OFFICE OF RESEARCH AND DEVELOPMENT (ORD)

Office of Research and Development

Office of Research and Development
The Queen’s Medical Center
1301 Punchbowl Street, UHT 508
Honolulu, HI 96813

Submitting Modification, Renewal or Closure

Submitting a Modification or Renewal

After your protocol is approved by the IRB, you must submit a modification request in HE and obtain IRB approval for ANY changes prior to the implementation of the changes. Below is a guide to explain how to submit a modification to an approved study.

  1. Click https://queens.app.cayuse.com to log in
  2. Navigate to the Human Ethics portal
  3. Click on the study you would like to modify.
  4. In the upper right-hand corner, click the blue button “+New Submission” and select “Modification”.
  5. Select Edit.
  6. Complete the modification page, explaining all of the changes you would like to make to your approved study.
  7. Navigate to the affected sections of your study and complete the updates.
  8. Once complete, mark the routing button as “Complete Submission”
  9. The Principal Investigator will receive a notice to “Certify” the submission.
  10. Once the principal investigator certifies, the submission will be received by the UNT IRB and will undergo review.
*Please note: Only one modification submission can be active at a time. If a submitted modification is still being reviewed, you will not be able to create a separate modification for the same study until the previous modification submission has been processed with a determination.
 
 
Adding Personnel

If you are adding new personnel to your study via modification submission and are unable to find them within the Cayuse directory, please request that an account be created for the person(s) you plan to add. 

Complete the HE Account Request Form

Please allow 2 business days from the time of completing your account request for the RRO to fulfill your request.

Quick Links

Renewing or Updating Status of a Study

Please allot at least two (2) months prior to your expiration date or four (4) weeks prior to your admin check-in date to submit your renewal or status update application, respectively.

Exempt studies do not have an expiration date or an admin check-in date, so there is no need to submit a Renewal application.

Below is a guide to explain how to submit a renewal/status update to an approved study.

  1. Click https://queens.app.cayuse.com to log in
  2. Navigate to the Human Ethics portal
  3. Click on the study you would like to renew or provide a status update.
  4. On the ‘Study Details’ page, click on the ‘Attachments’ tab. Ensure that the study documents listed are the most recently approved versions.
    • For studies that have an expiration date, these documents will be used to stamp the new approval and expiration date.
  5. In the upper right-hand corner, click the blue button “+New Submission” and select “Renewal”.
  6. Select Edit.
  7. Complete the renewal form. Make sure all required questions are answered. Otherwise, the “Complete Submission” button will not appear.
  8. Ensure that the most recently approved documents attached to the study’s ‘Study Details’ – “Attachments’ tab reflects the most recently approved study documents for your study. These documents will be used for stamping new IRB approval dates once the renewal has been IRB approved.
  9. Once complete, mark the routing button as “Complete Submission”
  10. The Principal Investigator will receive a notice to “Certify” the submission.
  11. Once the principal investigator certifies, the submission will be received by the RRO and will undergo review.

For visual instructions, please visit https://support.cayuse.com/hc/en-us/articles/360046339113-Creating-a-Renewal-Submission-in-Human-Ethics

If you have any questions, please contact:

rirc@queens.org