Research Regulatory Office (RRO)

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The Research Regulatory Office (RRO):

administrates and supports the Research and Institutional Review Committee (RIRC/IRB). The department is charged with upholding regulatory policies and procedures related to the protection of human subjects in research.

Services
- IRB review and approval of human subjects research (initial, modification, and renewal).
- Determination of non-human subjects research projects (e.g., quality improvement, process improvement).
- Reporting of adverse events and/or deviations from protocol.
  Coordinating review with external IRBs.
Coordinates and provides Medicare Coverage Analysis/Coverage Analysis (MCA/CA) and calendar builds within the clinical trial management system, Clinical Conductor, for all clinical research studies. The CA is a systematic review of the clinical trial documents to determine whether the study is a qualifying clinical trial and which items/services/procedures are billable to insurance or study-paid.
Conducts institutional quality assurance/compliance Monitoring to ensure applicable research policies and procedures are followed.

Sections	Contact	Email	Phone
RRO	Rebecca Ohta, Manager	rohta@queens.org	808.691.4106
RIRC	Denise Lin-Deshetler, Ops-Manager	dlindeshetler@queens.org	808.691.7986
MCA/CA	Jeremiah Villasin, Coordinator	jvillasin@queens.org	808.691.4645
Monitoring	Nina Bermudez, Coordinator	nbermudez@queens.org	808.691.4892