How To Submit a HE Protocol

• Log In & Browser Information

• Logging In

  Step 1: Navigate to the WPUNJ Cayuse Login Portal: https://wpunj.app.cayuse.com/

  Step 2: Enter your login information.

  Your username and password are the same as your standard WP credentials. 

  This will take you through the DUO process.

  Step 3: Click “Sign in”.

  Once logged in to the system, you will be taken to the Cayuse Home Screen:

  

   

  Step 4: Click on the “Products” and select “Human Ethics.”

  

  Browser Information 

  The Cayuse Human Ethics Module can be accessed on various browsers on either Windows or Macintosh systems. 

  Windows 

  • Recent versions of Google Chrome, Microsoft Internet Explorer 11 or Mozilla Firefox are supported. 
  • Provisional support for Microsoft Edge. 
  • Internet Explorer 10 and older versions are not supported. 

  Macintosh 

  • Provisional support for recent versions of Google Chrome and Apple Safari. 

   

  NOTE:  Cayuse HE runs entirely in a web browser. Upon navigating to Cayuse for the first time, your browser may present a security warning prompting you to accept a certificate. This is safe. Cayuse purchases and maintains electronic certificates that are approved for Internet commerce and are compliant with Internet security standards. Accept the certificate permanently and you will proceed to the login screen. 

  Troubleshooting

  First, close and reopen the browser and try to login. If that doesn’t work, clear the cookies/cache in your browser. Then close and reopen the browser again and try to login. 

  For more information on clearing the cookies/cache in a browser, click here.

  If you have any further browser-related issues or problems logging into the Cayuse SP system, you will need to submit a request to  cayuseadmin@wpunj.edu.

• Submitting a New IRB Protocol

• Submitting a New IRB Protocol

  Once you've logged in and navigated to the Human Ethics Module (see previous section), complete the following steps to submit a new IRB protocol.

  Step 1: Click on “New Study.”

  

   

  Step 2: Enter a new study title and click on the blue check mark:

  • This creates a new folder for your study.
  • All submissions for this study will reside in this “folder.”
  • Add the study title and then click the blue check mark

  

   

  Step 3: Click on New Submission to begin your initial IRB protocol submission.

  

   

  Step 4: Click on Submissions (sub-folder next to Study Details)

  

   

  Step 5: Click on “New Submission” (a drop down menu will appear) click on “Initial”

  

  

   

  Step 6: Click Edit to begin the application.  (This is where you complete the application form and attach protocol documents)

  

   

  In the “Key Study Personnel” section of the application, you will be asked to Assign a PI.  The study must have both a PI and a Primary Contact.  This may be the same person or two different people depending on your situation. 

  Faculty, Staff and Doctoral Students can be Primary Investigators (PI).

  Undergraduate and Masters level students: The lead student will submit the protocol and list themselves as the Primary Contact and will list their faculty advisor as the PI.

  You must complete all required questions in each section of the application.  If you do not see a white checkmark for a section, it means you have not responded to a required question, and you will need to review that section again and complete any unanswered questions.

   

  

  
  

   

  Step 7: Complete the Submission.  (You may also do this in the application in the “Complete Submission section.)

  • You may also do this in the application in the “Complete Submission” section
  • NOTE THIS IS NOT THE LAST STEP!!

  

  OR

  

   

  Step 8: Certify the Protocol

  The PI Must certify the application to initiate the IRB Office Review:

  • If you are the PI, you will need to “Certify” the application.
  • All PI’s listed on the study will be required to “certify” the application.
  • The system will send each PI an email stating the application is awaiting their certification. However, you do not need to wait for the email, you can certify directly from your Cayuse Dashboard. 

  To certify your application, click the “certify” button under routing

  

  You can check the Status by clicking on the Studies Tab:

  A successfully submitted application will show the status “submitted”

   

  

   

  You will also receive an email confirmation.

  

   

  *Note: The IRB may send the protocol back to you for revisions/edits/clarifications. If so, you will be notified via email and will need to follow the steps in the next section.

