you have questions concerning an E-IRB full or expedited review submission. Please contact Joe Brown at Joe.Brown@uky.edu, Jenny Smith at Jenny.Smith@uky.edu, or Craig Vaughn at firstname.lastname@example.org if you have questions concerning submission of an Exemption Certification Request, or for any additional exemption application information.
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.
To log-in to E-IRB, click here. [a new window will open]
How and when will my current IRB approved protocol(s) get into the E-IRB system?
For existing full or expedited review studies previously approved external to the E-IRB system, 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),
- filling-in the incomplete application sections in E-IRB, and
- attach applicable Continuation Review (CR) materials.
NOTE: If the researcher starts a new E-IRB application for a protocol that should have been imported, the new application may be returned as "withdrawn" along with a request to import the protocol.
Minimizing the type of new E-IRB submissions to just Initial and CR will streamline 1) IRB review, 2) training of researchers, 3) management of materials by ORI staff, and last but not least 4) support continued compliance with federal regulations through this transition. The decision for this approach was made with the intent of optimizing accuracy of research records, streamlining review and approval, 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 (or you may include modifications to represent the version as you wish it to be next approved by the IRB). The completed CR report form, including a description of any changes incorporated into the E-IRB application for approval if applicable, will need to be attached to the imported application under the "Additional Information" section (detailed instructions are available in the video tutorial "How to Import a Full or Expedited Application").
Starting January 22, 2018, researchers are required to import IRB applications approved external to E-IRB when Continuation Review is due.
Up until the CR is due, all other submissions (e.g., Modification Request, Protocol Violation, Unanticipated Problem/Adverse Event) can be sent to ORI/IRB in PDF format to IRBsubmission@uky.edu. Once an application has been established in E-IRB ('approved'), all future submissions for that study will be managed in E-IRB.
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). Note the "Print Protocol" pop-up window may be blank for a little while as the PDF is being created. The PDF created can be printed to paper as-needed.
What web browsers and/or platforms will I be able to use to get to E-IRB?
Research Information Services (RIS) recommends using desktop browsers running Chrome and Firefox for optimal user experience. IE 11 or higher may also be used with E-IRB, although due to its varying adherence to web coding standards, you may experience issues when using it, or other non-recommended browsers or devices. 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.
Note that if you log-in to E-IRB in more than one web browser, or open another web browser to try and view more than one application, there could be synchronization issues with the data that displays. While E-IRB has been designed to prevent the user from being able to open more than one session browser, if you are in a platform that enables this to occur, be sure to only log-in to and work in one web browser for E-IRB.
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, Continuation Review, and study closure. 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?
ORI encourages PI's and study personnel to utilize CITI for their mandatory initial and renewal HRP training. See ORI's Human Subject Protection Training FAQs 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 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.
Researcher names (tied to Link Blue ID and UK User ID) in E-IRB update on a nightly basis from the SAP database, and will be reflected on all active and inactive applications.
In some cases when a PI has a clinical department that differs from his/her academic department, the wrong department for the study being proposed may display in the PI Contact Info section. On May 17, 2018, a feature was installed in the E-IRB system to enable selection of a different department and department code via a drop-down box. These fields for PI Contact Info are maintained per protocol and will not affect contact info for that PI on other applications.
Why does my draft application or previously approved E-IRB application have uncheck-marked sections?
Whenever an update to the E-IRB application template is put into production, it could involve new questions or sections that the researcher has not seen in an existing application.
For previously approved applications, the updated application is triggered when a Modification Request (MR) or Continuation Review (CR) is created. No previously saved data is lost; however, the research investigator will need to verify the information in certain sections of the application, and if applicable, provide supplemental information before submission.
For draft applications, or those submitted but not yet approved, the application is automatically converted to the newest version so the most current application can be submitted to the IRB for review. No previously saved data is lost; however, the research investigator will need to verify the information in certain sections of the application, and if applicable, provide supplemental information before submission.
If an application did not undergo the system update, the update will not occur until an MR or CR is created on the approved application.
Will an email go to the Principal Investigator (PI) after the Department Authorization (DA) (& if applicable, other selected signees) assurance statements have been completed?
