E-IRB News 2024
October 23, 2024
The following announcement describes in detail the changes implemented in E-IRB on October 23, 2024. [PDF]
E-IRB System Update to Version 5 Today!
The Version 5 (V5) system update scheduled for October 23rd encompasses edits and additions to questions and attributes, refinement of existing tools, and addition of new features.
E-IRB applications submitted to ORI/IRB before noon on October 23, 2024, will not contain the updates (those applications will remain Version 4 (V4)). This includes applications in the researcher’s Inbox (default Dashboard view upon logging into E-IRB), and on ORI’s or the IRB’s Dashboard.
How Applications in Process will Transition:
After your V4 application is approved, creating a new Modification Request (MR)/Reliance Renewal, or a Continuation Review (CR)/Annual Administrative Review (AAR) will automatically convert the application to V5.
All E-IRB applications in draft form and not yet submitted to ORI/IRB by noon on October 23, 2024 will automatically convert to the updated V5 E-IRB application.
- No previously saved data or attachments will be lost;
- A blue checkmark indicates the section is complete, while a pencil icon signifies additional information/verification is required.
- The sections directly affected by the conversion to V5 and that will lose their checkmark even if previously completed are:
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- Informed Consent
- Research Description
- HIPAA
- Research Sites
- Research Attributes
If any section of the application has a pencil icon next to it, it means there is missing information and the researcher needs to answer and save the section before being able to submit the application. The researcher is responsible for reading through sections with a pencil icon and ensuring the questions are accurately answered in order to acquire the blue checkmark next to the section title.
If you encounter any issues with E-IRB as a result of this system update, please submit a ticket to E-IRBsupport@uky.edu and it will be addressed as soon as possible. If you have questions about your application, or navigating E-IRB, you may reach out to the ORI staff person who manages your application, or IRBsubmission@uky.edu.
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Click the link of your choice to jump to: Changes Affecting the Application Changes Affecting Other Reviews Use the “Back to Top” link to return to this “jump-to” menu.
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Changes Affecting the Application |
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Protocol TypeSwitching Protocol TypeThe researcher now has the option in their INITIAL REVIEW application with the “PRE” Approval Stage to switch between:
Applications in “PRE” Approval Stage could be in DRAFT mode (unsubmitted), or have been submitted and returned to the Researcher (available in their E-IRB Inbox) after either ORI screening or IRB review.
Changes to either the IRB Type or Process Type will be reflected in Tracked Changes for a submitted application (e.g., requested revisions and researcher edited as a result) – but not reflected in a Draft (unsubmitted) application. This feature to switch IRB Type or Protocol Process Type is not available to the researcher for Modification Request (MR) or Continuation Review (CR)/Annual Administrative Review (AAR)/Final Review (FR).
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Informed ConsentAttachments – Document Type Name Change“Cover Letter (for survey/questionnaire research)”Changed to: “Survey Consent”
If you have an attachment you uploaded and previously selected “Cover Letter (for survey/questionnaire research),” for it in the Document Type (DocType) drop down field, it will automatically be changed to reflect “Survey Consent.”
New Electronic Consent QuestionA new question has been added that you will be required to answer. If you will be using an electronic consent process, please be sure to follow the instructions below the question to help streamline screening of your application.
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Research Description:Record RetentionThe record retention question has switched from a ‘Yes/No’ radio button response, to a checkbox. If “Yes” to this question previously, the checkbox will automatically be marked upon conversion to V5. If the question had not been previously answered, or it had been answered with a “No,” the checkbox will be blank; note that the researcher must click the checkbox to confirm they will retain all IRB-related records for a minimum of 6 years after study closure in order to get the Research Description section checkmark.
HIPAA – Health Insurance Portability and Accountability ActDe-Identification Certification FormThis is no longer an option for selection. Waiver of Authorization (WoA)If the researcher indicates that HIPAA is applicable, the WoA panel activates, and the researcher must respond with a “Yes” or “No” answer in order to get the blue checkmark for the section. If the researcher previously had WoA check-marked, the answer will automatically be populated with a “Yes,” and any previously uploaded attachments will be listed in a table below the “Attachments” button. If the WoA element was previously not check-marked, the answer will automatically be populated with a “No.”
