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Building capacity to increase community member involvement at a clinical and translational science award (CTSA)
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Building capacity to increase community member involvement at a clinical and translational science award (CTSA)
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Content
BUILDING CAPACITY TO INCREASE COMMUNITY MEMBER INVOLVEMENT AT A
CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)
by
Aileen Orlino Dinkjian, MPH
A Dissertation Presented to the
FACULTY OF THE USC ROSSIER SCHOOL OF EDUCATION
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF EDUCATION
May 2021
Copyright 2021 Aileen Peralta Orlino Dinkjian, MPH
ii
DEDICATION
From the year I was accepted into my doctoral program to the final year of my dissertation, I was
grieving but always trying to find solace in between having lost my greatest sources of
inspiration within the last three years.
To my grandmother, Evangeline Peralta (who passed in 2017), my grandfather, Filomeno Peralta
Jr. (who passed in 2018), and my aunt Violeta Orlino Unabia (who passed in 2020), I am who I
am because of all you have shown me how life should be lived – prayerful and meaningful.
To Vartan and our beautiful, intelligent daughters, Nora and Taleen. You are the renewed source
of inspiration and energy that kept me going in this program. Thank you for being the sun and
moon that always shines down on me.
To my mom, Natividad Orlino, and dad, Augusto Orlino. You paved the way to my academic
and professional career by providing me with all the support and tools I’ll ever need in life.
To my sister, Abigail and brother-in-law Surendra – my forever confidant and best friends. You
are the guiding force that has led me towards my academic achievements.
To my brother, Dustin – my big brother forever. You are never failed to be there for me.
This degree belongs to all of us.
iii
ACKNOWLEDGEMENTS
To my dissertation committee, Dr. Courtney Malloy, Dr. Kathy Stowe, and Dr. Wayne
Combs, thank you for your ongoing support and encouragement to help me get through this
doctoral program. I am grateful for your patience and guidance to help me succeed. It has been
an honor to have you serve on my committee.
I want to thank my wonderful and patient husband (and dedicated father), Vartan, who
has been with me throughout this entire journey, supporting me every step of the way. I cannot
imagine going through this program with two toddlers with anyone else. By far, this was my
most challenging academic journey I have ever embarked on, and his willingness to allow me the
time to focus and be successful does not go unrecognized. Thank you for loving me and being
my partner for life. I love you with all my heart.
To the loves of my life - my daughters, Nora and Taleen Dinkjian who were only 2 and 3
years old, respectively, when I first started the Organizational Change and Leadership program at
the USC Rossier School of Education. For my girls, I wish for you to pursue your dreams at
your highest potential ever imaginable. I am ever so grateful to go through this thing called life
and be your mom.
This study would not have been possible without the inspiration of the valued work that
my research institute pursues in working towards “translating science into solutions for better
health.” I am grateful to our institute leaders, including my supervisor, the Director of Research
Development, Dr. Sarah Hamm-Alvarez, and institute co-Directors, Dr. Thomas Buchanan and
Dr. Michele Kipke, for allowing me the space to conduct my research in the hopes of creating an
opportunity for community members to understand and participate in the biomedical research
process. I also want to personally thank my friend and classmate, Matthew Mayer for helping me
conduct an interview where I had to recuse myself.
iv
My upbringing plays a giant role in the life decisions that I make, and I would not be
where I am without the love, support and encouragement from my Orlino family - Augusto
(dad), Natividad (mom), Abigail (sister), Surendra (brother-in-law), and Dustin (brother). I love
you for never missing a beat with anything that I have decided to pursue in my life and for
celebrating all the ups and downs with me. Thank you and I love you for being able to watch my
daughters in times when I needed additional support and for always having great food at home.
You showered my family with so much love and I am nothing but indebted to you. For my
Dinkjian family, Nora (mother-in-law), Hagop (father-in-law), Hovig (brother-in-law), Susie
(sister-in-law), and Harout (brother-in-law), Dominic, Christian and Vincent (nephews), thank
you for always being there for me and my family and for loving me as your daughter, sister and
“tantig” (aunt). I love you all from the bottom of my heart. I also cannot forget my pet therapy
from my dogs, Armani and Chanel. I love my furry friends too.
To my hardworking cousin, Krystle, I can’t believe we went through grad school
together. Thank you for being my study buddy. To my bright and creative cousin Jazmin, thank
you for your refreshing source of energy and showing me ways that I know nothing about with
younger millennials. To my cousins Beverly and Lloyd Artizada and their children Lloyd Jr.,
Bennett and Landon, Carol and Glen Takahashi and their son Brandon, Racquel and Rollie
Cacho and their children Sean, Jiro and Kian, thank you for your love and support throughout
this journey and for helping keep all of us sane. To my nieces and nephews, always know that I
am here cheering you on and will always support you the way you have supported me. This
dissertation is for you too! To my Aunt Carmen and Uncle Bernard, thank you for always being
supportive of me and my family. To the De Los Reyes, Peralta, and Rosete village, you are a
huge part of my life and I can’t imagine life without you in it with me on this journey. Thank
you for your constant encouragement and support. I love you all very much.
v
To my Charmed family Lynette Braga, Leeanne Lee, Matthew Trinidad and Yuri
Mochizuki, anytime I needed any support, you were always there. Thank you so much for being
my persons. To Loren, Matthew and Zara, this dissertation is also dedicated to you. Always
remember that the author of this dissertation will always believe in you.
Finally, I would like to thank these individuals who have been a big source of inspiration
in my life. My grandparents, Evangeline Peralta and Filomeno Peralta Jr. How I got through
this dissertation and doctoral program without hearing your words of wisdom, I don’t know. On
January 17, 2018, I said goodbye to my grandfather and six months before that, I said goodbye to
my grandmother. Having lost both within a short amount of time was difficult, but they taught
me many life-long spiritual lessons on how to stay vigilant and strong. The day after my
grandfather’s funeral happened to be the first day of class and immersion (January 18, 2018).
That day, I found myself still grieving but at the same time, I received a glimpse of hope when I
immediately connected with my cohort (10), who have been nothing but supportive throughout
my time with them virtually and in-person. My deepest gratitude for this great group of
individuals who have helped carry me through the entire doctoral process. Although we could
not be together because of COVID-19 during graduation, I am ever so grateful for the time we
have been able to spend together.
During my final year in the program, (2020), I lost another source of inspiration in my
life. To my auntie Violy Unabia, my role model, I can still hear your voice telling me how proud
you are of me. Your positive energy is immensely missed, and you have encouraged me to be a
good example and representation of my family and Filipino community. Thank you for showing
me the way to a fruitful life – I love you from the bottom of my heart.
vi
TABLE OF CONTENTS
DEDICATION ii
ACKNOWLEDGEMENTS iii
LIST OF TABLES viii
ABSTRACT ix
CHAPTER ONE: INTRODUCTION 1
Introduction of the Problem of Practice 1
Organizational Context and Mission 2
Organizational Performance Status/Need 3
Related Literature 3
Organizational Performance Goal 4
Description of Stakeholder Groups 5
Stakeholder Group for the Study 6
Importance of the Study 6
Purpose of the Project and Questions 7
Methodological Framework 8
Definitions 8
Organization of the Study 11
CHAPTER TWO: REVIEW OF THE LITERATURE 12
Review on the Problem of Practice 13
Clark and Estes’ (2008) Knowledge, Motivation and Organizational Influences Framework 33
Stakeholder Knowledge, Motivation and Organizational Influences 34
Conceptual Framework: The Interaction of Stakeholders’ Knowledge and Motivation and the
Organizational Context 48
Conclusion 50
vii
CHAPTER THREE: METHODS 52
Participating Stakeholders 52
Data Collection and Instrumentation 54
Credibility and Trustworthiness 55
Ethics 57
Limitations and Delimitations 57
CHAPTER FOUR: RESULTS AND FINDINGS 59
Purpose of the Project and Questions 59
Participating Stakeholders 59
Results and Findings 61
Research Question 1 61
Research Question 2 82
Conclusion 98
CHAPTER 5: RECOMMENDATIONS 100
Introduction and Overview 100
Recommendation for Practice to Address KMO Influences 100
Integrated Implementation and Evaluation Plan 126
Data Analysis and Reporting 143
Summary 144
Implication for Future Research 145
Conclusion 146
REFERENCES 147
APPENDIX A: INTERVIEW PROTOCOL 163
APPENDIX B: IMMEDIATE EVALUATION TOOL 165
APPENDIX C: DELAYED FEEDBACK 167
viii
LIST OF TABLES
Table 1 Knowledge Influence and Knowledge Types 38
Table 2 Assumed Motivational Influences 42
Table 3 Assumed Organizational Influences 46
Table 4 Summary Table of Assumed Influences on Performance 47
Table 5 Participating Western CTSA Core Representatives Sample Demographics 60
Table 6 Summary of Knowledge Influences and Recommendations 102
Table 7 Summary of Motivation Influences and Recommendations 108
Table 8 Summary of Organization Influences and Recommendations 114
Table 9. Outcomes, Metrics, and Methods for External and Internal Outcomes 128
Table 10 Critical Behaviors, Metrics, Methods, and Timing for Evaluation 132
Table 11 Required Drivers to Support Critical Behaviors 134
Table 12 Evaluation of the Components of Learning for the Program 140
Table 13 Components to Measure Reactions to the Program 141
LIST OF FIGURES
Figure A Organizational Change Conceptual Framework 48
ix
ABSTRACT
The purpose of this study was to assess the existing leadership capacity of the Western
CTSA with the goal of increasing and integrating community members into the research process.
CTSA administrators have a critical role in facilitating opportunities to build capacity for
community involvement. This dissertation focused on investigating the existing CTSA processes
involving community members at the Western CTSA and assessed if CTSA leadership has the
knowledge, motivation, and organizational resources to integrate community involvement at a
CTSA and build capacity for community input. The research was conducted by using a
qualitative research approach to assess the existing CTSA leadership capacity of the Western
CTSA. The Clark and Estes (2008) framework was used to understand the performance gaps as
it relates to knowledge and skills, motivation, and organizational barriers (KMO framework). A
total of eleven (11) (100%) CTSA senior administrators were interviewed. Knowledge findings
included CTSA administrators 1) did not have adequate knowledge to facilitate community
integration; 2) had scare opportunities for bidirectional learning opportunities with community
members: 3) needed to define the term "community" clearly; 4) varied in perspectives and
expectations of community members; and 5) needed to understand challenges that existed.
Motivation findings include CTSA administrators needed to 1) self-reflect and understand their
self-biases; 2) acquire tools to community members and 3) understand what impact community
members made in biomedical research. Organizational findings included that CTSA
administrators had 1) professional accountability; 2) leadership; 3) cultural competency; and 4)
collaborative leadership. CTSA administrators have the opportunity expand or modify the
community engagement’s core role and the community advisory board. In conclusion, the hope
is to eventually receive anecdotal feedback from CTSA administrators, community members,
x
and training instructors to inform the Western CTSA about the relative success of integrating
community members into the Western CTSA and build capacity.
1
CHAPTER ONE: INTRODUCTION
Introduction of the Problem of Practice
This dissertation addresses the problem of minimal input from community members at
the National Institutes of Health (NIH), Clinical and Translational Science Awards (CTSA)
consortium, related to community-engaged and non-community-engaged research. The CTSA
program is designed to develop innovative solutions that improve the efficiency, quality and
impact of the process for turning observations in the laboratory, clinic and community into
interventions that improve individuals and the public’s health. A 2011 study found that 19%
(n=60) of CTSA institutions reported having community representatives advise CTSA core
programs (Wilkins et al., 2013). Additionally, 11% reported having a community representative
as part of the CTSA leadership team. Community member involvement (or public participation)
in biomedical research is one of the central challenges facing clinical research studies. As such,
insufficient public involvement threatens clinical trials' completion (Davis et al., 2013). Many
researchers are not trained to engage key community stakeholders effectively, and academic
institutions do not have the appropriate infrastructure to support community member
involvement for specific aspects of research and/or research administration at a CTSA (Joosten
et al., 2015). Joosten, 2015, emphasized the significant gaps in the methods used to engage
communities in research. The process is often resource-intensive and time-consuming (e.g., cost
to involve community members, the time commitment that community members need to spend,
etc.).
Research suggests that community members are generally underutilized in research
(including leadership roles) (Paberzs et al., 2014). Furthermore, vulnerable and underrepresented
populations have historically been harmed by or excluded from research due to the shortage of
2
community representation in the research process, making community voices critically crucial in
advancing translational research. It is necessary to address this problem because the absence of
community input can seriously compromise the effectiveness of clinical and community research
projects (Paberzs et al., 2014).
This dissertation focused on addressing the problem of practice of insufficient input from
community members in the CTSAs related to the administrative, clinical, and translational
research process. This dissertation investigated the existing capacity and procedures for
involving community members at the Western CTSA (a pseudonym) in an attempt to uncover
recommendations for improving community input regarding clinical research.
Organizational Context and Mission
The Western CTSA is one of the 62 funded CTSAs by the National Institutes of Health,
National Center for Advancing Translational Science (NCATS). The primary goals for creating a
CTSA are to increase public awareness and trust in clinical research, and to increase efficiencies
in developing new treatments and approaches for both rare diseases and common diseases
(“Clinical and Translational Science Awards Program,” 2019). The ultimate purpose is for the
CTSAs to become an integral part of healthcare delivery that can benefit all persons in the
United States. Across the spectrum of translational science, the Western CTSA focuses on
research involving people, clinical trials, community-partnered research, and implementation and
dissemination of science. Currently, the Western CTSA includes ten core groups focused on
areas such as biostatistics, epidemiology and research design (BERD), clinical research
informatics (CRI), community engagement (CE), and workforce development (WD) cores.
About one hundred fifty (150) individuals work in the Western CTSA to facilitate and develop
innovative solutions that will improve the efficiency, quality, and impact of interventions that
will enhance individuals and the public's health.
3
Organizational Performance Status/Need
To fulfill its purpose, the Western CTSA needs to provide ongoing bidirectional learning
opportunities between community members and academic researchers. Engaging and mutually
educating both community members and academic researchers can fulfill the CTSA mission of
increasing community members’ integration into the biomedical research process. Some
examples of integration may include identifying useful strategies that will lead to sustaining
community-academic partnership (or broadly engaged “team science”), relationship, trust, buy-
in, and shared health outcomes (Hacker et al., 2012; Lizaola et al., 2011). Failure to sustain
bidirectional learning can aggravate the distrust between academic researchers and community
members (mainly in recruiting community members into clinical trials), leaving clinical research
gaps in the translational continuum. Although a community engagement core exists within the
Western CTSA, it currently focuses primarily on educating underserved populations about
clinical and community research and public participation and addressing specific research issues
with underrepresented communities. No formal infrastructure is currently in place to increase
community member participation in clinical research efforts.
Related Literature
Many researchers lack the training to engage community stakeholders effectively and
academic institutions lack the infrastructure to support community engagement (Joosten et al.,
2015). There is a need to build trust among academic researchers and community members to
improve research relevance, participation, and outcomes (Anderson et al., 2013; Eder et al.,
2013; Joosten et al., 2015; Kaiser, Thomas & Bowers, 2017; Liazola et al., 2011; National
Institutes of Health, 2011; Paberzs et al., 2014; Stewart et al., 2018; Winckler et al., 2013).
Building trust is particularly important for communities who are underrepresented in research
and burdened by health disparities. Communities, in general, may feel intimidated by research,
4
due in part to historical injustices, and may lack control over their access to opportunities to
partner or participate in research (Dave et al., 2018; Joosten et al., 2015; Selker & Wilkins, 2017;
Translational Science, 2017; Wilkins et al., 2013; Yancey, Ortega & Kumanyika, 2006). Distrust
is a predominant issue, particularly when trying to engage researchers and ethnic minorities
(Abdoul et al., 2012; Dave et al., 2018; Kaiser, Thomas & Bower, 2017; Winckler et al., 2013).
Heller & Melo-Martin (2009) identified the research workforce and research operations
as barriers to speeding clinical and translational research, due in part to the low number of
clinical trial participants (or community representatives) and underqualified clinical trial
investigators. Additionally, the field of clinical and translational research is known to have
inadequate mentoring, extensive regulatory burdens, and fragmented infrastructures to support
clinical trials. Further, barriers to involving community members, patient advocates, and other
stakeholders outside the scientific community in pilot grant review have been documented and
often include concerns that scientists do not value community contributions (Hacker et al., 2012;
Heller & Melo-Martin, 2009; Holzer & Kass, 2014; Kaiser, Thomas & Bowers, 2017; Paberzs et
al., 2014; Selker & Wilkins, 2017; Wilkins et al., 2013).
Organizational Performance Goal
By 2025, the Western CTSA core leaders (and potentially others that may emerge) will
systematically increase and integrate community members into all phases of the translational
research process. Community members will be active and substantive participants in priority
setting and decision making across all phases of clinical and translational research and in the
leadership and governance of the CTSA program. This goal of increasing community member
involvement has been the National Institutes of Health’s top priority for over a decade.
5
Description of Stakeholder Groups
Numerous stakeholders are responsible for the goal of increasing community
involvement in the biomedical research process. Stakeholders include CTSA administrators (e.g.,
research navigators, community engagement staff, etc.), clinical and research faculty (e.g.,
scientists, clinicians, etc.), and community members (e.g., lay individuals, community advisory
boards, community experts, etc.).
CTSA administrators play a key role in creating an infrastructure to allow community
participation in the research process. CTSA administrators need to learn and implement ways to
integrate community members into each CTSA core program to increase community member
participation in research. Guided by a community-partnered participatory research framework,
CTSA administrators need to help increase buy-in from other CTSA administrators regarding the
need to improve and sustain this kind of integration of community members into the CTSAs by
attaining shared goals from every person working in the institute (Lizaola et al., 2011). Clinical
and academic research faculty play a key role in building capacity to increase community
member participation in the CTSAs by creating co-learning and shared experiences throughout
this research process. Co-learning opportunities that engage and mutually educate both
community members and faculty can help identify meaningful strategies to achieve research
outcomes. For example, to build capacity, academic research faculty and community members
can develop shared definitions of community capacity building and sustainability related to
community-based partnered research (CBPR) and identify obstacles to be addressed (Hacker et
al., 2012).
Finally, community members are integral in setting research priorities, enhancing
research perspectives (e.g., health disparity research), training for CTSA researchers, trainees,
and scholars, providing an understanding of cultural sensitivity, and population and community-
6
based research methods (Wilkins et al., 2013). Community members have a broad spectrum of
backgrounds and abilities to offer at a CTSA. They can contribute in various ways and in
multiple capacities to help advance clinical and translational research. When community
members have a shared leadership role trust between researchers and community members
(mainly in underrepresented groups in research) is improved, and in turn, helps increase
community member involvement in the CTSAs (Wallerstein & Duran, 2010; Dave et al., 2018).
Stakeholder Group for the Study
Joint efforts of all stakeholders are necessary for the inclusion of community members in
every translational research phase. However this study, focused on the roles of CTSA
administrators specifically, because they are responsible for developing and implementing plans
with academic researchers to include community members in their specific core program. This
focus will aid the researcher in assessing the feasibility and likelihood of increasing and
incorporating community members at the Western CTSA.
Importance of the Study
The Western CTSA administrators play a key role in facilitating the opportunity to build
capacity for community involvement. Western CTSA administrators taking the initiative to
advance clinical and translational science could bring forth community input to drive the
dissemination and sustainability of a research study’s benefit to human health (Anderson et al.,
2013). Suppose the Western CTSA is unable to fully integrate community members into the
translational research process (administratively and collaboratively). In that case, the range of
disciplines and backgrounds needed for community-engaged research, clinical trials recruitment,
and other community-related/team-based activities will limit potential opportunities to address
pressing human health issues that directly affect the translational research process and the
community as a whole. Selker & Wilkins (2017), emphasized the need for a participatory
7
framework of team science that will allow the organization to integrate diverse perspectives,
develop new theories, and transcend disciplinary and role-based silos using translational research
approaches. Administrative leadership in the Western CTSA can navigate opportunities for
diverse communities to be active partners, meaningfully engaged, and committed to participating
in long-term projects that hold the promise of shared benefits. Failure to increase community
members’ integration into the CTSA mission will lead to a shortage of community oversight,
design, conduct, and evaluation of meaningful and impactful research supported by the Western
CTSA. Without the CTSA administrative leadership support, insufficient community
participation will exacerbate the gap between academic researchers and community members’
trust in biomedical research.
Purpose of the Project and Questions
The purpose of this study was to assess the existing leadership capacity of the Western
CTSA regarding the goal of increasing and integrating community members into the research
process. Specifically, this study sought to understand the current needs and assets in knowledge
and skill, motivation, and organizational resources. While a complete needs and assets analysis
would focus on all stakeholders, for practical purposes, the stakeholder groups focused on in this
analysis were CTSA administrative leaders. The following research questions guided this study:
1. What are the Western CTSA leadership knowledge and motivation needs and assets
regarding the increase and integration of community members into the Western CTSA
research processes?
2. What are the organizational needs and assets regarding integrating community
members into the Western CTSA research processes?
8
Methodological Framework
Clark and Estes’ (2008) gap analysis, a systematic, analytical method that clarifies
organizational goals and identifies gaps in organizations, was used as the framework for
analyzing existing needs and assets. Assumed knowledge, motivation and organizational
influences were generated based on personal experience and related literature. These influences
were examined through interviews with CTSA administrators.
Definitions
Academic Medical Center (AMC): An AMC is the medical school and a hospital
(university-based).
Biomedical Research: Basic research involves scientific exploration that can reveal
fundamental mechanisms of biology, disease or behavior. Every stage of the translational
research spectrum builds upon and informs basic research, which is conducted at many Institutes
and Centers across NIH. NCATS scientists typically do not conduct basic research. However,
insights gained from the Center’s studies along the translational spectrum can inform basic
research.
Clinical Implementation: The clinical implementation stage of translation involves the
adoption of interventions into routine clinical care for the general population. This stage also
includes implementation research to evaluate clinical trial results and identify new clinical
questions and gaps in care.
Clinical Research: Clinical research includes clinical trials with human subjects to test
intervention safety and effectiveness, behavioral and observational studies, outcomes and health
services research, and the testing and refinement of new technologies. The goal of many clinical
trials is to obtain regulatory approval for an intervention.
9
Community-based Organization: A public or private nonprofit organization that is
representative of a community or a significant segment of a community and works to meet
community needs.
Community-based Participatory Research: This is a partnership approach to research that
equitably involves community members, organizational representatives, researchers, and others
in all aspects of the research process, with all partners in the process contributing expertise and
sharing in the decision-making and ownership.
Community-engaged research: Community-engaged research describes a continuum of
possibilities for research conducted with community partner participation. Examples include:
1. Collaborating fully in all aspects of research, including defining study questions,
writing the funding proposal, designing the methods, implementing the research
project, analyzing the results and disseminating the findings;
2. Assisting with implementation of a researcher-designed study including
participant recruitment, data collection, and/or providing feedback on aspects of
study design or findings; the community partner often acts as a subcontractor with
a defined set of responsibilities; and
3. Assisting in discrete steps of a researcher-designed study, such as participant
recruitment.
Community Engagement: A dynamic relational process that facilitates communication,
interaction, involvement, and exchange between an organization and a community for a range of
social and organizational outcomes.
National Institutes of Health (NIH): An agency within the U.S. Department of Health and
Human Services that provides funding for research, conducts studies, and funds multi-site
10
national studies. NIH is the nation’s medical research agency - making important discoveries that
improve health and save lives.
National Center for Advancing Translational Sciences (NCATS): One of 27 Institutes
and Centers at the National Institutes of Health (NIH), which was established to transform the
translational process so that new treatments and cures for disease can be delivered to patients
faster.
Pilot Study: A small-scale test of the methods and procedures to be used on a larger scale
such as examining the feasibility of an approach that is intended to ultimately be used in a larger
scale study.
Public Health: In this stage of translation, researchers study health outcomes at the
population level to determine the effects of diseases and efforts to prevent, diagnose and treat
them. Findings help guide scientists working to improve interventions or develop new ones.
Team Science: A collaborative effort to address a scientific challenge that leverages the
strengths and expertise of professionals trained in different fields.
Therapeutic: In biomedical research, the term is used to connect any of the following
purposes: preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for,
a disease, ailment, defect, or injury; or influencing, inhibiting, or modifying a physiological
process.
Translation: The process of turning observations in the laboratory, clinic and community
into interventions that improve the health of individuals and the public, transforming diagnostics
and therapeutics to medical procedures and behavioral changes.
Translational Research: The process of applying knowledge from basic biology and
clinical trials to techniques and tools that address critical medical needs.
11
Translational Science: The field of investigation focused on understanding the scientific
and operational principles underlying each step of the translational process.
Organization of the Study
Five chapters were used to organize this study. This chapter provided the reader with the
key concepts and terminology commonly found in a discussion about clinical and translational
science research. Chapter One also introduced the organization’s mission, goals, and
stakeholders, and the study’s purpose and research questions. Chapter Two provides a review of
the current literature surrounding the research scope and will include:
● History of the CTSAs
● CTSA administrators' role in facilitating communication between academic researchers
and community members.
