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

Frequently Asked Questions

Frequently Asked Questions (FAQ)

If you have suggestions for additional FAQ, please submit them to RIRC@queens.org. 

For additional assistance, please check Cayuse Help Center https://support.cayuse.com/hc/en-us/categories/115001977467-Human-Ethics 

PRE-APPROVAL

The Dashboard allows you to view all study submissions you are linked to in different ways. It also provides a to-do list of any tasks awaiting your response. For more information, review Overview of Dashboard

Each user will have a User Profile that will include your contact information and records of your credentials and training, and any other pertinent documents of the user. The purpose of the Profile is to reduce the need to attach credentials and training documentation to each new submission for review. Administrators, reviewers, and analysts have access to your Profile to check for qualification and education requirements during review. For more information, Review Profile.

A submission is usually returned to the investigators because the IRB Analyst and/or IRB Reviewer has questions or comments about the submission that require clarification or revisions from the study team. Please visit Addressing Comments in Human Ethics to learn about how to respond to the return of your submission.

Within a Submission, you can view where your submission is currently residing by looking at the top banner:

In-Draft” means that the submission is still with the study team and/or Principal Investigator (PI). This occurs if the submission is still being created or if the submission was returned to the PI/study team for clarification or modification after being reviewed by the IRB or IRB analyst.

Awaiting Authorization” means that the submission is complete but is waiting for the Principal Investigator to certify the submission so that it can be passed to the IRB office for review. The IRB is unable to review until the submission has been certified. The PI will need to certify each time a submission has been edited before it can be transferred over to the IRB side for review.

Pre-Review” means that the submission is with the IRB analyst (IRB staff) for review. The IRB analyst is responsible for initial intake to ensure that all required documents are included in the submission, as well as administrative review of submissions before they are sent to the either the IRB Chair or IRB committee for final review and determination.

Under Review” means that the submission is being reviewed by either the IRB Chair (for expedited review) or the IRB (for full-board review). Expedited reviews are reviewed in the order they are received, whereas full-board review is reviewed monthly during the second Wednesday of each month by assigned IRB reviewers.

POST-APPROVAL

Only studies that you have worked on the Platform or are listed as a Principal Investigator can be accessible through your Dashboard. For details on how to search for a study or a submission within a particular study, please refer to Researchers: Searching for Studies and Submission in Human Ethics.

Once you are on your Dashboard, you can search for studies and submissions to which you are involved in. Please refer to Researchers: Searching for Studies and Submissions in Human Ethics to learn about how to find specific studies or submissions within your Dashboard. 

The Platform houses both IRB determination letters and study documents within each submission. To view and download letters from the Platform, review the following article Viewing and Downloading Letters in Human Ethics. In lieu of using the Save As function (as described in the article), please use “Print as pdf” function.

Under the study’s Study Details page, scroll down to the three tabs as shown below:

Click on the ‘Attachments’ tab to find and download the last approved version of all study documents associated with the study.  This tab will include the final version and the IRB-stamped approval version for easy access to participant-facing documents for printing. 

Likewise, you can also find the most recently approved study documents in the last ‘Initial’ and/or ‘Modification’ submission under the ‘Submissions’ page for the submission in which it was submitted and approved. 

If you have any questions, please contact: