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Implementation of tobacco regulatory science competencies in the tobacco centers of regulatory science (TCORS): stakeholder views
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Content
IMPLEMENTATION OF TOBACCO REGULATORY SCIENCE
COMPETENCIES IN THE TOBACCO CENTERS OF REGULATORY SCIENCE
(TCORS):
STAKEHOLDER VIEWS
by
Lilit Aladadyan, M.S., M.P.H.
A Dissertation Presented to the
FACULTY OF THE USC MANN SCHOOL OF PHARMACY AND
PHARMACEUTICAL SCIENCES
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE
December 2023
Copyright 2023 Lilit Aladadyan
ii
Dedication
I dedicate this work to my family. To my boys, Arthur and Michael, who have
gone on too many trips and outings without mom so that I can get this work done. To my
husband Grant, for his love and support. If he weren’t such a committed dad, I may not
have been able to come this far. And to my mom, Ofelya, who has supported me with
anything and everything. Thanks for the days, months, and years of babysitting, and not
just!
iii
Acknowledgments
First and foremost, I would like to express my deepest appreciation to my thesis
adviser, Dr. Eunjoo Pacifici, PhD, for her patient support of this project, for keeping my
spirits and motivation high, and for her friendship and invaluable wisdom and advice. To
Dr. Frances Richmond, PhD—who never ceases to amaze me with her work ethic and
dedication—for taking me along on this journey from the beginning. I’ll be forever
grateful for all the unique experiences she created for us. I would also like to thank Drs.
Susan Bain, DRSc and Joann Pfeiffer, DRSc for serving on my dissertation committee
and for challenging me with their questions and suggestions. To members of my focus
group—thank you for your time and feedback. To the entire regulatory science program
team, thank you for all the support over the years. Lastly, to everyone who participated
in this study, thank you for so freely sharing your views and feedback.
iv
TABLE OF CONTENTS
Dedication .................................................................................................................... ii
Acknowledgments....................................................................................................... iii
List of Tables ............................................................................................................. vii
List of Figures ........................................................................................................... viii
Abstract ........................................................................................................................ x
Chapter 1. Overview .................................................................................................... 1
1.1 Introduction ............................................................................................ 1
1.1 Statement of the Problem........................................................................ 6
1.2 Purpose of the Study ............................................................................... 7
1.3 Importance of the Study.......................................................................... 7
1.4 Limitations, Delimitations, Assumptions ............................................... 8
1.5 Organization of Thesis ............................................................................ 9
Chapter 2. Literature Review ..................................................................................... 10
2.1 History of the Tobacco Industry ........................................................... 10
2.1.1 Discovery and Spread of Tobacco Use ................................... 11
2.1.2 The Cigarette Century ............................................................. 11
2.1.2.1 What’s in a Cigarette? ................................................ 13
2.1.2.2 Technological Innovations Leading to the Popularity
of the Cigarette ........................................................... 15
2.1.3 The Big Tobacco Marketing Machine .................................... 17
2.2 Emergence of Evidence of Harm from Tobacco Use ........................... 23
2.2.1 Industry’s Response ................................................................ 27
2.2.2 Litigation and the Master Settlement Agreement ................... 30
2.3 The Tobacco Industry Today: A Dynamic Product Landscape ........... 32
2.3.1 Continuing Demand and Consumption ................................... 32
2.3.2 Electronic Nicotine Delivery Systems (ENDS) ...................... 33
2.4 Regulation of Tobacco .......................................................................... 37
2.4.1 The Rise of Anti-Smoking Movements .................................. 37
2.4.2 The 1964 Surgeon General’s Report—the Tipping Point ....... 39
2.4.3 The Emergence of Federal Tobacco Regulations ................... 41
2.4.3.1 The “1996 Rule” and the Court’s Findings ................ 45
2.4.4 The Family Smoking Prevention and Tobacco Control Act
(FSPTCA) of 2009 (H.R. 1256, 2009) .................................... 47
2.4.4.1 FDA Center for Tobacco Products ............................. 50
2.4.4.2 Focus on Tobacco Regulatory Science ...................... 52
2.4.5 Tobacco Centers of Regulatory Science ................................. 54
2.4.5.1 TCORS Training Program ......................................... 55
v
2.4.5.2 Defining Competencies in Tobacco Regulatory
Science ....................................................................... 56
2.5 Competency-based Education .............................................................. 59
2.5.1 Competency-based education models ..................................... 60
2.5.2 Implementing CBE .................................................................. 62
2.5.3 Assessment of Implementation ............................................... 64
2.6 Research Frameworks ........................................................................... 65
2.6.1 Implementation Framework .................................................... 65
Chapter 3. Methodology ............................................................................................ 73
