Kuali Research Protocols (KRP)
KR Protocols is made to help you go through UCI's research determination process. This would involve going through the Institutional Review Board (IRB) or the Human Stem Cell Research Oversight (hSCRO) committee.
Note: This user guide is still a work in progress, and any section with the marker "[INC]" is incomplete. If you have any questions that are not covered in here, feel free to email our Electronic Research Administration team at era@research.uci.edu. Our team would be happy to assist.
NEW! KRP Mapping Tool
You can now view our entire protocols questions including Amendment, Close Request, Event, and Renewal forms! This tool is designed to assist users in navigating KRP better by showing all possible paths for protocols.
Here is an example form question from the mapping tool. Examples are written in the blue text boxes.
Please visit the UCI HRP website at https://research.uci.edu/human-research-protocols or contact IRB@uci.edu.
Please contact ERA@research.uci.edu.
The KRP User Guide
IRB & hSCRO Submissions
Direct Link: https://uci.kuali.co/protocols/
Via Zotportal
Via Office of Research website
The login for KR Protocols uses the standard UCI Single-Sign-On system.
- Have your UCINetId and password ready
- Choose an authentication method (push notification or passcode)
As an UCSB hSCRO researcher, you will receive an email from the Electronic Research Administration (ERA) team providing you with a unique username and password. This email will also include detailed instructions for accessing the Kuali Research Protocols (KRP) system.
To log in to KRP, follow the steps outlined below:
1. Access the Login Page: Navigate to the KRP login page via the following URL: https://uci.kuali.co/auth/kuali
-
- Note: The login URL is unique and differs from the one in "Access KRP."
- Note: The login URL is unique and differs from the one in "Access KRP."
2. Enter Your Credentials: On the login screen, enter the username and password provided to you by the ERA email. After entering your details, click “Sign In.”
-
- If you misplace or forget your login credentials, contact ERA support for assistance at era@research.uci.edu .
3. Select the 'Protocols' Card: Once logged in, click on the 'Protocols' card to enter the KR Protocols system.
4. Manage Your Protocols: Your protocol(s) will be visible on the 'Manage Protocols' page.
After logging in, you should be directed to the Manage Protocols page.
-
- Click the blue "+ New Protocol" button on the top right.
- Click the "IRB" option that appears beneath it to begin a new protocol.
Using Tooltips and External Links
As you fill out this form, you may come across tooltips, the blue circle icons with a question mark. These can provide helpful information about the language within a specific question.
-
- From a mobile phone or tablet, press and hold the tooltip to reveal the text, and release to hide the text.
-
- From a personal computer, hover over the tooltip with your mouse to reveal the text. Moving the mouse away from the tooltip will hide the text.
Sections may also contain links to external sites, shown as blue text, that can be used to clarify questions further.
General Information
Answer the following questions in the General Information section.
1. To find a lead researcher, begin typing in their name and select the correct name from the search dropdown that appears.
2. To find a department, type in the Lead Unit name or the IR Code (ex. IR-9021 Pharmaceutical Science) and select the correct one from the search dropdown that appears.Certain departments may have multiple options to select from. When this happens, select the lead unit from the list, denoted by 3 asterisks (***) and the label "lead unit"
Submission Type
-
- Select a submission type
Per the directions, Administrative Determination allows you to use the NHSR Form, Exempt Self-Determination, or requests to rely on non-UCI IRB review. More details can be found on the upcoming guide for these determination forms. - Click the "→ Next" button on the right panel to proceed to the next section
- Select a submission type
Filling Out the Remainder of the Form
As the form is completed, sections will be shown or hidden based on how questions are answered.
-
- Depending on how you answer each question, you may be asked to abandon the form earlier.
-
- The Project Details, General Questionnaire, and Study Team Personnel are required sections, so by default they will be marked as completed with a green checkmark
-
- The personnel list can be modified, but by default it will be populated with the Lead Researcher you listed in the Project Details. See the Add/Edit Personnel section of this guide for more details.
-
- The Project Details, General Questionnaire, and Study Team Personnel are required sections, so by default they will be marked as completed with a green checkmark
-
- You will be asked to either Abandon or Submit the form depending on how questions are answered
-
-
-
- The following message to abandon the application will appear if the study does not qualify as Non-Human Subjects Research (NHSR), based on your questionnaire responses. Please see the Abandon the Protocol section of this guide for more details.
-
-
-
- This message will appear if you have answered "No" in response to the question, "Do you need written confirmation from the IRB that UCI is 'Not Engaged in Human Subjects Research'?". If you answer "Yes", please see the Submit the Protocol section of this guide. If you answer "No", please see the Abandon the Protocol section of this guide.