● Importance of increasing community involvement in research and building capacity.
● Promising practices and models for building capacity for community involvement in
research.
● The importance of translational research and consequences of lack of community
involvement.
Chapter Three details the methodology, including the choice of participants, data collection, and
analysis. In Chapter Four, the assessment of the data and the results are presented. Chapter Five
provides solutions, based on data and literature, for building the capacity of the Western CTSA
leadership to increase the integration of community members in research processes.
12
CHAPTER TWO: REVIEW OF THE LITERATURE
This literature review will begin with an overview of the need for community
involvement in biomedical research and the infrastructure created to support the advancement of
scientific discoveries into applicable clinical settings. Since community members are critical
players in translational research, this chapter will cover the background of translational research
and why CTSA administrators are crucial stakeholders to increase and integrate community
involvement at the Western CTSA. Community involvement will be extensively defined to
provide breadth and clarity, leading to the problem of practice. This literature review will then
examine the CTSA administrator's role in facilitating communication among academic
researchers and community members regarding the CTSA program’s purpose.
The review addresses the problem of having insufficient community representation on
various levels at the CTSAs. In many cases community members are not aware of the CTSA
program, which contributes to the absence of community input in the NIH CTSA clinical and
translational research process for biomedical research and can influence and compromise the
effectiveness of clinical and translational research that would directly affect the community.
This chapter examines the underrepresentation of community members living in the physical and
social environments where research is taking place and the vulnerability of communities
involved in research. Following this discussion, the next focus will be on the infrastructure of
academic medical centers (such as the Western CTSA) and how unaligned the academic-
community partnership is in biomedical research. After that, the attention will then turn to CTSA
administrators' stakeholders (stakeholder group of focus). Finally, an explanation of the
knowledge, motivation, and organizational influences used in this study will be described, and
the chapter presents the conceptual framework.
13
Review on the Problem of Practice
Advancing Biomedical Research
Advancing clinical science and medical care depend fundamentally on the participation
of healthy community volunteers and patients with specific biological conditions (Davis et al.,
2013). Insufficient involvement of community members in biomedical research threatens the
completion of clinical trials, which is essential in the translational science spectrum. Turning
scientific discoveries into clinical advances often is an inefficient process due to insufficient
resources, too few specially trained CTSA administrators and researchers, and scant training for
community participation. However, the CTSA Program supports an innovative national network
of medical research institutions that work together to improve the translational research process
to get more treatments to more patients more quickly.
History of the Clinical and Translational Science Awards (CTSAs)
The CTSA is a type of U.S. federal grant administered by the National Center for
Advancing Translational Science (NCATS), which is part of the National Institutes of Health
(NIH). The CTSA program began in October 2006 under the National Center for Resources’
auspices with a consortium of twelve (12) academic medical centers. The critical concentration
of supporting translational efforts in the academic medical centers is to have a role in working
with communities and conducting clinical trials. CTSA administrators are anchored to support
the administration and facilitation of translational research. Still, they may not have the
appropriate skills or training to support the integration of community roles in the CTSAs. After
the NIH created NCATS, the CTSA program was fully implemented in 2012, comprising sixty
(60) grantee institutions and their partners (“Re-engineering the Clinical Research Enterprise:
Translational Research,” 2009). The CTSA program helps institutions create an integrated
academic home for clinical and translational science to support researchers and research teams
14
working to apply new knowledge and techniques to patient care. The program is structured to
encourage collaborations among researchers from different scientific fields (“Institutional
Clinical and Translational Science Award (U54),” 2010).
Strategic CTSA goals. CTSA consortium leaders have set five broad goals to guide their
administrative research activities:
1. Building national clinical and translational research capability;
2. Providing training and improving career development of clinical and translational
scientists;
3. Enhancing consortium-wide collaborations;
4. Improving the health of U.S. communities and the nation; and
5. Advancing “T1” translational research to move basic laboratory discoveries and
knowledge into clinical testing (NCRR Fact Sheet: Clinical and Translational
Science Awards, 2010).
Of note, capacity building to integrate community participation in the CTSA is not part of
the current CTSA strategic goal, but community participation is embedded in the administration
of translational research through the CTSA institutions. The CTSA program research centers
serve as hubs locally and regionally to catalyze innovation in training, research tools, and
processes (National Center for Advancing Translational Science, 2018). CTSA Program hubs
collaborate locally, regionally, and nationally, fostering innovation in training and research
methodologies. NCATS continues to build on the strong foundation of the CTSA program to
tackle system-wide scientific and operational problems to make the clinical and translational
research enterprise more efficient (Clinical and Translational Science Awards, 2019).
CTSA program goals. The program goal of the CTSA is to eliminate growing barriers
between clinical and basic research, address the increasing complexities involved in conducting
15
clinical research (which involves community members), and help institutions nationwide create
an academic home for clinical and translational science (Zerhouni, 2006). CTSA administrators
enable research teams, including scientists, patient advocacy organizations, and community
members, to tackle system-wide scientific and operational problems in clinical and translational
research that no one team can overcome. CTSA administrators shape the NCATS program goals
(CTSA program Goal 1, 2020) to:
● Train and cultivate the translational science workforce;
● Engage patients and communities in every phase of the translational process;
● Promote the integration of special and underserved populations in translational
research across the human lifespan;
● Innovate processes to increase the quality and efficiency of translational research,
particularly of multisite clinical trials; and
● Advance the use of cutting-edge informatics.
Each CTSA institution is expected to participate actively in the CTSA national
consortium. The consortium comprises sixty (60) academic medical centers to develop and
strengthen community-academic research partnerships in a strategic manner. Further, it is
essential to enhance academic medical centers’ capacity to improve the health of the
communities and the nation (Clinical and Translational Science Awards Program, 2019).
The Importance of Translational Research and Lack of Community Involvement
Translational Research
The term translational research is a trending term at the NIH, especially when considering
the need to speed the science and discoveries of therapeutics and treatments. According to
Davidson (2011), translational research’s original meaning was to address the “lag between basic
discovery and the appearance of new drugs and treatments.” The term was used to bridge the
16
gap from bench to bedside discoveries. The challenge with advancing scientific research was to
address the decline of clinician-scientists taking on research roles to link basic science research
into clinical practice. Later, the meaning of translational research was to address the gap between
the development of a new treatment and the acceptance of that treatment. After that, the
treatment would turn into a policy that would improve a population’s health (aka the
community). The community is not typically involved in any of these processes or in defining
the meaning of translational research.
The term “translational research” continues to be used as a common term that translates
new information or knowledge created in one area to another application. In sum, translational
research would involve anything from research in the laboratory to dissemination and
implementation of the research in the community (Davidson, 2011). The NIH has made
translational research a priority, forming translational research institutes at academic medical
centers (AMCs) for the CTSA program in 2006 (Woolf, 2008). The goal was to enhance the
AMC infrastructure by having CTSA administrators facilitate the translational research efforts of
scientific discoveries into clinical settings. The CTSA infrastructure would support the
development of getting therapeutics, drugs, and treatments into the community more expediently
(FitzGerald, 2009). Today, translational research stands as a bidirectional process that involves
multidisciplinary integration among basic, clinical, practice, population, and policy-based
research (Zoellner & Porter, 2017). However, community involvement and input in the
translational spectrum has been minimal to nonexistent across the sixty-two (62) currently
funded CTSAs. A handful of CTSA institutions have “community engagement cores” to
facilitate and navigate community members' integration and involvement into the research
process. Since their inception, CTSAs have faced a barrier to building community involvement
across the translational spectrum due in part to the mistrust and misconceptions between
17
academic researchers and community members (Dave et al., 2018). The goal of translational
research stands to speed up scientific discovery for patient and community benefit. However,
despite some promising advances for community health research, the process of translating basic
discoveries into safe and effective clinical applications remains problematic (Collins, 2011).
History of the National Institutes of Health Initiative and Community Engagement
The success rate of NIH grants has fallen from 34% in 2001 to 19% in 2012, and that of
new targeted proposals fell from 28% to 14% during the same period (Gurwitz, Milanesi &
Koenig, 2014). NIH defines success rates as the likelihood of a grant getting funded, divided by
the number of grant applications funded by the sum of the total number of competing grant
applications reviewed (Fellowship & career development application rates, n.d.). On average, it
takes about 17 years for 14% of the original (i.e., discovery stage) research to be integrated into
physician practice (Ross et al., 2006). A significant gap exists between the volume of public
health knowledge generated through research and the application of that research in community
settings. The CTSA initiative calls on academic health centers to engage communities around a
clinical research relationship measured ultimately in public health (Eder et al., 2013).
CTSA administrators and community engagement. Some of the fundamentals of
translational research are strong collaborations between academic medical centers and
communities, which is known as community engagement (CE) (Institutional Clinical and
Translational Science Award (U54), 2008; Michener et al., 2008; Sung et al., 2003). Historically,
community engagement was not a well-known term before finding its home in the CTSA
environment. The charge of CTSA administrators is to serve as a federated network to conduct
multi-site clinical and translational research studies to optimize the efficiency of core facilities,
to develop research tools, and to engage common stakeholders (e.g., lay community, industry,
etc.) (Reis et al., 2010). The community engagement within the CTSA also serves as a national
18
model to encourage community-based participatory research, identification of health disparities,
public input in the delineation of unmet medical needs, sharing of best practices, interfacing with
practicing community physicians, increasing public trust, public education, identification of
creative financial sources for community-based research, and leveraging ongoing efforts of NIH
and other federal agencies (Reis et al., 2010). Some of the key elements and best practices in
community engagement include administrators facilitating workshops and discussion around the
topics of 1) learning first about the community in terms of its history, culture, economic and
social conditions, political and power structures, norms and values, demographic trends, and
experience with research; 2) sharing power and showing respect; 3) including partners in all
phases of research and planning; and 4) compensating community partners fairly during the
engagement process (Michener et al., 2012). Funding support is essential in making community
engagement possible. However, each CTSA-funded institution is challenged with the need to
build capacity in this effort. Some CTSA administrators experienced having a lack of positive
relationships with community members, a lack of leadership, funding constraints, time and
staffing constraints, and unsustainable models (Holzer & Kass, 2014). There is an ultimate need
to build capacity and prepare for engagement on the part of both the CTSA institution and
community partners. Holzer & Kass (2014) have shown that respondents believed community
partners were not always prepared to partner in research, and need to build capacity for
identifying how research could help their mission and prepare them to participate as a research
partner.
CTSA administrators’ role in facilitating communication between academic
researchers and community members. CTSA administrators are the driving force behind the
strategic planning and management of operations between academic research faculty and
community members. Communication between academic research faculty and community
19
members do not always occur organically. Academic researchers and community members think
differently about health prevention and treatment (i.e., focusing on disease and treatments vs.
focusing on lifestyle and broader public health issues) (Frechtling, 2012). Frechtling (2012)
emphasized the need to increase academic researchers’ awareness of the CTSA program and
what it offers as they may not fully understand the purpose of a CTSA.
Additionally, CTSA administrators have a role in informing academic researchers and
community members of what the CTSA goals are and the role each representative group can play
in fostering scientific breakthroughs and medical advances. A clearer understanding of what the
CTSA is and how academic researchers and community members can contribute to the research
culture and sustain changes that it desires to fulfill with the community’s participation is work
set out for CTSA administrators to execute. Equally important, CTSA administrators with a
background in community engagement can create a foundation of trust among academic
researchers and community members through a community-engaged logic model of “shared
leadership” (Eder et al., 2013). Without this trust-building effort, capacity-building for
community involvement at the CTSA will continue to be challenging.
Training for CTSA Administration to Build Capacity
CTSA grant funding provides an academic home for translational science and the
opportunity to systematically build capacity for managing relationships among various entities
from pediatric clinicians to academic faculty and community members. Dedicated funding to
training administrators to build capacity is key to creating an infrastructure to involve and
integrate community members at a CTSA (Chambers et al., 2020). For example, the workforce
development core at a CTSA would be an appropriate component to provide training on best
practices to address public health issues. CTSA administrators can enable both research faculty
and community members to focus on activities to advance skills and provide opportunities for a
20
collaborative partnership and shared leadership to build capacity (Cottler et al., 2020). Primary
strategies for capacity building skills for CTSA administrators include training on the principles
of community engagement and how communities have been involved in community advisory
boards and expert panels (Holzer & Kass, 2014). However, Holzer and Kass (2014) found that
providing education to faculty, staff, and students within a CTSA and community partners is
timely and costly and requires substantial institutional funding and dedication to supporting
training to build capacity for involving community members in multiple processes (e.g.,
community members serving as consultants, participating in research boards for decision making
etc.).
Challenges of CTSA Administrators Facilitating Community Member Involvement in Pilot
Grant Reviews
Piloting community member involvement through the Western CTSA has shown some
promising results yet there remain challenges for CTSA administrators trying to sustain
community involvement in scientific grant reviews. Pilot funding is typically seed funding for
feasibility testing and preliminary data generation to support future research efforts that will
make a measurable impact on health issues facing a particular community. Reviewing grant
applications relies heavily on peer review to assess the quality of grant applications, but the
evidence of these procedures' effects is scarce (Demicheli, 2007). Funding “meritorious”
applications require scientific expertise to assess a grant adequately. However, it is equally
essential for CTSA administrators to support patients and communities’ engagement in every
phase of the translational process by promoting the integration of special and underserved
populations in translational research across the human lifespan and include them in the research
grant review process. However, CTSA administrators have a challenging role in integrating
21
community members due to their varied experiences and perspectives and generally rooted
concerns for involving community members in grant reviews.
Because experts in the field already have varying perspectives on how to rate grant
applications, community members may also experience similar challenges. However, their input
is important as community members add a new layer of perspectives that could significantly
impact the type of research being funded and advanced in the biomedical research field. In many
cases, the grant review outcome depended more on the reviewer assignment than the proposed
research (Elizabeth et al., 2018). CTSA administrators can involve community members in
reviewing pilot grants, increase the quality and relevance of research, and enhance public
participation in research, which is one of the central challenges facing clinical research
enterprises (i.e., recruiting for clinical trial participation) (Joosten et al., 2015). Funding
“meritorious” applications may not be clear cut. It is still unclear whether developing panels of
experts with diverse backgrounds would support CTSAs in determining which applications
should receive funding to contribute to the translational research advancement. Lizaola et al.
(2011) found that having both expert scientists and expert community partners support the rigor
of reviewing scientific applications paved the way to a two-way exchange of research
approaches, strategies, findings, and programs. Yet, there is still little empirical evidence on
grant reviews' effects (regardless of whether they are scientific or community reviewers). There
is no study that assess the impact of grant reviews on the quality of funded research. Although
community integration may lead to a paradigm shift, understanding this process is still
understudied. This is something CTSA administrators can help investigate.
Importance of Increasing Community Involvement in Research and Building Capacity
More than 80,0000 clinical trials are conducted each year in the United States, but less
than 1% of the population participates in these studies (Murthy et al., 2004; Sheffet et al., 2018).
22
Consequently, research findings lead to research that does not account for genetic, cultural,
linguistic, racial/ethnic, gender, and age differences. There is a need for a representative sample
from a population in clinical trials that is both critical and ethical to ensure adequate
representation of specific groups of individuals (Osler & Schroll, 1992; Rochon et al., 2004).
CTSA administrators have a hand in creating opportunities for community member involvement
in all stages of clinical and translational research. Joosten et al. (2015) claim that the
community’s involvement can increase the quality and relevance of research but enhancing
public participation in research is one of the central challenges facing the clinical research
enterprise. Engaging communities in research increases its significance and may speed the
translation of discoveries into improved health outcomes. Yet, stakeholders such as CTSA
administrators and academic researchers lack the training to effectively engage community
members, which leads to ineffective translation of scientific discoveries into improvements in
individual and population health (Joosten et al., 2015). In general, community engagement is
difficult to integrate into translational science effectively. Community engagement requires 1)
interactions with stakeholders (e.g., community leaders, industry) and resources (e.g., legal
counsel, product development; and 2) a special skill set for health researchers and choosing to
embark on community-engaged research changes academicians' scholarly trajectory
substantially.
Professional Accountability in CTSA Leadership and Community Involvement
Professionals that possess sufficient expertise to determine the best way to meet people’s
needs are able to hold themselves professionally accountable. Professional accountability is a
person’s commitment to a community of professionals and a teacher of moral endeavors (Moller,
2009). Professional accountability implies that CTSA administrators should acquire and apply
the knowledge and skills needed for successfully putting the needs of the community at the
23
center of their work, collaborating and sharing of knowledge, and a commitment to the
improvement of practice. Part of professional accountability at the Western CTSA is developing
trust between community members and academic institutions; establishing trust requires time
and is an area that CTSA administrators can design and facilitate. Community members have
limited time and may have other goals as their primary focus. Lizaola et al. (2011) explained that
the mixed views of community members’ value in academic roles should be critically assessed
(Lizaola et al., 2011). Additionally, Joosten et al. (2015) agrees with Lizaola et al. (2011) and
found that significant gaps still exist in the methods used to engage communities in research.
CTSA administrators' role in facilitating this process and community members' participation is
often resource-intensive and time-consuming but it could be part of their professional
accountability.
CTSA administrator’s role in addressing community underrepresentation in science.
CTSA administrators must uphold their professional accountability to address concerns of the
underrepresentation of community participation in science. Several factors concerning the
underrepresentation of community participation in the CTSAs include the hindrances to building
capacity for community integration. As previously mentioned, less than 1% of the population
participate in clinical trials. Notably, women, the elderly, racial/ethnic minority groups, and rural
populations are often underrepresented in research. In a 2011 survey, only 19% of CTSA
institutions reported having community members advise CTSA core programs (Wilkins et al.,
2013) and 11% reported the inclusion of a community member in the CTSA leadership team.
This finding highlighted the under-utilization of community members from physical and social
environments where research is taking place (Paberzs et al., 2014). Wilkins et al. (2013)
provided an inventory of reasons regarding fundamental barriers to engaging community
representatives among 47 CTSAs:
24
● 60% of community members have limited time;
● 43% perceived power differentials between academic leadership and community
representatives;
● 43% experienced unclear expectations; and
● 32% were inadequately compensated.
Barriers to community member, patient, and other stakeholders' involvement outside the
academic environment often include concern that academic institutions do not value community
contributions. CTSA administrators serve as a bridge to this issue by becoming essential in
communicating academic research goals to the community-at-large. As an example, CTSA
administrators have the capability to host workshops or seminars that allow the community to
participate. The key to overcoming the under-representation barriers of community members in
research is communicating with the community in lay terms. General concerns include
discomfort of community members unfamiliar with the scientific language and subject matter
and divergent perspectives between academic researchers and community members (Paberzs et
al., 2014). For example, community members do not regularly receive formal training and
education on evaluating grant applications at the CTSAs. Community members are not experts in
understanding what a research design is and which methodologies are the most appropriate to
approach a grant review.
Challenges with academic-community partnership in biomedical research. Effective
translational research requires engagement and collaboration among communities, academic
researchers, and practitioners (Stewart et al., 2018). Unfortunately, not all lay members of the
community share the same sentiment in participating in the biomedical research process. This is
a challenge that CTSA administrators can bridge and address among these stakeholders. A study
found scientists to be more supportive of having cancer patients/survivors sit as lay panelists than
25
lay respondents for grant reviews (Monahan & Stewart, 2003). Lay panelists viewed themselves
as serving an ambassadorial role instead. In light of this, Paberzs et al. (2014) found that
community-engaged research brought a unique set of challenges for funding agencies, reviewers,
and applicants, particularly about equity and effectiveness within the grant review process. As an
example, most CTSA institutions mirror the NIH-style review process. CTSA administrators
built the review process within an academic culture that required scientific training and expertise
to evaluate research proposals. The thought of involving community members in the review
process was to balance academic perspectives and add valuable insights that would otherwise be
missing from review discussions (Paberzs et al., 2014). A 2011 survey of CTSA community
engagement cores showed 94% of community involvement in all CTSAs. However, their work
was mostly compartmentalized within a “community engagement” program and not extended to
other programs. Thus, building capacity within the CTSAs to ensure community involvement is
applicable in different areas within the CTSAs is essential.
Building a necessary infrastructure to involve community members. According to
Joosten et al. (2015), the infrastructure and incentives at many academic medical centers are not
well aligned to support community engagement. Significant gaps still exist in the methods used
to engage communities in research, particularly in racial/ethnic minorities and indigenous or
underrepresented populations (Christopher et al., 2008; Fong, Braun & Tsark, 2003). The
partnering of academic researchers with community groups has shown promising and sustainable
results. Yet, the continued distrust between academic researchers and underrepresented
community members makes it difficult to create an infrastructure to sustain community
involvement in research. Underrepresented communities are most at risk for poor health
outcomes, and their participation is vital for translational research studies (Tse et al., 2015).
Joosten et al. (2015) argue that many researchers lack the training to engage stakeholders,
26
whereas academic institutions lack the infrastructure to effectively support community
engagement. This infrastructure would include a central place to spot and address differences of
opinions, misunderstandings, or conflicting interests, critical to building capacity to increase
community member involvement in research. (Lizaola et al., 2011). However, given the growing
demand for research to engage community stakeholders, there is limited evidence in the literature
to demonstrate any return on investment of their time and engagement activities. However, the
value is still there (Esmail, Moore, & Rein, 2015).
CTSA administrators can employ capacity-building strategies to engage the community.
Examples of capacity building strategies include education, pilot grants, connecting potential
partners, and community research centers. Research engagement strategies can also add little
input from communities, such as announcements, to those that allowed for a high amount of
information from communities, such as community-researcher teams (Holzer & Kass, 2014).
Building capacity between community members and researchers. Building
community-academic capacity is critical to advancing clinical and translational science.
However, in a study on community research needs assessment for future capacity building
programs for community-based organizations, 58% of the 75% who had collaborated with
academic institutions in the past stated they did not have a pleasant experience during this
collaborative process (Goytia et al., 2013). The reason is the lack of shared definitions of
community capacity building and sustainability-related goals for the organization. There is a
need to define community capacity building and sustainability and identify facilitators and
barriers to achieving both (Hacker et al., 2012). The most fitting facilitators here are CTSA
administrators.
Some CTSAs took a team science approach to successfully implement community-
engaged research programs to build capacity between community members and researchers.
27
However, they were often independent, leaving gaps in the translational continuum (Selker &
Wilkins, 2017). Barriers to collaboration within an academic setting include the mental model of
the researcher's immediate priorities and minimal consideration of the principles of community
engagement and community priorities. The involvement of diverse community members (e.g.,
racial and ethnic minorities, women, and those with compromised access to health care) is key to
increasing public trust in research and creating a more efficient and engaged research workforce
through the CTSA administrator’s facilitation and support.
Promising Practices and Models for Building Capacity for Community Involvement in the
Research Process
Several models for community involvement in the CTSAs exist and have increased
community participation in either research studies or research processes. For example, the
Michigan Institute for Clinical and Health Research (MICHR) pilot funding program provided
tangible evidence that engaged and knowledgeable community members can enhance the rigor of
clinical research in the grant review process. Ongoing bidirectional learning and the presence of
trained community members can guide research teams at the pilot funding stage to facilitate the
longer-term development of large-scale research efforts that continue to engage communities
(Paberzs et al., 2014)
Another example is the Vanderbilt Institute for Clinical and Translational Research
(VICTR) which, in 2009, established the “Community Engagement Studio” (CE Studio). The
VICTR administrators created a platform for community members to serve as consultants for
academic researchers interested in receiving input on their work from patients, caregivers, health
care providers, community members, and other non-researcher stakeholders. The CE Studio
allowed academic researchers to obtain feedback from their community of interest or patient
group about design, implementation, recruitment, retention, and other potential barriers to
28
research participation. Additionally, the VICTR administrators created an infrastructure to
effectively address the need for academic researchers to have formal training to engage
community stakeholders.
In contrast, other academic institutions lacked the infrastructure to support community
engagement when MICHR and VICTR were developing their programs. CTSA administrators
of the CE Studio helped funders and researchers enhance current research practices and improve
dissemination by offering cost-effective and time-efficient methods that engage groups of
stakeholders and patients. CTSA administrators of the CE studio streamlined the process by
gathering feedback and creating an infrastructure that works to empower community members to
provide meaningful insight into all research phases (Joosten et al., 2015).
In 2013, the Patient-Center Outcomes Research Institute (PCORI), an independent
funding agency, began engaging patients and other stakeholders to review PCORI research
funding applications. The PCORI stakeholder review community includes patients, caregivers,
clinicians, policymakers, and other healthcare system stakeholders who offer added value and
perspectives to PCORI-funded research from a wide variety of individuals from diverse
communities (Fleurence et al., 2014). In 2016, the CTSA administrators of the University of
Arkansas for Medical Science (UAMS), Translational Research Institute (TRI) developed a
Community Scientist Academy (CSA) to involve lay community members in the pilot grant
review process. The purpose of the CSA was to increase community understanding of and
involvement in research. The UAMS CTSA administrators designed it to engage community
members and patients who may be less represented in research, have no research background,
and lack trust or interest in participating in research. CTSA administrators who have structured a
process to involve community members have helped demystify the research process for those
29
underrepresented in research and facilitate their engagement and influence within the CTSA
(Stewart et al., 2018).