3.1 Introduction .......................................................................................... 73
3.2 Development of the Survey .................................................................. 73
3.2.1 Survey Refinement by Focus Group ....................................... 74
3.3 Data Collection and Analysis ............................................................... 75
Chapter 4. Results ...................................................................................................... 77
4.1 Survey Logistics ................................................................................... 77
4.2 Profiles and Backgrounds of Respondents ........................................... 77
4.2.1 Characterizing Faculty, Staff and “Other” .............................. 80
4.2.2 Characterizing Trainees........................................................... 82
4.3 Level of Implementation of Competencies into Training Programs .... 86
4.4 Understanding Implementation Components and Drivers ................. 102
4.4.1 Challenges to Implementation ............................................... 102
4.4.2 Enablers to Implementation .................................................. 108
4.4.3 Stakeholder Engagement ....................................................... 113
4.5 Modification of Competencies for future efforts ................................ 114
Chapter 5. Discussion .............................................................................................. 121
5.1 Overview............................................................................................. 121
5.2 Methodological Considerations .......................................................... 122
5.3 Consideration of Results ..................................................................... 125
5.3.1 Stages of Implementation ...................................................... 126
5.3.1.1 Curriculum Mapping as Demonstration of Program
Implementation ........................................................ 128
5.3.2 Components of Implementation ............................................ 130
5.3.2.1 Stakeholder Engagement .......................................... 131
5.3.2.2 Mentor Development and Training .......................... 133
5.4 Future Directions and Concluding Thoughts ...................................... 134
References ................................................................................................................ 137
Appendix A. ..................................................................................................... 147
Appendix B. ..................................................................................................... 149
Appendix C. ..................................................................................................... 152
vi
Appendix D. ..................................................................................................... 154
Appendix E. ..................................................................................................... 156
Appendix F. ..................................................................................................... 157
Appendix G. ..................................................................................................... 159
vii
List of Tables
Table 1: Typical Contents of a Cigarette ......................................................................15
Table 2: Cigarette Brand Market Share in the United States ........................................36
Table 3: Tobacco Consumption by Product Type ........................................................36
Table 4: Sections of the FSPTCA .................................................................................48
Table 5: Regulated Tobacco Products ..........................................................................49
Table 6: CTP Research Priorities ..................................................................................53
Table 7: TCORS Research Areas .................................................................................55
Table 8: Core Competency Domains ............................................................................57
Table 9: Core Specialized Domains ..............................................................................58
Table 10: Example of Competencies in Core Domain ...................................................58
Table 11: Example of Competencies in Specialized Domain .........................................59
Table 12: How did you learn about TRS competencies? ................................................89
Table 13: Open Text Comments .....................................................................................94
Table 14: Additional Comments - How Have Competencies Been Used?.....................95
Table 15: Level of Satisfaction with Implementation Activities ..................................100
Table 16: Extent of Development of Competency Domains ........................................102
Table 17: Challenges to Implementation ......................................................................104
Table 18: Significant Barriers to Implementation (Mentor Feedback) .........................106
Table 19: Significant Barriers to Implementation (Trainee Feedback) ........................107
Table 20: Centralized and Accessible Resources .........................................................109
Table 21: Affiliated Comments: Centralized and Accessible Resources .....................109
Table 22: Importance of Resources as Enablers to Full Implementation .....................110
Table 23: Helpful Resources .........................................................................................113
Table 24: Stakeholder Engagement in Competency Development Process .................114
Table 25: Views on Relevancy of Competencies .........................................................117
Table 26: Additional Thoughts from Respondents .......................................................119
viii
List of Figures
