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

Getting Started

Plan Ahead

Please plan ahead to allow a sufficient amount of time for submission, review, and approval of your project.  The turnaround time for IRB protocol approval can be impacted by many factors and will vary throughout the year.  Protocols are reviewed on a first-come, first-serve basis.  Protocols of greater complexity or risk will take more time to review.  Please contact the Research Regulatory Office if you have questions or concerns regarding your protocol’s review timeline at RIRC@queens.org. 

Protocols that are received incomplete or lack details will be returned to the Principal Investigator (PI), further delaying the review and approval processes.  Please review the Investigator’s Guide (TBD) to assess the readiness of your study documents for review. 

Accessing Queen’s Electronic IRB Submission Portal

IRB Protocol Submission requires access to Cayuse Human Ethics (HE), Queen’s electronic IRB submission portal.  If you are new, please start at Step 1 to Request a Human Ethics (HE) Account.  All research personnel that will be listed on the protocol will need an HE Account.  Current investigators who have previously logged into HE, please skip to Step 3 to Log into Cayuse Human Ethics. 

Complete HE Account Request Form 

Please complete an online HE Account Request Form for each investigator, research personnel, or study contact that will be added to the protocol.  You may submit a request form on another person’s behalf, but each request allows for only person at a time. 

Within 2 business days, you will receive an HE account activation email from do-not-reply@cayuse.com.  Please check your junk inbox if you do not see this email. 

Within the email, you will be provided with your username and your temporary password.  Please activate this account as soon as possible.  The temporary password is valid for 30 days from the day the account was created. 

If your account is not activated within 30 days, you may need to request for a new activation password.  To request a new activation password, please contact RIRC@queens.org or call the Research Regulatory Office (RRO) at 691-7986 for this request. 

*Note: HE Accounts do not need to be activated for the person to be added to the IRB protocol in the HE portal, but it is required to access the portal to view statuses of protocols the person is added. 

Queen’s IRB Protocol submission is processed in Cayuse Human Ethics. 

    • Please click https://queens.app.cayuse.com to log in.
    • After you login, you will be taken to your Home Page labeled “My Tasks”.
    • On the top right corner, click on “Products” as show on the picture below.
    • A drop down menu will appear. Click on “Human Ethics” as shown on the picture below, and you will be taken to the Human Ethics Dashboard.

Pre-Submission

Once you have successfully accessed Human Ethics, please follow the guidance provided below to help you navigate the submission process.  If you have any questions regarding the contents of your application or requirements for submission, please contact RIRC@queens.org. 

Investigators are responsible for obtaining IRB approval before beginning any human subjects research that meets the federal definitions of ‘human subjects research’.   The Office of Human Research Protections (OHRP) recommends that institutions ensure knowledgeable individuals, in this case Research Regulatory Office (RRO) staff and Queen’s IRB members, assist investigators in making the appropriate decision about the status of their project, determine if IRB approval is required, and ensure that an IRB reviews all studies that are determined to be human subjects research. 

Investigators should err on the side of caution and are encouraged to submit their project in the HE portal to determine if the project meets the federal definition of ‘human subjects research’ and requires IRB approval. 

Please contact RIRC@queens.org if you have any questions. 

All Investigators and Other Research Personnel on the research team working with human subjects must complete:

  1. Required Human Subjects Protection Training before receiving IRB approval. Human Subjects Protection Training must be retaken every 3 years.  To complete the required Human Subjects Protection training, follow the directions located in the Training and Education section located here
  2. Proof of training completion (for example: Completion Certificate) for all study personnel is required to be included with study submissions in Cayuse. 

You will be asked to upload study document as attachments throughout the submission application form.  It is highly recommended that you prepare by setting aside the following study documents as .doc or .pdf versions PRIOR to creating your study:

  • CV and Training
    • Curriculum Vitae (signed and dated within the last two years)
    • Research HIPAA Training
    • CITI Human Subjects Research Training (non-Queen’s)
  • Financial Conflict-of-Interest Disclosure (for prospective studies only)*

  • Protocol

    • Site Protocol*
    • Investigator’s Brochure
    • Clinical Investigational Plan
    • Budget
  • Recruitment Material
    • Recruitment Flyer
    • Recruitment Script
  • Data Collection Material
    • Questionnaires
    • Surveys
    • Interview Questions
    • Data Collection Forms
  • Informed Consent*
    • Informed Consent Forms
    • Parental Consent Forms/Assent Forms
    • Information Sheets
    • Short Forms
    • Translated (non-English) Informed Consent Forms
  • Drug and Device Forms, if applicable
    • FDA Exemption Determination Letter
    • Drug or Device Form*
  • Agreements (when applicable)
    • IRB Authorization Agreement (i.e., ceding agreement)
    • Business Associate Agreement (e.g., Data Use Agreement, Materials Transfer Agreement, etc.)

* Visit the IRB Forms and Template page.

New Study Submission

Below is a step-by-step summary of how to create, complete, and submit and new study: 

  1. Log into Cayuse Human Ethics
  2. In the upper right-hand corner, click blue button “+ New Study”
  3. Complete the title of your study and click save.
  4. In the upper right-hand corner, click the blue button “+ New Submission”.
  5. You will now see a ribbon that says “Unsubmitted”. You will have the choice to edit, delete, or pdf the submission.
  6. Select Edit.
  7. If you are not the principal investigator of the study, first add yourself as the primary contact in the personnel section, and then edit the personnel to list the appropriate principal investigator.
  8. Continue with the other sections until complete.
  9. The principal investigator will receive an email notice to certify the submission.
  10. Once the principal investigator certifies, the submission will be received by the Research Regulatory Office and will undergo review.

For help submitting a new study (new submission) to the QMC RIRC, consult this Investigator’s Guide (TBD).

If you still have questions, contact RIRC@queens.org to schedule a meeting with RRO Staff who can assist with your submission. 

For additional assistance, you can visit the following site for visual instructions: https://support.cayuse.com/hc/en-us/articles/15128050897683-How-do-I-create-an-initial-submission 

IRB Review and Approval

All IRB submissions are reviewed in the order that they are received. You can check on the status of your protocol in the Cayuse Human Ethics System from your Cayuse Dashboard. 

Once the Regulatory Analyst has conducted an initial review of your study, if clarification or revisions are needed, we will return the study to you in the Cayuse Human Ethics System for edits. You will receive an email from the Cayuse Human Ethics System, which will let you know your protocol has been returned. Please complete the revisions in their entirety ASAP and resubmit the revised documents within the Cayuse Human Ethics System, following the steps above.

For instructions on how to address IRB review questions or concerns that have been returned to the researcher, please the Frequently Asked Questions page 

Once you receive an official approval letter from the IRB via the Cayuse Human Ethics System, you are welcome to begin your research activities. Note that you cannot begin research activities (including recruiting human subjects or collecting human subject data) until the IRB has officially issued you an approval letter for your IRB protocol. 

You may find your approved informed consent document on the study details page of your IRB submission. It will be located on the attachments tab at the bottom of the page. 

All approvals are final, and nothing may be changed once approval is issued without obtaining IRB approval for the changes. After your protocol is approved, a modification request must be reviewed and approved by the IRB before changes may be implemented. Failure to obtain IRB approval prior to the implementation of changes is considered noncompliance and will be subject to corrective action. This includes, but is not limited to, changes to study documents, personnel, activities, recruitment methods, or to your Cayuse submission form. 

For instructions on how to access or download IRB determination letters for your study, please visit the Frequently Asked Questions page. 

If you have any questions, please contact:

rirc@queens.org