Communicating Science to the Public
The communication of science is complex, affected by a range of institutional
imperatives and constraints, which influence not just how much science is communicated but
also the nature of that science. Different media, with different agendas, audiences, and ways of
speaking about the world, have different ways of talking about science. The mass media differ in
terms of the quality of science coverage and the relative prominence of certain kinds of science
(Silverstone, 1991). Scientists presenting findings and evidence from sophisticated microscopes
in the 19th century was the beginning of what would become a conventional process of sharing
research ideas and collaborating on specific research questions in today’s research conferences
and events. Then as now, this process excluded community member participation. The concept
of “leaving science to scientists” was predominant in the field of biomedical research and the
idea of facilitating research collaboratively among scientists and community members was
inconceivable when the National Institutes of Health was created in 1887.
The Creation of the National Institute of Health.
The idea of involving community members in the administrative and facilitative process
in science and medicine was not conceived when the NIH was created. It launched a research
fellowship program related to biological and medical health problems. Several years after the
NIH’s inception, the first specialized institute was created and sponsored by Congress, the
National Cancer Institute (NCI). Throughout World War II, NIH mainly focused on war-related
health issues, including vaccines and viruses. After the war, NIH’s first grants program was
launched through NCI in 1946. The expansion of the grants program grew into new categorical
30
institutes and eventually moved towards the growing field of biomedical research. New
knowledge was being discovered, which, in turn, led to new drugs, devices, and procedures (A
Short History of the National Institutes of Health, n.d.). The NIH was created with researchers,
scientists, and medical professionals at the forefront of leading the institution. Obtaining
community input or involving them during the development of this infrastructure remained
inconceivable.
The National Institutes (plural) of Health. Today, the NIH is part of the United States
Department of Health and Human Services and is the nation’s medical research agency. The NIH
comprises twenty-seven (27) Institutes and Centers with specific research plans, focused on
particular diseases or processes. All but three of these Institutes and Centers receive funding
directly from Congress and administer their budgets (“NIH Organization,” 2017). Funding
currently does not include the hiring of personnel for community members or leadership. The
NIH leadership is integral in setting the research agenda, activities, and positions for its institutes
and centers. The Office of the Director is the central office responsible for setting NIH policy
and planning, managing, and coordinating the programs and activities of all the NIH Institutes
and Centers. NCATS falls under the NIH organization. Instituting community involvement and
creating leadership opportunities at this level of leadership is ideal but is an opportunity that is
yet to be thoroughly developed (Zerhouni, 2003).
Key NIH initiatives. Some of the key NIH initiatives include responding to
Congressional legislation to meet ongoing changes in research needs, and urging research
scientists to work in cross-disciplinary teams to bring together innovative research areas and
opportunities strategically. The NIH’s overall goal is to continue to pave the way for important
medical research discoveries to improve population health and save lives (Abeles, 2001). For
over 30 years, NIH has made significant advances impacting the U.S.’s health, fostered by the
31
translation of scientific discoveries. The rising costs for both research and health care have led to
NIH creating a Roadmap for Biomedical Research, which is an incubator space for funding
innovative programs to address an array of scientific challenges, including the need to develop a
culture of research collaboration or team science (Zerhouni, 2006). An essential feature of the
roadmap is the CTSAs. Yet, again, this roadmap excludes community involvement.
The organization of the National Center for Advancing Translational Science
(NCATS) and the Clinical and Translational Science Awards. In December 2011, NCATS
was established with the mission of catalyzing the generation of innovative methods and
technologies to enhance the development, testing, and implementation of diagnostics and
therapeutics across a wide range of human diseases and conditions (“National Center for
Advancing Translational Sciences,” 2018). The goal (and mantra) of NCATS is to get more
treatments to more patients more quickly. NCATS is one of 27 Institutes and Centers at the NIH
and was established to transform the translational process so that new treatments and cures for
disease can be delivered to patients faster. NCATS is organized by eight offices:
1. Office of the Director
2. Division of Clinical Innovation
3. Division of Pre-Clinical Innovation
4. Office of Administrative Management
5. Office of Grants Management and Scientific Review
6. Office of Policy, Communications, and Education
7. Office of Rare Diseases Research and
8. Office of Strategic Alliances.
32
The office pertinent to this dissertation is the Division of Clinical Innovation (DCI), which plans,
conducts, and supports research across the translational science spectrum’s clinical phases. Key
areas of this division include:
● Planning, leading, and supporting research to develop new methods and technologies to
enhance clinical processes;
● Planning, conducting, and supporting research to evaluate existing and emerging
approaches, techniques, and procedures in the clinical spectrum;
● Supporting training programs relevant to clinical phases of translational science;
● Allocating DCI resources to clinical and translational infrastructure and investigators;
● Collaborating with other NIH Institutes and Centers and the scientists they support; and
● Consulting with stakeholders, including patients, industry, and regulators.
A community-engaged research program is embedded within the NCATS but is not officially
instituted as an NIH office. NCATS’ primary focus is commonalities amongst diseases. It
collaborates with other government agencies, including other NIH institutes and centers,
industry, academia, and patient support organizations (“National Center for Advancing
Translational Sciences,” 2018). Today, NCATS demonstrates and disseminates innovations that
reduce, remove, or bypass system-wide bottlenecks in the translational process by way of CTSA
administrators who help facilitate this process. For example, NCATS and CTSA administrators
supported researchers who developed an automated machine-learning approach to diagnose
genetic diseases in seriously ill children, which could lead to faster diagnosis, initiation of
treatment, and, ultimately, better health outcomes. Additionally, NCATS supports innovative
work such as the CTSAs to address the development and implementation of national standards
and best practices for translation, from basic discovery to clinical and community-engaged
research. However, the problem of practice of building capacity to increase community input to
33
support the speed of medical discoveries is entrenched within the CTSA community engagement
cores and is not a leading initiative in the overall translational research process.
Clark and Estes’ (2008) Knowledge, Motivation and Organizational Influences Framework
Clark and Estes (2008) provided a framework that allows practitioner-researchers to
diagnose and find solutions to organizations' performance gaps. The authors framed these gaps in
three main areas: knowledge and skills, motivation, and organizational barriers (KMO
framework). Knowledge and skills refer to whether people know how to achieve their
performance goals (Clark & Estes, 2008). In his revision of Bloom's taxonomy, Krathwohl
(2002) defined four types of knowledge (factual, conceptual, procedural, and metacognitive),
which are helpful to understand whether stakeholders know how to meet a performance goal.
Motivation is the internal, psychological process that gets people going, keeps them moving, and
tells them how much effort to spend on tasks (Pintrich & Schunk, 1996). Motivation influences
revolve around the concepts of choice, persistence, and effort (Clark, 1998; Clark & Estes;
Rueda 2011). When a lack of performance cannot be attributed to knowledge or motivation gaps,
organizational barriers are often to blame. These barriers can include inadequate resources, work
processes, or organizational culture (Clark & Estes, 2008; Schein, 2004).
The KMO framework will be used to learn more about what is currently happening in the
organization and analyze potential gaps that prevent the Western CTSA from reaching its overall
goals of integrating and building capacity for community members in the Western CTSA.
Additionally, the KMO framework will also help in understanding the performance behaviors
and elements that influence individuals that may also influence a whole group. After identifying
the goals and then verifying the influences, a better understanding of which K's, M's, and O's are
influencing within an organization will be recognized.
34
Concerning the assumed “K” influences, this study focuses on Anderson and Krathwohl’s
Four Types of Knowledge for factual knowledge, conceptual knowledge, procedural knowledge,
and metacognitive knowledge (Rueda, 2011). The “M” influences will be considered as the
process whereby “goal-directed activity is instigated and sustained” (Pintrich & Schuyler, 2002).
Finally, the assumed “O” influences will be the organizational environment related to culture and
infrastructure (Clark and Estes, 2008).
Stakeholder Knowledge, Motivation and Organizational Influences
Knowledge and Skills
CTSA administrators must employ specific knowledge to achieve organizational
performance goals successfully. As previously mentioned, CTSA administrators carry their
perspectives and values based on what they intrinsically understand and know about a particular
situation or circumstance, especially as it relates to community involvement. Yet, new
knowledge is expected to be generated so that CTSA administrators can innovate towards the
common organizational performance goal of building capacity for community involvement in the
Western CTSA. Clark and Estes (2008) suggested that necessary knowledge and skills
enhancement for job performance is key if (a) people do not know how to reach their
performance goal and (b) if future challenges will need novel problem-solving. Thus, this
literature review will identify the knowledge influences that would help determine whether
CTSA administrators can learn and acquire the necessary knowledge to increase community
member involvement and build capacity in the Western CTSA.
Knowledge influences. Bloom’s revised taxonomy provided a framework that classifies
and allows the researcher to understand knowledge influences that may affect a leader’s
performance (Anderson, 2001; Krathwohl, 2002; Rueda, 2011). In a revision to Bloom’s
Taxonomy, Krathwohl (2002) identifies four knowledge types: factual knowledge, conceptual
35
knowledge, procedural knowledge, and metacognitive knowledge. Since knowledge is a
component of learning, understanding the differences between these knowledge types helps to
identify which type is most relevant for a particular context (Mayer, 2011). Factual knowledge
refers to the basic elements needed to solve problems, while conceptual knowledge refers to how
those basic elements are interrelated and can work together within larger constructs (Krathwohl,
2002). The third knowledge type proposed by Krathwohl (2002) is procedural knowledge, which
revolves around how to do something. The fourth knowledge type is metacognitive knowledge,
knowledge and awareness of cognition (Krathwohl, 2002). It has also been described as knowing
the when and why of proceeding with a task (Rueda, 2011).
Additionally, there are six cognitive processes: remember, understand, apply, analyze,
evaluate, and create (Anderson & Krathwohl, 2001; Krathwohl, 2002). The knowledge and skills
in problem-solving that CTSA administrators should have to integrate community members in
the CTSA translational research process (and build capacity) will be examined, which is still
rarely explored in the general CTSA consortium. For example, essential things to learn from
CTSA administrators include
● Research terms to see how well stakeholders understand translational research or
biomedical research (factual knowledge);
● Individuals being able to paraphrase or differentiate different concepts or thoughts to
learn how well stakeholders understood scientific material (conceptual knowledge);
● The ability to incorporate community members into the Western CTSA process and how
well they can perform their learned skills and articulate steps in providing appropriate input to
appropriate program cores at the Western CTSA (procedural knowledge); and
36
● Knowledge about oneself as a learner, the task that stakeholders have at hand, and
strategies they need to provide input to the Western CTSA program cores (metacognitive
knowledge).
Gaining input from community members and with those with no research background is
critical. If there are expectations to see new approaches to reach underserved populations, local
community organizations, and health-care providers, then ensuring medical advances are
reaching the people who need them can, in turn, increase community participation in the CTSAs
(Xerhouni, 2007). Thus, understanding which type of knowledge is involved and what level of
cognitive process is important. Appropriate implementation strategies from administrators can
help close the gap between the current and desired state of knowledge and skills for the
stakeholder groups of focus (Clark & Estes, 2008).
Conceptual knowledge related to the needs and assets of CTSA administrators. CTSA
administrators exist to support clinical and translational research endeavors. CTSA
administrators can provide an inventory to facilitate a process of involving community members
in translational research. The conceptual knowledge in identifying CTSA administrators' needs
and assets will provide an opportunity to create an environment conducive to community
participation in clinical and translational research. For example, CTSA administrators have
diverse educational backgrounds, experiences, and perspectives regarding what a community is.
CTSA administrators are familiar with significant facts about prevalent health issues that the
CTSA research institute supports. Still, CTSA administrators' terminology may differ
significantly from how these terms are spoken in the community.
Additionally, CTSA administrators may have advanced degrees and a very different
worldview from a typical layperson in the community. The education, knowledge, and
experience of CTSA administrators qualify them best to communicate health-related issues
37
between academic research and community members. This dissertation will investigate the
various forms of how CTSA administrators can increase the involvement and integration of
community participation in biomedical research. CTSA administrators also need to understand
what a vulnerable population is and how they have been excluded from research in the past (e.g.,
racial/ethnic minority communities/people living with HIV/AIDS) (Paberzs et al., 2014).
Understanding the complexities and intricacies related to the needs and assets of CTSA
administrators can serve as a guide for to best engage community members to provide input on
research program priorities, strategic planning, and reviews for pilot funding proposals
(Kirschner & Merriënboer, 2013). Knowing this could help CTSA administrators make ethical
and sensible decisions on how they would approach and develop a process to bring community
perspectives into the Western CTSA.
Procedural knowledge regarding how to facilitate the integration of community members
into the Western CTSA. Learning how to facilitate the integration of community members into
the Western CTSA is a critical factor to assess. The skills involved with understanding how to
prepare and train CTSA administrators to provide an opportunity for community participation in
the biomedical research process is an example of procedural knowledge. The knowledge of
shared understanding of translational research and standards of what all stakeholders need to
know before participating in the research process will help support what steps are necessary to
integrate community members in the Western CTSA.
Metacognitive knowledge including self-reflection and understanding one’s own
biases. Metacognitive knowledge is awareness of one's cognition and cognitive processes
(Rueda, 2011). It encompasses "knowledge about, reflection on, and regulation of one's cognitive
activities" (Butler, 2015, p. 294). It allows the individual to adapt their ways to think and operate
according to this awareness (Krathwohl, 2002). CTSA administrators need to be self-aware of
38
the multiple layers of community participation issues in the biomedical and translational research
process. The higher-order thinking process that allows learners to have awareness and control of
their cognitive processes is key to understanding the stakeholders’ way of processing information
(Baker, 2006, p.1). Baker (2006) asserted that the learner needs to know about oneself and the
task and skills/strategies required to accomplish a task – a metacognitive knowledge. This
dissertation looks to learn how CTSA administrators will reflect or manage their own biases in
being involved in the clinical and translational science process. How they use their
metacognition to minimize or eliminate bias is critical to understand how they can contribute to
creating a process to facilitate the involvement of community members in the clinical and
translational research process.
Table 1 presents the three main knowledge influences, the knowledge types that they relate to,
and methods of assessing the gaps in knowledge.
Table 1
Knowledge Influence and Knowledge Types
Organizational Mission
The Western CTSA’s mission is to understand the scientific and operational principles
underlying the translation of scientific knowledge into new approaches to improve the health of
individuals and the public.
Organizational Performance Goal
By 2025, the ten Western CTSA program cores (and potentially others that may emerge) will
systemically include and integrate community members into all phases of the translational
research process.
Stakeholder Goal
CTSA administrators will be integral to increasing community member participation in the
CTSAs by integrating community input in all program cores.
Knowledge Influence Knowledge Type (i.e., declarative (factual or
conceptual), procedural, or metacognitive)
Knowledge related to the needs and assets of
community members
Conceptual
Knowledge regarding how to facilitate the
integration of community members into the
Western CTSA.
Procedural
39
Knowledge including self-reflection and
understanding one’s biases.
Metacognitive
Motivation influences. Motivation is the internal, psychological process that gets people
going, keeps them moving, and tells them how much effort to spend on tasks (Pintrich &
Schunk, 1996). Motivation influences revolve around the concepts of active choice, persistence,
and mental effort (Clark, 1998; Clark & Estes, 2008; Rueda, 2011). Studying motivation is
essential to understanding performance and achievement in any organization (Rueda, 2011).
Understanding motivation is key to what will inform the researcher about what will motivate
CTSA administrators to integrate community members into the research process and for
community members to participate in clinical and translational research. Motivation is the
facilitator of performance and can inhibit a person’s willingness to “perform” (Shraw & Lehman,
2009). Motivation is also a critical factor in the stakeholders’ goal because it points to the beliefs
people develop for themselves as learners and achievers (Rueda, 2011). Additionally,
motivation impacts whether or not a person starts, continues, and finishes a task (Rueda, 2011).
Multiple factors can affect motivation.
Expectancy-value theory. The expectancy-value theory construct can be applied to the
CTSA administrator’s motivational belief to integrate community members and input into the
Western CTSA (Eccles, 2006). The expectancy-value of CTSA administrators to facilitate
community members' involvement in the Western CTSA can either increase or decrease their
interest in supporting the design and creation of a process or program to involve community
members in biomedical research. For example, CTSA administrators may be looking for a
reward for making an effort to facilitate community involvement at the CTSA as a motivational
factor, but Eccles, 2006 calls this as the utility value that motivates CTSA administrators to look
at the overall picture of ensuring community members have a voice in the biomedical research
process. Eccles 2006 describes utility value as facilitating one’s long-range goals or obtaining
40
immediate or long-range external rewards. That said, the utility value is one that goes hand-in-
hand with goal setting goals for CTSA administrators. There is far more benefit for CTSA
administrators to serve as facilitators in incorporating community member input in biomedical
research, even though it is not the most attractive task to perform. Avoiding menial, dense, and
less favorable tasks run the risk of being a disservice to the overall mission of the Western
CTSA. Further, providing an ongoing learning environment for scientific and community
members in the Western CTSA is key to motivating individuals to be active, persistent, and exert
mental effort in participating in science. The utility value is the benefit of CTSA administrators,
creating an infrastructure to support community members' integration and involvement in the
Western CTSA. The hope is that the Western CTSA administrators and community members
will both reap the rewards of finding health solutions to a specific problem due to their
participation in the biomedical research process.
The utility value of community input in the Western CTSA may help research scientists
explore research areas that may not have been thought of before. Information from the
community has the potential to be useful and meaningful, and can lead to solutions to health
problems in the community. Further, CTSA administrators need to see the value of including
community stakeholders in providing input on biomedical research. CTSA administrators should
see the utility value of involving community stakeholders in providing feedback to academic
research so that they can make new or validate assertions (Eccles, 2006). CTSA administrators'
role in increasing community input in the Western CTSA will inevitably create a learning
environment that fulfills this motivational influence.
Self-efficacy. Self-efficacy is a belief that, with effort and appropriate support, a goal is
achievable. Bandura’s social cognitive theory (1991) expresses that self-efficacy is the key to
positive outcomes and behaviors that support the successful attainment of a goal. According to
41
Bandura (1991), self-efficacy is a foundational component of motivation. This means that unless
individuals believe they are capable of the actions, they have little motivation to start, engage in,
or finish the action.
Several factors can influence self-efficacy. One of those factors is an individual’s positive
experience through a performance called mastery experience (Bandura, 1991). If an individual
believes that the performance went well, that experience raises self-efficacy. If the experience
was not successful, it lowers self-efficacy. Another factor is the feedback that one receives
through social persuasion, which, if positive, raises self-efficacy (Bandura, 1991). Lastly, if an
individual sees that another person who is similar in ability, models, or shows that he can
accomplish the task, modeling increases self-efficacy (Bandura, 1991). In other words, this
vicarious experience shows that the task can be done, and the outcome can be positive.
Self-efficacy to build capacity at a CTSA. Self-efficacy is key to the success of involving
community members at a CTSA and to building capacity. CTSA administrators need to feel
confident in their ability to provide bi-directional learning opportunities, including instituting
community-academic partnerships and opportunities to offer or receive input about relevant
clinical and translational research. Preparation is vital for CTSA administrators to facilitate the
process of including community input in the CTSAs. Through self-efficacy, it is essential to
increase the stakeholder’s knowledge and confidence in being involved in a CTSA.
Understanding the process is crucial because it provides the stakeholder groups with the
necessary competence and important context to help build community involvement capacity at a
CTSA. The level of confidence in understanding the clinical and translational research process
and the community’s role in it is also important because it can significantly impact the
stakeholder groups’ determination to remain proactive and engaged and have an overall positive
experience.
42
Table 2 shows the organizational mission, performance goal, stakeholder goal, motivational
influences and motivational influence assessments that were discussed in this literature review.
Table 2
Assumed Motivational Influences
Organizational Mission
The Western CTSA’s mission is to understand the scientific and operational principles
underlying the translation of scientific knowledge into new approaches to improve the health of
individuals and the public.
Organizational Performance Goal
By 2025, the ten Western CTSA program cores (and potentially others that may emerge) will
systemically include and integrate community members into all phases of the translational
research process.
Stakeholder Goal
CTSA administrators will be integral to increasing community member participation in the
CTSAs by integrating community input in all program cores.
Assumed Motivation Influences
Utility value
Self-efficacy
CTSA administrators need to feel confident in their ability to communicate and train the CTSA
staff on models and practices to build relationships with community and academic partners.
Organization influences. This section of the review will examine potential
organizational influences on the CTSA administrator’s ability to integrate and participate in the
clinical and translational research process. Cultural settings and cultural models can unveil an
organizational culture (Gallimore & Goldenberg, 2001). Cultural settings are concrete and
include the stakeholder groups, their tasks, how and why tasks are completed, and the social
context in which their work is performed. Cultural models refer to cultural practices and shared
mental schema within an organization (Gallimore & Goldenberg, 2001).
Cultural models. When describing the organizational culture, Schein (2004)
differentiated several analysis levels, defined by the degree to which the cultural phenomenon is
visible to the observer. Least visible are the deeply embedded, unconscious, basic underlying
43
assumptions (Schein, 2004). According to Argyris’s seminal studies, these assumptions guide
behavior and mandate group members' thoughts and perceptions (Argyris, 1976; Agyris &
Schön, 1974). They also constitute what Gallimore and Goldenberg (2001) call cultural models,
“a shared mental schema or normative understandings of how the world works, or ought to
work” (Gallimore & Goldenberg, 2001, p. 47). The type and degree of accountability and the
conception of CTSA administrators are related to cultural models within the CTSA organization.
Cultural model: professional accountability in CTSA leadership and community
involvement. There is an abundance of complementary literature frameworks that help
understand key relationships in an organizational setting (Burke, 2005; Firestone & Shipps,
2005; Romzek & Dubnick, 1987). Emanuel & Emanuel (1996) describe accountability as the
"procedures and processes by which one party justifies and takes responsibility for its activities."
In contrast, Burke (2005) defines accountability as the contractual relationship between a
director and a provider, where the provider is held responsible for providing service and reaching
specific goals. Goal achievement is assessed by the provider's performance and can also frame
professional accountability between agent, principal, and beneficiary of the service (Burke,
2005).
One type of accountability is particularly relevant in the integration of community
members in the CTSAs. According to Stecher & Kirby (2004), professional accountability is
built on the assumption that educators are professionals who possess sufficient expertise to
determine the best ways of meeting the individuals' needs of their students. Professional
accountability also includes peers working collegially as main agents toward the goal of
increasing product quality (Burke, 2005). CTSA administrators must be held accountable for the
process of integrating community members in the Western CTSA to accomplish the
organizational goal. CTSA administrators delivering training or facilitating opportunities to
44
involve community members in the CTSAs is a form of professional accountability.
Administrative rules that guide specific tasks and implement a community involvement program
are incumbent on the CTSA administrators. Since CTSA administrators play an essential role in
shaping the community members' behaviors and attitudes to integrate community involvement in
the Western CTSA, CTSA administrators need to partake in the sphere of professional
accountability.
Cultural model: collaborative leadership among CTSA administrators and community
members. Collaborative leaders typically play a facilitative role, encouraging and enabling
stakeholders to work together effectively (Ansell & Gash, 2012). Management and business
literature demonstrate that collaborative environments promote the ongoing integration of ideas
and interdependency among multiple stakeholders and reinforce a collective rather than
individual leadership approach within an organization (Raelin, 2016; VanVactor, 2012). A
collaborative model in which CTSA administrators work collectively with community members
and researchers on research-related tasks is the study’s driving force. Setting a cultural model
that encompasses a collaborative spirit among academic and community partners provides a
productive opportunity to consider flexibility in changing plans, purposes, and directions.
Cultural model: the role of CTSA administrators in the CTSA organization. CTSA
administrators play a key role in creating the cultural model for including community input at the
CTSAs. CTSA administrators offer a breadth of knowledge and information to help design the
infrastructure of involving community members at a CTSA. The organizational change sought
through this cultural model with CTSA administrators is integrating community input in the
CTSAs and building capacity. Building capacity also supports the National Institutes of Health’s
goal of bringing treatments and diagnoses out to the community faster in alignment with the
vision at the Western CTSA to add community domain experts in all CTSA core programs.
45
CTSA administrators would serve as the responsible party to communicate to the rest of the
organization at the clinical and translational science institute that the risk of changing the “status
quo” may lead to a radically different future - with potential rewards and benefits by instituting
a new vision moving forward (Denning, 2005).
Cultural settings. Cultural settings are visible, concrete manifestations of cultural
models that appear within activity settings (Rueda, 2011). They are similar to what Schein
defined as artifacts, which are easier to observe than underlying assumptions (Schein, 2004).
Gallimore and Goldenberg (2001), borrowing from Sarsons (1972) and Tharp and Gallimore
(1988), defined cultural settings as "those occasions when people come together to carry out a
joint activity that accomplishes something they value" (Gallimore & Goldenberg 2001, p. 48).
Rueda (2011) emphasized the importance of understanding the reciprocal relationships of
cultural models and cultural settings (or social context): cultural settings have the potential to
impact individuals' and groups' behaviors. They are also shaped by these individuals and groups,
who operate within cultural models that determine their behavior.
