NURS 9

Leading by Success: Impact of a Clinical & Translational Research Infrastructure Program to Address Health Inequities

Bruce Shiramizu1, Vicki Shambaugh2, Helen Petrovich2, Todd B. Seto3, Tammy Ho4, Noreen Mokuau5, and Jerris R. Hedges4

1Department of Tropical Medicine, Medical Microbiology & Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaii at Manoa (UHM), Honolulu, HI

2Pacific Health Research and Education Institute, Honolulu, HI

3Department of Medicine, JABSOM, UHM, Honolulu, HI

4JABSOM, UHM, Honolulu, HI

5Myron B. Thompson School of Social Work, UHM, Honolulu, HI

Abstract

Building research infrastructure capacity to address clinical and translational gaps has been a focus

of funding agencies and foundations. Clinical and Translational Sciences Awards, Research

Centers in Minority Institutions Infrastructure for Clinical and Translational Research (RCTR) and

the Institutional Development Award Infrastructure for Clinical and Translational Research funded

by United States (US) government to fund clinical translational research programs have existed for

over a decade to address racial and ethnic health disparities across the US. While the impact on the

nation’s health can’t be made in a short period, assessment of a program’s impact could be a

litmus test to gauge its effectiveness at the institution and communities. We report the success of a

Pilot Project Program in the University of Hawaii RCTR Award in advancing careers of emerging

investigators and community collaborators. Our findings demonstrated that the investment has a

far-reaching impact on engagement with community-based research collaborators, career

advancement of health disparities investigators, and favorable impacts on health policy.

Keywords

health disparity; clinical research; health inequity; translational research

INTRODUCTION

Health inequities continue to persist in communities across the disease spectrum throughout

the United States (US) and globally1–3. Contributing to the culture of health disparities has

Correspondence: Bruce Shiramizu, 651 Ilalo Street, BSB 325AA, Honolulu, Hawaii, 96813; bshirami@hawaii.edu.

COMPLIANCE WITH ETHICAL STANDARDS The scope of the work did not involve human participants as reviewed by the University of Hawaii Institutional Review Board.

The authors have no other potential conflicts of interests except for the funding agencies as acknowledged.

HHS Public Access Author manuscript J Racial Ethn Health Disparities. Author manuscript; available in PMC 2018 April 28.Au

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partly been a function of the imbalance of biomedical research funding from government

agencies, private foundations, industry and other sources4–7. Innovative concepts and bold

initiatives to increase collaborations and partnerships were established through government,

industry and foundations to increase translation of research into practice to accelerate

medical research6–10. Concepts and ideas to increase capacity to address clinical and

translational gaps in the health of the population included new approaches to discovery,

developing partnerships between government and private sectors, identifying research teams,

and redesigning the clinical research paradigm6, 10. A number of research initiatives were

instituted by various funding agencies to address clinical and translational gaps to bring

entities together to accelerate the pace of discovery, from the earliest discovery stages

through clinical research11–17. What followed in the USA, amongst many other

infrastructure programs, were the Clinical and Translational Sciences Award program

(CTSA) funded by the National Center for Advancing Translational Sciences (NCATS)18, 19,

Research Centers in Minority Institutions (RCMI) Infrastructure for Clinical and

Translational Research (RCTR) funded by National Institute of Minority Health and Health

Disparities (NIMHD)20, and the Institutional Development Award Program Infrastructure

for Clinical and Translational Research (IDeA-CTR) funded by National Institute of General

Medical Sciences (NIGMS), Table 1.