No. With the exception of the email to the DA (& other selected signees, if applicable) that is automatically issued when the PI completes the "Send for Signatures" task, automated emails are only issued at strategic points in the IRB review work flow to communicate IRB reviews and actions to the PI and those individuals designated as a contact (in study personnel details). The researchers are responsible for communicating with each other (outside the system) for other actions required by PI or personnel on the study.
Due to feedback from researchers, a request has been submitted to the IT team to add an automated email notification to the PI when all signatures have been acquired; however, the timeline for implementation of this is undetermined while required features in the system are still under development.
In the meantime, researchers may wish to rely on the "Signatures Needed" folder on the PI Dashboard menu to identify whether an application is awaiting assurance statement signatures (hover mouse cursor over menu title for a tool tip) and/or open the application to determine its progress towards completion.
What exactly is that "Add Related Grant" thing?
In the Funding/Support section of the E-IRB application, there is an “Add Related Grants” feature enabling the researcher to associate a specific research grant with the proposed (or approved) research activities.
If the application is in an active edit status for the researcher, a window will pop-up when the user clicks the “Add Related Grants” button. If an authorized user has already taken the steps to associate a grant with the E-IRB application, it will be listed in a table in this pop-up window.
If no related grants have been associated with the E-IRB application yet, only the “Add Grant” button will appear.
To add a related grant to the E-IRB application, follow these steps.
- In the “Add Related Grants” pop-up window, click “Add Grant” to search a list of grants for which:
- The Office of Sponsored Projects Administration (OSPA) has already created an account, AND
- the name(s) of the Principal Investigator and/or Study Personnel match up with who is listed on the E-IRB application being worked on.
- In the example depicted by this screen shot, David Devore and Sheri Patrick are listed as study personnel on the E-IRB application.
- There are other study personnel listed on the E-IRB application too, but none of them are named on a grant/contract for which OSPA has already created an account.
- Identify the related grant by UKRF #, account #, Sponsor name, person name, email, etc… and click “select” by that listing.
- The grant selected will then be listed on the “Related Grants” pop-up window.
- Close the pop-up window to return to the Funding/Support section and use the “Grant/Contract Attachments” button to upload the applicable grant and/or contract.
Note, the related grant selected in the pop-up window will not appear on the Funding/Support page (it only displays when the pop-up window is activated by clicking on “Add Related Grants”). Attachments uploaded using the Grant/Contract Attachments button will display on the Funding/Support page.
Creating this association between the E-IRB application and the grant in the OSPA system facilitates the grant/contract award process and improves reporting capability between units.
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.
If someone designated to receive correspondence about an E-IRB application is not receiving the automated E-IRB messages, it is recommended that the user check filters being applied to his/her email Inbox and set them to accept those with subject title "Automated eIRB message", or double check the Spam/Junk mailbox for messages with subject title “Automated eIRB message”.
**One exception to the automated email notifications is when an Expedited Application is deemed ineligible for expedited review, and the application is switched to a Full Review application by ORI staff (or vice versa). The application is returned to the researcher because it has changed and certain sections need answers verified; ORI staff are trying to remember to communicate with the researcher(s) outside the E-IRB system when this has to occur, however, failing that, you may notice your application in your Inbox with new comments from ORI (you can sort on the "modified date" column in the comments window).
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 accommodate 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.
How do I get special wording on my approval letter?
The Additional Information/Materials section of the E-IRB application has an “Approval Letter Details” feature. This feature allows the researcher to write specific verbiage in a text box for the system to automatically add to the IRB approval letter for Initial Review, Continuation Review, and Modification Requests, negating the step of involving ORI staff to perform this task on behalf of the researcher.
Note that if different verbiage is needed on the IRB approval letter as a result of revisions, Continuation Review, or a Modification Request, the researcher is responsible for returning to the Additional Information/Materials section and updating the contents of the text field accordingly.
Providing a similar feature for “Other Reviews” (Protocol Violations, Deviation/Exceptions, Unanticipated Problem/Safety Reports) is on the task list, but it is unknown at this time when that feature will become available. Until then, please alert ORI staff of any special wording that you will need in your approval/acknowledgement letter for an Other Review.
What do I do if I can't find the name of my study personnel in the search table?
If study personnel do not have an active Link Blue account they are considered "Non-UK" personnel. "Non-UK" personnel cannot be found using the search tool in E-IRB unless someone has already added the individual's information to the Non-UK Personnel table.
