# Clinical Research and Regulatory Support Core

> **NIH NIH U54** · UNIVERSITY OF HAWAII AT MANOA · 2023 · $326,205

## Abstract

The proposed Clinical Research and Regulatory Support (CRRS) Core will play a vital role in enhancing the
development of a robust clinical and translational (CTR) infrastructure for the Center for Pacific Innovations,
Knowledge, and Opportunities (PIKO). The CRRS Core will provide Junior Investigators (JI), and Established
Investigators (EI) transitioning to CTR across the CTR continuum, with the necessary clinical research expertise,
resources, and facilities to conduct CTR aimed at improving the health of Indigenous Pacific People (IPP),
defined as Native Hawaiians, Other Pacific Islanders, and Filipinos, and other medically underserved and
vulnerable groups. The CRRS Core will also assist JI/EI in navigating the daunting process of ensuring that their
proposed research is ethical and addresses all human subject and regulatory concerns. The CRRS Core will
promote harmonization of institutional review board procedures throughout community and partner institutions,
participate in mentoring activities organized by the Professional Development (PD) Core, collaborate with the
Biostatistics, Epidemiology, and Research Design (BERD) Core in developing case report forms and inputting
data into the study database, and work with the Community Engagement and Outreach (CEO) Core to share
information with health care professionals and community leaders. This Core’s Specific Aims are:
 Specific Aim 1: Mentor CTR investigators on the practical aspects of conducting high-quality CTR
by assisting JI/EI with study feasibility and implementation issues; facilitating linkage to medical resources and
advocate for transdisciplinary and team-science opportunities; providing regulatory mentoring support for CTR
implementation; participating in PIKO-sponsored professional development activities.
 Specific Aim 2: Enable direct access to critical CTR implementation resources and facilities by
providing CTR personnel resources (research nurse/associate and processing laboratory technician services);
providing access to clinic facilities; enabling access to an independent Data Safety Monitoring Board and Ethics
Board resources; advancing CTR technology and outreach to support T2–T5 clinical research.
 The CRRS Core will provide services at three clinical sites – John A. Burns School of Medicine (JABSOM),
Queen’s Medical Center (QMC), and Kapiolani Medical Center for Women and Children (KMCWC). As CRRS
Core Director, Cecilia M. Shikuma, MD, supported by Associate Core Directors Todd Seto, MD, and Bliss
Kaneshiro, MD, will oversee the Core operations at JABSOM, QMC and KMCWC, respectively. Venkataraman
Balaraman, MD, will oversee the ethics and regulatory services. The innovation of combining regulatory and
ethics resources with CTR implementation services within a single core will allow the CRRS Core to offer
integrated and personalized services to JI/EI engaging in CTR.

## Key facts

- **NIH application ID:** 10685401
- **Project number:** 5U54GM138062-03
- **Recipient organization:** UNIVERSITY OF HAWAII AT MANOA
- **Principal Investigator:** Cecilia M. Shikuma
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $326,205
- **Award type:** 5
- **Project period:** 2021-09-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10685401

## Citation

> US National Institutes of Health, RePORTER application 10685401, Clinical Research and Regulatory Support Core (5U54GM138062-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10685401. Licensed CC0.

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