• When A Protocol Is Sent Back

• When A Protocol Is Sent Back

  The IRB may send the protocol back to you for revisions/edits/clarifications. 

  You will receive an email informing you:

   

  

   

  Step 1: Login to Cayuse and navigate to the Tasks tab

  

   

  Step 2: Click and open the protocol that was sent back

  • Make sure to toggle from "Study Details" to "Submissions" and open your submission if you are not brought directly to the window below
  • The ribbon on the protocol will say "Reopened"
  • Click on "Edit"

  

  *Pro Tip: You can view the protocol history from the Task History Tab located toward the bottom of the screen.  This is accessed only from within the protocol

   

  Step 3: Navigate to the parts of the protocol that need revision.

  • They are the sections with a comment bubble on the left. 
  • The number indicates how many items need to be revised in the section
  • The sections marked with checkmarks do not require revisions.

  

   

  Step 4: Within the section, find the Expand Comments bubble and click on it to see the reviewer's feedback.

  

   

  Step 5: Enter the revised information for each section with a comment and change the dropdown under "Reply" from "Not Addressed" to "Addressed".

  

  A time stamp will display and the dropdown will show “Addressed” when complete

  

   

  Step 6: After addressing all comments, Complete the Submission.  

  • You may also do this in the application in the “Complete Submission" section.
  • Remember, you can’t re-submit your protocol until all comments have been addressed.

  

  OR

  

   

  Step 7: Certify the Protocol

  The PI MUST CERTIFY THE APPLICATION BEFORE THE SUBMISSION WILL BE RECEIVED BY THE IRB Office:

  • If you are the PI, you will need to “Certify” the application when you resubmit it.
  • IMPORTANT: All PI’s listed on the study are required to “certify” the resubmission of the application.
  • The system will send each PI an email stating the application is awaiting their certification. However, you do not need to wait for the email, you can certify directly from your Cayuse Dashboard. 

  

  The successfully submitted protocol status will show as “Under Pre-Review”

   

  You will also receive an email notification:

  

• Approvals

• Approvals

  Once the Protocol is Reviewed and Approved you will be notified by email that your Approval notice can be found in the Letters Tab of the Submission Details page.

  

  Navigating to Your Approval Notice and Other Approval Materials Under the Submission Details Page Tabs

  To get to the tabs on the Submission Details page and your approval materials do the following:

  Step 1: Login to Cayuse and Navigate to the Human Ethics Module (see "Login & Brower Info" section for more details)

  Step 2: Find the "Approved Studies" section on the homepage and click to open the approved study

  

   

  Step 3: Click on the submission tab

  

    

  Step 4: Click on your approved submission

  

   

  Step 5: Click on the letters tab at the bottom to view and download your IRB Approval notice. (Click on the other tabs to see additional approval materials)

  

   

  Step 6: Click here to view and download the approval notice

  

Information for Faculty Advisors

• Student Access to the Cayuse System

• Student Access to the Cayuse System

  Students will need to be setup in Cayuse otherwise they will not have access to the system.

  The faculty advisor can submit the access request on behalf of the entire class, for specific individuals, OR students may submit their own request using the Cayuse Access Request Form.

  Pro Tip: If most of a class will need access, submit the access request in advance for the entire class. It is okay to submit for the entire class even if some students may not need to submit to the IRB.

• Faculty Advisor "Approval" Certification

• Faculty Advisor "Approval" Certification

  The Faculty Advisor and all student PI’s must certify the application to initiate the IRB review process.

  The system will send each PI an email stating the application is awaiting their certification. However, you do not need to wait for the email, you can certify directly from your Cayuse Dashboard.

  You will receive an email “Initial Submission Requires Certification”

  

  You can either click on the link in the email or you can log into Cayuse to certify the protocol:

  *For logging into Cayuse see the section above "Logging In & Browser Information" under the How To Submit an HE Protocol heading.