Cultural setting: the goal of community member involvement at the CTSAs. The ultimate
change desired for the Western CTSA is to enhance research projects rigor and the research
processes by having community input in the Western CTSA core programs. Currently, Western
CTSA has low community member input. Involving and aligning the Western CTSA goals with
CTSA administrators and community members as key stakeholders support the change model,
including community voices in CTSA core programs. According to Lewis (2011), goals should
be known at the outset of change, be stable across the change process, and be assessed at any
given point and time. Community members need to be involved in this change effort at the
beginning of this process alongside CTSA administrators.
46
Cultural setting: community advisory boards and community engagements. The Western
CTSA community engagement core provides resources for integrating community voices into a
research study to support the existing community advisory board program. The community
advisory board creates an efficient and supportive infrastructure to accelerate the translation of
promising clinical practices and innovations into community settings. An important part of this
infrastructure is the integration of community organizations, clinics, and others into this process
to ensure that the research conducted at academic medical centers are meaningful to the
populations for whom they are intended. CTSA institutions must have a structure that can solicit
and integrate community input into the clinical and translational research process; to do this
successfully, CTSAs must collaborate with community organizations to identify and understand
public health needs.
Table 3
Assumed Organizational Influences
Organizational Mission
The Western CTSA’s mission is to understand the scientific and operational principles
underlying the translation of scientific knowledge into new approaches to improve the
health of individuals and the public.
Organizational Performance Goal
By 2025, the ten Western CTSA program cores (and potentially others that may
emerge) will systemically include and integrate community members into all phases of
the translational research process.
Stakeholder Goal
CTSA administrators will be integral to increasing community member participation in
the CTSAs by integrating community input in all program cores.
Assumed Organizational Influences
(Cultural Model)
The organization needs to have professional accountability in CTSA leadership and
community involvement
(Cultural Model)
The organization needs to have collaborative leadership among CTSA administrators
and community members.
(Cultural Model)
47
The organization needs to understand the role of CTSA administrators in the CTSA
organization.
(Cultural Settings)
The organization needs to set the goal of community member involvement at the
CTSA.
(Cultural Settings)
The organization needs to have a community advisory board and community
engagement.
Table 4
Summary Table of Assumed Influences on Performance
Stakeholder Assumed Influences on Performance
Knowledge Motivation Organization
● Knowledge related to
the needs and assets
of community
members
● Knowledge regarding
how to facilitate the
integration of
community members
into the Western
CTSA
● Knowledge including
self-reflection and
understanding one’s
biases.
● Utility Value
● Self-efficacy: CTSA
administrators need to feel
confident in their ability to
communicate and train the
CTSA staff on models and
practices to build relationships
with community and academic
partners.
● The organization needs
to have professional
accountability in
CTSA leadership and
community
involvement.
● The organization needs
to have collaborative
leadership among
administrators and
community members.
● The organization needs
to understand the role
of CTSA
administrators in the
CTSA organization.
● The organization needs
to set the goal of
community member
involvement at the
CTSA.
● The organization needs
to have a community
advisory board and
community
engagement.
48
Conceptual Framework: The Interaction of Stakeholders’ Knowledge and Motivation and
the Organizational Context
The purpose of a conceptual framework is to understand various components presented
through literature reviews, theoretical frameworks, and personal experiences that shape
designing and conducting a research study (Maxwell, 2013). The research approaches taken,
combined with theoretical constructs and personal experiences, bring forth an interactive
conceptual framework. This framework justifies considering a particular research method and
why it is significant to build upon what is known about the issue (Merriam & Tisdell, 2016).
According to Maxwell (2013), designing research does not begin with the research questions.
Research questions are centered around the interactive conceptual framework of amalgamating
new concepts or thoughts that existing theories and prior data reveal to the researcher (Maxwell,
2013). While each influencer identified in the tables is independent, they do not stand in
isolation from each other. The following figure will demonstrate how the stakeholders’
knowledge and motivations interact with the organizational cultural models and settings.
Figure 1
Organizational Change Conceptual Framework
49
The researcher’s organizational goal is that by 2025, the ten Western CTSA program
cores will systematically include and integrate community members into all phases of the
translational research process. CTSA administrators will be integral to increasing community
member participation in the CTSAs by integrating community input in all program cores. The
arrow pointing down shows the organization’s and stakeholder’s relationship to the interactive
conceptual framework regarding the cultural model and settings and the stakeholder knowledge
and motivations. In the organizational context, the cultural model is to have stakeholders
understand the critical role of professional accountability with CTSA administrators in
integrating community member involvement in a CTSA. The organization needs to also bear in
mind that a community advisory board and community engagement core exist to include
community members in biomedical research. Throughout the conceptual framework, the
organization needs to have collaborative leadership that interacts with the CTSA administrators’
knowledge and motivations. Within the organizational context, the knowledge and motivational
influences interact with each other, supporting the infrastructure of creating an opportunity for
CTSA administrators to facilitate community involvement and for community members to
engage at the Western CTSA proactively. As shown in Figure A, the stakeholders’ knowledge
and motivational influences demonstrate the relationship of CTSA administrators and
community members’ attitudes and behaviors in approaching how the facilitation of community
involvement will be approached in the Western CTSA. Generating an inventory of needs and
assets is integral in creating a baseline of knowledge from CTSA administrators. The knowledge
and motivational influences interaction are also key to bidirectional learning, allowing CTSA
administrators to learn and recognize the significance of the absence of community input that
may compromise clinical research effectiveness (Paberzs et al., 2014).
50
The goal of mastering involvement of community members in the cultural setting should
have CTSA leadership support, and enable the opportunity to engage community members in the
world of biomedical research (Paberzs et al., 2014). Motivation from all parties to support and
expand the existing infrastructure for community involvement at a CTSA is strongly desired.
Because many communities underrepresented in research and burdened by health disparities feel
intimidated by research, the stakeholder knowledge and motivational influences set up the CTSA
infrastructure to create an opportunity (and access) for all stakeholder groups to successfully
integrate community members in the clinical and translational research process. The conceptual
framework presented will help to unpack both the interactive knowledge and motivational
influences within the organizational context and how the facilitation and integration of
community members across the Western CTSA may help strengthen and advance clinical and
translational research.
Conclusion
Chapter One covered the need to build capacity and increase community member
participation in the Western CTSA by looking into the organization’s knowledge and skill,
motivation, and organizational resources. Chapter Two focused on the literature that covered the
underrepresentation of community members in research, the current infrastructure in academic
medical centers, and the CTSA administrator’s role in addressing this study’s problem of
practice. An explanation of the knowledge, motivation, and organizational influences was also
discussed to understand the conceptual framework used to conduct this study. Chapter Three will
discuss the research methodology that will be used to engage the stakeholders of focus (CTSA
administrators) who will be integral in supporting the efforts of involving community members
in the Western CTSA. Part of the research approach will include conducting interviews with
51
CTSA administrators to obtain feedback and insights to their abilities and willingness to
integrate community members at the Western CTSA.
52
CHAPTER THREE: METHODS
The purpose of this study was to assess the existing CTSA leadership capacity of the
Western CTSA regarding the goal of increasing and integrating community input into the
research process. Additionally, this study was conducted to understand the feasibility of
increasing community member involvement at the Western CTSA and the current needs and
assets in knowledge and skill, motivation, and organizational resources with CTSA
administrators.
Participating Stakeholders
CTSA administrators in this study were critical to achieving the overall organizational
goal of having CTSA core programs integrate community members in the Western CTSA.
Therefore, the population of focus consisted of CTSA administrators from the western region of
the United States. The goal of interviewing CTSA administrators was to obtain feedback that
would generate data that would speak to the innovative possibility of increasing community
participation in all ten CTSA core programs and one executive leadership to learn and analyze
how that specific integration would look at the Western CTSA and build capacity.
CTSA Administrator Interview Sampling Criteria and Rationale
The criteria used to recruit CTSA administrators was that one had to have the ability to
influence decisions for their specific core program. By definition, the participating stakeholder
for CTSA administrators comprised either director-level or senior-level administrators for each
core program. Recruitment for CTSA administrators to participate in this study came from an
existing roster of senior leadership from each core program at the Western CTSA.
Must have some knowledge of community engagement and involvement in the
CTSAs. The purpose of this study was to understand if the CTSA administrator knew or had
experience in how to integrate community input into the clinical and translational research
53
process. To facilitate community input in each core program, CTSA administrators needed to
understand the vulnerabilities of working with the community by having the knowledge and
experience to make this an attainable effort confidently. The stakeholder group was expected to
have a good sense of community engagement or community involvement at the CTSAs.
Must have some knowledge of clinical health research. CTSA administrators were
expected to have some knowledge of clinical health research to communicate health issues with
the community and facilitate the process of involving community members to gain their input in
the Western CTSA. The stakeholder group needed to understand the type of research that the
CTSAs support to understand their role in helping integrate community input at the CTSAs.
Must already have some familiarity with the Western CTSA. CTSA administrators
needed to have some understanding of what the Western CTSA is. Because CTSA administrators
play a crucial role in increasing community involvement at the Western CTSA, knowing what
would be feasible to implement to facilitate community member involvement needed to be
drawn from CTSA administrators' experiences.
CTSA Administrator Interview Sampling (Recruitment) Strategy and Rationale
Merriam and Tisdell (2016) saw nonprobability sampling as the best method for most
qualitative research. Thus, purposeful sampling (a non-probability sample selected based on
characteristics of a population and the objective of the study) was used to conduct interviews for
this research. This preferred method was the criteria set forth to recruit specific members of the
CTSA. This sort of purposeful sampling was one that “reflects the average person, situation, or
instance of the phenomenon of interest” (Merriam & Tisdell, 2016, p. 97). Typical purposeful
sampling was appropriate here. This study aimed to uncover the knowledge and motivation
influences for CTSA administrators to facilitate and integrate community members in the
CTSAs.
54
Western CTSA’s composition includes one hundred fifty (150) staff members from ten
(10) research core programs. A sample size of ten (10) senior CTSA administrators from each
core program and one (1) executive leader were recruited for an interview. Therefore, a total of
eleven (11) administrators were recruited for an interview.
Data Collection and Instrumentation
All participants were asked to sign a consent form to participate in the interviews. All
participants received a general information sheet about the purpose of this study and the meaning
of their participation. Thoughtful questions were asked in face-to-face and virtual sessions where
each participant made meaning from questions asked in their way (see Appendix A). For
example, conceptual knowledge questions included CTSA administrators' perspectives on what
clinical and translational research is and the need for community members to be involved in it, if
necessary. Procedural knowledge questions regarding how to facilitate the integration of
community members into the Western CTSA included questions about essential factors that
would support CTSA administrators to perform this task. Metacognitive knowledge questions
included self-reflection on understanding their biases. Some motivation questions included the
need for CTSA administrators to see the utility value of having community members in the
Western CTSA and feel confident in their ability to communicate and train CTSA staff on model
practices to build relationships with community members. The organization questions about the
cultural model for the Western CTSA were related to leadership and collaboration. Questions
related to the organization cultural setting included their role at the CTSA, the ideal environment
for community members, and a community advisory board and community engagement core
infrastructure.
Eleven (11) in-person interviews were conducted with CTSA administrators who
represented core programs at the Western CTSA. These interviewees were interpersonal
55
encounters in which the researcher established a rapport with the person interviewed (Johnson &
Christensen, 2015). Prior to the interview, the researcher spent some time reviewing each
interviewees' background to know who they were on a personal level and what they represented
in a professional setting at the Western CTSA. The recorded interviews were transcribed after
each meeting. The researcher maintained control of the conversation and kept the interview
focused. At times, the researcher utilized probes and follow-up questions to gain clarity and
depth of responses. After the interview, the researcher reviewed the interview notes and
recordings to check for quality and completeness.
Data Analysis
Analyzing the interviews began with the data collection phase. The researcher was
diligent in writing analytic memos after each interview. The researcher documented emergent
thoughts and theories, concerns, and initial conclusions about the data concerning the conceptual
framework and research questions. All data collected from the interviews were transcribed and
coded through the qualitative analysis software program, Atlas.ti. During the first phase of
analysis, open coding was used to identify empirical codes and in applying a priori codes from
the conceptual framework. The second phase of analysis was conducted where empirical and a
priori codes were aggregated into analytic/axial codes. The third phase of data analysis involved
identifying pattern codes and themes that emerged in relation to the conceptual framework and
research questions.
Credibility and Trustworthiness
Increasing and maintaining the credibility and trustworthiness of this study include the
implementation of the following:
1. Reflexivity, and
2. Member checking.
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Reflexivity was defined as how the researcher affected the research process (Merriam &
Tisdell, 2016) and is frequently referred to in the literature as researcher bias (Maxwell, 2013).
Pure objectivity on the researcher’s part was illusory since the researcher is part of the
organization. Maxwell (2013) specified that integrity, more than indifference, was the true bearer
of validity. Consequently, the researcher detailed assumptions, worldviews, biases, theoretical
orientation, and relationship to the study that affected the research (Merriam & Tisdell, 2016).
The researcher had the background knowledge regarding the Western CTSA that enhanced the
overall understanding of where interviewees from the study were drawing experiences and
expertise. Using reflexivity, the researcher’s perspectives of what a community is and what their
purpose would be at the Western CTSA brought forth an additional layer of perspective that may
not have been generally understood by CTSA administrators who have never worked with the
community.
Reflexivity was vital for the researcher, CTSA administrators, and the people involved in
the research. Given the various perceptions towards involving and integrating community
members in the clinical and translational research process, the researcher had to be reflective on
how data was collected and how people responded to those involved in the interviews (Bogdan
& Biklen, 2007). Any biases that emerged from the study were noted. Key informants were
those experienced with community stakeholders who were very knowledgeable about the
community’s behavior.
Member checking was used to solicit feedback about data and conclusions from the people
studied (Maxell, 2013, p.126). Member checking allowed the researcher involved in the study to
adjust and/or adapt to processes that helped improve the administration of the interviews and ask
pertinent questions that helped answer the research questions (Merriam & Tisdell, 2016). Thus,
probing questions were asked to triangulate some of the responses provided from the present
57
interview. Member checking ensured the transcripts' accuracy that has been recorded and
transcribed during the interviews. Lastly, the pseudonym chosen to conduct this study was
carefully chosen, given that the researcher did not want to reveal any hints as to which CTSA
institution conducted this study.
Ethics
The researcher for this study was a project manager for one of the Western CTSA cores
but was also a community advocate to ensure voices were included in the biomedical research
process. As the principal investigator, the researcher led the effort to recruit human participants,
conducted interviews, and collected data and data analysis to address the aforementioned
research questions. All recruited participants were provided with an information sheet to
understand their participation in the study. The researcher made participants aware that they
could walk away from the study at any given point in time. Any confidential information
obtained from them would be destroyed accordingly or stored in a locked cabinet for simple data
collection (Glesne, 2011). The researcher ensured and protected each participant's privacy rights
by obtaining permission from participants that the session was being recorded (Glesne, 2011).
Limitations and Delimitations
This study's limitations included CTSA administrators having different domains of
practices, possessing different vocabulary, instrumentation, and norms of how they view
community member participation in biomedical research. Because of their varied experiences
and practices, some CTSA administrators had more experience with the community members
than others. Their exposure to community members could have biased their responses to the
interview questions as opposed to those with no experience with the community who were not
able to provide any reflective anecdotes. Additionally, the interviews relied on self-report; it is
also possible that respondents may have had some hesitations or reservations in responding to all
58
the questions due to the level of their position and how their responses may be perceived, even if
it was anonymous. This data was also collected through a single type of research method; a
qualitative method through interviews.
Delimitations were the decisions the researcher made that brought forth implications for
the study. Some of those delimitations included collecting data solely from CTSA administrators
and not from community members or research scientists outside the CTSA. Therefore,
perspectives on how to increase community involvement and build capacity at the Western
CTSA was limited to solely CTSA administrators' views. The CTSA administrators interviewed
were all from the same institution, given the limited access to other CTSA administrators outside
the Western CTSA. Thus, this small sample is also not representative of the views and
perspectives of sixty-two (62) CTSA institutions.
Lastly, this study began with in-person interviews, but due to the COVID-19 pandemic, a
majority of the interviews had to be conducted virtually which could have impacted the way in
which interviewees responded to the researcher’s questions.
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CHAPTER FOUR: RESULTS AND FINDINGS
Purpose of the Project and Questions
The purpose of this study was to assess the existing leadership capacity of the Western
CTSA regarding the goal of increasing and integrating community members into the research
process. This study aimed to understand the current needs and assets in knowledge and skill,
motivation, and organizational resources. The analysis began by generating a list of possible
needs and examining these systems to focus on actual or validated needs. The overall analysis
focused on the recruited CTSA administrators, and as such, this study investigated the following
research questions:
1. What are the Western CTSA leadership knowledge and motivation needs and assets
regarding the increase and integration of increasing and integrating community members
into the Western CTSA research processes?
2. What are the organizational needs and assets regarding integrating community
members into the Western CTSA research processes?
Participating Stakeholders
Key participating stakeholders in this study were eleven (11) senior CTSA
administrators. Of the eleven (11) individuals interviewed, ten (10) (91%) were senior
administrations from specific core programs, and 1 (9%) held an executive-level position. This
study aimed to collect a sample of senior administrators at a CTSA. These senior administrators
demonstrated the ability to make important decisions for their respective programs and influence
the institute's operations that would be key to understanding their capabilities to support
community participation in a CTSA. Key influences included assessing the areas of knowledge
and skill, motivation, and organization resources necessary for senior administrators to build
capacity and increase community involvement in the Western CTSA.
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Table 5 provides an overview of the participants, including a pseudonym to preserve each
core group representative's confidentiality, years of professional experience at the Western
CTSA, years of experience working with community members, their job title, and how
participants identified themselves. Years of experience at the Western CTSA ranged from two
(2) to 10 years, and the years of experience they had in working with community members
ranged from zero (0) to thirty (30) years. As seen in Table 5, experience working with
community members varied considerably with seven (7) having no years of experience, one
administrator having two (2) years of experience, and one administrator having 30 years of
experience.
CTSA administrators interviewed for this study have academic training in various
disciplines. For example, some CTSA administrators were medical doctors trained as urologists
or pulmonologists with minimal experience working with the lay community apart from patients
they see in the clinic. Other CTSA administrators were academic researchers who studied basic
science in a lab, finance managers, or public health researchers with sporadic experience
working in the community.
Table 5
Participating Western CTSA Core Representatives Sample Demographics
Pseudonym
Years at the
Western
CTSA
Years of Experience
Working with Community
Members
Participant
Job Title
Formal
Training and
Discipline
Pseudonym
Andrea 8 0 Director
Urologist
Barry 4 0 Director
Pulmonologist
Chelsea 9 0 Director
Physiology
David 4 0 Director
Neuroscience
Eva 10 30 Director
Gerontology
Frank 2 0 Director
Business
Administration
Grace 4 2 Director
Global Health
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Henry 9 0 Director
Business
Administration
Ingrid 10 1 Director
Infectious
Disease
Jason 10 5 Director
Otolaryngology
Kate 10 0 Director
Public Health
Results and Findings
This section reports on the interviews' results and findings related to the research
questions and the conceptual framework, with a focus on knowledge, motivation, and
organization influences. A summary of prevailing themes and observations made within each
type of influence will be discussed followed by a summary from each influence type.
Research Question 1
What are the Western CTSA leadership knowledge and motivation needs and assets for
increasing and integrating community members into the Western CTSA research processes?
Knowledge
This section discusses results from the interviews related to the conceptual, procedural,
and metacognitive knowledge regarding building capacity for community integration at the
Western CTSA.
Conceptual knowledge related to the needs and assets of CTSA Administrators. In general,
CTSA administrators needed to learn how to implement ways to integrate community members
into each CTSA core program to increase community member participation in research. There
was a need to provide CTSA administrators with a community-partnered participatory research
framework to increase buy-in from peer administrators regarding the improvement and
sustainability of community members' integration into the Western CTSA. The interviews
revealed disparate goals among each CTSA administrator regarding community members’
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inclusion and input into the Western CTSA. Additionally, there was a desire to provide more
opportunities and exposure to CTSA administrators to work with community members and
create co-learning and shared spaces. In this section, the areas of knowledge influences that will
be discussed further in detail will be related to education and lack of understanding, perspectives
and expectations and clinical trials.
Overall, all CTSA administrators (11 participants) interviewed shared that they have
some knowledge about community members' needs and assets. Still, very few opportunities exist
within the CTSA for any bidirectional learning between community members and CTSA
administrators. Given that the term “community” is a broadly used term between CTSA
administrators and community members, all 11 (100%) administrators felt education was
necessary to help community members understand medical and scientific terms, such as clinical
trials. Clinical trials require community participation and the need to offer educational
opportunities for “members of the community to increase competencies in participating in
research.” The following sections will provide:
● Further insights into the needs and assets for education.
● CTSA administrators’ perspectives and expectations of community members.
● The importance of community understanding of clinical research and clinical trials.
Education. Eleven (11) (100%) participants mentioned education as core to the needs and
assets of CTSA administrators in understanding how to integrate community members and build
capacity at the Western CTSA. As it relates to education, nine (9) out of eleven (11) (82%)
CTSA administrators felt there was a lack of knowledge regarding what was defined as a
community member and specifically "who" would be the community member that should
participate in research. Additionally, CTSA administrators did not know the history of
community involvement in research and did not know whether they should expect community
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members to understand the research scope fully. CTSA administrators did not have the
edification or understanding of any impact that community members have contributed to the
research process. The interview showed that eight (8) out of nine (9) participants (73%) agreed
that there was a need to coalesce perspectives and expectations between researchers and
community members.
The Western CTSA is an organization born into a profusion of acronyms. Instinctively,
education comes with the need to understand the CTSA administrators' terminology and how
community members interpret or understand them and vice versa. The interviews revealed that
seven (7) out of eleven (11) (64%) of participants felt a need to understand the community’s
health literacy before involving them in research relevant to community health issues and needs.
Grace stated:
We utilize community members to be the voice of our clinical studies and make sure that
we’re representing them accurately and we can make any changes to our study
procedures or to our materials based on their feedback from experience and health
literacy.
Grace also shared that community voices are essential in clinical trials because they were meant
to inform the research community about specific diagnostics or therapeutics that would
eventually go back into the community. Still, community input and feedback depended on how
well-informed the community member was.
Findings in this study showed that all eleven (11) (100%) CTSA administrators felt
education was important with regards to the level of understanding that the community has
regarding clinical trials (a fundamental CTSA mission). Further, the need to offer community
members educational opportunities to increase biomedical research and translational science
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competencies was considered to be imperative, yet the “how” and “who” will be educated was
still unclear for CTSA administrators. For example, Henry shared:
… there has always been a belief that communities are not very open to try clinical trials
and so now with community members being concerned about immigration issues and
things like that, we need to emphasize how researchers can help them and we would be a
part of that educational and facilitation process.
Here, Henry openly acknowledged that more education in the community was needed to
understand a clinical trial and the importance of clinical research. As noted in the literature, this
is significantly more important for communities of color, who have trouble trusting traditional
institutions, let alone research institutions. All CTSA administrators were fundamentally aware
of the lack of trust between community members, research institutions, and researchers. If the
Western CTSA had unlimited resources, much of it would be invested to provide adequate
education to a large community population.
CTSA Administrators’ perspectives and expectations. The interviews revealed that seven
(7) out of eleven (11) (73%) participants felt academics with advanced degrees had very different
worldview perspectives than that of a typical layperson in the community, given their extensive
training and knowledge about specific community health issues. However, CTSA administrators
felt that there was an opportunity for community members to offer a beneficially refreshing and
new perspective as community domain experts that may be integral to advancing clinical and
translational science and build capacity for community involvement. Barry shared:
So there’s all this work of really understanding who your learner population is to be able
to design something that’s aligned with their expectation and not only yours.
In order to be effective and impactful in designing a training, David also shared:
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… there are different approaches and I think if you really wanted to engage the
community, you have to think about what city or size we are going to focus on and
perhaps look for ways of engagement from the grassroots… as you formulate and
conceive ideas.
Barry and David did not know how to design appropriate education materials that would resonate
with community members. Both administrators understood that involving community members
in the beginning stages of developing educational materials would lead to stronger relationships
and understanding between community members and research institutions.
The interviews have also revealed that nine (9) out of eleven (11) (82%) CTSA
administrators hoped to gain perspectives on how community members have been hurt by
research. CTSA administrators shared that they were conscious about making ethical and
sensible decisions on how they would approach participatory and community-engaged research,
let alone involve them in the research process. This finding validated the need to understand the
complexities and intricacies related to the needs and assets of CTSA administrators to guide how
to engage community members so they may provide input on research program priorities,
strategic planning, and reviews for pilot grant funding. Thus, currently, CTSA administrators do
not have the adequate knowledge to involve community members at the Western CTSA.