- Click the blue "+ New Protocol" button on the top right.
- Click the “IRB” option that appears beneath it to begin a new protocol
- The option for a separate drop-down for hSCRO is NOT available in KRP. Both IRB and hSCRO researchers must use the same indication initially, then select hSCRO at the next step.
Only the Lead Researcher can submit a transaction.
Administrative Contacts: To inform the LR that the submission is ready for review, select the "Notify PI to Submit" button on the right side of the screen.
Lead Researchers:
-
- Once you finish the application and verified its accuracy click the "Submit" button on the right side of the screen
- Once you finish the application and verified its accuracy click the "Submit" button on the right side of the screen
-
- After clicking "Submit", you will remain in the Protocols form. Scroll up to the top and you will see the Status has changed from 'In Progress' to 'Submitted for Review'.
The status change confirms your protocol has been submitted to the HRP office. You will also receive a confirmation email from the system.
- After clicking "Submit", you will remain in the Protocols form. Scroll up to the top and you will see the Status has changed from 'In Progress' to 'Submitted for Review'.
-
- From here, click the "Back" button in the top left to return to the Manage Protocols page. You will now see your submitted protocol in the Protocol List and its current status.
CAUTION! If the "Withdraw" button is selected after submission, the protocol will lose its place in the review queue.
After submitting your protocol, an HRP staff member may send the form back and specify specific action items, or sections that the research team should look over or elaborate on further. From your list of protocols, this will be denoted by a "Revisions In Progress" status.
-
- Click on the study title to begin revising the submission
-
- A due date for the researcher's revisions will be posted at the top of the form in a "Feedback" section. This may also include a comment from the HRP reviewer.
-
- Click on any sections marked with a yellow circle to address revisions that need to be made. In this case, the General Questionnaire and Activity information have text fields that need to be elaborated upon.
- Click on any sections marked with a yellow circle to address revisions that need to be made. In this case, the General Questionnaire and Activity information have text fields that need to be elaborated upon.
-
- As some items may not be visible on the left navigation, click "Action Items Summary" on the right side of the screen to view every action item
- As some items may not be visible on the left navigation, click "Action Items Summary" on the right side of the screen to view every action item
-
- Once you arrive at a section with an item, click on the "Action Items" button on the top right of the section to pull up the comments made by HRP
- Once you arrive at a section with an item, click on the "Action Items" button on the top right of the section to pull up the comments made by HRP
-
- Address all action items noted by the IRB Staff / Committee prior to re-submission.
-
- Make any revisions, then reply to the comments from HRP. This needs be done for every action item in order to resubmit.
- Make any revisions, then reply to the comments from HRP. This needs be done for every action item in order to resubmit.
-
- If attachments need to be revised, you can remove them (via the trash can icon to the left of an item), "Replace" them, or click "Add Item +" to add a new attachment.
- If attachments need to be revised, you can remove them (via the trash can icon to the left of an item), "Replace" them, or click "Add Item +" to add a new attachment.
-
- Once you have addressed all action items, click the arrow button in the top corner of the action item panel that appeared to show the "Resubmit" button.
- Once you have addressed all action items, click the arrow button in the top corner of the action item panel that appeared to show the "Resubmit" button.
-
- Click "Resubmit" once you have made the necessary revisions. If everything has been addressed, HRP will approve the protocol or send back further recommendations.
- Click "Resubmit" once you have made the necessary revisions. If everything has been addressed, HRP will approve the protocol or send back further recommendations.
Amendments, previously known as Modifications or eMods, can be initiated by finding your protocol and completing the Amend form in KR.
Note: As changes are made to the protocol within an amendment, your study team will not be able to see which sections are being changed until after the amendment is submitted. For example, if a co-researcher is creating the amendment and needs the lead researcher to review any changes, they will have to let them know which sections are being revised.
