Academics
Areas of Study

Resources for Researchers

Researcher Dashboard Overview

Creating a New Study

line of buttons, including Create Study, which is highlighted

As an IRB Researcher, you can create a new study within Cayuse IRB from your Dashboard or the Studies page.

Cayuse IRB Dashboard menu, with cursor pointing to Studies tab

Creating a Study

Click picture of button bearing a plus sign and the words New Study in the upper right-hand corner of your Dashboard or the Studies page.

Enter the title of your study. This can be up to 600 characters long.

picture of text field where a user has typed 'The Effects of Blue Light on Sleep'

Click picture of checkmark button/> to save your study.

After creating your study, you will be taken to the Study Details page. Here, you will see where important study information will populate once you begin your submission.

Study Details page

The person who creates the study is added by default as the primary contact. You can change this when editing the submission.

You can rename your study up until the completion of a withdrawal or admin closure submission. From the Study Details screen, hover over the study title and click within the field to edit.

animation showing how to edit the title of a study by clicking on it, then saving the change by clicking the checkmark

Once you create your study, you can begin your initial submission. Click on New Submission in the upper right-hand corner to start completing your forms.

Close-up of New Submission button

Creating an Initial Submission

line of buttons, including Initial Submission, which is highlighted

Once you’ve created a new study, you can begin completing forms for your initial submission by clicking first on New Submission, and then Initial from the drop-down menu.

Submission information will populate beneath the Submission Details tab. The person who creates the study is added by default as the primary contact, but this can be changed when editing the submission. Make sure to not remove yourself from all roles, or you will not be able to access your submission once you leave.

Click on Edit button to begin your submission forms. You will always be able to return to an incomplete submission by clicking this button.

On your initial submission form, you can return to the Submission Details page by clicking on Study in the upper left-hand corner of the screen.

close-up of the Study button with a cursor hovering over it

Use the  left-angle bracket and right-angle bracket buttons buttons to toggle between sections. You can also click on a section name in the menu at left to jump to that section.

Close-up of Sections with a cursor hovering over an item called Research Team

Completing Submission Forms

There are several types of questions that you may need to answer on the submission forms. Please note: Some questions have red asterisk next to the question number. This indicates a required question.

  • Radio Buttons: Select one of the available options. sample of radio button question
  • Check Boxes: Select one or more of the available options. sample of checkbox question
  • Date Picker: Click within the field to browse for a date. sample of date picker question
  • Text Box: Provide a short answer to the stated question (200-character limit). If you need to enter multiple lines of text, the box will expand to fit. sample of text box question
  • Text Area: Provide a detailed answer to the stated question. You can use formatting such as bold, italics, underline, strikethrough, bulleted lists, numbered lists, and hyperlinks. sample of text area question You can also add PNG or JPG images using the image button showing the image button. Once your image is inserted, you can edit the image by clicking on the image and then clicking Edit. Close-up of the Edit button on an image
  • Person and Sponsor Finders: While every initial submission will require you to add a Primary Contact and Principal Investigator, you may have to add other people or sponsors to different sections within your submission. Click on the finder button to bring up a search dialogue. Close-up of the Principal Investigator box, with a cursor hovering over Find People Search for the individual or sponsor that you wish to add, select them, and click Save. Animation showing the user typing in a name, selecting a person, which creates a green highlight, and clicking Save
  • Attachments: Upload one or more files to the study by clicking Attach button. Cayuse IRB supports the following file types: picture of a table showing Files (Text, Adobe, Raster image formats, Vector image formats, Microsoft Word, Microsoft Excel, and Microsoft PowerPoint) and Extensions

    You can also include hyperlinks as “attachments” by choosing Add Link from the + drop-down menu.

    Close-up of the drop-down menu with a cursor hovering over the plus sign to reveal Add Link and Add File as options To delete an attachment, click the X button icon next to the attachment.

Saving Your Changes

Sections with unsaved changes have an asterisk next to the section name.

Close-up of a section menu with a red asterisk signifying that Research Locations is not saved

To save your changes, click Save button in the upper right-hand corner.