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Research SitesQuestions Edited and RearrangedTo reduce redundancy, the former “Yes/No” question regarding whether the activities are a multi-site study for which you are the lead investigator or UK is the lead site, has been removed. If applicable, a description of the non-UK sites reporting management plan should be provided in the corresponding text field, but is not required in order for the section to get its blue checkmark indicating completion.
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Research AttributesNew Clinical Research and Clinical Trial QuestionsThe attributes “Clinical Research,” “Clinical Trial,” and “Clinical Trial – Phase 1” have been removed from the checkbox list on this page. We are refining our ability to report on clinical research vs. clinical trials with the following series of questions which must be answered in order to get the blue checkmark for the section:
If the answer is “No” to the first four questions, the last question does not activate because the activities are not considered to be clinical research and, therefore, it is unnecessary to determine whether it’s also a clinical trial. Additional Edits to Research Attribute NamesIf you previously selected one (or more) of the following attributes, they will automatically be changed to reflect the revised name. Collection of Biological Specimens for internal banking and use (not sharing) GWAS (Genome-Wide Association Study) or NIH Genomic Data Sharing (GDS) Human cells, tissues, cellular based products |
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Signatures (Assurances)New Management Feature for SigneesIndividuals who have been assigned a Department Authorization (DA), Faculty Advisor (FA), or “Review by Other” role to complete an Assurance Statement now have the option to remove an application from their Inbox without signing the Assurance Statement by clicking “Return to PI” with a comment about why the application is being returned without a signature (e.g., specific edits are deemed necessary).
The PI, and personnel chosen as a contact, will receive an email with instructions and notification that edits are needed, and can edit the application found in either the “Draft” folder, or the “Signatures Needed” folder located in the menu in the left margin of the default Inbox page. The researcher does not have an option to ‘reply’ to the signee’s comments and must either make the requested edits directly in the application, or communicate outside the E-IRB system to discuss why the edits will not be made. Once the researcher’s response is finalized, the researcher must re-visit the “Assurances Required” section to click the “Return to Signee” button for their reconsideration; the signee will receive an email notification at that time.
Highlighting and Tracked ChangesIf any changes are made to the Signees listed in the “Required Signatures” table, the section title will highlight in gold, as will the entry for the person’s record in the “Required Signatures” table. The signee changes will also be reflected in Tracked Changes.
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Changes Involving Other Reviews |
Administrative Study ClosuresCombined Study Closure Form and Approval LetterAdministrative Closure approval materials are now being stored as a single PDF file for the applicable submission under the “Completed Other Reviews” tab, so user’s don’t need to go to two different views to acquire all of the documentation of the closure. The PDF that opens upon clicking the link for the applicable Entity ID (e.g., View #__) contains the form the researcher completed to request closure, along with any attachments, any comments (Review Notes), and the closure letter on letterhead.
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October 16, 2024
The following announcement, issued October 16, 2024, introduces the changes scheduled to go into effect as of the afternoon of October 23, 2024 [HTML]:
E-IRB System Update to Version 5 on October 23, 2024The Version 5 (V5) system update scheduled for October 23rd encompasses edits and additions to questions and attributes, refinement of existing tools, and addition of new features. E-IRB applications submitted to ORI/IRB before noon on October 23, 2024, will not contain the updates (they will remain Version 4 (V4)). This includes applications in the researcher’s Inbox (default Dashboard view upon logging into E-IRB), and on ORI’s or the IRB’s Dashboard.
How Applications in Process will Transition:After your V4 application is approved, creating a new Modification Request (MR)/Reliance Renewal, or a Continuation Review (CR)/Annual Administrative Review (AAR) will automatically convert the application to V5. All E-IRB applications in draft and not submitted to ORI/IRB by noon on October 23, 2024 will automatically be converted to the updated E-IRB application (V5).
The researcher is responsible for reading through any un-checkmarked sections and ensuring the questions are accurately answered in order to acquire the blue checkmark next to the section title, rather than a pencil. If any section of the application has a pencil icon next to it, it means there is missing information and the researcher needs to answer and save the section before being able to submit the application. E-IRB will be offline for approximately two hours for this implementation, so please plan accordingly. A summary detailing more of the V5 changes will be issued soon – stay tuned! |