-
- Enter the number for your KR Protocol in the search bar, then click on the protocol title to open
- Enter the number for your KR Protocol in the search bar, then click on the protocol title to open
-
- Choose "Amend" from the options on the right side of the screen for amending a protocol. Choose "Renew and Amend" when a protocol requires both Modification and IRB Continuing review:
- Choose "Amend" from the options on the right side of the screen for amending a protocol. Choose "Renew and Amend" when a protocol requires both Modification and IRB Continuing review:
-
- Enter the relevant information related to whether this is for a UCI IRB / sIRB or hSCRO protocol in the screener question. If it is the study team's first transaction in KR protocols, please indicate, and click on the hyperlink to email ERA staff. This step is critical as ERA may need to manually update KR protocols to ensure the Protocol is aligned with the current IRB Approval prior to proceeding:
- Enter the relevant information related to whether this is for a UCI IRB / sIRB or hSCRO protocol in the screener question. If it is the study team's first transaction in KR protocols, please indicate, and click on the hyperlink to email ERA staff. This step is critical as ERA may need to manually update KR protocols to ensure the Protocol is aligned with the current IRB Approval prior to proceeding:
-
- If KR has already transcribed the Protocol, please select the appropriate option. In addition, indicate whether the protocol received IRB Approval prior to the revised Common rule. Please note that at this time, ALL existing IRB Approved protocols will be required to align with the revised common rule. Please follow the hyperlinks for more information:
- If KR has already transcribed the Protocol, please select the appropriate option. In addition, indicate whether the protocol received IRB Approval prior to the revised Common rule. Please note that at this time, ALL existing IRB Approved protocols will be required to align with the revised common rule. Please follow the hyperlinks for more information:
-
- Indicate whether the Amendment is minor (requires Subcommittee review) or Major (requires Full Committee review), or includes a Consent Translation request.
-
- Additionally indicate the current enrollment status, the number of subjects currently receiving active intervention (if applicable). For Major (significant) revisions, specify whether the new information would warrant re-consenting of study participants:
- Additionally indicate the current enrollment status, the number of subjects currently receiving active intervention (if applicable). For Major (significant) revisions, specify whether the new information would warrant re-consenting of study participants:
-
- If applicable, specify the method of re-consent.
-
- In the IRB Requested Revisions" section, list the specific changes involved with your amendment by clicking on the double arrow. Click "add a line" for each separate amendment:
- In the IRB Requested Revisions" section, list the specific changes involved with your amendment by clicking on the double arrow. Click "add a line" for each separate amendment:
-
- Attach all relevant documents in the attachments section. If any documents (such as a Master Protocol) will be replaced, click "replace":
- Attach all relevant documents in the attachments section. If any documents (such as a Master Protocol) will be replaced, click "replace":
The study team can be modified from the Study Team section. It will automatically populate the first row with the lead researcher that was inserted in the Project Details section. Note the "Training" column, which includes any Citi training the study team member has received.
Click on the trash icon (boxed in red) to delete a person from the list.
To add personnel, click "Add Line +" in the top right (clicking on it will reveal the popup below). From here, you can search for the person and their department, set disclosable financial interest, assign a department, add a research role, and define their permissions, and more. Click "Done on the bottom right of the popup to add the researcher
The pencil icon (boxed in blue) allows you to edit a person's information (clicking on it will reveal the popup below).
Faculty sponsors and Lead researchers will require full permission to view, edit, and submit the entire protocol.
-
-
-
- Adding A.C.'s can be done via the Permissions tab, completely self service
-
-
To begin a renewal (previously known as CPA's or continuations), your protocol needs to have an Approved status. Search for
From the Manage protocols page, click on the relevant protocol's title to open it. You will have the option to amend, renew, or renew & amend your protocol in one submission. Click Renew and Amend to begin the renewal.
-
- At the moment, you should not select "Renewal" on it's own, as choosing this option will not allow the IRB staff to upload an IRB Approval Letter.
-
- Revisions can be made at the time of submission. However, you should be aware that the amendment and renewal would be reviewed together and the committee's vote would be the same for both. If one of the two (between amendment and renewal) is not ready for approval, the protocol may be tabled for re-review, and minor revisions may be requested by the committee.
No-Transcription Renewal:
To ensure a timely review of renewals, we are providing a new option in KR Protocols. If you have a renewal without any changes to the protocols, you can continue with the renewal without requesting a transcription. ERA transcription can occur with the next amendment. You should still select "Renew and Amend" to begin.
When in the renewal selection, select 'No, the renewal does not require changes.'
In the amendment section, select 'No, this is a renewal that does not require changes.'
- To abandon, click the "Abandon" button at the top right of the form.
Keep in mind that protocols that are abandoned before submission cannot be edited, but can be viewed as read-only.
- Click "Confirm" to abandon the protocol
IMPORTANT! For expired protocols, the Close Request button is NOT available. Please contact HRP / hSCRO Staff and request to complete the closing report via email: https://research.uci.edu/human-research-protections/contact-hrp-staff/
For protocol that are not expired in KRP, select 'Request Close' and complete the closing report.
General Tips
Searching for Older Protocols
Older protocols in this case refers to those created via the previous IRB Web Application, before our office implemented KR Protocols. These older protocols would have an 8 digit number associated with it (ex. 2022-1204). You can search for these protocols without the dash (ex. 20221204) to find them.