Figure 1: Per Capita Consumption of Different Forms of Tobacco in the U.S.,
1880-2011 ..................................................................................................12
Figure 2: Per Capita Consumption of Cigarettes among Adults Ages 18 Years
and Older from 1900 to 2004 .....................................................................13
Figure 3: Duke of Durham Box of Cigarettes, 1892 ......................................................14
Figure 4: First Tobacco Advertisement in the U.S., 1789 ..............................................19
Figure 5: The Launch of Camel Brand Cigarettes—The First Viral Ad
Campaign ...................................................................................................20
Figure 6: Iconic Cigarette Advertisements .....................................................................22
Figure 7: The Health Consequences Causally Linked to Smoking ................................25
Figure 8: The Health Consequences Causally Linked to Exposure to
Secondhand Smoke ....................................................................................25
Figure 9: A Frank Statement to Cigarette Smokers .......................................................30
Figure 10: Timeline of Tobacco Control Measures .........................................................43
Figure 11: FDA CTP Organizational Structure ................................................................50
Figure 12: Conceptual Framework for Key Components of Implementation..................68
Figure 13: Stages of Implementation ...............................................................................70
Figure 14: TCORS Association ........................................................................................78
Figure 15: Current TCORS Role ......................................................................................79
Figure 16: Previous Trainee Status ..................................................................................80
Figure 17: Involvement in Training Activities, Faculty Respondents .............................81
Figure 18: Involvement in Training Activities, Staff/Other Respondents .......................81
Figure 19: Participation in National Training Working Group ........................................82
Figure 20: Trainee Type, Current Trainees ......................................................................83
Figure 21: Trainee Type, Past Trainees............................................................................83
Figure 22: Current Employment Field .............................................................................84
Figure 23: Current Employer ...........................................................................................85
Figure 24: Future Career Goals ........................................................................................86
Figure 25: Awareness about TCORS Competencies per TCORS Role ...........................87
Figure 26: Awareness about Competencies Per Cohort Association ...............................88
Figure 27: Level of Focus on Core Competency Domains .............................................91
Figure 28: Level of Focus on Specialized Competency Domains ...................................92
Figure 29: Emphasis on Implementing Competencies into Training Programs ................93
Figure 30: How Have Competencies Been Used? ...........................................................95
Figure 31: Stage of Implementation .................................................................................97
Figure 32: Mapping of Competencies to Coursework .....................................................98
Figure 33: Usefulness of Competencies .........................................................................115
ix
Figure 34: Utility of Competencies ................................................................................116
Figure 35: Oversight Bodies ..........................................................................................118
x
Abstract
Regulatory science to inform the regulation of tobacco products is a scientific discipline
that emerged from the 2009 passage of the Family Smoking Prevention and Tobacco
Control Act (FSPTCA) (H.R. 1256, 2009), which gave the U.S. Food and Drug
Administration (FDA) broad authority to regulate the manufacture, sale and marketing of
tobacco products. The FDA, through an interagency partnership with the National
Institutes of Health (NIH), funded a network of Tobacco Centers of Regulatory Science
(TCORS) in 2013 and 2018 to conduct research that would inform tobacco-related policy
and train new graduates in the new field of tobacco regulatory science (TRS). To guide
the TCORS in the development of their training programs, an inter-center panel was
formed in 2014 to identify and establish a set of competencies. The panel, however, did
not include a formal process for reviewing or accrediting the programs and there was no
clear strategy on how the implementation of the competencies would be assessed. By
applying a well-recognized implementation science framework, this study surveyed
stakeholders to evaluate the implementation of the TRS competencies across the TCORS
sites, identified challenges and enablers that may have influenced the implementation
process, and examined the perceived usefulness of the competencies themselves. Results
were obtained from 97 respondents (mentors and trainees) from across the TCORS
network. Findings indicate that, collectively, the TCORS seem to be at the initial stages
of implementation and point to certain deficiencies that likely challenged
implementation, such as the lack of stakeholder engagement. Respondent views suggest
satisfaction in the area of mentor training, which likely positively influenced the
implementation process. Generally, respondents found utility in the competencies and
xi
suggest that they be only slightly revised for future training programs. Findings from this
study should help inform the TCORS, the NIH Tobacco Regulatory Science Program,
and the FDA, as they embark on the next iteration of the TCORS, slated for Fall 2023.