Help with Questions

If there is help text for a question, you can click on the Question Markbutton to view it.

Example of question mark button revealing help text, with an arrow hovering over the question mark

Once there are green check marks next to all of your sections, you have completed the submission forms and are ready for routing.

Please note: If one of your sections doesn’t have a check mark and you aren’t sure why, search the section for any required questions you may have missed. With every section completed, you can complete your submission and send it to the PI for certification.

Close-up of Routing section, with cursor hovering above 'Complete Submission'

Please note: Cayuse IRB will warn you with a red lock icon if another user is currently editing a section. You won’t be able to edit that section until that person is done making edits.

Close-up of Sections list, with red asterisk next to '1 General Information' and a red lock next to '6 Data Collection, St...'

Completing a Submission

line of buttons, including Complete Submission, which is highlighted

The Complete Submission button will appear onlywhen you have green check marks next to all of your sections. If one of your sections doesn’t have a check mark and you aren’t sure why, click on the section to search for any required questions you may have missed.

Animation showing missing checkmark next to Purpose and Rationale, where a required question was not answered

Once you have filled out every section of your submission and have added all required attachments, a Complete Submission option appears beneath Routing within the menu.

Close-up of Sections menu with cursor hovering over Complete Submission

After clicking Complete Submission, you will be prompted to Confirm or Cancel.

Dialog window asking, 'Are you sure you want to continue?' with Cancel and Confirm as options

Upon confirmation, you will see the status of your submission change on the Submission Details page.

Close-up of status change, with In-Draft checked and Awaiting Authorization highlighted

Certification

Your completed submission is sent to the PI for certification. The PI will be notified by email. When the PI certifies the submission, they are asserting the submission is complete and accurate and are accepting their PI responsibilities.

If the PI decides that changes need to be made, they will send the submission back. All research team members will receive an email notifying them of the change in status so they can make the necessary edits and complete the submission once more.

Once the PI has certified it, the submission will be reviewed by the organizational approver, if any, and then routed to the IRB Analyst. The submission may be returned at any point for edits or clarification.

Completing Submission as a PI: If you are a PI completing your submission, you should be able to then certify it right away.

Co-PIs: Your institution’s settings may require that any Co-PIs on the study also certify the submission. These individuals also have the ability to return to the submission to the research team. IRB Administrators can specify this behavior in the Application Settings.

Recertification: If the submission does get returned to the research team, all previous certifications are cleared. All individuals who were required to certify the submission in previous rounds of routing must recertify every time the submission is returned before it can move forward.

Reopening Your Submission

To reopen the submission and make edits, click on the Edit button button within Submission Details.

Submission Routing

Flow chart showing possible paths between the submission beginning and the analyst preparing for review

Viewing and Downloading Letters

line of buttons, including Reopen Submission, which is highlighted

During the submission process, the compliance office may send communication to the PI in the form letters notifying the PI of status changes, approvals, and needed information. Letters are sent via email and are available to download directly from Submission Details in Cayuse IRB.

Close-up of Submissions window, with a cursor hovering over a hyperlinked line that says Initial

The Letters tab appears for a submission when there is at least one letter associated with that submission. To view a letter, click on the letter tab.

Details for a submission, with a box around the word 'Letters'

You will be able to view the subject, send date, and recipient(s) for each letter. You can click anywhere on the line to open a PDF of the letter in a new window.

Within the letters tab, the cursor hovers over a hyperlinked document

To save the letter to a file:

  • Chrome: Right-click within the opened PDF and select Save As. Dialog window showing right-click options, with a box around 'Save as...'
  • Firefox: Right-click within the opened PDF and select Save Page As. Dialog window showing right-click options, with a box around 'Save Page as...'
  • Internet Explorer: In the menu bar, click on gear icon > File > Save As. Dialog window showing File options, with cursor hovering over 'Save as...'

Addressing Comments

line of buttons, including Reopen Submission, which is highlighted

When a submission has been certified by a PI and sent to the IRB Analyst, the Analyst or other individuals reviewing the submission may comment on various questions within the submission forms. The Analyst will return the submission to the investigators, and the investigators will need to address any of the comments.