Filters
Filtering can be a useful tool if you have multiple protocols that you have worked on or been assigned to. To create a new filter, click the "Advanced Filters" button at the top of the Protocols page.
From here, you can create rules for a filter and save them from the "Save These As" text field.
For example, protocols can be sorted by the principal investigator/lead researcher by selecting "PI" as the field
You can change the columns that are visible on the Manage Protocols tab by clicking "Manage Columns" near the top right of your screen.
-
- Log in to Kuali Research
-
- Click on your profile name at the bottom left
- Click on your profile name at the bottom left
-
- Click on the "Edit" button to update your profile. (Profile info has been blurred out in the example screenshot. You will see your own current information in those fields)
- Click on the "Edit" button to update your profile. (Profile info has been blurred out in the example screenshot. You will see your own current information in those fields)
-
- You may change your first name, last name, display name, and email
-
- Click the "Save" button when you are done!
- Click the "Save" button when you are done!
Using the Search Bar
The search bar, outlined below, is the primary method of finding the your desired protocol.
To use the search bar, simply enter your desired word(s) and/or phrase(s) in the bar.
What You Can Find With the Search Bar
In the Search Bar, you can search for protocols by:
-
- Title
-
- Protocol Number
-
- PI Name
KRP will automatically determine which of these fields to look in. Simply enter the text you would like to search by.
NOTE: When searching by Protocol Number, please enter the complete Protocol Number.
To add filters to your search, first press on the outlined Advanced Filters button.
Then, click on the outlined Add Rule button that opens up.
Three dropdown menus will open up, allowing you to customize your filter.
The Choose Field dropdown relates to all of the columns you can select, as outlined below.
Here, you can select which column will be affected by your criteria.
NOTE: To filter by multiple columns, press Add Rule underneath the outlined portion below.
The Choose Operator dropdown gives options to different operators to customize your filter.
Operators will be discussed in more detail under the Filter Operators Explained tab.
When filtering in KRP, you will be using operators to customize searches to your needs.
Operators Cheatsheet
| Operator | Definition |
|---|---|
| is blank | Only includes results where the selected field has no characters. |
| is not blank | Only includes results where the selected field has characters. |
| contains | Only includes results where the selected field contains specified characters. |
| does not contains | Only includes results where the selected field does not contain specified characters. |
| is equal to | Only includes results where the selected field is an exact match to specified characters. |
| is not equal to | Only includes results where the selected field is not an exact match to specified characters. |
| starts with | Only includes results where the selected field's first characters are an exact match to the specified characters. |
| ends with | Only includes results where the selected field's last characters are an exact match to the specified characters. |
Examples
In the screenshot below, Number is the specified field and is equal to is the operator.
A more human-friendly way to understand this filter is: "Give me protocols where the Number is 10."
With the filter applied we can see the result is narrowed down to 1 protocol, and that protocol is determined because its Number is 10.
Saving Filters
To save filters for reuse or use at a later time, simply enter a name for filter in the area outlined below.
Then, press the Save button outlined below.
Using Saved Filters
To use Filters you have saved previously, click on Saved Filters outlined below.
Then select your desired Filter by checking the box adjacent to said Filter.
NOTE: To delete a saved filter, press the blue trash icon on the right of the Filter name.
All files in the Attachment List Section can now be downloaded as a single zip file. A new “Download All” button has been added next to the “Columns” button in Attachments.
When the user clicks on the “Download All” button, all files will be zipped and the new zip file will download automatically.
The zipped file will include the protocol number, version number and date/time it was downloaded.
When unzipping the files, the attachment type will prefix the actual filename:
“Recruitment Material – Recruitment Flyer.pdf”
Click on the Print button on the right side of the protocol.
A new tab will open with a different protocol layout.
Saving Methods:
-
- MacOS users: CMD + P
-
- Windows users: Ctrl + P
NOTE: If you would like to print out the protocol page, please proceed with the printing instructions as usual. If you would like to save the protocol page as a PDF, please select Save As PDF option during the printing window.
Withdrawing Submitted Amendments
You will now have an action button of 'Withdraw' available which allows you to pull back the protocol from review if you need to make additional edits prior to review. Once the protocol administrator assigns your protocol to a committee the 'Withdraw' action is no longer available. Withdraw will put a protocol back in the In Progress status and any Action Items have been added to a protocol before it was withdrawn will not display.
To withdraw a submission, press Withdraw on the right side of your browser, outlined in the screenshot below.
NOTE: KRP will NOT ask for confirmation upon pressing Withdraw. Please be certain you wish to withdraw your submission as your work will be lost.