Clinical Trials. This study found that eight (8) out of eleven (11) (73%) participants saw
clinical trials as a critical asset to translational research. Community members are relied upon to
participate in this process to support researchers in finding solutions to specific health-related
issues. However, recruitment for clinical trials required the need to meet a particular criterion of
eligibility before participating. For example, a clinical trial studying a rare disease may need
patients with that rare disease and no other co-occurring diseases. When very few community
66
members participate in this trial that meets this eligibility criteria, the effectiveness of the clinical
trial in translational research diminishes.
This study also found that eight (8) out of eleven (11) (73%) participants felt that there
were varying degrees of perspectives and expectations from community members and found it
challenging to understand where community members would best fit at the Western CTSA. For
example, Ingrid shared:
And I think a patient advocate can bring a certain perspective, they are obviously a
community member, but I think that community members are broader than patient
advocates. So, I think that having an understanding of the value of that input is important.
Ingrid expressed how CTSA administrators and community members each define community
members and patient advocates; their terms were not necessarily synonymous. Ingrid revealed in
her interview that there may be a dictionary of definitions that need to be defined between the
Western CTSA and community members to have a candid conversation about specific health
research areas. However, the challenge was that even if terms were defined between both groups,
the interpretation level was also dependent upon the individual’s values, perspectives, and
general understanding.
Respondents from the interviews conducted showed that seven (7) out of eleven (11)
(73%) agreed there was a need to address perspectives and expectations between CTSA
administrators and community members to cultivate a process to learn about the community’s
needs and assets continuously. A majority of CTSA administrators did not have the appropriate
experience or perspectives regarding community needs and assets. With education came an
understanding of community’s terminology. For example, Andrea expressed:
Of the research lifecycle, everything from identifying the needs of our local community
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members, what needs to be researched and what kinds of knowledge needs to be
understood and developed and researched all the way through recruitment, how to adapt
participant recruitment plan, there comes a need to understand culturally and
linguistically terminology.
Eva would agree with this statement in saying that:
We spend so much time building capacity of community members to be good partners
and the research one-on-one training helps them understand research methodology and
terminology in hopes to demystify and address misperceptions about clinical trials.
Both Andrea and Eva agreed that they had the knowledge to educate both CTSA administrators
and community members regarding the importance of community involvement (especially as it
relates to clinical trials and clinical research). Further, it was vital to understand what type of
educational opportunities should be offered to help peer CTSA administrators and community
members increase their biomedical research competencies. CTSA administrators needed to
improve the community's perspectives on biomedical research and provide practical training that
would lead to realistic expectations and outcomes in building community capacity.
Metacognitive knowledge including self-reflection and understanding one’s biases.
In this section, the areas of knowledge influences that are discussed further in detail are related to
the CTSA administrator's challenges and limited knowledge related to community engagement
towards increasing the community value of research and benefit.
Challenges and limitations. Western CTSA administrators self-reflected on adapting
their ways to think and operate according to their awareness of cognition and cognitive
processes. Additionally, CTSA administrators reflected on multiple layers of community
participation issues in the biomedical and translational research processes. The higher-order
thinking process that allowed CTSA administrators to have awareness and control over their
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cognitive processes was key to understanding the CTSA administrators’ way of processing
information. All CTSA eleven (11) (100%) administrators felt some challenges existed for, and
they had limited knowledge of, integrating community members in the process, let alone
building capacity within the institute. However, they reflected on what they needed to hear from
the community to move forward in an effective way that would be feasible and sustainable. For
example, significant limitations prevented the advancement of community integration in the
Western CTSA from being accomplished. Grace stated:
Sometimes community members will tell you something that you may not have the
resources for or that it may be too difficult to do. Like you’re always trying to do more
with less, and we need the expertise and the experience in implementation with the
community who has a lot of theoretical and academic knowledge.
Grace reflected how she could not meet the community's needs and demands due to her limited
education about the community and resource availability. She reflected on the importance of
having experienced individuals who knew how to implement community members' involvement
in a scientific environment with sensitive, theoretical and academic understanding. Kate reflected
on her knowledge and definition of community:
Defining the communities and what levels of community you’re going to be engaging in
and how you do so is a challenge. So is it health organizations in the community, or is it
business organizations?
Kate felt that a need for additional training and education that would benefit both CTSA
administrators and community members existed. Kate echoed some of the similar sentiments
from other CTSA administrators. Most CTSA administrators found it beneficial to identify
someone who understood community values and relevance and integrate them into the Western
CTSA in a culturally competent way. Further, most CTSA administrators reflected on how
69
research institutions may not value community input due to their limited knowledge about the
purpose of involving them in the first place. This lack of knowledge appeared to be an
impediment to involving community members within the Western CTSA.
Frank stated:
Everybody comes from different levels of knowledge and you have to train individuals to
a certain aptitude and level. This gets lost when you create mass training programs and
the biggest challenge is how do you cater to community members who may care deeply
about a certain research issue, and how do you get them to train at a certain level when
people are coming from different takes on research.
As previously mentioned as an asset, the results in this study showed that eight (8) out of eleven
(11) (73%) CTSA administrators felt perspectives and expectations were vital to understanding
various views from community members, researchers, and administrators. CTSA administrators
reflected on their perception of the community and whether they felt confident that they would
obtain objectivity from a community population. CTSA administrators did not have an intricate
understanding of community motivations to participate in biomedical research. CTSA
administrators also did not have the metacognition to approach a representative group to
encourage them to participate in the biomedical research process. CTSA administrators self-
reflected on their roles as administrators and the perspectives and expectations towards how they
would facilitate community involvement at the CTSA. A majority of CTSA administrators do
not have the metacognition to facilitate community involvement in the Western CTSA
effectively. They recognized that their background training was within defined areas of
discipline, and working to facilitate and integrate community members in clinical and
translational research was not their strength. Thus, receiving expert advice and training from the
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community appeared necessary for CTSA administrators to understand how to create community
involvement opportunities and increase community members' participation to build capacity.
Community engagement and recruitment. This study showed that all eleven 11 (100%)
CTSA administrators reflected on their own self-bias and felt a need to address community
engagement and community recruitment efforts related to their understanding of community
involvement and historical harm caused against the community. CTSA administrators doubted
that the distrust between research institutions and community members had been dispelled, and
CTSA administrators did not want to contribute to the community's existing distrust. CTSA
administrators reflected on how they have personally involved community members within their
research core program and if they genuinely valued community input. Two (2) out of eleven (11)
(18%) of CTSA administrators felt they would still struggle with seeing the value of community
input in providing feedback to scientific content if they were not formally trained in
understanding sensitive community health issues and other health research areas. Although some
CTSA administrators had made an effort to engage community members in the research process,
these programs' sustainability was called into question given the core leaders’ hesitation of how
valuable their contribution indeed was in the process. CTSA administrators stated they were
looking for evidence of best practices that would convince them that involving community
members had been successful in the past and had significantly impacted biomedical research
outcomes. By doing this, CTSA administrators would have the ability to effectively engage
community members by understanding what a useful mode of communication for the
dissemination of pertinent information to the community would be. As an example, Barry
described this opportunity as the following:
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To disseminate research results and community recruitment materials, we want to make
sure they are engaged to help us tailor the different graphics and different languages in
our materials and publications to align with the community values.
Barry reflected on how community recruitment in clinical trials and reviewing clinical research
protocols were crucial components of the Western CTSA. All eleven (11) (100%) CTSA
administrators acknowledged that community voices were missing in the research process in
light of the number of clinical trials that failed because of community recruitment issues. By
having active community members and partners involved and integrated into the research
process, CTSA administrators needed the metacognition to develop the cultural sensitivity and
experience to understand the value and benefit of community perspectives and be held
accountable for communicating research successes, challenges, and expectations.
Knowledge regarding how to facilitate the integration of community members into
the Western CTSA. CTSA administrators did not know how to integrate community members
at the Western CTSA optimally. Learning how to facilitate community members' integration into
the Western CTSA was a critical factor to assess. All eleven (11) (100%) of CTSA
administrators reflected that training, education, community members' involvement/engagement,
the process, and structure were critical components to supporting community involvement in
biomedical research. In this section, the areas of knowledge influences discussed relate to CTSA
administrators’ and community members' bidirectional involvement. This includes the
integration and input connected to the CTSA infrastructure and innovative processes to integrate
CTSA administrators about access and resources available to facilitate the effort of integrating
CTSA administrators and building capacity.
Bidirectional involvement and communication of CTSA administrators and community
members. A common theme across all eleven (11) (100%) CTSA administrators was the need to
72
involve community members without having them feel as though CTSA administrators and
research institutions were being intrusive or perceived as insensitive due to the distrust issues
that have been previously mentioned. Equally important, CTSA administrators reflected that
community members should be involved in every level of research, and lay language should be
used in every form of communication to make it feasible for community members to partake in
the biomedical research process. Ingrid shared:
I like the possibility of having people self-affiliate, you know, to have content from our
website or from our communication team that’s generated maybe in the form of a
monthly newsletter that goes to the community and maybe in the education forum held
once a year.
Here Ingrid had the perspective that communicating with community members could be
achieved by public information made accessible online to those interested in participating in the
research process. Because ten (10) out of eleven (11) (91%) CTSA administrators felt
communication was a vital component to begin to learn who in the community was interested in
being a part of the CTSA process, the website seemed to be an apparent platform choice. David
added:
The CTSA could provide that kind of a triage, you know, organization of the website of
how we can make it attractive and engaging for community members to learn about what
we’re doing.
Grace also shared:
The community can understand your content and can use it to both from a technological
standpoint and from like a usefulness standpoint, like, do they actually like the format.
Do they think it helps them or are they like, I don’t care about this? This is not relevant
73
to me or I don’t understand this, either from a health literacy or numeracy level and so
on.
In the above statements, David and Grace shared that CTSA administrators had research
priorities known on a public website where community members can choose to get involved or
not, depending on what resonated with the individual potentially seeking to get involved at the
Western CTSA. Yet, this did not mean that the CTSA did not prioritize areas of research that
concern the community, given that one of the missions of the Western CTSA was to engage the
community and obtain input. David and Grace validated that there was some form of reciprocity
through online communication with community members.
Community integration and input within the CTSA infrastructure. Some CTSA
administrators were not aware of how to contribute to the logistical design to integrate
community members into the Western CTSA and build capacity. However, eight (8) out of
eleven (11) (73%) shared that structuring community members' integration and input into the
CTSA poses some challenges related to the community’s willingness to be involved in the
biomedical research process. CTSA administrators have not developed the proper competency to
contribute to this process of designing and facilitating community integration at the Western
CTSA but reflected on possible ideas that could support some infrastructure. For example, one
CTSA administrator felt community members could serve as a “pool of interested individuals
who are willing to participate in the biomedical research process.” In contrast, there would be
minimal need to recruit individuals who may not find any excitement to participate in the
biomedical research process, even though they may fit the criteria of what was necessary for
community input at the CTSA. Therefore, CTSA administrators were willing to use what they
knew as a launching point for creating infrastructure. Still, a majority expressed the need to see
some evidence-based literature regarding successful models. Jason shared:
74
One of the biggest challenges in the leadership structure's ability across our core directors
is to have the bandwidth to support these efforts involving community members and
building capacity….It’s almost not an attitude thing but practical implementation and
bandwidth needs to be considered within the CTSA infrastructure.
Jason reflected on his thoughts on the staffing issue that the Western CTSA had run into, given
the core leadership’s limited bandwidth to do more beyond their role. If CTSA administrators
were not required to work with the community, the opportunity to gain additional training or
knowledge regarding community participation in biomedical research would not present itself.
He further explained that asking staff to support community integration would be related to
metacognitively understanding the feasibility and implementation strategies instead of the
leadership’s attitude of whether they have the capacity and ability to integrate community
members as part of their core program.
If staffing needs were addressed to integrate community members into the Western
CTSA, then priority alignment between the Western CTSA and community members would
need to be achieved. CTSA administrators felt they should prioritize research needs and work
with community members to self-identify research areas that they thought were important. This
would lead to a process that may work for CTSA administrators who have minimal knowledge,
training, and capacity to add additional responsibilities to their existing roles if community
involvement was not part of their job description. Grace elaborated, stating:
I wish we had more of a regular and concerted effort in integrating the community. It
seems like we sort of go into these ad hoc pockets of like activity within the community
but that’s not the best practice. I feel like we need to have them be equal partners in every
step of the process and want to gain their trust.
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Grace felt that not all CTSA leaders knew how to communicate articulately with appropriate lay
language with the community members. For the most part, CTSA administrators relied on the
community engagement core program, and a group called the “community advisory board” to
serve as the institute’s community liaison. Community advisory boards (aka CABs) exist under
the Western CTSA community engagement (CE) core program. The staff within this core recruit
community members to serve as a CAB member for each of the existing core programs within
the Western CTSA. CABs serve as the best advocates to liaise between CTSA administrators and
community members, which in turn potentially addressed the leadership’s limited bandwidth and
knowledge of working with community members.
Process and innovation related to access and resources. All eleven (11) (100%) CTSA
administrators had the ability to generate ideas of innovatively integrating community members
into the biomedical research process and build capacity. For example, most CTSA administrators
were aware of the Community Reviewer Training Program pilot project, and community
members were involved in reviewing scientific grant applications. CTSA administrators
conceptualized how this program could grow where community members would be allowed to
practice how they looked at scientific grants objectively. Ingrid shared:
As an example, if community members want to see more research done in cancer, we can
put them in that review panel where they can self-assess their motivations and enthusiasm
in looking at a proposal and ensure they are being objective in the process.
In the above statement, Ingrid reflected on an innovative process to involve community members
in the biomedical research process. Still, she also expressed the difficulty for community
members to remain objective in looking at scientific content and providing feedback without
being influenced by their own bias – which was also a struggle that academic grant reviewers
have to endure. Reviewing multiple grant applications took time to understand how to provide
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appropriate input in research adequately. CTSA administrators have not reached a level of
understanding for what would be considered a best practice for how they would integrate
community members into the grant review process.
Further, CTSA administrators needed to be aware of their own bias when prioritizing
research areas that first and foremost addresses the Western CTSA’s research mission. CTSA
administrators are empowered to set research priorities at the Western CTSA and understood that
these should be considered carefully before integrating community members into the Western
CTSA. The Western CTSA is a federally funded research institution that needed to address the
parent grant institution's priorities related to community engagement in research. However, a
majority of senior CTSA administrators did not know how to align CTSA priorities with those of
community members. CTSA administrators needed further understanding of why not all health-
related issues affecting the community can be addressed under the current grant funding structure
at the Western CTSA.
Barry shared some of his knowledge regarding what was feasible to do within the
Western CTSA and what needed to be aligned with CTSA priorities. The CTSA “does not go off
track in solving the entire world’s problems due to limited access and resources.” As such, it was
essential to note that seven (7) out of eleven (11) (64%) CTSA administrators reflected on their
concerns about limited access and resources for developing the process to involve community
members within the Western CTSA. Although the core leadership was willing to share and
listen to innovative ideas to integrate community members within the Western CTSA, it was also
imperative to understand that it would cost money to build capacity. CTSA administrators did
not have the knowledge to develop a program within their specific administrative limits. Henry
stated:
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If we had a lot more money, we would have an army of people working directly with the
community to educate folks about clinical research and help people understand more
about how clinical researchers can help support them.
Henry shared his knowledge about how money can enable the CTSA administrators to do many
things to support community members' integration in the CTSA, including sustaining their
efforts and involvement. Henry understood that the Western CTSA would need standing
resources to cultivate ideas and resources to ensure that community contribution in the CTSA
and integrating them was realistic and sustainable, leading to tangible impact and outcomes.
Finally, the “buy-in” process from all CTSA administrators to commit to integrating
community members into the Western CTSA was critical to assess. Although all CTSA
administrators shared their knowledge regarding the significance of community involvement at
the Western CTSA, there was still hesitation related to integrating and partnering with
community members. For example, two (2) out of eleven (11) (18%) felt there might be some
partnership and trust issues between the Western CTSA as a research institution and community
members. Additionally, three (3) out of eleven (11) (27%) still had some uncertainty with
integrating community members into the Western CTSA, which could deter the possibility of
building capacity. Ingrid shared:
… there would need to be an advocate, somebody whose job it was to make sure this
happened and not you know oh let’s just add this to the checklist of all the other things
we’re supposed to be doing. So we would have to agree as an institute that this is an
important initiative and that we would need to put aside some dedicated funding that
would be used only for this purpose.
Ingrid shared her knowledge that there had to be some form of institutional agreement with
funding to support this effort to make a statement that the Western CTSA was serious about
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integrating community members into the Western CTSA. Overall, community input was viewed
valuable in the organizational structure. Without the full support of the Western CTSA
leadership, community involvement would remain an idea that could not be fully realized
without a 100% commitment from all core CTSA administrators.
Motivation
Two motivational influences were explored in this dissertation: utility value and self-
efficacy.
Utility Value. In this study, the researcher learned that CTSA administrators were
motivated to rally behind the effort of integrating community members into the CTSA by
ensuring there was appropriate alignment between CTSA goals and community goals. CTSA
administrators were also motivated to ensure CTSA priorities were transparent to the community
to engage the proper audience for a specific research area (e.g., cancer projects that affect many
people). As Andrea stated:
There is so much breadth of knowledge and people broadly exposed to a lot of exciting
research and many interesting types of people and have many different interests in
science in general. Yet it is a challenge to bring so many disciplines and community
members with so many different perspectives into the same room and align everyone
with a similar goal.
Andrea expressed the benefit of having various perspectives and viewpoints assembled to
understand the CTSA's research mission. Still, there was a need to implement strategies to ensure
differing views and goals were aligned somehow. Additionally, Barry stated:
The key thing is prioritization and finding alignments of areas where there’s a greatest
impact. And I think without that there will be a lot of great ideas, people will feel spread
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thin and so I’m a bit afraid of you know where things may not come into fruition because
people all have their own kind of motivation …
In this study, seven (7) out of eleven (11) (64%) CTSA administrators felt that the impact that
community members would make by being integrated into the research institution must be
valued and considered carefully. In the above statement, Barry was motivated to support the
integration of community members into the CTSA as long as the CTSA prioritized and aligned
goals that would continue to be efficient and effective for both administrators and community
members to produce the most significant impact in biomedical research. Chelsea shared:
We just don’t have the workforce to do everything, but if we are going to be successful at
integrating community members into the CTSA, we should start to see the impact of
community involvement from the past 10 years in the next five years and see how the
community has really helped us go forward.
Based on Chelsea’s and Barry’s statements, both administrators had very disparate
perspectives and motivations on the “what” and “how” to prioritize and align CTSA goals with
community members. Barry was interested in having the CTSA administrators prioritize
scientific efforts first and for community members to partake in these priorities. In turn, Chelsea
felt that the community should help set the priority and agenda by analyzing the impact of
community involvement at the CTSA and to go from there.
Barry denoted that administrators had limited bandwidth. To be successful at building
capacity for community members at the CTSA, the institute should build on what already existed
and align priorities from community members to CTSA goals. On the other hand, Chelsea
viewed the community as champions for information. She felt community members would offer
valuable input to researchers, leading to successful outcomes in addressing essential health issues
in the community. Both administrators were advocating for a particular process. Regardless of
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which direction CTSA administrators chose to go with, such efforts would require administrators
to possess the “mastery goal” of understanding and master what was expected of them in an
academic-community research environment. Thus, CTSA administrators needed to make a
conscious effort to grow from this process and self-improve if they contemplated how they could
fully support community members' integration into the CTSA and build capacity.
Self-efficacy. When CTSA administrators were asked, “How confident do you feel in
your ability to integrate community participation into specific aspects of the CTSA and within
your core program,” the responses the researcher received were mixed. Overall, seven (7)
administrators reported low self-efficacy and four reported feeling confident they could integrate
community members. Four (4) out of eleven (11) administrators (36%) had low self-efficacy
because they had no direct experience with the community and did not feel confident in
integrating community members due to their minimal knowledge of how to do so. Three (3) out
of eleven (11) (27%) had low self-efficacy to integrate community members into the Western
CTSA and preferred to defer to their respective core teams to perform this task.
Notably, some CTSA administrators with less experience working with the community
felt more confident to integrate community members into the Western CTSA than those with
more experience. Part of the reason appears to be related to their line of profession as it relates
to public speaking to a general audience (e.g., speaking at a scientific community, conferences,
etc.). For example, Ingrid had one (1) year of experience working with the community but
reported feeling confident she could integrate community members. Ingrid’s background is in
infectious diseases, and she has ten (10) years of experience at the Western CTSA. Ingrid shared:
I think my confidence level is mixed. I think that if I have a team that we have now, and
someone whose role it is to identify the participants and guide me into the best practices
for communication and evaluation, I think I’m fairly confident.
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Ingrid has the ability to articulate and communicate scientific findings to a general audience and
felt confident in supporting the community integration process by speaking to the community.
However, given that community involvement is not her direct area of expertise, she would prefer
to defer the process of integrating community members into the CTSA to a team with the
appropriate skills to do so. Ingrid felt comfortable relying on the team to guide her in providing
best practices for communication and evaluation to be able to support the efforts of integrating
community members at the Western CTSA.
On the other hand, Henry had no experience working with the community but felt
confident in providing the financial support to integrate community members into the Western
CTSA and support this type of integration. He has been with the Western CTSA for nine (9)
years. Henry shared:
I feel pretty confident in being able to integrate community members through the
financial aspect of it. We’ve invested a lot in the community engagement group and so
we are expanding and I am certain we will be putting a lot of effort and resources into the
community engagement efforts.
Henry felt very confident in being able to support the integration of community members into the
Western CTSA given his knowledge of how much the community engagement core has
expanded and how more resources will be made available to this group to continue to support the
current ongoing efforts with the community.
Chelsea has never worked directly with the community in her current role, but she felt
confident in integrating community members at the Western CTSA, given that she has direct
experience working with non-English speaking community members. Chelsea has been with the
Western CTSA for nine (9) years. Chelsea shared:
I speak Spanish fluently. I have that natural ability to connect with any Hispanic
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community, and I think that’s a big strength of mine.
Chelsea felt very confident in integrating community members into the Western CTSA given her
communication ability to speak Spanish to a predominantly Hispanic / Latinx community that
the Western CTSA served. During the interview, Chelsea demonstrated a deep interest in
encouraging communities of color to participate in research. Although her current role does not
allow her to work with the community directly, she feels empowered and confident that she can
contribute to integrating more community members to partake in the biomedical research
process.
Research Question 2
What are the organizational needs and assets regarding integrating community members
into the Western CTSA research processes?
Organizational influences
Professional accountability in CTSA leadership and community involvement. This study
revealed that CTSA administrators understood that they were accountable for their ability to
support the process of integrating community members in the Western CTSA and accomplish the
organizational goal of building capacity. Two themes related to professional accountability
emerged: the role of leadership and cultural sensitivity.
Leadership. Ten (10) out of eleven (11) 91% of CTSA administrators saw leadership as
a key indicator of professional accountability to ensure the fulfillment of community integration
in the Western CTSA. As shown in Figure B, four (4) out of eleven (11) (36%) of CTSA
administrators (leaders of their core program) felt confident in working with the community
directly. One (1) of them relied on their staff to execute the integration process. Given each
administrator’s unique background in education, experience, and leadership training, all have
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different perspectives on how the community should be approached. As an example, Barry
stated:
We either have to change the way we communicate as scientists or how we involve the
community in meeting settings. I just think when we have a meeting, it has to be a good
experience for everyone. So that comes from leaders understanding where their input is
most relevant and valuable.
Barry expressed his awareness of the community member’s time and if their time spent alongside
scientists was worthwhile and reciprocated. A leader needed to possess the ability to understand
how to best work with community members to ensure the experience was not only enjoyable but
productive. Another approach to leadership was echoed by Ingrid, who stated:
You probably need leadership that would have some familiarity with the role and the
scientific literature on engaging diverse stakeholders… You need leaders who highly
value collaboration.
Ingrid’s servant leadership style differed from Barry’s transactional leadership style. Ingrid had a
greater understanding of the breadth it took for a leader to fully embrace community members'
opportunity to engage in the biomedical research process. Both Barry and Ingrid have different
experiences and perspectives on engaging community members. Barry preferred to organize
community member involvement by engaging them in particular research areas or the research
processes as to how the organization would see appropriate. Ingrid felt a leader needed to take
risks to see what may transpire. This type of leadership from the Western CTSA needed to come
from a well-rounded, well-trained administrative individual prepared to work with a diverse
community. Andrea also shared:
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…just motivating people to do something new, you have to get great authority figures to
encourage the effort and the reasoning behind doing it and then, hopefully, people will
follow along.
Andrea recognized that CTSA administrators, in good faith, would like to see community
members involved in the biomedical research process. However, not all CTSA administrators
were equipped to try something new given their existing responsibilities and limited
understanding of the definition of community and who to engage. A prominent figure from the
organization would need to emphasize the importance of integrating community members into
the Western CTSA and encouraging a collaborative effort towards this goal. Other CTSA
administrators expressed their willingness to try something new as long as there was a form of
monitoring to keep each CTSA administrator accountable to the integration process. Jason
candidly shared:
I’ve come to understand the importance of work being done in the community. My job is
to understand it from the experts and help lead with a lot of input into the strategic
development and then implement and monitor and then make sure we’re setting an
objective goal to understand whether it is working or not and during course corrections.