1
Chapter 1. Overview
1.1 Introduction
Tobacco use is the leading cause of preventable death and disease in the U.S.,
killing more than 480,000 people annually (CDC) and making tobacco control a national
priority. Nonetheless, early efforts to regulate tobacco products at the federal level had
been stalled when the United States Supreme Court ruled in 2000 that the FDA did not
have authority over tobacco and tobacco marketing (FDA v. Brown & Williamson
Tobacco Corp., 2000). It was only with the passage of the Family Smoking Prevention
and Tobacco Control Act in 2009 (H.R. 1256, 2009), that the Food and Drug
Administration (FDA) gained the authority “to regulate the manufacturing, sale,
distribution, and marketing of tobacco products” (H.R. 1256, 2009). To implement the
newly enacted law, the FDA quickly established the Center for Tobacco Products (CTP)
with a mission to protect Americans from tobacco-related death and disease. A key
objective of the CTP is to foster the development of a scientific base to help guide
regulatory decision-making with respect to tobacco products. To accomplish this, CTP
has partnered with the National Institutes of Health (NIH) to fund a network of Tobacco
Centers of Regulatory Science (TCORS) at academic institutions throughout the U.S.
These centers are designed to conduct scientific research that could inform the regulation
of tobacco products and to develop a training program that would cultivate the next
generation of researchers in the emerging field of tobacco regulatory science (TRS). A
common framework for training programs was developed in 2015-16 by assembling a
committee to help identify key competencies essential to researchers in TRS. Through a
decision-making method known as the Delphi process (Cantrill, Sibbald & Buetow,
2
1996), the committee established a list of 11 competency domains and 79 competencies
for TRS. However, guidance on how the competencies should be mapped to training
curricula or be incorporated into the individual TCORS training programs has not been
provided. Furthermore, there has been no formal evaluation process to track how the
sites are performing or to identify gaps and challenges experienced during
implementation. As more than seven years have passed since the initial set of TRS
competencies were developed, it would be helpful at this time to examine their
implementation across the TCORS training programs through the views of key
stakeholders.
Tobacco has a long history that dates back thousands of years to its use by the
indigenous people of the Americas, who considered tobacco sacred and often used it for
spiritual and ceremonial purposes. It was unknown to the Western world until early
European settlers brought it back to Europe after their expeditions. Once introduced to
Europe, tobacco use spread quickly and widely, fueling European colonialism in the
Americas, where the tobacco plant could be cultivated. There was concern over the
possible negative health effects of tobacco use from very early on—its addictive
properties were already recognized—but any objections to its use were overwhelmed by
its growing popularity and its importance as an economic driver. It was not until the
1950s that scientific evidence started to show a strong association between smoking and
disease, including lung cancer, something the tobacco industry attempted to obscure by
creating doubt and controversy over the scientific findings. With the evidence mounting
and rates of associated death and disease rising, government bodies and other
organizations began implementing measures to help curb smoking and other tobacco use.
