A: It is common for studies to be returned with revisions being requested by the reviewer before they can give an approval. An action item might be as simple as ensuring that you answered all parts of the Kuali application thoroughly or as complex as requesting that you revise part of your protocol to minimize risk to research participants. You can tell there are action items needing review when you look at your protocol in Kuali and notice orange/yellow circles in your Kuali application. If you press on the yellow/orange circle, the action item(s) will be visible on the right side of your screen. If you need to respond to the action item, please follow the link below for directions on how to do so:
https://support.ucsd.edu/research?id=kb_article_view&sys_kb_id=a41dbad21b294118b8d255b5604bcb0d&sysparm_article=KB0033646
If you see there are Action Items but do not have the ability to respond, it is likely due to the permissions settings selected for your account on the study. Please contact irb@ucsd.edu for assistance.
A: The way the amendment applications function in Kuali is to allow the submitter to select and isolate the specific application sections they want to edit in the amendment submission. Once the application sections are selected and the amendment has been submitted, those selected sections are locked for further editing until the amendment has been reviewed/approved, or if the submission is returned for revisions. This locking feature is intended to give users the ability to submit multiple amendments at the same time.
For example, your project has study personnel updates and wants to make a change in the study procedures that requires edits to the protocol document. Since the study personnel changes would be a minor amendment and take less time for review/approval, you can submit an amendment that has only the Study Personnel section selected and requests those study personnel updates. Then, you can submit another amendment that has only the Supporting Information section selected to submit the tracked changes version of the protocol and the clean version of the protocol for review/approval.
This functionality is intended to give research teams flexibility/more options in the amendment process, but when there are multiple amendments submitted at once, especially if one or more have been sent back requesting revisions, this section isolation/locking can get a bit confusing to manage. If there is a section that is locked that you need to edit, return to your protocol dashboard and search by the 6 digit Kuali project # to view the active versions of the project that are open. Click on each amendment version to identify the version that has the section you want open for editing. If you need assistance identifying if you should abandon/withdraw an amendment to unlock a section for editing, please contact irb@ucsd.edu.
A: The terms "continuing review" and "renewal" are used interchangeably by OIA to refer to the application required to be submitted by investigators prior to expiration of a study to allow its continuance and the subsequent review by the OIA or IRB. The Kuali system has fields for two dates, an "expiration date" and a "continuing review date," for every study.
If your study has an expiration date, then continuing review or renewal is required. If your study is not reviewed and renewed before the expiration date, your study will expire and all research activities must halt until the study is renewed. Ensure you submit renewals at least 30 days before expiration to give the IRB enough time to review your study submission and send it back for any necessary revisions. The link below provides step by step directions on how to submit a renewal in the Kuali system.
https://support.ucsd.edu/research?id=kb_article_view&sys_kb_id=93fec55a1b43995448e9cae5604bcb37&sysparm_article=KB0034319
If your study has a continuing review date, this means the Kuali system will send you a yearly check-in to ensure the Kuali record is up to date and the study is still active. Your study won't expire come the continuing review date, however it is the responsibility of the research team to make sure everything for their study is up to date. This includes all research staff's CITI training being up to date, ensuring any reportable events have been submitted to the IRB, and making sure your documents have up to date stamps among other things. If something is not up to date, then when you receive the annual Kuali notice, please submit an amendment to the IRB to make any of these updates. Additionally, if the study has closed, it is the responsibility of the research team to submit a closure application to OIA.
Note for studies relying on an external IRB: Studies where the UCSD IRB has ceded its review to an external IRB will not have an expiration date but will have a continuing review date in the Kuali system. Nevertheless, the study may have an expiration date or continuing review date in the external IRB's system. Researchers should ensure they're compliant with the external IRB's policies and procedures to keep their study current. When a study is renewed with an external IRB and the renewal approval is received, the approval must be submitted in the Kuali system as a renewal application to keep our records current.
A: With the switch from the eIRB legacy system to the new Kuali application, uploading study documents is no longer required in the renewal/continuing review process. If there are updates or modifications you would like to submit, please proceed with submitting an Amendment. Renewal applications do not allow edits to the Kuali application sections, including study personnel updates. The process for making changes to a project is designated to the Amendment request process. The Renewal application process does not allow for changes to be requested within the review, as it is only a process for updating the approval of the research. If you have additional questions/concerns, please contact irb@ucsd.edu.