Recognizing that building capacity to engage in clinical translational research at institutions

across the USA requires collaborations and partnerships, the CTSA mechanism was

launched to support programs and infrastructures for translational science7, 19. The success

of the CTSA programs impacted geographical regions based at the institutions involved with

their respective CTSA programs21–25. On a smaller scale and owing to the limitations placed

by the NIH IDeA Program, institutions from IDeA-eligible states developed clinical and

translational research capacity at their institutions beginning in 201426. In a similar fashion,

RCMI institutions were provided opportunities to develop infrastructures to conduct clinical

and translational research11–17. The University of Hawaii (UH), as an RCMI institution,

established the RCMI Multidisciplinary And Translational Research Infrastructure

Expansion (RMATRIX) Program as an RCTR which has grown to be a successful clinical

and translational research foundation for faculty members at UH.20 Nationally, millions of

federal and foundation dollars have been invested into these and other clinical and

translational research infrastructure programs. We report the success of a Pilot Project

Program of RMATRIX at UH which not only built research capacity locally but also

impacted clinical and translational research far beyond Hawaii through the support of

academic investigators with Pilot Project Awards. One of unique characteristics of Hawaii

was that as the 50th state of the USA, its geographical isolation in the Pacific Ocean

distinguished it as having the only accredited USA medical school within a 2400 mile

radius. With its diverse ethnic population including Native Hawaiians, Pacific Islanders,

Asians and Filipinos, the RMATRIX program at UH was uniquely situated with its

infrastructure to potentially contribute to the clinical translational landscape in Hawaii to

benefit its population. One component of the RMATRIX program was the Pilot Project

program which provided resources and funds for emerging investigators to support research

projects focusing on health inequities in the communities. We report that the investment not

only built the clinical and translational research infrastructure at UH but the dollars had a

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far-reaching impact that connected communities and collaborators both locally and

nationally where health inequities also persisted.

METHODS

RMATRIX Program

The Institutional Review Board (IRB) of the UH Human Studies Program reviewed the

principle of the project. The RMATRIX Program was initially funded as an RCTR in 2010

for 3 years with a 1 year no-cost extension in response to an NIH Program Announcement,

PAR-09-261, "Limited Competition for Research Centers in Minority Institutions

Infrastructure for Clinical and Translational Research". Following a competitive renewal

application, RMATRIX was refunded for 5 years in 2014. Through the RCTR award,

RMATRIX was established as the integrated "home" for clinical and translational science in

Hawaii through the UH.

In the first 4 years, we reorganized and expanded existing (and previously disconnected)

RCMI research infrastructure programs at UH working with community and hospital

partners. The RMATRIX Key Functions were carefully designed to provide the clinical and

translational research infrastructure to expand proposed HEALTH (Health, Equity and

Lifestyle Transformation in Hawai’i) Initiatives to address health disparities throughout

Hawaii. The RMATRIX Key Functions which served as resources to support investigators

(during study development and implementation and career development) included: Program

Administration, Professional Development, Collaborations and Partnerships, Biomedical

Informatics, Clinical Research Resources and Facilities, Community-Based Research,

Research Design and Biostatistics, Regulatory Knowledge, and Evaluation. These 8 Key

Functions focused initially on projects and investigators interested in health disparity issues

related to six HEALTH Initiatives: cardiovascular; respiratory; nutrition & metabolic;

cancer; perinatal, growth, & development; and aging & neurocognition. In the successful

renewal application, lessons learned allowed the program to focus on three HEALTH

Initiatives which resonated with the communities and investigators through needs

assessments: nutrition & metabolic health; reproductive growth & developmental health; and

aging & chronic disease prevention/management.

While RMATRIX supported investigators interested in clinical and translational research

across the spectrum of the HEALTH Initiatives, this report will highlight the continuing

activities of investigators from the first three years of the RMATRIX Pilot Project Program.

Data from 3–5 years after the pilot projects were award provided facts and figures on the

ongoing impact of the RMATRIX program which informed this report.

