FOUNDED IN 1859 BY QUEEN EMMA AND KING KAMEHAMEHA IV

Office of Research and Development

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

Submit a Study

How to Submit a Study for RIRC/IRB Review

Study Initiation
Determine Which IRB to Use &
Frequently Asked Questions

Step 1.
How to Submit a Study for Scientific Administrative Review (SAR)

Step 2.
How to Submit a Study for RIRC/IRB Review

There are two (2) avenues to submit complete applications:

Electronic Submission

Hardcopy Submission

  • Mailed to:
    Chairman, Research & Institutional Review Committee (RIRC)
    The Queen’s Medical Center
    1301 Punchbowl Street, UH Tower 505
    Honolulu, Hawaii 96813
  • Prospective study
    • New: 4 sets of documents (at least 1 set single sided)
    • Continuing renewal and Amendments: 3 sets of documents (at least 1 set single sided)
  • Retrospective study
    • New/Continuing renewal/Amendments: 1 single-sided set of documents

Checklists for Submissions

All New Prospective Study Only

Forms 1-9, 11-13
(Fill out and save both PDF and Doc versions*)

Form 9 only

N/A

All New Retrospective Record Reviews Only

Forms 1-4, 12-13
(Fill out and save both PDF and Doc versions*)

Serious Adverse Events (SAE) Reporting Requirements

SAE Reporting Requirements

HIPAA Training Manual and Acknowledgement Form

HIPAA Training Manual

Additional Templates

Consent Form Guidelines and Template

N/A

Separate HIPAA Authorization Addendum to Consent Form Template

Sample Letters of Agreement

Letter to Co-Investigator

Departmental Letter of Support

Study Protocol Templates

Prospective Studies

N/A

Retrospective Studies

N/A

Case Report Template

N/A

RIRC SOP

RIRC SOP Informed Consent

N/A

RIRC SOP Research Subjects

N/A

RIRC SOP Review Procedure

N/A

RIRC SOP Research Record Keeping Requirements

N/A

RIRC SOP Adverse Event and Unanticipated Event Reporting

N/A

RIRC SOP FDA Requirements

N/A

RIRC NonCompliance Reporting

N/A

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

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Uniform Guidance

RE: DECLARATION OF PROCUREMENT STANDARDS

The Queen’s Medical Center (QMC) hereby elects to utilize the grace period established in the Office of Management & Budget Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; final Rule – 2 CFR Chapter I, Chapter II, Part 200, et al. also known as the Uniform Guidance (UG) for July 1, 2015 (FY 16) and continue use of Circular A-110.

Excerpt from § 200.110 (a): “For the procurement standards in §§ 200.317 – 200.326, non-Federal entities may continue to comply with the procurement standards in previous OMB guidance (superseded by this part as described in § 200.104) for two additional fiscal years after this part goes into effect. If a non-Federal entity chooses to use the previous procurement standards for two additional fiscal years before adopting the procurement standards in this part, the non-Federal entity must document this decision in their internal procurement policies.”

In the meantime, QMC shall modify and develop procurement procedures to become consistent with the Uniform Guidance. QMC shall be in compliance with the UG effective July 1, 2018 (FY 19).