A: The best way to confirm if you've properly submitted an application in Kuali is to check the Status of the application. The status of a submission is shown in two places in Kuali: the Manage Protocols page in the Status column and at the top of the application when viewing a submission (See images below)
Statuses that confirm your application has been submitted include:
Submitted for Review
Resubmitted
Statuses that indicate you have yet to submit your application or it is currently open for editing/not submitted to OIA for review include:
In Progress
In Progress (Withdrawn)
Revisions In Progress
Returned to Researcher
Abandoned*
*studies with this status cannot be restored/recovered. Once a project is abandoned, it cannot be reopened.
Statuses that indicate your submission has been approved:
Approved
External Reliance
Exempt
Not Human Subjects Research
Colored dot key for Kuali Statuses on the Manage Protocols page:
Green = Approved
Blue = Awaiting review by IRB
Yellow = Researcher preparing to submit to IRB
Orange/Brown = Submission has been reviewed and IRB has asked the researcher to make some revisions
Grey = The study is closed OR a submission that has been abandoned OR a submission that was previously approved and has been superseded by a submission more recently approved
A: Starting Sept. 1, 2022, all new studies (except for secondary use studies which only require the Kuali application) are required to use the master protocol if one exists (e.g. from an industry sponsor, cooperative group, etc.). Otherwise, you must use one of the three new protocol templates that are available on OIA's forms page. Additionally, all new UCSD/RCHSD studies requiring an informed consent or assent document will be required to use the new ICF and assent templates, also available on the OIA website at the link provided.
A: If consenting participants is part of your research activities, use one of the following consent form templates to create your ICF. These templates are located under the UCSD Templates heading on our website:
Adult/Parent Permission Consent Form template - Use this form for participants aged 18+ or when parents will consent for a minor.
Adolescent Assent template - Use this form for participants aged 13-17 years old.
Child Assent template - Use this form for participants aged 7-12 years old.
Exempt Information Sheet template - Use this form for research that may qualify for an exempt determination. For example interview/surveys/educational research/benign behavioral interventions with adult subjects may use this consent form template.
Expanded Access Consent Form template - Use this form for expanded access treatment applications. For example, expanded access, managed access, treatment access, compassionate use, use this form.
A: For Children under the age of 7, we do not provide an assent template as children under 7 who are capable of indicating their preference most commonly do not have the reading comprehension for an assent document. Additionally, they are likely to not be able to sign their name, therefore we have not provided an assent template for children under 7 and this is the standard practice in this country. The study team may still need to write a note in their own regulatory documentation about the child’s capability, that the assenting process took place, and the child’s decision. Children in this age group may not be capable of assent due to their age.
A: The following are examples of times OIA will accept a non-UCSD protocol template:
-The protocol is provided by a study sponsor or a cooperative group, or
-The study has an IND or IDE from the FDA
-The project will be relying on another IRB for approval
-Exempt research projects that ask OIA to concur with another IRB's determination
OIA provided consent templates must be used when the UCSD or RCHSD teams will consent subjects, unless relying on an external IRB.
A: We suggest you submit your consent/assent forms in other languages AFTER you receive initial approval on your English language version of your consent/assent form to avoid the financial and administrative burden of additional translations if/when revisions are required.
Be sure to include a language translation certification with any additional language documents. The certification of translation can be from the translation agency/company that provided the translation, or a letter from the research team member that translated the document(s) describing their language experience and fluency background. This certification document should include the signature of the translator along with the title, version, and date of each document translated.
A: UCSD does not have internal translation services available to request for the translation of study documents at this time. Many research teams use translation agencies or companies for their document translation needs. It is also common for research teams to have a member of their study personnel that is fluent in the desired language to translate the required documents. Additionally, if the study is sponsored by industry, they may have translation services available for sites. OIA requires a copy of the translated document and a certificate of translation certifying the translation was conducted by a qualified individual. If you use a translation agency/company, they will typically provide a certificate of translation with their services. If you use a member of the research team or someone associated with the project that is fluent in the desired language, a letter from the translator describing their language experience would also be an acceptable form a certification of translation. This certification document should include the signature of the translator and the name of each document translated.
For information on the use for Short Form consent for non-English language speakers, please visit our website to find guidance on the short form consenting process on the following page under the Short Form Consent heading.