RMATRIX Pilot Project Program

The Pilot Project Program promoted inter-professional translational research in health

disparities by supporting research endeavors and collaborations among emerging

investigators. The Pilot Project Program released an annual institution-wide request for

proposals which encouraged multiple principal investigators and/or collaborators across

disciplines. Presentations at department and school faculty meetings were also held to

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disseminate information about the funding opportunities. Direct costs up to $30,000 per year

for 1-year projects were allowed, with priority given to those studies which focused on one

of the HEALTH Initiatives. From 2010–2012, 18 Pilot Project Investigators were awarded

from 55 Pilot Project applications which were submitted in response to the RFP. At the time

of the RFP release, webinars were held to guide and provide potential applicants information

on the Pilot Project application process. Each cycle of applications underwent external

review with at least 2 experienced external reviewers assigned to each application and scored

similarly to the current NIH extramural grant review guidelines.27 The level of funding

available in 2010–2012 determined the number of Pilot Project Awards which were provided

in each year: 3 awards to 3 investigators in 2010; 8 awards to 8 investigators in 2011; and 6

awards to 7 investigators in 2012. The Pilot Project investigators’ disciplines and Pilot

Project titles are summarized in Table 2.

RMATRIX Pilot Project Program Evaluation

The RMATRIX evaluators (from the second funding cycle) consisted of one MD and one

MA/MPH with over 30 years each in health research including federal funding on multi-year

grants and contracts as well as infrastructure development grants in minority health

involving academia, medical centers, and community organizations throughout Hawaii. The

Evaluators were from an independent, nonprofit organization with research backgrounds

who were each funded by grants and contracts and each understanding challenges that

researchers faced. They employed qualitative methodology using semi-structured interviews

to collect information on Pilot Project Investigators’ perspectives and experiences. The semi-

structured interview process permitted maximum use of face-to-face time with each Pilot

Project Investigator. Interviews were conducted at a location selected by the Pilot Project

Investigator; usually a conference room at their department or in their office at the

University or Medical Center.

Data were collected beginning 1 year after each Pilot Project Investigator was awarded the

RMATRIX Pilot Award through December 2015. RMATRIX Pilot Project Investigators

received their awards in 2010, 2011, and 2012, providing 3 to 5 years of follow-up data for

analysis. A standardized list of outcomes was used to guide the interview process while not

restricting the Pilot Project Investigator from sharing additional information he/she felt

important. This included: publications; presentations; patents; further research after pilot

award; continuation of pilot or new research; research role; awards/recognitions;

promotions; job/career change; research findings that brought change to clinical or social

service practice, resulted in change in organizational, local, state, or federal policies;

findings used in advocacy; collaborators; disciplines; community involvement; and federal

contacts, Table 3. A copy of the outcomes to be discussed as well as evaluation questions

were sent to all Pilot Project Investigators before their interview. Each Pilot Project

Investigator was requested to send an updated resume to the Evaluators prior to the in-person

meeting. This allowed the Evaluators to review the resume, note outcomes, and identify

additional questions for the meeting. This helped to maximize the interview process and

keep the total interview time to one hour. The academic professional outcomes and

measurements were reported based on the interview information of the pilot project

investigators, Table 3.

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RESULTS

Eighteen Pilot Project Investigators received seventeen pilot awards from 2010–2012 in

RMATRIX. Seventeen of eighteen investigators in RMATRIX were contacted; however, the

lack of contact information for the last investigator prevented follow-up. Fifteen

investigators provided updated resumes and met with the Evaluators. One Pilot Project

Investigator provided a resume but elected to not participate in the interview while a second

who moved to the mainland United States furnished an updated resume and answered the

evaluation questions via email. The data presented summarizes information from 17

investigators based on self-report and public documentation. The academic demographics of

the investigators represented diverse disciplines across the spectrum and academic ranks,

Table 4.