- To see what protocols are pending for your Ancillary Review, first click "Protocols Assigned to Me" on the left menu bar.
- Click the caret to expand the filter rules.
- Click Add Rule button and select "Ancillary Review Status", "is not equal to", and "Approved".
- Under Table Column visibility, click “Choose Columns'' and then select Ancillary Review Status. This will change the columns you see but do NOT change the results.
- You will see all the Pending protocols.
- If you would like to save the filter and the visibility for reuse or use at a later time, enter a name for the filter and click the "Save" button.
For more information about saving filters, please visit the "Saving Filters and Using Saved Filters [INC]" section
Please note that only the Lead Researcher receives all email notifications from KRP by default. In order for other study team members (including Faculty Sponsor) and admin contacts (ACs) to receive email notifications from KRP, see below:
- For study team members already listed under the Study Team subsection - create a second entry for the person & select "Full Access"
- For study team members or ACs NOT listed under the Study Team subsection already - create a new entry for the person & select "Full Access"
Example:
In the Permissions tab, you will see that Barbara Inderwiesche has Full Access now. This is a default setting as Barbara is already listed under the Study Team as Co-Researcher.
For Barbara to receive email notifications from KRP, you need to manually add Barbara as a second entry by clicking ‘Add User’ button. Then, type their name in the section under ‘Name.’ It auto-populates as you type so select the correct user.
Select ‘Full Access’ and ‘Add’ button.
Once you see Barbara’s second entry, Barbara will start receiving KRP email notifications.
Click 'Notify PI To Submit' runs form validations first to alert you of any errors you may want to correct.
If there are validation errors, you will get a popup window informing you of the error count.
Choose 'Show me' - the popup will close, and you can review the validation errors on the form.
If you choose 'Notify PI Anyways', the notification will send to the PI anyway without addressing the errors.
Your project status can be found in two ways.
- Check “Project Status” under Administrative Details
To check your protocol status, click Project Status under Administrative Details in the left bar and check “Project Status”.
Kuali’s Protocol Status Definitions
| Protocol Status | Protocol Status Definition |
|---|---|
| In Progress | This is the first version of the Protocol and it has not yet been submitted for review. |
| Submitted for Review | This submission has been submitted to the compliance office (IRB) for review for the first time. |
| Resubmitted | This protocol submission has been returned by the compliance office (IRB) and resubmitted by the researcher. |
| Approved | This version of the protocol has been approved by the compliance office (IRB). |
| Disapproved | This protocol was disapproved by the compliance office (IRB). |
| Withdrawn | This protocol was withdrawn from the compliance office (IRB) by the researcher. This status will only apply to protocol versions in the version history. |
| In Progress (Withdrawn) | This is the new version of a protocol created when the Withdraw action is taken. If the compare to previous functionality is used the data in this version will be compared to the last version in the Withdrawn status. |
| Abandoned | This submission was abandoned by the researcher. |
| Revisions Required | The protocol was returned to the researcher by the compliance office (IRB) with specific requested changes or comments. This status only applies to versions of a protocol in the version history. |
| Revisions in Progress | This is the new version of a protocol created when the Revisions Requested action is taken. This version is sent to the researcher so they can make their changes. If the compare to previous functionality is used the data in this version will be compared to the last version in the Revisions Requested status. |
| Amendment In Progress | An Amendment is being worked on in this version and has not yet been submitted for review. |
| Renewal In Progress | A Renewal is being worked on and has not yet been submitted for review. |
| Renewal/Amendment In Progress | A combined Amendment and Renewal is being worked on and has not yet been submitted for review. |
| Close Request in Progress | A request to close the protocol is being worked on and has not yet been submitted for review. |
| Returned to Researcher | The Protocol has been Returned to the LR for general revisions. |
| Suspended | This protocol has been suspended and is not currently active. |
| Expired | This protocol is expired and is no longer active. |
| Superseded | This protocol version was previously approved, but has since been replaced by an approved amendment action. |
| Merged Amendment | This amendment was merged with the main protocol. This status will only apply in the Version History. |
| Merged Renewal/Amendment | This combined renewal and amendment was merged with the main protocol. This status will only apply in the Version History. |
| Exempt | This protocol was approved as Exempt. |
| Closed | This protocol has been closed and is no longer active. |
| Not Human Subject Research | This protocol was identified by the IRB admin as Not Human Subject Research. |
| External Reliance | This protocol is part of a Single IRB Protocol being managed by another institution. |
IRB Status Definitions
| IRB Status | IRB Status Definition |
|---|---|