A: If the Kuali IRB application sections are completed and a user would like responses reviewed, please proceed with submitting the application in Kuali. It's best to get into the specifics of what and how exactly to revise/change with a reviewing analyst, which is not assigned until the project is submitted in Kuali IRB. Please note that it is to be expected to be asked for revisions/changes during the review process.
A: Users may be asked to submit responses to Action Items in Kuali, but not see an option to Reply or see how they can follow the guidance provided in the article How to Respond to Action Items in Kuali IRB. This issue can be due to the user having Read-Only permissions selected, both Full Access and Read-Only permissions selected, or a mismatch of Full Access permissions selected in the Permissions tab and Read-Only selected under the Study Personnel section or vice versa, in the Kuali application. Please contact irb@ucsd.edu for assistance resetting your permissions selections if your application is in a status that is open for editing.
A: View the upper right side menu of your Protocol application for a button that says "Withdraw". If this button is available, click it to retrieve the application back for editing. If this button is not available (greyed out or not visible), please contact irb@ucsd.edu for assistance. OIA analysts have the ability to "Return to Researcher" when the Withdraw feature isn't available.
A: Kuali has a helpful feature that allows users to Compare Versions of the protocol in the same page view. Use the "Selected Version:" drop down located at the top of the Kuali application under the study title displayed in black text. Click on the text below Selected Version to choose the desired version/submission of the application. The "Compare Versions" feature is located to the right of the study title in black text, click the check box to populate the second version drop down feature. Click the text under the "Compare a Version:" to select the version/submission you would like to compare responses with. Once versions are selected under each drop down, the Kuali application will then show the differences between the two selected versions/submissions in red and green text. Kuali will show which responses are associated with the specific version with a colored icon to the right of the text noting the version, for example if comparing versions 1 and 2 of your application, Kuali will show "v1" or "v2" to indicate which responses/documents belong to each version/submission. For a visual representation of the drop down menus and compare versions checkbox, see screenshot below.
If you need assistance navigating the Kuali Selected Version or Compare Versions feature, or are having trouble deciphering how to proceed when multiple amendments are In Progress and Kuali application sections being locked for editing, please contact irb@ucsd.edu for assistance.
A: To request an OCAA review only, proceed by making an amendment submission and respond "Yes" to the first question noting "Is this an amendment where review of the study is conducted by an external IRB and the changes do not meet the criteria for OIA submission and are being submitted only to trigger OCAA review?" This question is commonly selected erroneously by researchers and OIA will Return for Revisions requesting confirmation that the purpose of the amendment is to trigger the OCAA review. Researchers can also add the "Added Information" section to their amendment and note the purpose of the amendment is to trigger OCAA review to avoid the Return for Revisions confirmation request.
If you have additional changes to submit AND need to request OCAA and/or OCTA Ancillary Review(s), respond "No" to the first OCAA question and respond with one of the below options to the question, “Will this amendment result in changes to procedures that are billed to the research participants or changes to the budget negotiated with the sponsor?”:
"Will result in changes to procedures billed to sponsor" = OCAA Ancillary review request
"Will result in changes to negotiated budget = OCTA Ancillary review request
"Both changes to procedures billed to sponsor and changes to negotiated budget" = OCAA and OCTA Ancillary review requests
A: If the review of the study is conducted by UCSD’s IRB and you need to trigger OCAA or OCTA review, but have no other proposed changes to the study, please email irb@ucsd.edu to request OIA to add the OCAA/OCTA Ancillary Review to your protocol.
To request OCAA and/or OCTA Ancillary Review(s) along with other proposed changes to the study, proceed by making an amendment submission and respond "No" to the first question about triggering and OCAA review (this question is specifically for studies reviewed by an external IRB). Then, respond with one of the below options to the question, “Will this amendment result in changes to procedures that are billed to the research participants or changes to the budget negotiated with the sponsor?”:
"Will result in changes to procedures billed to sponsor" = OCAA Ancillary review request
"Will result in changes to negotiated budget = OCTA Ancillary review request
"Both changes to procedures billed to sponsor and changes to negotiated budget" = OCAA and OCTA Ancillary review requests
A: Microsoft has a helpful guide on their tracked changes review features available on their website here: https://support.microsoft.com/en-us/office/track-changes-in-word-197ba630-0f5f-4a8e-9a77-3712475e806a Although Microsoft Word is the most common word processing application used, if you're using a different application to edit your documents, we suggest you visit the application's website for assistance in locating the tracked changes review controls available to create your tracked changes document.