3
However, the first attempt to regulate tobacco comprehensively at the federal level was
not until the 1990s, when the FDA attempted to assert jurisdiction over tobacco products.
As expected, the tobacco industry took the FDA to court, and the Supreme Court
concluded that the FDA had not been given explicit authority to regulate tobacco
products under its governing law—the Food, Drug, and Cosmetic Act (FDCA).
Following this decision, in 2009, Congress passed the Family Smoking Prevention and
Tobacco Control Act (H.R. 1256, 2009), marking the first time that a U.S. federal agency
gained the authority to regulate tobacco products comprehensively.
Under the Act, FDA authorities range from the regulation of product ingredients
and constituents and conducting compliance and inspection activities to imposing
advertising and promotion restrictions, among others. As a mandate of the Act, with
funding generated through a new user fee scheme, the FDA quickly established its first
new center in over 21 years, the Center for Tobacco Products (CTP). The goal of the CTP
is to reduce the harm from tobacco products through a comprehensive approach that
includes defining policy, issuing regulations, conducting research, and educating the
public on tobacco products.
In evaluating how best to regulate tobacco products within the framework and
limitations of the Tobacco Control Act, the CTP relies on current scientific evidence to
support its development of risk-based regulatory strategies. In addition to assessing
existing scientific evidence, the CTP supports new research that can help better inform
the FDA about tobacco products, their ingredients, and constituents, how different
products are marketed, perceived, and used, and the impact of various products on
individual consumers and the population as whole. To help broaden and advance this
4
scientific base, FDA collaborated with the National Institutes of Health (NIH) to fund a
network of Tobacco Centers of Regulatory Science (TCORS) across the U.S. These
Centers are intended to understand further a range of tobacco-associated issues from
basic mechanisms of addiction and nicotine action to cultural and behavioral factors
fueling tobacco use. Additionally, as stated in an FDA press release, a hallmark of the
program is to provide “young investigators with training opportunities to ensure the
development of the next generation of tobacco regulatory scientists,” practitioners and
leaders of the new scientific field that arose with the passing of the Tobacco Control Act
(NIH, 2013).
As defined by the FDA CTP Office of Science, tobacco regulatory science (TRS)
is the “scientific discipline that supports the evaluation of the risks and benefits of
tobacco regulatory decisions and provides a robust scientific foundation for regulatory
policies” (Ashley et al., 2014). It’s important to note that TRS is distinct from other
types of regulatory science. Tobacco products are inherently unsafe. Thus, the
traditional “safe and effective” standard applied to regulating, for example, drugs and
medical devices, cannot be applied to regulating tobacco products. Instead, as mandated
by the TCA, the FDA must apply a new “public health standard” to regulate tobacco
products. While the former considers the risks and benefits of a product to individual
users, the new standard considers the effects of tobacco products and any regulations on
the health of the population as a whole, including users and non-users of tobacco. Hence,
the science needed to evaluate the impact of potential regulatory actions for tobacco
products differs from other categories of FDA-regulated products. Tobacco regulatory
science is also distinct from traditional tobacco control research. While the two fields
5
certainly have areas of overlap, many principles and concepts of TRS are new to tobacco
control researchers. For example, the development of product standards or regulation of
modified-risk product claims were not topics that were considered by tobacco control
researchers prior to the passing of the TCA. Conversely, areas of considerable tobacco
control research, such as tobacco taxation and clean indoor air, are not in the purview of
the FDA and thus are not areas of focus for TRS.
An emphasis on the training of tobacco regulatory scientists was not something
that might have been predicted even 5 years before the passage of the TCA and gave rise
to the question: What is a tobacco regulatory scientist? What skills, knowledge, and
abilities would be central to training young professionals with the necessary
competencies to fit this description? To answer these and other related questions, the
need to define TRS competencies and then incorporate those into the educational
enterprise became part of the immediate agenda across the TCORS network.