| Administratively Closed | A. Full Committee: It is necessary for Investigators to submit to and address various ancillary committee requirements, along with HRP requirements upon submission of a new study. When a new study submission is determined not ready for IRB review (e.g., major information not provided, ancillary committee clearance not provided) it may take several weeks or months, over multiple IRB agendas for an item to be placed on an agenda. B. Expedited / Exempt: Likewise, for minimal risk research, sometimes it may take months for a researcher to respond to requests for required documentation. C. Studies that are not ready for IRB review will remain pending in the queue for a maximum of three (3) months from the date of submission. If the study is not ready for IRB review after 3 months, it will be administratively closed out. |
| Administrative Hold | The IRB Committee or IRB Chairperson or designated Committee member may request the Investigator place some or all research activities of a currently approved study on hold when more information is needed. The determination may be requested and lifted at the level of review for which the study qualifies. |
| Approved | This protocol has been approved by the IRB. |
| Clearance Notice | Clearance Notice and applicable documents are available in the 'Admin Notes & Files' section. Upon receiving approval from the IRB of Record, respond to 'Require Revisions' and 'Resubmit'. |
| Disapproved | The IRB may disapprove the study. Disapproval of a protocol is generally only considered after multiple attempts have been made to resolve the issues (i.e., Tabled for Re-review) including, at the discretion of the IRB, discussing the issues with the LR or inviting the LR to the Committee meeting. A study can only be disapproved by the full IRB Committee. |
| Exempt Self-Determination | This protocol is qualified for Exempt Self-Determination. For more information, visit https://research.uci.edu/human-research-protections/do-you-need-irb-review/self-exempt/ |
| Incomplete Submission | Submission is held based upon the following criteria: the protocol expiration date, date and time of receipt, whether or not all of the submission requirements have been fulfilled, whether or not the requisite expertise is available at the scheduled meeting, whether or not the meeting agenda is full (25 items maximum). Submission is considered eligible for review at the next IRB meeting pending resolution of the issue(s) listed above by the next IRB submission deadline date. All 'Action Items' specify the reasons why submission is held from IRB review. |
| Minor Revisions Required | Specific, non-substantial revisions are required. The IRB requests simple concurrences or specific, non-substantial changes. Upon receipt of the required changes, the IRB Chair or another member designated by the Chair will verify that the appropriate additions/corrections were made and will approve the study. |
| Non-Human Subjects Research | This protocol is Non-Human Subjects Research. |
| Pre-Review Sent | ERA transcription is required. |
| Scheduled For Committee Review | This protocol is scheduled for committee review. |
| Suspended | A currently approved study may be suspended when evidence of a possible increase in risk to participants or non-compliance by the Investigator has been determined by the IRB. Suspensions are made by the IRB under full Committee review procedures. |
| Tabled For-Review | Substantial revisions and/or additional information (e.g., details, clarification, justifications) are required that are directly relevant to the Criteria for IRB approval. Tabling a protocol requires that the study with the inclusion of additional information or revisions be reviewed by either a subcommittee or at a convened meeting. |
| Terminated | A currently approved study may be terminated if the study is not being conducted in accordance with the IRB policies, is not in compliance with Federal regulations, and/or has been associated with unexpected serious harm to participants. Terminations are made under full Committee review procedures. |
2. Admin Notes & Files
Reviewers sometimes leave protocol notes under Admin Notes & Files. It contains important communication and updates about the protocol, for example -
- Comments to recent uploaded documents that study team needs to review
- Records of when protocol is submitted, updates from subcommittee, detailed protocol status, and more
- Follow-up comments/communication to study team besides email communication
When Admin Notes & Files gets updated, it shows the green circle like this on the right column in protocol page. The number in the green circle corresponds to the number of how many notes and files there are.
Note:
- Reviewers use Admin Notes & Files section to supplement Action Items.
- Reviewers archive the notes and files once a transaction is completed so it won’t cause confusion.
All KRP auto-generated emails are sent from no-reply@kuali.co .
Occasionally, these emails may be directed to your Junk folder, so we recommend taking these steps below to receive the emails in your regular inbox.
For Outlook
1. Click “Junk” under the Home tab.
2. Click “Junk E-mail Options”.
3. In the pop-up, click “Safe Senders” and select “Add”.
4. Enter “no-reply@kuali.co” in the box and click “OK”.
5. It should show what you just added on the screen. Then click “Apply” and hit “OK”.
For Gmail
1. Click the settings icon on the right top on your Gmail screen.
2. Click “See all settings”.
3. Click “Filters and Blocked Addresses” and “Create a new filter”.
4. Type “no-reply@kuali.co” in “From” and click “Create filter”.
5. Check “Never send it to Spam” and click “Create filter”.
6. Now you can see what’s added in the Filters and Blocked Addresses.
Ancillary IRB Partner Review
How to Navigate a Protocol
Please note the images below are color coded.