Sections with unresolved comments have a comment bubble icon indicating the total number of unresolved comments in that section. Click on the section to see which questions have a comment attached.

Sections menu with a cursor hovering over a comment bubble, with the number 3 in it, next to Research Team

Depending on how far the submission progressed, you may see comments from the IRB Analyst, your Organizational Approver, or from the IRB member(s) reviewing the submission.

Addressing Comments

You must mark all comments as addressed before the submission can be completed.

Once all comments on the submission have been addressed and it has been completed, the PI will need to re-certify the submission to return it to the IRB Analyst.

  • Click on the numbered comment bubble to view the unaddressed comments associated with each question. Box showing comment window, with cursor hovering over a comment bubble, with the number 1 in it, next to Expand Comments
  • Click Reply. Enter your reply and click Save. Animation showing expanded comment window, with user typing a reply to a comment bubble and then clicking Save
  • Once you have resolved an issue, change the status drop-down from Not Addressed to Addressed. Box showing comment window with reply and a status drop-down list; the cursor is hovering over 'Address'

Viewing Submission Details and History

line of buttons, including Complete Submission and Reopen Submission, which are highlighted

You can access all details and history for a submission within the Submissions tab on the Study Details page, or from the menu on your Dashboard.

From Study Details

From the Study Details page, click on the Submissions tab.

Close-up of Study Details window, with a cursor hovering over the Submissions tab

The Submissions tab shows the list of submissions associated with the study, including the submission type, review type and status, decision, and last modified date. Click on the submission you wish to view.

Close-up of Submissions tab, with the cursor hovering over a linked document titled 'Initial'

At the bottom of the Submission Details screen, you’ll see tabs that vary depending on the submission stage. Tabs may include Approvals, Task History, Letters, Meetings, Decisions, and Linked Proposals.

Click on the desired tab to locate the required information.

Close-up of Submissions window, with the tab options highlighted by a box and Task History showing

From Your Dashboard

Click on Submissions in the menu.

Close-up of the nav-bar menu, with the cursor hovering over Submissions

Search for the submission you wish to view, and then click on the submission.

Close-up of a dialog box, with the cursor hovering over a hyperlinked document with a IRB number

This will bring you to the Submission Details page.

Resources for Reviewers

Reviewer Dashboard Overview

Reviewing and Commenting on Submissions

After an IRB Analyst assigns a submission to you for review, you will receive an email letting you know that the submission requires your review.

On your dashboard, change your role to Reviewer.

Close-up of Menu drop-down list, with a secondary drop-down list showing Roles and the cursor hovering over Reviewer

Click on the review in need of submission beneath My Tasks.

Close-up of My Tasks list, with cursor hovering over a hyperlinked IRB document

Reviewing a Submission with Your Checklist

  • From the Submission Details page, click on Checklist. Close-up Submission Details page, with cursor hovering above Checklist
  • Review the submission using the provided checklist. If you need to need to leave your computer before you are finished, clicking Save Checklist will save what you have checked off until you return. Close-up of Checklist with cursor hovering over Save Checklist

Commenting on a Submission

To leave a comment on a submission, click Add Comment beneath a submission question. Type up your comment, and click Save Comment.

Comment window with a comment typed in and the cursor hovering over Save Comment

Once your comment is saved, you can Edit or Reply to the comment, or toggle the visibility of the comment.

You can toggle visibility by clicking on the down arrow. Restricted visibility means that researchers cannot see your comments, and unrestricted means that they can see your comments. If your comment is directed toward the researcher, you will want to toggle the visibility to Unrestricted.

Close-up of the Visibility toggle, with the cursor hovering above Unrestricted

Once you’re finished reviewing and commenting, click on Study to return to the Submission Details page.

Cursor pointing to the Study link on an IRB submission

Making Decisions for Limited IRB Reviews (FBR)

The Limited IRB Review Type assists institutions with complying with the new common rule regulations. Limited IRB review is required for the new categories of exemption outlined in the Revised Common Rule. Refer to your IRB Office on when this review type is used.