CTSA administrators expressed their different leadership styles, but Jason was able to best
monitor this process of integrating community members by reflecting on his own experiences
and growth areas to learn from experts about community values and input in biomedical
research. Jason’s optimism and willingness to learn about community member values seemed to
naturally invite opportunities to understand how to integrate them into the Western CTSA.
Cultural Sensitivity. Two (2) out of eleven (11) (18%) CTSA administrators felt the
need to address general cultural sensitivity from community members and CTSA administrators.
To uphold professional accountability, CTSA administrators needed to understand cultural
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sensitivity and diverse language, perspectives, and experiences to ensure that CTSA
administrators were finding ways to be inclusive in engaging the community through a
thoughtful process. Henry shared:
I think the challenge is going to be that every community has very different cultures and
has a different way of communicating. We have to make sure they (CTSA
administrators) are trained to be able to be sensitive to all of the different cultures and not
just within a specific community.
CTSA administrators felt they should have the professional accountability to navigate and
address the challenges that their peer administrators may face when faced with unfamiliar
territories of specific communities, and learn how to engage them appropriately at the CTSA.
For example, they should have ongoing conversations about things happening in the community
or events to stay current. In the current environment ongoing discussions related to the
coronavirus would be a topic of concern that many community members may link to, specifically
in communities of color which the virus has gravely impacted.
A CTSA administrator with a breadth of knowledge and exposure to different
communities emerged in this study, commenting on what CTSA administrators' roles may look
like if given the opportunity to serve as champions for involving community members CTSA. As
it relates to leadership, Henry agreed with Ingrid’s earlier statement sharing:
I would think that to be effective, the leadership has to be aware to have the
understanding and experience in working with communities. We have to be sensitive and
open to different cultures because we’re catering to a diverse community as well. To have
direct experience is something that I think would also help make a leader stay informed…
Not all CTSA administrators had the experience of working with the community. However,
Henry recognized that a leader with professional accountability and direct experience in the
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community would be most effective in integrating community members at the CTSA and
building capacity. Similar to what Barry had expressed regarding engaging the community
concerning a leader’s perspective, Eva shared a sentiment regarding discomfort on both sides of
the administrator and community:
Someone in the community, their understanding of research is different than a scientist. I
meant that if we put them alongside a scientist and they feel completely overwhelmed
and may feel scientists are just talking at them. Then it’s hard for them to have a voice
and use that voice.
Here, Eva lamented that scientists needed to make sure they didn't just talk to community
members. Still, they also needed to serve as a good partner and be open to bidirectional learning
and understanding of one’s background and participation. CTSA administrators should carry out
professional accountability to help scientists recognize the value in having the community
participate in research, not just in clinical trials. Eva shared that confidence was necessary for
community members to have a voice in the process. CTSA administrators can help scientists
learn how to be sensitive to not “overpower” or “undermine” the purpose of having community
members integrated into the biomedical research process.
Collaborative leadership among CTSA administrators and community members. A
majority of CTSA administrators felt they could lead and facilitate collaborations between
community members and CTSA administrators. There were three key themes identified in
collaborative leadership: partnership and trust, culture, and diversity.
Building partnership and trust. Nine (9) out of eleven (11) (82%) felt establishing a
strong partnership and trust with the community would be instrumental in facilitating the process
of involving community members in biomedical research. As explained in Chapter 2, when
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researchers interview community members and do not report back on their research findings, it
has resulted in distrust. Frank openly shared:
I lived in a region where people organize. Community members are so invested and
deeply involved, and they walk the university bell and feel like they were betrayed you
know if they feel like it’s self-serving for PI’s to come in and then leave. PI’s need to
own this misstep and change that.
Frank gravely understood the ramification of leaving communities hurt and disillusioned when
they hear scientific study results through different, conflicting sources. This emboldens the
distrust between community members and research institutions. A few CTSA administrators
shared that the lack of bandwidth to disseminate results has been partly to blame. As Frank stated
above, many community members were invested in their community. Research institutions were
responsible for carrying out a true research partnership with the community, which meant going
back to the community and updating them on research results. On the upside, Eva shared some
positive ways to build relationships and partnerships with the community:
The nice thing about community relationships is that once you start developing trust, we
get out there and it becomes easier to develop more relationships even with COVID right
now.
Eva’s decades of experience working in the community and passion for building relationships to
ensure community voices were heard was revealed in research. Because of her background, she
has the experience to amplify the research cause and gain the community’s trust based on her
track record of success in supporting the community, regardless of their culture or background.
Eva added:
We know partnerships will continue to evolve, some more intensive than others, but the
ones that are probably most beneficial or are the ones where shared values and needs are
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communicated, where you can sort of align what we’re trying to do with what they are
trying to accomplish.
Eva had a thorough understanding of how relationships and partnerships could change or evolve
and was aware of how to navigate best and channel these relationships to ensure they last and not
falter from possibly poor communication.
A majority of CTSA administrators mentioned the importance of partnerships with
foundations and organizations to work with the community. One key theme that recurred among
CTSA administrators (and will be further discussed in this study) was the need for a Community
Advisory Board (CAB). Community Advisory Boards are members of the community who were
provided a stipend to serve as a liaison between the community and research institutions. They
served as a critical partner to research and served as key community members to create a bridge
between research institutions and community organizations.
Cultural competency. In this study, eight (8) out of eleven (11) (73%) CTSA
administrators felt that working with different ethnic cultures should be considered carefully
before approaching any engagement with the community. Additionally, seven (7) out of eleven
(11) (64%) felt the need to understand that diverse populations go hand in hand with
understanding the different cultures that exist within the community. If the CTSA was to engage
the community in helping make decisions at the Western CTSA or provide an opportunity for
input in biomedical research, careful consideration and selection of who would represent
community voices in the CTSA depended on the critical areas of research that the CTSA
prioritized (e.g., engage cancer patients or advocates to provide input on cancer-related research).
The CTSA community engagement core hires community research ambassadors who are
individuals directly from the community. Specifically, the Western CTSA has hired Latinx
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descent individuals to address predominant health issues in a largely Latinx community. Grace
shared:
There are specific nuances in cultures and people might have some cultural competency,
but more training is always good for people to be culturally competent across all different
backgrounds, socioeconomic levels, ages, geographical regions, religion etc.
Grace felt that it was important for people who plan to work in the community to have cultural
competency training or cultural sensitivity training to be mindful when reaching out to
community members. Such activity needed to be grounded on evidence-based literature, with
substantial outcomes. Individuals trained on cultural competency and applying what they learned
into the community as a general practice is appropriate but defining metrics to ensure the
effectiveness of the cultural competency skills developed is also important. Barry also shared:
I think cultural training is always helpful and understanding things that are unsaid or are
helpful like, I don’t want to say something and then someone will say in the open later
that I didn’t know what I was really talking about.
In the above statement, Barry added that communicating with different cultures was vital. How
CTSA administrators speak and understand each diverse culture in the community was necessary
to prevent research institutions from being viewed as naïve to the community’s current
economic, religious or cultural situation. However, given the depth and breadth of cultures in a
diverse community, it was challenging to try to self-train oneself on the “how-to” work with the
community when social and economic issues continue to evolve in the United States.
Role of CTSA administrators in the CTSA Organization. CTSA administrators play a
crucial role in creating a cultural model for including community input at the CTSA’s. CTSA
administrators need to know their role and expand it to create an infrastructure involving
community members. For example, CTSA administrators who understood their role in the CTSA
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would have the ability to build community capacity with the existing community engagement
core and community advisory board. To integrate community members and build capacity at the
Western CTSA, CTSA administrators felt they needed to first be familiar with the fundamentals
of community integration at a CTSA and understand if there were promising models that existed
on what this type of integration would look like and how effective it was as it relates to
advancing biomedical research. Challenges existed in terms of how community involvement
could occur at a CTSA. For example, Jason shared:
It makes more sense to have something where we have been successful at which rather
than on hearing what the community wants to have done, we have a KL2 program that
provides community mentorship and is a good avenue because many of the people we
train in the institute are learning how to work with the community.
As previously mentioned in this dissertation, Jason reaffirmed that CTSA administrators would
feel more confident in deferring to have staff members work directly with community members
given their inexperience with the “how-to” integrate them in biomedical research. Like having a
community engagement core representing the CTSA in the community and serving as the liaison
to community members, Jason also emphasized a scholarship program called the “KL2
program,” where clinician-scientists are trained to work with the community. Again, this was a
form of deferring senior CTSA administrators' role to those who were more available,
experienced and trained in this particular area.
Community advisory boards and community engagement. All eleven (11) (100%)
CTSA administrators were familiar with the community engagement core's role or knew they
existed. Additionally, six (6) out of eleven (11) (55%) were familiar with the role of the
community advisory board, which was a group of employed community members hired under
the community engagement core. Several CTSA administrators were familiar with CABs and
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have partnered with the community engagement core on specific projects related to community
involvement. As an example, Ingrid shared:
Our community engagement core is primarily focused on engaging communities and
questions of research interests that impact that community more so than just engaging
community members in the evaluation or conduct of general research. We have that
capacity that’s built in, but we haven’t necessarily operationalized that across the
different groups...
Ingrid’s statement validated the statements above regarding the CAB’s involvement and how
CTSA administrators preferred to either work with them as an opportunity to work with
community members or to defer any community-related activities to the community engagement
core to facilitate. In this case, Ingrid shared how they were able to work with the community
engagement core to accomplish a study they were conducting to understand how to involve
community members in evaluating grant applications. The community engagement core was the
liaison to the community in helping Ingrid’s program recruit individuals interested in providing
input to scientific grant applications. Further, Barry also shared his experience in working with
the community engagement core as it relates to recruiting for clinical trials:
The partnership with my core and the community engagement team has helped fill in the
void we have experienced in recruiting community members in clinical trials.
Barry found that partnering with the community engagement core supported his effort to identify
community members to participate in clinical trials. This “core-to-core” partnership was a
bidirectional learning opportunity given each core’s common aspect of involving community
members in research and for both core administrators to lead in this process's facilitation.
However, not all felt that they had an opportunity to work with the community engagement team.
David shared the sentiment of his general concerns and thoughts about community engagement:
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This overall concept is still hard for me to understand because I don’t fully understand
what the community engagement structure looks like and how we can integrate
community members and build that capacity.
David’s perspective with community engagement was inadequate given his limited interactions
with the community engagement core and the community in general. David’s direct role and
responsibility were towards drug development and regulatory science and thus had no link, given
his position, to work directly with the community. Yet, David shared during his interview that
he was willing to be trained on how his specific core could integrate community members if an
opportunity did arise.
Community advisory boards (CAB). There were mixed thoughts and feelings regarding
the utilization of a community advisory board (CAB) at the CTSA. Six (6) out of eleven (11)
(55%) of CTSA administrators valued having a CAB at the Western CTSA. CABs create an
efficient and supportive infrastructure to accelerate the translation of promising clinical practices
and innovations into community settings. However, at the Western CTSA, the inner workings
were still not entirely understood based on the interviews conducted in this study. Kate’s
familiarity of a CAB was described as such:
There are several community advisory boards or formats used to listen to the community
about their issues about health and research, biomedical research, and community-
engaged in particular types of research. There are engaged community interactions in
which the CTSA’s work to educate communities and persons involved in health aspects
of the communities about research …
Kate did not work directly with community members, given that her role was strictly related to
research program management at the Western CTSA. Having a CAB for her program core was
not entirely necessary, but she was open to ideas and ways to work more intimately with the
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community if an opportunity arose. She did not provide any concrete examples, but she did feel
detached from the actual community needs. She was only familiar with community needs based
on research that researchers presented to her. Eva further explained the current status quo of the
CAB at the CTSA:
So we got to get back to those community advisory groups and figure out what that
model looks like. We had one big group that was pretty disconnected from our CTSA
activities in the past. And then, we tried to move towards having smaller groups attached
to each core program. And it didn’t move forward. And so I think it’s probably doing a
post-part mortem on that and saying what worked and what didn’t work.
Eva was the most experienced in working with different CAB groups at the CTSA and further
explained during her interview the staffing struggle she had encountered in ensuring that the
process of hiring and partnering CABs with program cores did not reach its full potential. Eva
found it challenging to launch and sustain a smaller CAB group, but she felt that having one was
still essential at the Western CTSA. Jason expressed a differing perspective on how the CABs
could be utilized in the future, given that the current CAB model was not working well. Jason
shared an innovative thought concerning a form of a community advisory board:
I think we need something that in academia, we would call an academy. So you’re
recognized as a qualified community mentor with a good track record.... We set up
community advisory boards for different projects, but I think we need to have a sort of a
pool of people that we can engage with by bringing them together at regular intervals and
discussing how they can better provide input...
Jason presented a different outlook on how the CAB could be restructured by having a
“community mentor” trained to be a useful research ally to the Western CTSA. Here, Jason
recognized the value of having the community contribute to the biomedical research process and
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science in general by having a pool of trained community members for a particular research area
of interest. This pool would serve as a way to avoid overextending the Western CTSA’s reach
into the community, especially in unfamiliar places, until more CTSA leaders were well-
equipped and adept at understanding a practical approach to work with these unknown
community territories.
Goal of community member involvement at the Western CTSA. The Western CTSA
aspired to enhance research projects' rigor and the research processes by having community input
at the Western CTSA core program. This study showed that community input into the
biomedical research process at the CTSA was still low and staggered across all CTSA core
programs. The goals of community member involvement varied from program sustainability,
ongoing support, and policy.
Sustainability. As addressed earlier in this chapter, funding was vital to sustaining
community involvement at the Western CTSA. Currently, the Western CTSA funds the
community engagement core and CAB, but to advance community involvement across the other
program cores, this required dedicated funding. Ingrid elaborated on this point:
I think we need dedicated funding. So we would have to agree as an institute that this is
an important initiative and that we would need to put aside some dedicated funding that
would be used only for this purpose.
Although dedicated funding was key to sustaining the community engagement and CAB efforts
at the Western CTSA, ongoing communication and messaging of the roles and purpose for both
CTSA administrators and community members must be clear. Also, when changes occur or
community engagement needs to become critical for a specific research study, CTSA
administrators must prepare a way to approach the community in a manner that is open and
culturally sensitive in a given population. Barry emphasized sustainability as below:
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Sustainability comes down to sustained connection, articulation of the purpose, and that
has to be constant because of some of the stuff that is not exciting. And then, you have to
continually tell them why you are doing something and appreciate their involvement,
especially if they are having a hard time putting food on the table for their family.
CTSA leadership needed to understand that although the goal was to involve community
members in the CTSA and sustain an established relationship with community members and
organizations, specific individuals have different priorities apart from a research institution.
Barry affirmed that to maintain a relationship with the community, the CTSA needed to
compensate the community adequately for their time. Additionally, David shared:
We have to truly understand the purpose of the community engagement core and the
existing engagements. For sustainability to be built, biomedical research work must be
built into the core structure like community engagement.
David suggested that ongoing engagement needed to remain housed in the community
engagement core. They were the primary liaison and representatives of the CTSA for the
community—trying to integrate them into other CTSA core programs still deemed ambitious and
not yet sustainable. However, there were opportunities to build capacity within existing
infrastructures, such as the community engagement core.
Support. This study revealed some hesitations that CTSA administrators had regarding
supporting the idea of community integration across all core programs at the CTSA.
Confounding factors included but were not limited to their knowledge around best practices for
involving community members in a research institution, which centered around the impact and
outcome of the community’s involvement that could lead to advancing biomedical research.
Optimistically, Henry shared:
96
I personally have not been in a community engagement training, but I think that working
with our community engagement very closely has helped me understand the activities
they do. My work through our different programs and our staff has helped me understand
how we can support these different groups.
Henry’s perspective of community involvement at the Western CTSA had been peripheral. Still,
he generally understood the community engagement program's critical activities and why they do
the work they do. As an example, although there was no tangible evidence yet of the impact of
involving community members across all CTSA core programs, there was evidence of successes
in the community where the Western CTSA had been engaged and had been able to report a
research impact. One example is the support that the Western CTSA provides to fund pilot
studies that directly impact the community. To bring this school of thought to full circle, Jason
shared:
One of our highest priorities is to mature from an organization where we’ve supported
good research… We need to show that we’re having a bigger impact and demonstrate
these impacts in our community so that the needs for community input become more
apparent to understand.
Jason alluded to the idea that the ongoing assessment of the work that the CTSA did in
partnership with the community needed to be validated somehow. However, validation would
not be a standard evaluation criterion given that each situation that would involve the community
would be different. Thus, an ongoing assessment of the work conducted to support community
input integration in the CTSA would occur on a case-by-case basis. Successful findings from the
assessments on the impact of community integration would eventually translate into policy.
Policy. Translating research efforts into policy has been a great challenge at the Western
CTSA. For example, the Western CTSA provided pilot funding to research investigators. The
97
time it took to influence or create any form of institutional or governmental policy changes
across the translational spectrum took several years to accomplish. As mentioned above, five (5)
out of eleven (11) (45%) CTSA administrators felt confident that the integration of community
members at the CTSA would influence any future potential policy changes. As an example,
Jason expressed:
As a team, we have a community engagement group and people outside this core who are
doing a lot of work in the community. However, we are still trying to understand the
impact that we are making and we don’t have any real strengths and haven’t emphasized
policy to people yet. We ask the university what we could be doing better as a CTSA to
lead and invest in the people as it relates to research, but I think we need to find a
community partner and university partners at the very least so they can teach us and work
with us on how to get to the mayor’s office, how to get DC and other organizations to
influence policy changes.
Jason expressed that there were vague areas that the CTSA was still trying to understand and
learn as it relates to the impact of community involvement in the biomedical research process.
Part of the community’s ambiguity in the research process was the scarce models of integrating
community members in the CTSA’S. Small-scale successes were based on activities that the
community engagement core and CABs have accomplished by partnering with community
organizations and research investigators involved in population research. In general, the
overarching impact in making policy changes at a generalizable level is still unknown.
Moreover, Grace also shared:
The bureaucracy at a CTSA is very high, and from talking to other colleagues and other
CTSAs members, people have very mixed experiences. There is some level of
bureaucracy at the Western CTSA, but I also think that we have a relative amount of
98
freedom in what we do and how we run our programs as long as we’re adhering to the
policies and guidelines set in place by the university and the organization, so forth.
Grace openly shared that a high level of bureaucracy existed within all CTSA structures and had
a very arduous and specific vetting process to implement a policy change through the research
institution and the local, state, and national levels at-large. However, as Grace mentioned, the
Western CTSA had some freedom to design and run a program that CTSA administrators would
adhere to concerning the policies and guidelines that already exist. Paradoxically, trying to
remain compliant with existing policies while simultaneously changing policies within an
infrastructure may be a challenging task to undertake within itself.
Conclusion
This chapter presented the qualitative study results: interviews of eleven (11) (100%)
CTSA administrators, all of whom were in senior-level positions at the Western CTSA. These
interviews were conducted to help the researcher answer the research questions. The results were
presented with a discussion of the assumed influences, corresponding literature, and conceptual
framework. The findings helped present the participating CTSA administrators' unique
viewpoints and the various needs and potential solutions for CTSA administrators to facilitate
and integrate community members at the Western CTSA and build capacity.
In terms of knowledge and motivation, most CTSA administrators felt they did not have
the adequate knowledge to facilitate the community integration process. CTSA administrators
needed to learn how to implement ways to integrate community members and needed a
community-partnered participatory research framework to begin the buy-in process from peer
administrators to support the need to incorporate community members into the Western CTSA.
Very few opportunities existed for any bidirectional learning for CTSA administrators and
community members. CTSA administrators also had varying perspectives and expectations of
99
community members and needed a more robust understanding of which community to involve
and why. Clinical trials were also identified as a critical asset to translational research. A need
for an honest conversation with the community regarding health issues still needed to take place,
and CTSA administrators required the knowledge to understand challenges that existed in
involving them in research. Part of the discussion also included the need to understand the
differences between patient advocates and community members, given that their roles had
different meanings and contexts in research.
In terms of metacognition, CTSA administrators needed to self-reflect and understand
their self-biases. Part of this self-reflection included the need to recognize challenges and
limitations in their cognitive process regarding community participation issues and how their
bias could inflict the way they conduct or facilitate community integration at the Western CTSA.
CTSA administrators need some form of immersion training in the community to understand the
community better and create an infrastructure for building community capacity at the Western
CTSA. Acquiring tools to communicate to community members appropriately was key to
integrating them at the Western CTSA. Community integration and input within the CTSA
infrastructure were surrounded by challenges such as CTSA administrators not having the
competency to contribute to the design to facilitate community integration. However, CTSA
administrators could create an innovative process to develop evidence-based resources to
facilitate the current infrastructure change and ensure community involvement at the Western
CTSA.
In terms of organization influences, professional accountability in CTSA leadership and
community involvement centered around the CTSA administrator's ability to lead the community
integration and facilitation efforts by being trained in cultural competency and cultural sensitivity
issues. Leadership in the organization was vital to ensuring the fulfillment of community
100
integration. The leader needed to be confident that one can execute a process of community
members' objective involvement in the Western CTSA. The organization needed to have
cultural competence in understanding diverse languages, perspectives, and experiences to ensure
CTSA administrators found ways to be inclusive and engaging. The organization needed
collaborative leadership among CTSA administrators and community members, encompassing
the need to build partnership and trust and ensure diversity and inclusion.
Chapter 5 will discuss recommendations informed by the validated needs of CTSA
administrators during the interviews, as well as integrate suggestions from the literature and
conceptual framework.
CHAPTER 5: RECOMMENDATIONS
Introduction and Overview
The purpose of this study was to assess the existing leadership capacity of the Western
CTSA regarding the goal of increasing and integrating community members into the research
process. Specifically, this study sought to understand the current needs and assets in knowledge
and skill, motivation, and organizational resources. Chapters One, Two, and Three presented the
problem of integrating community members into the Western CTSA and building capacity. This
chapter discusses the recommended solutions to the identified and validated needs with CTSA
administrators’ ability and capacity to facilitate and integrate community members into the
Western CTSA and build capacity. Implications for practice will also be presented, as well as an
analysis related to the implications for future research.
Recommendation for Practice to Address KMO Influences
The recommendations are organized by the knowledge, motivation, and organizational
needs and assets identified through qualitative data analysis. The tables in each section serve as
an organizer and summarizer of the specific influence, principles from the literature supporting
101
the proposed solution, and a description of the recommended action. For each recommendation,
expected results (indicators and outcomes), behaviors, learning, and reactions are described.
Collectively, the recommendations comprise of the following:
1. Provide an educational training opportunity for CTSA administrators to understand the
definition of community as it relates to creating trust in community and biomedical
research partnership.
2. Provide an opportunity for community members to participate in a listening session to
obtain community members' specific needs and assets.
3. Provide an evidence-based training toolkit on facilitating training to include community
members in the Western CTSA.
4. Provide an overview of the goals of the Western CTSA and subsequent and participatory
training regarding the role of CTSA administrators and community members in the
academic-community research environment.
5. Provide tools and resources to CTSA administrators to recognize the purpose of
integrating and building capacity for community members in the clinical and translational
research process.
6. Establish standing meetings that address organizational policies, procedures, and official
documents.
7. Establish collaborative leadership training for CTSA administrative leaders and all
organization members to support an open-minded culture.
8. Expand the professional development training with CTSA administrators to learn about
the infrastructure and CTSA roles and responsibilities.
9. Provide evidence of successful community involvement models in biomedical research or
demonstrate some benefit that the community has in being a part of the research process.
102
10. Provide training based on an organizational improvement model to build capacity with
the community engagement core and community advisory board to engage, cultivate and
sustain community partners already doing specific biomedical research work in the
community (e.g., foundations, community-based organizations etc.)
Following an overview of recommendations will be a discussion of an implementation and
evaluation plan, informed by Kirkpatrick and Kirkpatrick’s (2016) New World Evaluation
Model, beginning with program outcomes (Level 4), demonstration of adoption of critical
behaviors (Level 3), skill (Level 2) and engagement (Level 1). Specifically, the program
evaluation plan will utilize a Blended Evaluation approach to capture all Four evaluation levels
with a single instrument.
Knowledge Recommendations
Introduction. The knowledge influences in Table 6 represent a complete list of assumed
knowledge influences and were validated based on the most frequently mentioned knowledge
influences to achieving the stakeholders’ goal. The knowledge influences were validated as a gap
(Y) or not (N), and whether the influence is a priority to address to achieve the stakeholders’
goal. Table 6 also shows the recommendations for those validated influences based on theoretical
principles. The following abbreviations indicate knowledge types: (D)eclarative; (P)rocedural;
(M)etacognitive.
Table 6
Summary of Knowledge Influences and Recommendations
Assumed Knowledge
Influence
C = Conceptual
Validated
as a Need?
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
103
P = Procedural
M = Metacognitive
Y =
Validated
N = Not
validated
The Western CTSA
needs to identify the
needs and assets of
community members.
(C)
Y Y Conceptual
knowledge refers
to how basic
elements are
interrelated and
can work
together within
large constructs
(Krathwohl,
2002)
Provide an
educational training
opportunity for
CTSA
administrators to
understand the
definition of
community as it
relates to creating
trust in community
and biomedical
research partnership.