-
- (GREEN, left) Navigation bar: Houses the different sections of the protocol. Think of this as the chapters of a book.
-
- (BLUE, middle) Main protocol: Details of the protocol. Think of this as the text within each chapter.
-
- (RED, right) Amendment tab: For staff to approve protocols. For ancillary review purposes, this section is not needed.
For the purpose of reviewing protocols, please only use (GREEN, left) Navigation bar and (BLUE, middle) Main protocol.
(BLUE) Main Protocol
All details of the protocol will be in this scrollable section. Please review the material for protocols here.
For example,
-
- Background & Purpose of the Research
-
- Subject Population(s)
(GREEN) Navigation Bar
The navigation bar corresponds to specific major sections of the protocol.
Here, you can jump from section to section without having to scroll through.
Navigating to Ancillary Review Tab
Click on Ancillary Review on top of the protocol.
Submitting a Comment only
When submitting a comment, please navigate to the appropriate Ancillary Review, and click the arrow to expand the review tab.
Next, press Add Comment highlighted below.
Type your comment(s) into the text field and click Post to submit it.
PLEASE NOTE: No further action is needed after this point if you only want to add a comment.
Approving an Ancillary Review
Click on the Status for the appropriate review.
Select Approved from the dropdown menu.
Department Chair Sign-Off
Receiving an Email from KR Protocols
When a lead researcher from your department submits a new IRB Application in KR Protocols, you will receive an email notification from KR Protocols and a direct link to said protocol.
If you do not receive the email notification from KR Protocols in your inbox, please check your Clutter or Junk folders. Optionally, you may contact ERA (era@research.uci.edu) for help with filtering KRP emails in your mailbox.
To access KR Protocols and the submitted protocol, click on the link in the email.
Proceed to log in with your UCInetID and password.
Browsing the Protocol
Upon clicking the link to the submitted protocol, you will be greeted with this page.
The protocol is broken up into sections on the left hand side. You can click on any of the tabs to jump directly to the desired section. Alternatively, you can also scroll down with your mouse.
Abstract/Non-technical Summary
The abstract/non-technical summary is located under the Project Screener section. You may use the tabs on the left hand side to quickly jump to the appropriate section or simply scroll down
Supplemental Documents
You can access supplemental documents for the protocol in the Attachments section.
Documents can be opened by clicking on the file, and downloaded by clicking download on the window that opens up.
Lead Researcher Section
The Lead Researcher section confirms the Lead Researcher has discussed and shared information from the application with you.
If you have any questions or issues with the protocol, please communicate with the Lead Researcher directly before signing off in KR Protocols.
Signing Off on the Protocol
IMPORTANT! If the Department Chair is also the Lead Researcher for a study, the Department Chair is not required to sign off on their own protocol.
In addition, the Department Chair does NOT need the Dean of their school (if applicable) to sign off on their protocol.
To start the sign-off, click on the Ancillary Review Tab at the top of the protocol.
You will be taken to the Ancillary Review page, where you will be greeted with your Ancillary Review Home Department.
To sign-off on the protocol, click on the arrows and change the status from "Pending" to "Approved".
The Ancillary Review Tab will turn from Orange to Green and the Status will change from "Pending" to "Approved".
IRB staff will be notified and they will be able to process the protocol for approval after IRB review.
You have completed the sign-off and can now exit the application by closing the tab or window in your browser.
Saving the Protocol for a Later Sign-Off Date
If the Department Chair needs more time to review the protocol, they can always log out of KRP and come back to it.
After logging back into KRP, the DC can click on the "Protocols Assigned to Me" tab and access the protocol again.
Reportable Events [INC]
From your protocol homepage, click on Reportable Events tab.
In the new screen, press the Report an Event to start.
Proceed to answer subsequent questions and fill out the form.
To save an unfinished Reportable Event, simply press the Save button outlined in red.
In the Reportable Event Tab, click on the Event Type pertaining to the Reportable Event you would like to resume.
To remove a Reportable Event that is no longer needed, press the Delete button on the right side.
You will be prompted with a confirmation message. Please select Confirm to proceed with deleting the Reportable Event.
NOTE: Deleting the Reportable Event CANNOT be undone.
To return to the Protocol Page, press the View Protocol button on the right side.
To submit a Reportable Event, please click the Submit for Review button on the right.