Scholarly Assessment

Scholarly assessment was measured by the publications, presentations at scientific meetings

and by funded grants. The successful achievements of the Pilot Project Investigators were

highlighted by publications in peer-reviewed journals and books since receiving their pilot

awards as well as their contributions at scientific meetings with presentations, Table 4. Since

the completion of their Pilot Project, the 17 investigators had 47 grants which were currently

active at the time of this report. An additional 34 grants were funded and completed since

their Pilot Projects. In addition to the funding agencies noted in Table 2, private foundations

and pharmaceutical companies also contributed as sources. The 81 grants contributed over

$79.5 million in research with each of the 17 investigators being Principal Investigators (PI)

on 60 grants which totaled $22.4 million in direct award dollars. The litmus test for

RMATRIX investigators’ research successes was based on being awarded federally-funded

grants4.

Professional Academic Assessment

Pilot project investigators were assessed on their academic achievements since being

awarded the pilot project funds including promotions and new academic appointments, Table

4.

Entrepreneurship Assessment

Entrepreneurship achievements were assessed by successful business ventures or related

enterprises, Table 3. Three investigators developed new startup companies based on their

research and contributions from their Pilot Project data. These startup companies are

employing graduates from UH, providing them with jobs in Hawaii in their discipline. Three

patents were received and four intellectual property agreements were filed.

Training the Next Generation of Faculty Researchers Assessment

Career development of faculty includes developing skills and ability to train emerging

investigators and students to contribute to the pipeline of new clinical translational research

faculty, Table 3. To accomplish this, continued collaborations with other investigators

contribute to the foundation. All of the Pilot Project Investigators continued collaborations

from their RMATRIX pilot work. Additionally, they have all become mentors themselves for

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students and other faculty. In 2015 alone, the 17 investigators have mentored 159 mentees

including medical students, MDs, Master Candidates, PhD Candidates, PhDs and

undergraduate students.

Awards/Honors Assessment

Recognition of the accomplishments as a direct or indirect result of the pilot project awards

can contribute to clinical translation research through additional funding opportunities and

scientific opportunities, Table 3. Among the numerous awards and recognitions cumulatively

bestowed upon the RMATRIX Pilot Project Investigators were: the Robert W. Clopton

Award, Distinguished Community Service, Certificate of Recognition and Invited Member

National Academy of Inventors, Institute of Electrical and Electronics Engineers Fellow,

Hawaii Comprehensive Cancer Coalition Chair, American Cancer Society Hawaii/Pacific

Chapter Board, Royal Geographical Society Research Fellow, Migrant Clinicians Network

External Advisory Board, Washington State Commission on Asian Pacific American Affairs,

Queens’s Health Systems, Queen’s Medical Center and Hawaii Pacific Health Board

members, American Academy of Neurology Emerging Leadership Forum Award, NSF

Career Award, and American College of Physicians Laureate Award.

Scientific Impact Assessment

The scientific impact of the pilot project and/or contribution by the investigator was assessed

by how the knowledge gained or results contributed to the health of the communities, Table

3. Because of Hawaii’s unique geographic location and diverse population, there are rich

opportunities to examine how the environment, race and ethnicity, and culture impact the

access, delivery and outcomes of care, and contribute to the significant health inequities

identified among Native Hawaiians and Other Pacific Islanders. The potential scientific

impact that the awarded Pilot Projects proposed were viewed positively by the external

reviewers. As such, the success of the Pilot Projects provided scientific contributions across

a wide spectrum including: 1) Physiological radar technology for sleep monitoring; 2)

Behavioral modification to reduce health disparities and chronic disease in Native Hawaiians

and other high risk populations; 3) Neuroimaging technique targeting monocytes for brain

inflammation; 4) Properties of pulmonary surfactant in premature infants; 5) Patent award

and product development of a compound to effectively treat box jellyfish stings; and 6)

Patent on methods for prevention of cardiac hypertrophy.

Advocacy Assessment

The litmus test for effective clinical and translational research that impacts the population in

Hawaii is policy and advocacy Table 3. RMATRIX Pilot Project Investigators reported the

following actions: 1) Hawaii State Senate Resolution to convene Native Hawaiian Health

Task Force addressing health inequities; 2) Establishment of Hawaii State Stroke Registry;

and 3) Disparities findings used for advocacy by community leaders and health professionals

locally, nationally, and internationally.