The Western CTSA
needs to self-reflect and
understand one’s biases.
(M)
Y Y Metacognitive
knowledge is the
knowledge and
awareness of
cognition and
has been
described as
Provide a listening
session among
community members
and academics to
understand the
current and existing
104
knowing when
and why of
proceeding with
a task
(Krathwohl,
2002; Rueda,
2011)
dynamics and
relationships.
The Western CTSA
needs to know how to
facilitate the integration
of community members
into the Western CTSA
(P)
Y Y Procedural
knowledge
revolves around
the knowledge
of how to do
something
(Krathwohl,
2002)
Provide an evidence-
based training
toolkit on how to
facilitate a training
on including
community members
in the Western
CTSA.
The Western CTSA needs to identify the needs and assets of community members.
Understanding community members' needs and assets is key to creating a strategy to integrate
community members into the Western CTSA successfully. The recommendation was selected to
address the conceptual knowledge gap by providing educational training for CTSA
administrators on how essential elements (such as understanding what community is) are
interrelated and can work together within large constructs (such as community value in research)
(Krathwohl, 2002). By breaking down the meaning of “community” and sharing this definition
among CTSA administrators is an example of conceptual knowledge. Understanding the
105
meaning of community and various forms and definitions will help CTSA administrators better
strategize and create opportunities to involve and integrate community members into the CTSA.
For example, the current public health crisis of COVID-19 presents an opportunity for
community members and CTSA administrators to create a dialogue around a virus that has
impacted individuals' lives, specifically in vulnerable and underrepresented communities.
Starting a conversation between CTSA administrators and community members on a topic
sensitive to both groups offers a chance to break down barriers, change behaviors on the
perception of research, and address hesitations in working with research institutions. The hope
would be to collectively work together as solution-oriented partners to combat a virus that has
predominantly affected many lives, socially, and economically. Therefore, the recommendation
is to provide an educational training opportunity for CTSA administrators to understand the
definition of community related terminology to creating trust in community and biomedical
research partnership. As demonstrated in Chapter 4, building trust and partnership between
research institutions and community members is necessary. Trust is a critical factor in
developing and maintaining effective collaborations (Dave et al., 2018). Part of the training to
CTSA administrators would include the process of concept mapping, where this mixed-method
approach will allow participants to brainstorm and identify factors that contribute to the concept
of community and describe ways in which those factors relate to building a community of trust
(Kim et al., 2020).
The Western CTSA needs to self-reflect and understand one’s biases. This study’s
findings validated that community engagement is the primary focus of the Western CTSA. The
interrelationship among community members, CTSA administrators, and academic scientists
exists to support the clinical and translational research endeavors. A recommendation was
selected to address this metacognitive knowledge gap: provide a listening session based on
106
strategies to implement such sessions towards an action plan (Jackson et al., 2002). Engaging
community members to provide an inventory of assets about their community can help facilitate
this cultivating relationship between community members and academic researchers. This
suggests that the conceptual knowledge in identifying community members' needs and assets
will help CTSA administrators innovate ways to include community participation in the clinical
and translational research process. Therefore, the recommendation is to provide an opportunity
for community members to participate in a listening session to obtain specific needs and assets of
community members. For example, lay community members have diverse educational
backgrounds, experiences, and perspectives regarding the meaning of research. Community
members are familiar with the significant facts about prevalent diseases affecting them and the
environmental conditions where they live. Understanding the community’s lay terminology may
significantly differ from the scientific community.
CTSA administrators obtaining information from local neighborhoods may help conduct
community needs and community strengths or assets to provide data for health improvement
efforts, identify areas of strength, and leverage these strengths to address academic scientists'
needs or concerns. Further, academic scientists, on the other hand, have advanced degrees and a
very different worldview from a typical layperson in the community, given their extensive
training and knowledge about specific community health issues. Community members may offer
a beneficially refreshing and new perspective as community domain experts that may be integral
to advancing clinical and translational science. Learning about key community assets could help
academic researchers make ethical and sensible decisions on approaching community-engaged
research. CTSA administrators also need to understand what a vulnerable population is and how
they have been excluded from research in the past (e.g., racial/ethnic minority
communities/people living with HIV/AIDS) (Paberzs et a., 2014). Understanding the
107
complexities and intricacies related to community members' needs and assets can guide how to
engage community members best to provide input on research program priorities, strategic
planning, and reviews for pilot funding proposals (Kirschner & Merriënboer, 2013).
The Western CTSA needs to know how to facilitate the integration of community
members into the Western CTSA. Learning how to facilitate community members' integration
into the Western CTSA was a critical factor to assess. A recommendation was grounded in
applied behavior analysis and its application to teaching models and practices (Daly, 2006). As
such, procedural knowledge revolves around knowing how to do something (Krathwohl, 2002).
The knowledge of shared understanding about translational research and standards of what all
stakeholders need to know before participating in the research process will help support what
steps are necessary to integrate community members in the Western CTSA. Therefore, the
recommendation is to provide an evidence-based training toolkit on facilitating training to
include community members in the Western CTSA. In biomedical research, closing the gap
between research and practice has been a priority for many agencies, including the United States
National Institutes of Health, Veterans Health Administration (VHA), and the Agency for
Healthcare Research and Quality (Kilbourne et al., 2007). Kilbourne et al., 2007, has a
framework called the “Replicating Effective Programs (REP) project.” The four key components
of REP deem crucial to implementing effective interventions for facilitating training. The four
key phases include intervention packaging, training, technical assistance, and fidelity assessment.
Motivation Recommendations
Introduction. The motivation influences in Table 7 represent a complete list of assumed
motivation influences and were validated as a gap (Y) or not (N), and whether the influence is a
priority to address to achieve the stakeholders’ goal. Table 7 also shows the recommendations
for those validated influences based on theoretical principles. Also noted were motivation types.
108
As discussed, motivation is the internal, psychological process that gets people going, keeps
them moving, and tells them how much effort to spend on tasks (Pintrich & Schunk, 1996).
Motivation influences revolve around the concepts of choice, persistence, and effort (Clark,
1998; Clark & Estes, 2009; Rueda 2011).
Table 7
Summary of Motivation Influences and Recommendations
Assumed Motivation
Influence
Validated
as a Gap
Yes, No
(V, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendatio
n
CTSA administrators need to
see the value of including
community input in the
Western CTSA.
Y Y Eccles describes
utility value as
facilitating
one’s long-
range goals or
helping obtain
immediate or
long-range
external
rewards.
(Eccles, 2006)
Provide an
overview of the
goals of the
Western CTSA
and subsequent
and participatory
training regarding
the role of
community
members in the
academic-
community
109
research
environment.
CTSA administrators need to
feel confident in their ability
to communicate and train the
CTSA staff on models and
practices to build
relationships with community
and academic partners.
Y Y Self-efficacy is
a belief that,
with effort and
appropriate
support, a goal
is achievable
(Bandura, 1991)
Provide tools and
resources to each
stakeholder group
to fully grasp the
purpose of their
participation in
the clinical and
translational
research process.
The Western CTSA needs to see the value of including community input in the
Western CTSA. Eccles 2006 describes utility value as facilitating one’s long-range goals or
obtaining immediate or long-range external rewards. CTSA administrators found it important to
110
consider where and how CTSA administrators would be involved and build capacity. CTSA
administrators wanted to ensure that goals and priorities were aligned between the Western
CTSA and community members. Given that CTSA administrators were knowledgeable about the
success of including community members in the grant review process and community members
have already gone through the process, CTSA administrators were more motivated to support
this endeavor's ongoing efforts because of the alignment of goals and priorities.
Further, providing an ongoing learning environment for both CTSA administrators and
community members in the grant review process motivates both groups to be active participants
in the grant review process. The utility value is the benefit that comes when CTSA
administrators see the impact of completed grant reviews and how community members were
able to put forth the mental efforts of helping identify health solutions to specific problems due
to their participation in the grant review process. The utility value of CTSA administrators
facilitating this process is the information sharing process with community members and how
their efforts may help research scientists explore areas of research that may not have been
thought of before. The return of investment from involving community members in the Western
CTSA through a process that already exists as a model will support the motivational efforts of
encouraging CTSA administrators to find opportunities to increase community participation and
build capacity within their core program.
CTSA administrators are encouraged to attend meetings where community members are
in action to see how their input in the Western CTSA may help improve or support the
institution's overall health mission. Participation of both CTSA administrators and community
members in the grant review process will inevitably create a bidirectional learning environment
that fulfills this motivational influence. The recommendation, therefore, is to provide an
overview of the goals of the Western CTSA and subsequent and participatory training regarding
111
the role of CTSA administrators and community members in the academic-community research
environment.
The background of the Western CTSA may be perceived as complicated and challenging
to digest for CTSA administrators, especially if they are unfamiliar with community-related
initiatives within the institution. A recommendation is for robust academic-community
participatory training for all CTSA administrators regarding community-related issues to help
CTSA administrators fully comprehend the steps required to communicate and involve
community members. According to Aguinis and Kraiger, 2009, training will have the most
significant impact when bundled with other human resource management practices. Expert
trainers should implement evidence-based training with sound principles and empirical research.
Training provided to community members should be similar to the training employees
take as members of the Western CTSA. Thus, training should be designed so that the learners
(i.e., CTSA administrators) are encouraged to spend as much working-memory capacity relevant
to program operations and not waste resources on functions that may be detrimental to the
learning process (Gerven, P.w.m Van, et al., 2002). Training and professional development are
vital contributors to organizational success and will continue to be so in the foreseeable future
(Martin, 2010). Equipping CTSA administrators with essential information through participatory
training will help increase their competency regarding best practices to involve community
members in the Western CTSA and, in general, support the biomedical research enterprise.
Equally important, sharing the impact the community has on biomedical research brings forth a
way for CTSA administrators to see potential policy changes that support the overall Western
CTSA mission. Part of an organized training may include creating a listening session for CTSA
administrators to learn about community health priorities. By understanding these priorities, the
CTSA administrators can gain a better sense of how to integrate best and increase community
112
member input and build capacity. This sense of training empowerment may lead to productivity
boost, keeping pace with technological advances, meeting competitive pressures, and boosting
team-based decision-making and problem-solving to help CTSA administrators maintain and
sustain community involvement. For any organization, supporting the learning and skill
development will prospectively yield a favorable return on the organization’s training
investments.
Stakeholder groups need to feel confident in their ability to integrate and/or participate
in the clinical and translational research process. Self-efficacy is a belief that, with effort and
appropriate support, a goal is achievable. Bandura’s social cognitive theory (1991) expresses that
self-efficacy is the key to positive outcomes and behaviors that support the successful attainment
of a goal. According to Bandura (1991), self-efficacy is a foundational component of motivation.
This means that unless individuals believe they are capable of the actions, they have little
motivation to start, engage in, or finish the action. Self-efficacy is key to the success of involving
community members at the Western CTSA. CTSA administrators need to feel confident in their
ability to provide bi-directional learning opportunities, including instituting community-
academic partnerships and opportunities to offer or receive input about relevant clinical and
translational research. Therefore, the recommendation is to provide tools and resources to CTSA
administrators to fully grasp the purpose of integrating and building capacity for community
members in the clinical and translational research process, such as implementing an evidence-
based toolkit. The level of confidence in understanding how to facilitate community involvement
in the clinical and translational research process is vital because it can significantly impact their
determination to remain proactive and engaged and have an overall positive experience.
Transferring of knowledge or the “transfer climate” has been conceptualized as
observable or perceived situations in organizations that inhibit or facilitate the use of learned
113
skills (Rouiller & Goldstein, 1993). When trainees perceive a positive transfer climate, they tend
to apply learned competencies more readily on the job (Salas et al., 2006). Part of the tools and
resources that should be made available to CTSA administrators include knowing how to set
goals. Goal setting can have a significant impact on the transfer of knowledge from training into
outcomes. (Grossman & Salas, 2011). Tools and resources can come in the forms of slides,
handouts, manuals, or guides to support delivery to and refinement of a specific program
(Mccabe, et al., 2014). Developing and customizing tools regarding community members'
facilitation into the clinical and translational science institute is key to helping the learners
(stakeholder groups). The best way to provide tools and resources to increase CTSA
administrator's confidence level is to implement an evidence-based toolkit called the Community
Engagement Studio Toolkit developed by the Meharry-Vanderbilt Community Engagement
Research Core at their Clinical and Translational Science Institute. With this toolkit, CTSA
administrators will better understand how to best support the efforts of improving recruitment
and retention for clinical trials and enhance public participation that has been the central
challenges facing clinical research activities today. The Community Engagement Studio toolkit
provides strategies for CTSA administrators to consider as part of their daily work. For example,
CTSA administrators should bear in mind potential opportunities to engage community
members, patients, caregivers, community health providers, advocates, and policymakers
(defining them as community members) in their specific research core. The Community
Engagement Studio provides a framework for CTSA administrators to create an infrastructure to
involve community members in giving feedback on specific areas of concern before a research
project is implemented or assists a struggling project if necessary, at the Western CTSA (Joosten,
2015).
114
Organization Recommendations
Introduction. The organizational influence in Table 8 represents the complete list of
assumed organizational influences and whether they were validated as a gap (Y) or not (N), and
whether the influence is a priority to address in order to achieve the stakeholders’ goal. Table 8
also shows the recommendations for those validated influences based on theoretical principles.
Clark and Estes (2008) suggest that organization and stakeholder goals are often not achieved
due to a lack of resources, usually time and money, and stakeholder goals are not aligned with its
mission and goals. Gallimore and Goldenberg (2001) propose two constructs about culture –
cultural models or the observable beliefs and values shared by individuals in groups, cultural
models, or the settings and activities in which performance occurs. Thus, both resources and
processes and cultural models and settings must align throughout the organization’s structure to
achieve the mission and goals. Table 8 also shows the recommendations for these influences
based on theoretical principles.
Table 8
Summary of Organization Influences and Recommendations
Assumed Organization
Influence
Validated
as a Gap
Yes, High
Probability,
No
(V, N)
Priority
Yes, No
(Y, N)
Principle
and Citation
Context-Specific
Recommendation
115
The organization needs to
have professional
accountability in CTSA
leadership and community
involvement (cultural model)
Y Y Cultural
models:
cultural
practices in
the
organization
that are
practices and
shared mental
schema
enacted by
employees
(Gallimore &
Goldenberg
(2001).
Managers
will enact
those
practices
related to
inquiry that
are practiced
with them. If
Establish standing
meetings that addresses
(as necessary)
organizational policies,
procedures and official
documents.
116
inquiry is
valued by
their bosses
(through
actions),
managers will
engage in
those
behaviors and
expect them
of others.
The organization needs to
have collaborative leadership
among CTSA administrators
and community members
(cultural model).
Y Y Cultural
models:
cultural
practices in
the
organization
that are
practices and
shared mental
schema
enacted by
employees
Establish collaborative
leadership trainings for
leaders and members of
the organization to
support an open-minded
culture within the
organization.
117
(Gallimore &
Goldenberg
(2001).
Managers
will enact
those
practices
related to
inquiry that
are practiced
with them. If
inquiry is
valued by
their bosses
(through
actions),
managers will
engage in
those
behaviors and
expect them
of others.
118
The organization needs to
understand the role of CTSA
administrators in the CTSA
organization (cultural model)
Y Y Cultural
models:
cultural
practices in
the
organization
that are
practices and
shared mental
schema
enacted by
employees
(Gallimore &
Goldenberg
(2001).
Managers
will enact
those
practices
related to
inquiry that
are practiced
with them. If
Expand professional
development trainings
to learning about the
CTSA infrastructure and
CTSA roles and
responsibilities.
119
inquiry is
valued by
their bosses
(through
actions),
managers will
engage in
those
behaviors and
expect them
of others.
The organization needs to set
the goal of community
member involvement at the
CTSA (cultural setting)
Y Y Cultural
settings are
visible,
concrete
manifestation
s of cultural
models that
appear within
activity
settings
(Rueda,
2011).
Provide evidence of
successful models of
community involvement
in biomedical research.
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The organization needs to
have a community advisory
board and community
engagement (cultural setting)
Y Y Cultural
settings are
visible,
concrete
manifestation
s of cultural
models that
appear within
activity
settings
(Rueda,
2011).
Provide a training on
how to build capacity
with the community
engagement core and
community advisory
board.
The organization needs to have professional accountability in CTSA leadership and
community involvement. The type of CTSA administrative leadership installed within the
organization plays a crucial role in supporting the integration of community involvement at a
CTSA. Accountable leadership that focuses on the development of internal accountability should
be implemented at the Western CTSA. Internal accountability is defined as coherence and
alignment among individuals’ conceptions of what they are responsible for and how, collective
expectations at the organizational level, and how people within the organization account for what
they do (Elmore, 2005). A recommendation here is grounded in the organization's cultural
practices that are practices and shared mental schema enacted by employees (Gallimore &
Goldenberg (2001). Clark and Estes (2008) contend that organizational policies and practices
must align with their goals. As such, the organization needs to provide engaging and consistent
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communication around policies, procedures, and official documents to keep the organization
accountable for improving how CTSA administrators facilitate the integration of community
members' involvement. The recommendation, therefore, is to establish standing meetings that
address (as necessary) organizational policies, procedures, and official documents. By having
standing meetings to review important policies and procedures, the CTSA administrators and
members of the organization will be equipped to respond to specific issues at hand and refer to
what has been set forth to ensure community members' involvement in biomedical research.
There is an abundance of complimentary literature frameworks that can help CTSA
administrators understand vital relationships in an organizational setting (Burke, 2005; Firestone
& Shipps, 2005; Romzek & Dubnick, 1987). Emanuel & Emanuel (1996) described
accountability as the “procedures and processes by which one party justifies and takes
responsibility for its activities.” In contrast, Burke (2005) defines accountability as the
contractual relationship between a director and a provider, where the provider is held responsible
for providing service and reaching specific goals. Thus, hierarchical professional accountability
for community input can be established. Administrative rules that guide specific tasks and
implementing a community involvement program could be placed on the CTSA administrators.
Since CTSA administrators play an essential role in shaping both the CTSA administrators’ and
community members’ behaviors and attitudes to integrate community involvement in the
Western CTSA, both members of these groups need to partake in the sphere of professional
accountability.
The organization needs to have collaborative leadership among CTSA administrators
and community members. The study currently revealed that 45% of CTSA administrators (as it
relates to policy) indicated that the organization does not currently engage in the direction where
change needs to occur (i.e., more CTSA administrators should be more involved in community-
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related activities). For example, CTSA administrators who practice a culture of inquiry bring
forth engaged members of an organization who may enable members to become open-minded
and behave towards a shared vision (Dowd, 2005). Yet, regardless of how much a CTSA
administrative leader provides an opportunity for career or training events to keep the
organization flexible to changes, some individuals are comfortable with the status quo and are
resistant to change. A recommendation here is grounded in the Western CTSA's cultural
practices and shared mental schema enacted by employees (Gallimore & Goldenberg (2001).
Knowles (1980), in a seminal work on leadership, posited that leaders could advance an
organization’s effectiveness by clarifying the connection between the call to action that members
can adopt. The recommendation is to establish collaborative leadership training for CTSA
administrative leaders and all organization members to support an open-minded culture. For
example, a survey could be disseminated to request input on specific areas that need
improvement regarding facilitating community involvement. Feedback provided would be
anonymous, allowing members to express their opinions candidly.
Bugg and Dewey (1934) characterized open-mindedness as one’s attitude of being
“hospitable.” Hospitability would mean to be playful and not cling to individual ideas but to
release the mind to play over and around ideas. Additionally, open-mindedness includes
engaging CTSA administrative leaders and followers in ongoing communication, which is
essential in initiating an organization's flexibility (Clark & Estes, 2004). The performance of
diverse teams is affected by member openness to experience and the extent to which team reward
structure emphasizes intragroup differences (Homan et al., 2008). Research has shown that
transparency depends on a team's personality composition (in this case, within an organization),
demonstrating that a group’s composition and makeup are related to the openness to experience.
This also affects performance and how diversity is dealt with at a group level, indicating how
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ideas are generated depend on their attitudes and beliefs in a group setting (Homan et al., 2008).
CTSA administrators need to maintain transparency across all other CTSA administrators and
community members in order to have collaborative leadership.
The organization needs to understand the role of CTSA administrators in the CTSA
organization. CTSA administrators have specific and unique roles related to their respective
core programs. While some have more experience working with community members, others
have very limited knowledge and training on how to engage with the community. As a priority,
CTSA administrators have a role in facilitating and accelerating clinical and translational
research by developing, refining, widely disseminating, and implementing novel research and
health studies (Shirey-Rice, 2014). Again, a recommendation here is grounded in the
organization's cultural practices that are practices and shared mental schema enacted by
employees (Gallimore & Goldenberg (2001). Clark and Estes (2008) purport that many people
play more than one role in an organization. Practitioners are responsible for implementing and
delivering solutions to their clients and may move among various parts as their needs, interests,
and opportunities allow. The recommendation, therefore, is to expand the professional
development training with CTSA administrators to learn about the CTSA infrastructure and
CTSA roles and responsibilities. Expanding the professional development training from learning
the overall organization of the CTSA, starting with its historical background, to learning each
purpose of the core programs will enable CTSA administrators to strategize and think of
innovative ways to work with community members, facilitate an integration process and build
capacity in a well-developed manner.
The organization needs to set the goal of community member involvement at the
Western CTSA. Community involvement needs to be a Western CTSA goal. CTSA
administrators should fully understand how their participation or involvement benefits them and
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vice versa. To address this, having discussions, conducting interviews, comparing existing tools,
pilot-testing, and additional stakeholder feedback can bring forth frameworks, approaches,
assessments, and a general understanding of developing an integrated team composition (Reyes
et al., 2014). This process creates a learning community where norms and values could be
discussed and reflected upon to bring forth shared values and even a shared vision towards
building capacity collectively among community members and CTSA administrators (Marsh &
Farrell, 2014).
Additionally, being motivated to work as a team may help bring forth the value desired to
build capacity to increase community members' involvement in biomedical research. To help the
Western CTSA stakeholders obtain the maximum benefits from forming a team and team
production, it is imperative that distrust, lack of cooperation, and general unwillingness to work
with others be overcome (Lembke & Wilson, 1998). Effective teamwork requires members to
recognize a team as a unit with common goals, values, and norms. The more the team members
identify with one another, the more likely they will cooperate and work together as a team (Eckel
& Grossman, 2005). This example of infrastructure should be considered and instituted.
The value to build capacity for increasing community involvement in the CTSA is high,
but the organization's impact needs to be assessed and measured. Once there is a full
understanding of the impact research is making in the community, CTSA administrators would
then have the power to decide the direction it needs to take to plan for a more significant impact
that can be demonstrated as it relates to community participation in the research process. Thus,
the research process should not be only for researchers to go into the community and collect
data, forgetting to report back but to exemplify how the community is part of a change process
needed in the Western CTSA. The recommendation is grounded on the principle of having a
visible, concrete manifestation of cultural models that appear within activity settings (Rueda,
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2011). The recommendation is to provide evidence of successful community involvement
models in biomedical research or demonstrate some benefit that the community has in being a
part of the research process. One evidence of successful integration for community participation
in the CTSA is from the University of Arkansas for Medical Sciences, Translational Research
Institute. The organization was able to increase community understanding of and involvement in
research designed to engage community members and patients who may be less represented in
research, have no research background, and lack trust or interest in participating in research.
Having a structured process involving community members has helped demystify the research
process for those underrepresented in research and facilitate their engagement and influence
within the CTSA (Stewart et al., 2018).
The organization needs to have a community advisory board and community
engagement. The community engagement core (CE) is a standing operational core program at
the CTSA. The CTSA’s “adoption of CE aligns with other projects that address the public
accountability of universities to their surrounding communities” (Eder, 2013). The CE at the
Western CTSA has longstanding relationships with community partners, community-based
organizations, and various foundations. Cultivating and preserving these relationships will help
build the capacity for more opportunities for community members to participate in the
biomedical research process. Further, the primary function of a community advisory board
(CAB) is to carry out an “effective strategy for CTSA programs to increase community-engaged
research” but not necessarily engage community members in the research process (Patten, 2019).
At the Western CTSA, the CAB is housed under the CE core program and both entities have
jointly been the leading trailblazers in working and engaging with various community
organizations and members. Thus, other CTSA administrators who lead other core programs
defer to the CE and CAB to work directly with community members and are relied upon to serve
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as the liaison from the CTSA to the community-at-large. Given its current existence and built-in
structure at the CTSA, there is an opportunity to improve how the CE and CAB function and
how it can evolve into potentially a new meaning of “community engagement” that addresses the
overall mission of the institute. The recommendation here is grounded on the principle of having
a visible, concrete manifestation of cultural models that appear within activity settings (Rueda,
2011). The recommendation is to provide training based on an organizational improvement
model to build capacity with the community engagement core and community advisory board.