To view the activity users have made on the Reportable Event, click the View Activity button on the right side.
A window will pop up showing all user activity on the Reportable Event.
IRB Members Only
Agenda items such as minutes, education items, and subcommittee approval reports can be found in KR protocols here - please scroll down for the list of items on the agenda: https://uci.kuali.co/protocols/meetings/61427e1f6401a500357a3f51
- Once in Kuali Research Protocols - KRP (https://uci.kuali.co/protocols/), briefly review each item on the agenda:For an overview of the Administrative Reviewer's & IRB Reviewer comments and/or questions to the IRB, go to 'Action Items Summary' at the top right.
Note: to go back to the protocol from the Action Items summary, click on the 'X' on the top right side or re-enter the study from the "Protocols assigned to me"
- Review entire protocol (the narrative and appendices are now incorporated in main protocol)You can navigate the sections of the protocol using the section links on the left side.
- To view supporting documentation (Master Protocol (MP), Investigator's Brochure (IB), Consents, etc.), click on the document links provided in Agenda 2.0.
Alternatively, you can navigate the documents in the 'Attachments' section of the protocolSort the attachments section so that you can see what documents have been flagged for the agenda.
You can sort the last column to the right in the attachments table by clicking the tiny white arrow - this also works by clicking anywhere in the column title "AGENDA (IRB USE ONLY)":
If the last column of the attachments table is hidden to the right of the screen, either zoom out, or scroll all the way down in the attachments table and drag the side scroll bar to the right, then scroll back up and click on the top of the right side:
- Items assigned for your review can be found under 'Protocols assigned to me' in KRP.
- To strike items or questions posed by the HRP Staff, go to the specific action item in the protocol and reply that the action is not required.Important Reminder: Should the IRB agree, an action item may be forwarded to the LR, even if you as the reviewer indicate that the action item is not required. This is similar in if you had a comment or question in your (prior) IRB Reviewer Checklist, but it was not raised or discussed during the meeting, and thus not agreed upon by the IRB - it would not be presented to the LR as an item to address. Likewise, if you did not raise an issue on your (prior) IRB Reviewer Checklist, but a substantive issue was discussed and agreed to need attention by the IRB, that issue would be presented to the LR as an item to address.
- Feel free to add any action items for the LR to address. When creating an action item, select the level of visibility. Assign 'Meeting' and 'Assigned Reviewers' so that the entire IRB will be able to view your action items/ comments.
- The LR ('Researchers') can only view your comments once the protocol is returned to them by HRP Staff. This occurs after the meeting and as part of a formal IRB determination.
- IRB Reviewers are unable to attach documents. Please enter all comments as an 'Action Item' or specify in the comments section of the reviewer checklist.
- To see what was revised in an amendment, click on "compare versions"Then click on the right side text under 'compare a version' - then choose 'approved' - this will show you all the changes made since the approved protocol.
- When ready, go to the 'My Checklists' tab at the top and complete the COMMITTEE Checklist.
Please click on "My checklist" marked in green below not the "Checklists"After you have completed the checklist and the vote was either A or M then "Mark Complete". Do not "Mark Complete" for T.
If the study is Tabled then please on "Save" the checklist. This would aid in going back to the checklist for adding re-review comments. Currently KR provides only one checklist per reviewer.
- In certain rare cases there is a possibility that the reviewer does not see a checklist to complete under "My Checklist" as the checklist has already been marked complete. For example, if a study requires "minor revisions" after the initial full committee review and the reviewers complete the checklist by marking complete at initial review. However, later, when a response is received it is determined by the IRB Chair that the study would require a re-review by the IRB Full Committee. For such instances, please use the "General action item" button to add reviewer comments
- HRP Staff will ensure that any action items presented to the LR after the meeting are aligned with the determinations of the COMMITTEE. HRP Staff will resolve all action items or flag for LR to address as determined by the COMMITTEE.
Return to Researcher
Upon review of a given protocol, the administrator may send it back to the PI for additional information or other requested changes. When a protocol is returned the status of the protocol will either be Returned to PI or Requires Revision in the researcher portal. Protocols are returned to PI when they are incomplete or not ready for review and protocols that require revision have been reviewed but need some sort of edit or additional information prior to approval.
NOTE: Action Items must be assigned BEFORE returning the protocol.
To return the submission to the PI, click on Return to Researcher outlined below.
A window will appear where you can enter comments to further clarify the rationale.
Press Return when you are ready to send the protocol back to the researcher.
-
- For questions with using or navigating KRP, contact era@research.uci.edu
-
- For questions with IRB agenda items, contact the HRP Staff