An IRB Analyst may assign submissions to one or more IRB members for Limited IRB reviews. While non-primary reviewers have the option to review and comment on the submission directly, the primary reviewer is tasked with making a decision.

Primary Reviewers

If you are a primary reviewer assigned to a Limited IRB submission, you will see a task called Complete Limited IRB Review beneath My Tasks.

Example list showing one Complete Limited IRB Review option among three documents

Clicking this link will bring you to the Submission Details page. Click Make Decision beneath Required Tasks after you have reviewed the submission.

Example list showing the Make Decision link under Required Tasks

On the decision panel, you will be asked to complete a series of questions. All questions are optional with the exception of the Decision. The available decisions are:

  • Exempt – Limited IRB
  • Minor Stipulations
  • No Engagement in Research
  • No Human Subjects Research
  • Not Limited IRB
  • Rely on External IRB
  • Rely on NCI-CIRB
  • Return to PI
  • Suspended

You can also select the Categories applicable to the decision, enter information about Findings, and include Researcher Notes or Internal Notes.

Animation showing the Categories with their checkboxes, followed by text fields for Findings, Researcher Notes, and Internal Notes

When you are finished filling out the questions on the decision panel, click Save button.

Beneath Routing, click Review Complete.

Close-up showing the Review Complete button

The submission’s status will change to Under Post Review.

Non-Primary Reviewers

If you are a non-primary reviewer assigned to a Limited IRB review, you will see a task called Complete IRB Review beneath My Tasks.

Example list showing three Complete IRB Review options among five documents

Clicking this link will bring you to the Submission Details page. Click on Review to begin your review of the submission.

Close-up of Submission Details page, with cursor hovering over Review

Within the submission, you can leave comments on each question by clicking Add Comment, typing your comment, and clicking Save Comment.

Animation showing how to add and save a comment

You can also toggle if the comment is Restricted (visible only to reviewers) or Unrestricted (visible to anyone with study access).

Close-up of the Visibility toggle, with the cursor hovering above Unrestricted

Making Decisions for Exempt and Expedited Reviews

If a primary reviewer has been assigned to a submission with an exempt or expedited review, they will make the decision based on their review and comments from any other reviewers. Otherwise, all reviewers assigned to the submission may enter their decision, and the IRB Analyst will make the final decision. All Exempt submissions have a primary reviewer, but Expedited submissions may not have one.

Making a Decision

  • Review and comment on the submission by clicking on Review on the Submission Details page. Close-up of Submission Details page, with cursor hovering over Review
  • Once the review is complete, click Make Decision beneath Tasks. Example list showing the Make Decision link under Required Tasks
  • Fill out the review decision information, and click .

Review Information

  • Decision: If you need to return the submission to the analyst to arrange a full board review, you should select Not Exempt or Not Expedited as the decision and complete the review.
  • Result Date: This is the date that the decision was made.
  • Administrative Check-In Date: This field will appear for expedited and exempt reviews with no expiration date. When an Administrative Check-In date for a review is set, it will trigger an email to the research team on that date. The email template for this message can be configured by an IRB Analyst or administrator.
  • Continuing review is mandatory: When checking this box, an expiration date can still be enforced on post-Common Rule 2018 expedited review submissions.
  • Expiration Date: The expiration date is automatically calculated for Initial and Renewal submissions that have been approved. Modification, Incident, and Closure submissions will display the expiration date set in the most recent Initial or Renewal submission for the study. You can also manually edit the expiration date for “Rely on NCI-CIRB” and “Rely on External IRB” decisions. The expiration date is optional for exempt studies.
  • Justification for expiration: You can use this field to explain an unconventional expiration date for the submission.
  • Categories: You can select categories explaining why this study qualifies for an expedited or exempt decision.
  • Findings: Any text entered in the Findings box may be used as part of the letter(s) sent to the research team in relation to this submission.
  • Researcher Notes: Notes that are intended for the research team and can be used as part of the letters(s) sent in relation to this submission.
  • Internal Notes: Private notes that will not be visible to the research team.