   

  Once logged in, you should see the Human Ethics Dashboard.
  (You can also click on Dashboard to return to this screen.)

  

   

  In the My Task section of the Human Ethics Dashboard there will be a list of protocols which require an action from you.

  

   

  Click on the link next to each of the protocols that indicates “Certify Submission.”

  • You are listed as the faculty advisor or a Co-PI on a study and will need to certify the protocol in order for it to proceed to be submitted to the IRB.

  

  This will open the protocol and bring you to this screen.

  

   

  To review the protocol, click on gray “View” to review it in Cayuse
  OR click on “PDF” to view it in PDF form.

  

  If no changes are needed: approve the protocol

  1. Click on the blue “Certify” button.
  2. Click on “Confirm” to submit.

  

  The successfully submitted protocol status will show as “Under Pre-Review”

  

  OR

  If you determine that changes are needed:

  1. Return the protocol to the student.

  2. Please communicate any changes or revisions with the student.

  This will be done outside of the Cayuse system.
  Please note that your communication with the student will be the only notification the student receives informing them of the needed revisions to the protocol.

  To Return the protocol to the student, click on the blue “Return” button.

  

  This will reopen the protocol and allow the student to make edits to the protocol directly inside Cayuse. The student will need to re-certify the protocol.

  Each time the student makes a change, they will be required to re-certify. As a Co-Pi or Faculty Advisor, you will also be required to re-certify the protocol.

  *Pro Tip: You can view the protocol history using the Task History Tab toward the bottom of the screen. This is accessed only from within the protocol.

  

   

  If you’ve certified the protocol, you will also receive an email:

  

• When A Protocol Is Sent Back

• When A Protocol Is Sent Back

  The IRB may send the protocol back to you for revisions/edits/clarifications. 

  The Faculty Advisors and Student Investigators will receive an email informing them:

   

  

  Either the student(s) or the faculty advisor(s) can edit/revise the protocol.

  Once edits/revisions are made, the protocol will need to be resubmitted and re-certified.

  *All PI’s will be required to recertify the protocol. The faculty advisor will also need to re-certify the protocol.

  To just re-certify a protocol, follow the steps in the “Faculty Advisor “Approval” Certification” section.
  
  

  Editing/Revising A Sent Back Protocol

  Step 1: Login to Cayuse and navigate to the Tasks tab

  

   

  Step 2: Click and open the protocol that was sent back

  • Make sure to toggle from "Study Details" to "Submissions" and open your submission if you are not brought directly to the window below
  • The ribbon on the protocol will say "Reopened"
  • Click on "Edit"

  

  *Pro Tip: You can view the protocol history from the Task History Tab located toward the bottom of the screen.  This is accessed only from within the protocol

   

  Step 3: Navigate to the parts of the protocol that need revision.

  • They are the sections with a comment bubble on the left. 
  • The number indicates how many items need to be revised in the section
  • The sections marked with checkmarks do not require revisions.

  

   

  Step 4: Within the section, find the Expand Comments bubble and click on it to see the reviewer's feedback.

  

   

  Step 5: Enter the revised information for each section with a comment and change the dropdown under "Reply" from "Not Addressed" to "Addressed".

  

  A time stamp will display and the dropdown will show “Addressed” when complete

  

   

  Step 6: After addressing all comments, Complete the Submission.  

  • You may also do this in the application in the “Complete Submission" section.
  • Remember, you can’t re-submit your protocol until all comments have been addressed.

  

  OR

  

   

  Step 7: Certify the Protocol

  The FACULTY ADVISOR and all Student PI's MUST CERTIFY THE APPLICATION BEFORE THE SUBMISSION WILL BE RECEIVED BY THE IRB Office:

  • If you are the PI, you will need to “Certify” the application when you resubmit it.
  • IMPORTANT: All PI’s listed on the study are required to “certify” the resubmission of the application.
  • The system will send each PI an email stating the application is awaiting their certification. However, you do not need to wait for the email, you can certify directly from your Cayuse Dashboard. 

  

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