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Synergy and Collaborations Assessment

Establishing synergy and collaborations between the pilot project investigator and other

leaders locally, nationally, and internationally has the potential to increase the impact that

the research has on the population health in Hawaii as well as beyond the state, Table 3. The

creation and launching of a new interdisciplinary translational class at UH combining

engineering and pediatrics was one of the first of its kind at the institution. A statewide effort

involving communities, health professionals, and academia united to support healthy choices

to address obesity with launch of a successful program weight control program for children

and families. The synergy and collaboration between engineering investigators working

alongside health professionals to apply radar for sleep monitoring in the medical center

bridged the engineering and medical disciplines in a positive and successful effort.

Collaborations amongst academia, communities, and industry from local, national, and

international regions are summarized in Figure 1 which also shows the direct connections of

the collaborators from other geographical regions of the world.

DISCUSSION

The RMATRIX Pilot Project Program successfully launched and expanded clinical

translational research opportunities for the emerging faculty who were instrumental in

leveraging the resources and their pilot project data to benefit the institution and state. In

addition to enhancing their respective academic careers, their efforts contributed to policies

and launched collaborations to start new ventures and projects to potentially benefit the

populations in Hawaii and expand beyond the state.

At its inception, RMATRIX was conceived and envisioned to be a catalyst to build a critical

mass of investigators who would conduct translational and clinical research in the HEALTH

Initiatives that disproportionately affect Native Hawaiian and other Pacific Peoples in

Hawaii. For many clinical and translational research infrastructure programs in the US, a

similar theme purveys to benefit the populations they serve or with whom they engage in

their activities4, 6, 7, 16–18, 20, 23, 26, 28. While the long-term goal of promoting and improving

health equity across all stages of life for the most disparate populations (by contributing to

improving the health of all people in Hawaii) is an ambitious undertaking and not quickly

attainable in a short period of time (3 years), the RMATRIX has put in place a valuable

infrastructure for academic and community investigators to work together on approaches for

the prevention, diagnosis and treatment of diseases to improve health and reduce health

disparities. RMATRIX is committed to further expanding and strengthening the

infrastructure to lead by its success. Ultimately, the next steps for RMATRIX will be to

demonstrate its success in improving health equities for the population in Hawaii.

RMATRIX has demonstrated the importance of career development and mentorship through

the building of a critical mass of investigators committed to eliminating health inequities

through clinical and translational health disparities research and collaborations with other

institutions and communities as well as various professional disciplines locally, nationally

and internationally. RMATRIX further strengthened the synergy between organizations,

professional disciplines and individual investigators.

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With the large number of clinical and translational research infrastructure awards in

existence7, 12, 14, 16, 17, 24, 26, 29, 30, RMATRIX is likely not unique in its impact or

importance to the institution, state, or communities. Other successful infrastructure programs

have Pilot Project mechanisms to jumpstart research careers of faculty28, 30, however,

because of the uniqueness of its size, location, and modest landscape in clinical and

translational research at the UH, the magnitude of its impact may be more pronounced. As

one of our pilot investigators noted, RMATRIX changed the intellectual atmosphere at UH

and JABSOM, raising awareness of ethnic disparities in health, work that is supported by

funding agencies, and bringing local indigenous investigators together with other groups

nationally and internationally providing an avenue for new research. This successful

program demonstrated how support for clinical and translational research could be leveraged

and could set the cornerstone for similar programs to collaborate to ultimately benefit the

health and well-being of the populations.

It has taken decades to recognize and acknowledge health inequities in our communities.

Addressing these issues now using the mechanism of successful clinical and translational

research infrastructure programs will help communities move from identification of the

causes of health inequities toward the training of investigators with strong community

partners who will develop effective interventions with strong scientific support that will lead

to commercial products, changes in health professional practice, and well-grounded health

policy that can turn the tide of health disparities affecting the population.