Integrated Implementation and Evaluation Plan
Implementation and Evaluation Framework
The organization needs to have a community advisory board and community
engagement. The community engagement core (CE) is a standing operational core program at
the CTSA. The CTSA’s “adoption of CE aligns with other projects that address the public
accountability of universities to their surrounding communities” (Eder, 2013). Further, the
primary function of a community advisory board (CAB) is to carry out an “effective strategy for
CTSA programs to increase community-engaged research” but not necessarily engage
community members in the research process (Patten, 2019). At the Western CTSA, the CAB is
housed under the CE core program, and both entities have jointly been the leading trailblazers in
working and engaging with various community organizations and members. Thus, other CTSA
administrators who lead other core programs defer to the CE and CAB to work directly with
community members and are relied upon to serve as the liaison from the CTSA to the
community-at-large. Given its current existence and built-in structure at the Western CTSA,
there is an opportunity to improve how the CE and CAB functions and how it can evolve into
potentially a new meaning of “community engagement” that addresses the overall mission of the
institute. The recommendation here is grounded on the principle of having a visible, concrete
127
manifestation of cultural models that appear within activity settings (Rueda, 2011). The
recommendation is to provide training based on an organizational improvement model to build
capacity with the community engagement core and community advisory board.
Organizational Purpose, Need, and Expectations. The Western CTSA’s mission is to
understand the scientific and operational principles underlying scientific knowledge translation
into new approaches to improve individuals and the public's health. By 2025, the ten Western
CTSA program cores (and potentially others that may emerge) will systematically include and
integrate community members into all phases of the translational research process. Institute
stakeholders (administrators) play a key role in creating an infrastructure to allow community
participation in the research process. CTSA administrators need to learn and implement ways to
integrate community members into each CTSA core program to increase community member
participation in research. Guided by a community partnered participatory research framework,
administrators need to help increase buy-in from other administrators regarding the need to
improve and sustain this kind of integration of community members into the CTSAs by gaining
shared goals from every person working in the institute (Lizaola et al., 2011). The expected
results from the recommendations produced by this study will help stakeholders cultivate high-
performing administrative leaders who will create a program to advance the institute’s ability to
continue to integrate community members into biomedical research and build capacity.
Level 4: Results and Leading Indicators. Results and leading indicators in the form of
outcomes, metrics, and methods for internal and external outcomes are shown in Table 9.
Expected outcomes should occur if the expected internal outcomes are met as a result of training.
These leading indicators will inform the CTSA administrators whether the implemented training
program increased community members' participation in the biomedical research process.
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Table 9
Outcomes, Metrics, and Methods for External and Internal Outcomes
Outcome Metric(s) Method(s)
External Outcomes
Increased participation of
community members in
activities that promote
community input in the
research process.
Number of community
members participating in
external activities related to the
organization’s mission and
vision.
Feedback / listening session
from community members
Track the number registered
and the number who attend
events/activities.
Both community members and
CTSA administrators monitor
the external activities and the
number being held.
Increased communication
with community members
regarding opportunities to
be involved in the CTSA.
The number of marketing
materials that is
disseminated.
The number of meetings
held between community
Establish a communication
platform between CTSA
administrators and community
members allowing all parties to
have access to this
communication platform.
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members and CTSA
administrators.
Provide materials readily
accessible in various platforms
for community members and
CTSA administrators to be
aware of opportunities to work
together.
Increased perception of
the biomedical research
process with community
member involvement.
The number of invitations
community members are
invited to specific events.
The number of community
members who attend these
events.
The number of opportunities
CTSA administrators offer.
Event invitations tracked by
CTSA administration.
Event attendees tracked by
CTSA administration.
Participation and adoption
of a shared vision for
community member
participation in the
CTSA.
The number of meetings held
for community to participate in
planning and visioning.
Track event trainings and
team-building opportunities.
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Internal Outcomes
Increased number of
community members and
CTSA administrators who
participate in trainings.
Number of trainings offered. Provide satisfaction survey of
training and obtain feedback
regarding training provided.
Improved engagement of
community members with
CTSA administrators in
administrative research
activities.
Number of activities that relates
to both community and CTSA
administrator involvement.
Advertise opportunity for both
CTSA administrators and
community members.
Track the number of activities
provided and offered.
Track number of attendees and
new relationships formed.
Track team-building
opportunities.
Track how opportunity was
advertised.
Improved coordination of
communication activities.
Communication plan Obtain a progress report from
the communication plan that
has been established by both
CTSA administrators and
community members.
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Increased number of
discussions reflecting on
the organization’s
progress towards building
capacity for community
involvement in the CTSA.
Number of meetings attended
by both CTSA administrators
and community members.
Anytime a meeting was held to
discuss any reflection regarding
building capacity with
community member
involvement.
Meetings and agendas from
meetings.
E-mail logs and
communications
Increased investment of
time/resources in
community activities
Staff time
Volunteer hours / time
Funding allocation for time and
resources
Progress reports.
Level 3: Critical Behaviors. The stakeholders of focus are CTSA administrators. The first
critical behavior is that CTSA administrators will provide input on the organization’s community
integration strategy. The second critical behavior is that they must visibly raise awareness of the
opportunity to involve community members in CTSA activities. The third critical behavior is
promoting the CTSA efforts to improve communications between community members and
CTSA administrators. The fourth critical behavior is that CTSA administrator stakeholders must
meet regularly with community members to reflect on their progress to building capacity for
community involvement at a CTSA. The fifth critical behavior is that they jointly develop and
submit grants to support community integration into the biomedical research process. The
specific metrics, methods, and timing for each of these outcome behaviors are noted in Table 10.
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Table 10
Critical Behaviors, Metrics, Methods, and Timing for Evaluation
Critical Behavior Metric(s) Method(s) Timing
1. CTSA
administrators will
provide input on the
organization’s
strategy for
community
integration
Amount of input
collected from CTSA
administrators byway
of e-mail, phone, in-
person meetings.
1a. Input collected from
CTSA administrators by
way of survey
instrument
1a. Quarterly
2. Must visibly raise
awareness of the
opportunity to
involve community
members into
CTSA activities
Number of
opportunities offered
regarding community
activities with the
CTSA.
2a. Communication
team track opportunities
and communication
with community
members.
2b. Track activities.
2a. Ongoing – every
quarter
2b. Monthly
3. Promote the
CTSA efforts to
improve
communications
between community
Number of promotion
materials
disseminated.
3a. Track where and
number of materials
disseminated digitally
and physically
3a. Quarterly
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members and CTSA
administrators
4. CTSA
administrator
stakeholders must
meet regularly with
community
members to reflect
on their progress to
build capacity for
community
involvement at a
CTSA.
Number of
communications
distributed to broader
community settings.
Number of targeted
invitations
4a. Tracked and
collected by CTSA
administrators by e-mail
and surveys.
4a. Monthly
5. Jointly develop
and submit grants to
support community
integration into the
biomedical research
process.
Number of
applications submitted
by the CTSA and
community members.
5a. Application
submitted to funding
agencies tracked by
CTSA administrators
5a. Quarterly
Required drivers. The CTSA administrators need the Communication team's support and
the CTSA administrative leadership of each core to reinforce and apply what they learned about
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how they can best sustain community members' integration into the CTSA biomedical research
process. Rewards should be established and focused on approval and relationship-building since
the community members do not have any real incentive to be involved in the research process.
Table 11 shows the recommended drivers to support critical behaviors of CTSA administrators.
Table 11
Required Drivers to Support Critical Behaviors
Method(s) Timing Critical Behaviors Supported
1, 2, 3 Etc.
Reinforcing
CTSA admin and community
member meetings where
training and practice on
cultural sensitivity and
competency are developed and
organized.
Ongoing 1, 2, 3, 4
Job aid outlining the training
on cultural competency and
sensitivity and recommended
schedule of communications
activities.
Ongoing 1, 2, 3, 4
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Job aid in the form of a self-
reflection tool enabling the
CTSA administrators and
community members to reflect
on progress in the
implementation of the training
program.
Ongoing 1, 2, 3, 4
Check-in meetings with CTSA
administrators to reflect on
progress and obtain feedback
for improvement
Ongoing 1, 2, 3, 4
Encouraging
CTSA administrators discuss
time and resources allocated
and spent on training activities
and celebrating successful
efforts.
Annually 1, 2, 3, 4
Discussion on possible funding
opportunities and other sources
of ongoing opportunities to
sustain open communication
and activities.
Ongoing 1, 2, 3, 4, 5
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Feedback session and training
from experts related to cultural
competency and sensitivity to
build capacity for community
integration at a CTSA
Quarterly 1, 2, 3, 4
Rewarding
Visible acknowledgement and
recognition during special
events.
Quarterly 1, 2, 3, 4
Annual appreciation
celebration hosted by the
CTSA Director
Annually 1, 2, 3, 4
Monitoring
Tracking of progress with
training activities, outreach to
community members, and time
spent on communication.
Quarterly 1, 2, 3, 4
Tracking of joint grant
submissions
Quarterly – ongoing 5
Organizational support. As noted above in Table 10, the organization will support the
CTSA administrators’ critical behaviors by hosting quarterly and monthly “check-in” meetings
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to monitor progress and ensure the engagement with the Communications team regarding the
messaging is being relayed to the community. As such, CTSA administrators (and community
members) will be supported with job aids, feedback, and training from experts. Both Clark and
Estes (2009) and Kirkpatrick and Kirkpatrick (2016) emphasize the importance of various
progress reporting methods and demonstrating program value as a method of both accountability
and support for training participants. Multiple activities designed to accomplish this are also
noted in Table 11, including publicly sharing progress through various internal and external-
facing communications.
Level 2: Learning goals. Following the completion of the recommended solutions,
stakeholders will be able to:
1. Explain key components of the cultural competency and sensitivity training plan and
communication plan related to the expected contributions to the organization’s mission
(P)
2. Design a communication plan that engages the CTSA administrators (stakeholders) and
community members (P).
3. Integrate the training as part of the organization’s ongoing opportunity to both CTSA
administrators and community members (P).
4. Plan and monitor how the training and communication plan has been implemented (M).
5. Reflect on the organization’s progress and its contribution toward the overall
organizational mission (M).
6. Develop a personal improvement of action (M).
7. Value in investing resources to support training opportunities (Value).
8. Confidence in collectively implementing a training program well (Joint Self-efficacy).
9. Value the planning and monitoring of work (Value).
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Program. Based on the interviews with the CTSA administrators, it was determined that the
best approach to closing the knowledge, motivational, and organizational gaps identified should
consist of the following:
1. Introducing regularly scheduled meetings with community members and regular
communication between CTSA administrators and community members to build upon
current activities that are being implemented within the organization. This effort includes
the launch of a cultural competency and sensitivity training;
2. Embedding training incorporated in all core programs within the CTSA as the
organization design, create, implement, and monitor the training program's progress to
support the efforts to build community integration and capacity. The embedded training
component of the program would be delivered by way of the following:
a. An email announcement from the institute director;
b. Senior leadership meeting regarding this effort; and
c. Offering informal sessions between community members and CTSA
administrators regarding the organizational direction of the program. Leadership
from the community and the Western CTSA will jointly serve as trusted leaders to
deliver the program initiatives.
Regular monthly meetings with community members will serve to create the traction that is very
much needed in biomedical research. This is an opportunity to set expectations for important
areas of discussion that is important for community members for which the CTSA should
support. Although the CTSA is prescriptive in its direction because it is a grant-funded
institution, community members are able to support this effort by way of a job aid that offers the
framework and plans that are set out to implement the appropriate training program. This would
include creating a checklist, outlining key steps and processes, including a timeline, tools,
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objectives and tasks that need to be accomplished. Additional job aids include a way for
participants to reflect and monitor progress. The value and importance of the organization
investing time and resources into ongoing communication and training activities will also be
discussed.
Cultural competency training is not currently offered as formal training throughout the
Western CTSA. Thus, CTSA leadership should lead the institution, specifically CTSA
administrators with little to no knowledge of cultural competency, through a thorough cultural
competency training. A cultural competency training would include:
● An opportunity for self-reflection.
● Sharing of the potential impact the training would make in their organizational mission.
● Engagement with the group in a safe and comfortable feedback session on addressing
sensitive issues in the community.
This standardized training would be part of the onboarding process for the organization and
should be incorporated alongside any diversity, equity and inclusion (DEI) training that already
exists within the institution. The priority for supporting biomedical research would include a
broad understanding of diversity and inclusion and cultural sensitivity for all community
members. The university where the CTSA sits would partner with this effort and vice versa to
foster the capitalization of resources that are already available on campus. Additional measures
to ensure members participating in this effort understand the material and the training objectives
would include a questionnaire that should be completed after attending a training workshop.
Additional support for dialogue and offering input into the design and implementation of the
training program would be openly available.
Evaluation of the components of learning. It is important to evaluate whether influential
CTSA administrators can apply the skills they are being taught. It is also essential to assess
140
whether or not they have grown in confidence and if their value on the importance of learning
the skills has increased as it relates to their role in the organization. Table 12 lists the evaluation
methods and timing for these components of learning.
Table 12
Evaluation of the Components of Learning for the Program
Method(s) or Activity(ies) Timing
Declarative Knowledge “I know it.”
Explaining and demonstrating of key
components of the cultural competency and
sensitivity training plan
During and after
Procedural Skills “I can do it right now.”
Demonstrations in a group setting they would
engage in the training efforts using the job aid
as well as key messages that can be shared with
stakeholders and community members.
During and after
Retrospective interview using self-reflection
tool
During and after
Application of the skill in developing
components of the training program and
communication plan
During and after
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Attitude “I believe this is worthwhile.”
Discussions about the value and rational of
investing time and resources in this training
program and communication plan
During
Confidence “I think I can do it on the job.”
Ask questions of the members to determine
their confidence in their joint ability to work
together in a shared direction.
During and after
Discussions involving practice and feedback During
Check-in with members After
Commitment “I will do it on the job.”
Discussions following practice and feedback During the training
Create action plans for each member involved During the training
Level 1: Reaction. Table 13 below lists the methods used to determine how CTSA administrators
react to the learning events and the timing of when those methods would be delivered.
Table 13
Components to Measure Reactions to the Program
Method(s) or Tool(s) Timing
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Engagement
Observations of learner interaction and
responses
During
One-on-one meeting with learners for
impressions
During and after
Attendance During
Relevance
Check-in with participants via discussion
and individual meetings (ongoing)
During and after
Customer Satisfaction
Check-in with participants via discussion
and individual meeting (ongoing)
After every module/lesson/unit and workshop
Evaluation Tools
Immediately following the program implementation. A formal evaluation of "Level 2
Learning" should be conducted during the program's workshop and training. An outside
consultant/expert should observe the participant's reactions and take notes during the discussion
about the planned steps and the value and rationale for investing time and resources in specific
activities. Participants should reflect and verbalize their program development plans. For Level
1, the institute director should provide check-ins with participants by asking members about the
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relevance of their work plans and the organization, delivery, and learning environment. Both
CTSA administrators and community members should actively be involved in this process.
After each training session, participants should immediately ask questions as part of the
Level 1 Learning (to assess engagement) and Level 2 Learning (to assess skill). Questions should
be delivered during an open discussion session with a recording (if permitted) to evaluate the
program's needs and for proper implementation. A summary of the blended observation and
questions being asked should be included in Appendix B. Appendix C contains the actual
immediate blended evaluation instrument.
Delayed for a period after the program implementation. Approximately six months after
the implementation of the program, and then at 15 weeks, the organization’s institute director
should conduct a check-in of learning by way of interview questions delivered by the director’s
team as well as sending an email announcement regarding the opportunity to share information
and feedback in line with the critical behaviors as aforementioned. This “blended evaluation”
approach will measure participant’s satisfaction and perception of the relevance of the training
(Level 1), confidence and value of applying their training (Level 2), application of the training to
the organization’s goal, and implementing a cultural competency training program (Level 3), and
achievement of desired outcomes (Level 4).
Data Analysis and Reporting
The Level 4 goal of the CTSA should be measured by the successful implementation of a
cultural competency training program. Periodically (e.g., monthly intervals), guidance will be
provided on external and internal communications, the implementation of which should be
tracked and monitored frequently by understanding the level of engagement and traction it has
received by the CTSA administrators and community members. Findings will be delivered
through ongoing communication and progress reporting, which should be made readily available
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for all members who were involved in the process. Results and tracking activities should be
monitored by the director’s team and widely disseminated for transparency of the program and
its impact on community involvement in the biomedical research process.
Summary
The New World Kirkpatrick Model was used to design this implementation and
evaluation plan, which begins with the end in mind – organizational goals – and then examines
critical behaviors and drivers that lead to those end goals. This approach seeks to foster a
breakthrough in closing the gap between the knowledge, motivation, and organizational
influences in building community involvement capacity in the Western CTSA. Therefore, the
recommendations were designed to clarify to CTSA administrators the impact of a transformed
way of approaching an old problem. Implementing and evaluating the recommendations ensured
that the solution fits the problem and builds engagement and support while creating a readiness
to lead change (Kirkpatrick & Kirkpatrick, 2019).
Accountability within the Western CTSA supporting CTSA administrators to facilitate
community involvement and build capacity was integral. This process was critical to keep in
mind key ingredients that lead to accountability – attention, motivation, knowledge development,
and resource allocation (Darling-Hammond, Wilhoit, & Pittenger, 2014). Leadership at CTSA
institutions need to pay attention to the bottom line of funding “good” science and attend to
activities that support the focus of ensuring CTSA administrators have the ability to incorporate
community input in all core programs. A training on expectation and what areas of community
involvement is needed should be clearly identified after obtaining information directly from the
community through listening sessions. Thus, qualified instructors should be motivated to teach
the competencies of how to facilitate the integration of a group in an academic-scientific
environment. The facilitator should be objective and professional in the way they deliver the
145
training. Further, the instructor should have a full scope of what community members know and
don’t know about the mission of the Western CTSA and have a general understanding of
previous research that has been conducted, including community members in the grant review
process (Marsh, Pane, & Hamilton, 2006). As part of knowledge development, best practices for
the CTSA administrator training should be applied (Childreses, Elmore, & Grossman, 2006).
Thus, components of successful accountability should be addressed by generating information
focused on the institutional process, the motivation of individuals to reflect on relevant
information and change strategies, identification of decision-makers as change agents, and focus
on building capacity among CTSA core programs through assessment design and evaluation
(Stecher & Kirby, 2004).
Implication for Future Research
The absence of community input in the CTSA research process has shown that the gap
between academic institutions and community partners/representatives widens when they are not
engaged to provide input in biomedical research. More research on models that have
successfully integrated community members at the CTSAs needs to be understood. CTSAs have
been working with the community for many years, but very little research is conducted to
understand best practices to include diverse community perspectives in the CTSA research
process. More research needs to be conducted to understand the relationships between academic
scientists, community members, and CTSA administrators. This social network of academic
professionals and community professionals may bring forth new insights that have not yet been
considered when thinking about innovating a process for community voices to be integrated into
the biomedical research process.
146
Conclusion
The purpose of this study was to assess the existing leadership capacity of the Western
CTSA regarding the goal of increasing and integrating community members into the research
process. The findings and recommendations can be used to strengthen community engagement
with CTSA administrators and develop new strategies and models to facilitate a process to
include community voices in the biomedical research process. This study brought forth an
understanding of the need for improved knowledge and skills, motivation and organizational
structure in facilitating community involvement at the Western CTSA.
147
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163
APPENDIX A: INTERVIEW PROTOCOL
Respondent: ____________________ CTSA Role: ____________________
Date: _____________________ Time__________________________
Interviewed By: ___________________________________
Location: _________________________________________
{PRESS RECORD}
Hi. My name is ________________ and thank you for taking the time out of your day to
meet with me. I will be asking a few questions related to my dissertation topic on involving
community members in the Western CTSA (a pseudonym). The goal of this project is to better
understand the CTSA administrator’s thoughts, feelings, and experiences with involving and
integrating community members into biomedical research, specifically in the CTSAs. I will be
recording this interview and the recording is only for my reference and will not be shared by
anyone else. However, after conducting 10 interviews from the group of individuals that were
selected for this project, information gathered from the entire interview process will be compiled
and informative findings will be shared with the CTSA stakeholders as a whole. As a reminder,
you were selected because you are of a senior-leadership position from your program core. The
entire interview process will take about 45 minutes. Before we begin, do you have any
questions, comments or concerns?
Interview Questions
● In your perspective, describe what clinical and translational research is.
● Describe, if any, the need for community members to be involved in clinical and
translational research.
● In what ways, if any, is your role recognized within the CTSA?
● Describe your role as an administrator for the Clinical and Translational Science
Institute?
164
● Please describe the role, if any, you may have in equipping or training CTSA
administrators to integrate community involvement.
● How would you describe a CTSA environment with community members?
● Describe some key factors that make up this scenario.
● Describe the community advisory board and community engagement core
● Describe a time when you worked and collaborated with community members, if any.
● Probing question: What were some contributing factors that lead to this collaboration.
● Describe the type of interaction that needs to take place between community members
and CTSA administrators.
● What are some important factors that would support CTSA administrators to facilitate
community involvement?
● Please describe how CTSA administrators get trained to support the integration of
community involvement in the clinical and translational research process.
● How would you describe the administration of community involvement in the CTSA?
● Describe the type of leadership that is necessary to support the integration of community
involvement.
● How confident do you feel in your ability to facilitate a process to integrate community
members at a CTSA?
● What do you see as the result for involving community members in the CTSAs?
● What do you feel certain you can do?
● Is there anything you feel doubtful about when it comes to the ability of communicating
and training community members at the CTSA?
● In your own words, please describe the importance of cultural appropriateness and ethical
conduct in research.
● Please share an instance where being aware of your own bias proved to be challenging.
Excellent.
It looks like we’ve come to the end. Do you have any questions for me at this time?
Thank you so much for your time and valuable input. I look forward to sharing the results of my
study with you.
165
APPENDIX B: IMMEDIATE EVALUATION TOOL
Immediate Evaluation Tool
Level 1 and Level 2 Survey Strongly
Agree
Agree Disagree Strongly
Disagree
It was helpful to understand the reasons
participants have ongoing discussions
and individual meetings.
(Level 1 – Relevance)
The observations of learner interaction
and responses were valuable.
(Level 1 – Engagement)
Attendance is key to a successful
training
(Level 1 – Engagement)
One-on-one meetings with learners for
impressions were useful and applicable.
(Level 1 – Engagement)
166
I received all the necessary information
and resources from my individual
meetings and check-ins.
(Level 1 – Satisfaction)
Discussing the resources for the training
was well worth the time and investment.
(Level 2 – Attitude)
I understood the shared direction that
the program is heading.
(Level 2 – Confidence)
I was able to fully participate in the
feedback sessions.
(Level 2 – Confidence)
I am creating an action plan to sustain
my involvement.
(Level 2 – Commitment)
167
APPENDIX C: DELAYED FEEDBACK
Delayed Feedback
Survey of Level 1, 2, 3, and 4 Strongly
Agree
Agree Disagree Strongly
Disagree
I am able to understand and
communicate the reasons for
understanding the components of the
cultural competency and sensitivity
training plan.
(Level 2 – Knowledge)
Prior to the training, I understood the
purpose of having a shared direction
that the program could be heading.
(Level 2 – Confidence)
I feel supported to discuss the
resources and time spent on the
training activities and potential
funding opportunities.
(Level 2 – Encouraging and Rewarding)
168
I have created my own tracking of
progress with training activities and
outreach to community members and
time spent on communication.
(Level 2 – Monitoring)
Abstract (if available)
Abstract
The purpose of this study was to assess the existing leadership capacity of the Western CTSA with the goal of increasing and integrating community members into the research process. CTSA administrators have a critical role in facilitating opportunities to build capacity for community involvement. This dissertation focused on investigating the existing CTSA processes involving community members at the Western CTSA and assessed if CTSA leadership has the knowledge, motivation, and organizational resources to integrate community involvement at a CTSA and build capacity for community input. The research was conducted by using a qualitative research approach to assess the existing CTSA leadership capacity of the Western CTSA. The Clark and Estes (2008) framework was used to understand the performance gaps as it relates to knowledge and skills, motivation, and organizational barriers (KMO framework). A total of eleven (11) (100%) CTSA senior administrators were interviewed. Knowledge findings included CTSA administrators 1) did not have adequate knowledge to facilitate community integration
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Asset Metadata
Creator
Orlino Dinkjian, Aileen Peralta
(author)
Core Title
Building capacity to increase community member involvement at a clinical and translational science award (CTSA)
School
Rossier School of Education
Degree
Doctor of Education
Degree Program
Organizational Change and Leadership (On Line)
Publication Date
04/19/2021
Defense Date
03/11/2021
Publisher
University of Southern California
(original),
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Tag
administrator,biomedical research,building capacity,Change,clinical,Communication,Community,community involvement,community-engaged,facilitation,Kirkpatrick model,KMO influences,Knowledge,leadership,Motivation,NIH,OAI-PMH Harvest,organizational,organizational structure,Public Health,Science,team science,translational,translational research
Language
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Advisor
Malloy, Courtney (
committee chair
), Combs, Wayne (
committee member
), Stowe, Kathy (
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)
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aileen.dinkjian@gmail.com
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Tags
biomedical research
building capacity
clinical
community-engaged
facilitation
Kirkpatrick model
KMO influences
NIH
organizational
organizational structure
team science
translational
translational research