Non-UK study personnel do not need a Link Blue account if they are able to acquire external to the E-IRB system the study materials pertinent to his/her responsibilities (e.g., data analysis); however, it will still be necessary to add the individual's name to E-IRB 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 "Add Non-UK Personnel" for specific instructions.
Non-UK personnel who need access to E-IRB in order to perform his/her study responsibilities will need to acquire a Link Blue account. To acquire a Link Blue account contact Judi Kuhl at email@example.com 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.
Do I have to create an application in E-IRB to close my study previously approved external to E-IRB (terminate IRB approval)?
I know I'm listed as study personnel on the study, why can't I see the application?
Note that the selection for "Role for E-IRB access" in the details of a study personnel's listing on the application determine what kind of access the individual will have to the E-IRB application.
If an individual has been designated in a "Reader" role (role Abbreviation = "SP"), that person will be only able to view and navigate through the currently approved application. If the application has not yet received IRB approval, individuals with SP role will not have access to view the application (e.g., DRAFT applications (IR, CR, MR) are not available for viewing).
If an individual has been designated in an "Editor" role (role Abbreviation = "DP"), that person will be able to view, navigate, edit, and submit the application for any review phase (IR, CR, MR) or 'Other Review", on behalf of the PI. The DP cannot submit an administrative closure request though (PI must submit).
Of additional importance in study personnel permission settings, anyone with "Yes" for the "Is Contact" question means that individual, in addition to the PI, receives email notifications about IRB activity for the application (e.g., requests for minor revisions, Continuation Review requests, IRB approval issued, etc...). If the individual is assigned as a contact, but has SP role, the individual will receive e-mail notifications about the status of the application but will not be able to edit or see draft versions of the application.
If you are sure the study personnel permission settings are appropriate to enable viewing of the application, please contact Judi.Kuhl@uky.edu with the protocol number and Link Blue ID of the person unable to view the application.
For imported applications due at Continuation Review, should I include previously approved materials that are no longer being used because the study is closed to subject accrual (e.g., flyer for advertising, informed consent document)?
Not necessarily. ORI's guidance to-date has been to enter into E-IRB whatever represents the currently approved study (or what you want the next approved version of the study to reflect), and that the entire history of a protocol will not need to be included. So, if the status of your research is such that consenting new subjects or re-consenting currently enrolled subjects is not necessary, then attaching clean copies of the last approved informed consent document is not required (you can mark whichever attribute under the Informed Consent section that did apply in order to get the check mark for that section, just don't include the attachment). Keep in mind there may be historical materials to include that could support the IRB’s understanding of what the research entailed and/or progress to-date, but a majority of that will likely be included in the Continuation Review materials submitted.
How do I know if my attachment in the Informed Consent Section will get an IRB approval stamp?
When uploading consent/assent document(s), the Document Type you select from the drop-down menu will determine whether an "IRB approval" stamp will be applied to the document upon IRB approval. Attachments that are assigned a Document Type to which an IRB approval stamp applies will be considered the version(s) to be used for enrolling subjects once IRB approval has been issued.
Document Types that do NOT get an IRB approval stamp are:
- "Highlighted Changes",
- "Phone Script", and
- "Sponsor's Sample Consent Form".
If you have a document that does not have an exact match with Document Type, select the closest equivalent and provide clarification in the document Description field available during the upload process.
Do I need to re-consent subjects with the informed consent document with the most recent ID# in the "IRB Approval" stamp even though it didn't have revisions?
The ID number in the IRB approval stamp is an internal E-IRB tracking mechanism for associating documents with application cycles (IR, CR, MR), and it has no direct bearing on ‘wrong’ vs. ‘right’ informed consent form (ICF) to use for enrolling subjects. Each ICF will be assigned a new document ID # whenever an approval is issued regardless of whether revisions to the ICF were made.
The approval begin date in the stamp is what should be used to identify whether a consent document is the most currently approved version:
- At CR time, no matter if you revised the ICF(s) or not, a new approval begin date will be applied in the stamp.
- At MR time, if you revised the consent document it will get a new approval begin date in the stamp; if you did not revise the ICF since the previous cycle, it will retain the same approval begin date.
If you have an unchanged ICF between two MR cycles, it won’t matter which you use for enrolling subjects as they’ll both have the same approval begin date on them (ignore docID#).