Once you have recorded and saved your decision, return to the Study Overview and select Review Complete to return the submission to the IRB Analyst.

Close-up of Review Complete button

Entering Decisions

When entering decisions, you can choose from the following selections. You will see different options depending on the type of review.

Decision Explanation Resulting Study Status Routing
Approved The study is approved. Approved Submission is approved and no longer editable.
The research team can add additional submissions to the study.
No Engagement in Research The study does not constitute research and therefore does not require IRB approval. Approved Submission is approved and no longer editable.
The research team can add additional submissions to the study.
No Human Subjects Research The study does not include human subjects research and therefore does not require IRB approval. Approved Submission is approved and no longer editable.
The research team can add additional submissions to the study.
Noted The incident report has been noted by the IRB. Approved Submission is approved and no longer editable.
The research team can add additional submissions to the study.
Rely on External IRB The study and submission were reviewed and approved by an external IRB and their decision has been recorded by the IRB. Approved Submission is approved and no longer editable.The research team can add additional submissions to the study.
Rely on NCI-CIRB The study and submission were reviewed and approved by an NCI-CIRB and their decision has been recorded by the IRB. Approved Submission is approved and no longer editable.
The research team can add additional submissions to the study.
Exempt The study is exempt because it fits into one of the specified categories for exemption. Exempt Submission is approved and no longer editable.
The research team can add additional submissions to the study.
Suspended A study is suspended when the IRB decides that the research needs to stop until changes have been made to the research. A suspended decision is available on Incident Reports, Modifications, and Renewals.
Suspension can only be lifted by selecting the “Suspension Removed” decision for a modification submission after it has had a full, full expedited, or expedited review. Lifting the suspension changes the study’s status back to “Approved”.
Note: Renewal submissions for an expired suspended study can receive a decision of “Approved” in order to extend the date without lifting the suspension, or “Suspension Removed” in order to extend the date and lift the suspension.
Suspended Submission is returned to the PI and is no longer editable.
Closed A closure submission is created and submitted when the research is done and the study can be closed. Closed The study is closed and no further research can be done.
Withdrawn The research team decided not to proceed with the initial submission. This decision is only available for withdrawal submissions. The research team can choose to withdraw the study at any point until the initial submission has been approved. If the initial submission has been approved, the research team must create a closure submission instead. Withdrawn The study is closed and no further research can be done.
Disapproved The full board identified major issues with the study or submission and disapproved the research. In the case of a disapproved initial study, a new study and submission will need to be created. For disapproved renewal, modification, etc. submissions, the research team will need to create a new submission if they wish to proceed. Disapproved The submission and/or study are disapproved and no longer editable. Disapproving an initial submission archives the study.
Deferred The reviewer(s) identified major issues that the research team must correct before the submission can be approved. Submission is returned to the PI and reopened for editing.
Minor Stipulations The reviewer(s) identified minor issues that the research team must correct before the submission can be approved. Requires Changes Submission is returned to the PI and reopened for editing.
Return to PI The study is being returned to the research team to make changes because the IRB will not approve it as-is. Requires Changes Submission is returned to the PI and reopened for editing.
Not Expedited/Not Exempt The study will be returned to the IRB Analyst to reassign it to the correct review type. N/A Submission is returned to the Analyst to reassign the review type and reviewers.
Not Reviewed Documents that the submission was unable to be discussed at the meeting. The “Not Reviewed” decision is logged in the decision history so that a new decision can be made at a subsequent meeting. This decision type is only available for full board reviews of initial, modification, incident, and renewal submissions. N/A Submission is returned to the Analyst to assign to a new meeting.

Resources for Analysts

Administratively Certifying a Submission

If you are an IRB Analyst, you can administratively certify submissions on behalf of the PI if the PI is unable to do so.

The steps to administratively certify a submission are the same as the steps a PI takes to certify a submission after it has been submitted for routing.

Beneath Routing, Click Administratively Certify to the right of Return.

Confirm certification by clicking Confirm.

You can now assign an IRB Analyst to the submission.

Contact Us

Institutional Review Board

Fowler Hall 202a

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