Acknowledgments

The authors would like to thank the RMATRIX Key Function Directors (Venkataraman Balaraman, Kathryn Braun, John Chen, Judith Inazu, J. Keawèaimoku Kaholokula, Kari Kim, Marjorie Mau, Neal Palafox, Cecilia Shikuma, Alexander Stokes, JoAnn Tsark) and Grace Matsuura and Lauren Soto. Support was provided by the National Institute on Minority Health and Health Disparities (U54MD007584; U54MD008149), National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Figure 1. RMATRIX Pilot Project Investigator Co-Author/Collaborator Network Links between the University of Hawaii RMATRIX Pilot Project investigators with

investigators/collaborators nationally and internationally.

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Table 1

Clinical Translational Research Infrastructure Programs, Funding Agencies & Institutions

Programs/Agencies/Institutions Abbreviations

Air Force Research Laboratory AFRL

Clinical and Translational Science Award CTSA

Department of Defense DOD

Health Resources and Services Administration HRSA

Institutional Development Award IDeA

National Center for Research Resources NCRR

National Heart, Lung, and Blood Institute NHLBI

National Institute of Diabetes and Digestive and Kidney Diseases NIDDK

National Institute of General Medical Sciences NIGMS

National Institute of Minority Health and Health Disparities NIMHD

National Institute of Neurological Diseases & Stroke NINDS

National Institute on Alcohol Abuse and Alcoholism NIAAA

National Science Foundation NSF

National Institute on Drug Abuse NIDA

Office of Naval Research ONR

Pacific Command PACOM

Research Centers in Minority Institutions RCMI

Research Centers in Minority Institutions Infrastructure for Clinical and Translational Research RCTR

United States Special Operations Command USSOCOM

J Racial Ethn Health Disparities. Author manuscript; available in PMC 2018 April 28.

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Shiramizu et al. Page 12

Ta b

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J Racial Ethn Health Disparities. Author manuscript; available in PMC 2018 April 28.

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Shiramizu et al. Page 13

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J Racial Ethn Health Disparities. Author manuscript; available in PMC 2018 April 28.

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Shiramizu et al. Page 14

Table 3

Outcome Measurements Used to Assess Impact of Pilot Projects

Assessment Outcome Measurements

Scholarly Work Publications, presentations at national/international meetings, funded grants/awards

Professional Academic Promotion Academic promotion, new academic position

Entrepreneurship New startup company, patents, intellectual property agreements

Training the Next Generation of Faculty Researchers Providing mentorship to students (medical students, Master Candidates, PhD Candidates, undergraduate students), physicians, postdocs, faculty

Awards/Honors Awards and recognitions from regional, national and international institutions and organizations

Scientific Impact Scientific impact on how the pilot project impacted access, delivery and outcomes of care, or contributed to health among Native Hawaiians and Other Pacific Islanders

Advocacy Impact of the pilot project on the population in Hawaii through new policy and advocacy.

Synergy and Collaborations As a result of the pilot projects, new collaborations which were formed amongst academia, communities, and industry from local, national, and international regions.

J Racial Ethn Health Disparities. Author manuscript; available in PMC 2018 April 28.

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Shiramizu et al. Page 15

Table 4

Professional & Academic Demographics of Pilot Project Investigators

Professional Discipline Highest Academic

Degree Obtained

Academic Rank Academic Promotions

Metric Outcomes

Public Health, Psychology, Nursing, Engineering, Tropical

Medicine, Cell and Molecular Biology,

Medicine

PhD (n=12), MD/PhD (n=2),

MD (n=3)

Assistant Professor (n=10), Associate Professor (n=3),

Professor (n=4)

Promoted to Associated

Professor (n=2); to Professor (n=2); New academic appointments

(n=2)

224 publications and 311 presentations (141 local, 93 national, and

77 international)

J Racial Ethn Health Disparities. Author manuscript; available in PMC 2018 April 28.