Resources

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

Creating a Study

1. Click  in the upper right-hand corner of your Dashboard or the Studies page.
2. Enter the title of your study. The title can be up to 600 characters long.
   
   
3. Click  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.

The person who creates the study is added as the primary contact by default. 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.

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.

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

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

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

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

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

Completing Submission Forms

There are several types of questions that your institution may have chosen to include on the submission forms:

• Radio Buttons: Select one of the available options.
  
  
• Check Boxes: Select one or more of the available options. 
  
  
• Date Picker: Click within the field to browse for a date.
  
  
• 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. 
  
  
• 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. 
  
  
  
  You can also add PNG or JPG images using the image button . Once your image is inserted, you can edit the image by clicking on the image and then clicking Edit.
  
  
• Person and Sponsor Finders: While every initial submission will require you to add a Primary Contact and Principal Investigator, your institution may have you add other people or sponsors to different sections within your submission. Click on the finder button to bring up a search dialogue. 
  
  
  
  Search for the individual or sponsor that you wish to add, select them, and click Save. 
  
  
• Attachments: Upload one or more files to the study by clicking . Cayuse Human Ethics supports the following file types:
  
  
  
  You can also include hyperlinks as "attachments" by choosing Add Link from the + drop-down menu. 
  
  
  
  To delete an attachment, click the  icon next to the attachment.

Please note: Some questions have  next to the question number. This indicates a required question.

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

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

Help with Questions

If there is help text for a question, you can click on the button to view the additional information for that question.

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.

Please note:  Cayuse Human Ethics 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 they're done with their edits. 

The Complete Submission button will only appear when 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.  

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.

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

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

Certification

Your completed submission is sent to the PI for certification. The PI will receive an email letting them know that the submission needs to be certified. 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 the submission, the submission will be reviewed by the organizational approver and routed to the IRB Analyst. The submission may be returned at any point for edits or clarification. Please note: If your institution does not have an approver, the submission may be routed directly to the IRB Analyst. 

Completing Submission as a PI: If you are a PI completing your submission, you should be able to then certify the submission 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  button within Submission Details.

Submission Routing

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 Human Ethics.

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.

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.

To save the letter to a file:

• • Chrome: Right-click within the opened PDF and select Save As.
    
     
  • Firefox: Right-click within the opened PDF and select Save Page As. 
    
    
  • Internet Explorer: In the menu bar, click on  > File > Save As. 
    
    

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.

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

1. Click on the numbered comment bubble to view the unaddressed comments associated with each question. 
   
   
2. Click Reply. Enter your reply and click Save. 
   
   
3. Once you have resolved an issue, change the status drop-down from   to .
   
    

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

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

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.

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.

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.

From Your Dashboard

Click on Submissions in the menu.

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

This will bring you to the Submission Details page.

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.

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

Reviewing a Submission with Your Checklist

1. 1. From the Submission Details page, click on Checklist.
      
      
   2. 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.
      
      

Commenting on a Submission

To leave a comment on a submission, click  beneath a submission question. Type up your comment, and click 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 be 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.

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

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.

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

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.

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

Beneath Routing, click Review Complete. 

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.

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

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

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

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

1. Review and comment on the submission by clicking on Review on the Submission Details page.
   
   
2. Once the review is complete, click Make Decision beneath Tasks.
   
   
3. 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.

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

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.