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

Determine Which IRB to Use & Frequently Asked Questions

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

Determine Which IRB to Use

There are 5 options for IRB submission depending upon funding type and specialty:

Non-oncology studies with ceding to other IRB (RA number series 900)

Hawaii Cancer Consortium process (RA number series 700)

UH Cooperative IRB review (RA number series 500)

MOU review (RA number series 300)

RIRC review (RA number series 000)

IRB Submission:

Hawaii Cancer Consortium Process

Where to Submit:

  1. Forward protocol and informed consent to rohta@queens.org for review/editing of QMC-specific issues/changes
  2. Then contact UHCC Clinical Trials Office for further information on Hawaii Cancer Consortium submission process to their IRB

RA number series:

700

IRB Submission:

UH Cooperative IRB review

Where to Submit:

  1. Send IRB submission to University of Hawaii (UH) Cooperative IRB. Their forms can be found at: https://research.hawaii.edu/orc/human-studies/eprotocols-submit-or-manage-a-protocol/

RA number series:

500

IRB Submission:

MOU review through RIRC

Where to Submit:

  1. Regular submission process here AND
  2. At same time, submit one copy of RIRC submission to UH Human Studies Protection at uhirb@hawaii.edu or Human Studies Program, UH Manoa, 1960 East-West Road, Biomed Bldg., Rm. B-104, Honolulu, HI 96822
  3. Include cover letter to both QMC and UH requesting review under the MOU

RA number series:

300

IRB Submission:

RIRC review

Where to Submit:

  1. Regular submission process to RIRC here

RA number series:

000

Please note:

  • All studies regardless of IRB oversight must fax or send signed signatory pages of informed consents (with RA#) to the Research Regulatory Office within 24 hours of signing. (808-691-7897 or University Towers room 501). Please remember that the Witness to Signature is only for signing and must be someone not working on the study. Include time and date for all signatures.
  • All studies must be assigned an RA number, particularly if the study is funded or includes charges.
  • Researchers will receive official RIRC correspondence for all studies except Consortium.
Type of study/funding
IRB Submission
Where to submit
RA number series

Non-oncology studies with ceding to other IRB 

Outside IRB with required RRO review

Where to Submit

  1. Request use of other IRB and submit study documents* to rohta@queens.org.
  2. Work with RRO on QMC-specific consent language for other IRB submission, at the same time as contract/budget and MCA
  3. RRO will shepherd IRB agreements with other IRB/Smart IRB
  4. *E.g. protocol, draft consent(s), eCRF, Investigator Brochure, contract, budget, letter of agreement with depts/investigators, CV/Research HIPAA acknowledgment form/CITI training

900

ALL oncology-related studies, except retrospective record reviews

Hawaii Cancer Consortium process

  1. Forward protocol and informed consent to rohta@queens.org for review/editing of QMC-specific issues/changes
  2. Then contact UHCC Clinical Trials Office for further information on Hawaii Cancer Consortium submission process to their IRB

700

Federally-funded AND requiring both UH and QMC coverage (non-oncology)

UH Cooperative IRB review

  1. Send IRB submission to University of Hawaii (UH) Cooperative IRB. Their forms can be found at: https://research.hawaii.edu/orc/human-studies/eprotocols-submit-or-manage-a-protocol/ 

500

Non-federally-funded AND requiring UH and QMC coverage (non-oncology)

MOU review through RIRC

  1. Regular submission process here AND
  2. At same time, submit one copy of RIRC submission to UH Human Studies Protection at uhirb@hawaii.edu or Human Studies Program, UH Manoa, 1960 East-West Road, Biomed Bldg., Rm. B-104, Honolulu, HI 96822
  3. Include cover letter to both QMC and UH requesting review under the MOU

300

All others

RIRC review

  1. Regular submission process to RIRC here

000

Please note:

  • All studies regardless of IRB oversight must fax or send signed signatory pages of informed consents (with RA#) to the Research Regulatory Office within 24 hours of signing. (808-691-7897 or University Towers room 505). Please remember that the Witness to Signature is only for signing and must be someone not working on the study. Include time and date for all signatures.
  • All studies must be assigned an RA number, particularly if the study is funded or includes charges.
  • Researchers will receive official RIRC correspondence for all studies except Consortium.

Frequently Asked Questions

The SAR process provides feedback to the investigator and the RIRC regarding the accuracy and completeness of their protocol. Components of the submission may be reviewed in varying detail based on the scope and complexity of the study.

The Research and Institutional Review Committee (RIRC):

  • ensures that human subject research activities are conducted in a way that fulfills all moral, ethical, and legal responsibilities
  • considers research protocols in the context of patient protection by evaluating the risks and benefits of each study, the completeness and clarity of informed consent, and compliance with other regulatory requirements

If you have further questions about the RIRC/IRB review process, contact Rebecca Ohta at 808.691.4512

 No, SAR is only required for new protocol submissions. Renewals or amendments of the protocol can be submitted directly to the RIRC.

A proposal is a general scientific study plan and is usually part of a grant application addressing the overall subject the sponsor wishes to fund. A protocol is a detailed scientific study plan usually very specific and describes who is going to do what, when, and where. (See a sample protocol template.)

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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).