In 2014, a national cross-TCORS Training Workgroup was assembled to help
facilitate the educational activities of the TCORS. Specifically, the Workgroup aimed to
facilitate the sharing of training materials and approaches and develop a common core set
of competencies in tobacco regulatory science. A subcommittee of the workgroup was
specifically charged with the latter, and after an almost two-year effort, delivered a final
list of 51 competencies across six core domains and an additional 28 competencies across
five specialized domains. This effort aimed to define the key competencies required of
professionals in this new scientific field to inform the development of the TCORS
training programs. The individual TCORS were encouraged to incorporate the
competencies into their training programs, but no formal, collective actions were taken to
6
ensure this. As more than seven years have passed since the development of the TRS
competencies, it would be timely and important to explore the extent and success of the
transition from developing the competencies to integrating them into the individual
TCORS training programs. It would also be important to explore stakeholder views and
attitudes about the diffusion and implementation of the competencies, and the
competencies themselves, to inform the development of the next generation of TCORS
training programs in TRS.
1.1 Statement of the Problem
The field of tobacco regulatory science is a nascent field with relatively few
experts in tobacco regulatory science. As the FDA continues to fund new initiatives in
tobacco regulatory science research, it becomes increasingly important to develop
effective programs to train individuals with such a focus more systematically. An
essential element of the Tobacco Centers of Regulatory Science (TCORS) is just this—a
program for career development to train researchers in tobacco regulatory science.
However, while these programs collaborated to develop competencies in tobacco
regulatory science, no effort has been made to evaluate the subsequent incorporation of
these competencies into the TCORS training programs. Hence, we do not know how
many centers implemented the competencies and incorporated them into their curricula
and training programs. In addition, no effort has been made to identify obstacles faced
by the centers as they integrate the competencies into their respective training programs,
and little is known about the attitudes and perceptions of the various stakeholders on the
utility of the competencies, or the strategies used for their integration into the training
programs.
7
1.2 Purpose of the Study
This research examined the systematic development and integration of TRS
competencies into the TCORS training programs. By reviewing available literature, it
first describes how and why tobacco research and knowledge have become so important
and traces the development of the tobacco regulatory science (TRS) competencies.
Applying the implementation science framework introduced by Fixsen and colleagues
(Fixsen et al., 2005; Fixsen et al., 2009), a novel survey tool was developed to investigate
the implementation of the TRS competencies within the Tobacco Centers of Regulatory
Science (TCORS) that are tasked with training and preparing the first generation of
tobacco regulatory scientists. The survey, distributed to mentors and trainees across the
TCORS network, assessed the views of these stakeholders pertaining to the maturity of
implementation of the competencies, influences on the implementation process, and the
general utility of the competencies themselves.
1.3 Importance of the Study
The FDA CTP funds a new cohort of TCORS every five years. The first cohort,
consisting of fourteen centers, was funded in 2013. In the Fall of 2018, the FDA funded
a second cohort of nine TCORS that comprised of some from the original cohort as well
as a few newly created ones. The FDA accepted competitive applications for the third
TCORS cohort in summer 2022 for funding in September 2023. While award
determinations have not yet been made, it is expected that this third cohort will consist of
eight centers, composed of both returning TCORS and newly awarded ones. The TCORS
program will continue to focus on the training and career development of tobacco
regulatory science researchers. Thus, this research is very timely, and findings could help
8
inform the upcoming TCORS as they continue to innovate and refine TRS training
programs. The information could also inform how the TRS training programs are
reviewed and refined by the funders and policymakers.
1.4 Limitations, Delimitations, Assumptions
This study was delimited to evaluate the implementation of tobacco regulatory
science competencies within the TCORS network. The study did not focus on evaluating
other competencies developed or implemented by other centers, including the FDA, NIH,
or other academic programs. Further, the study was delimited to data collection from
individuals with specific roles within the TCORS training programs (i.e., mentors,
trainees, training program directors, training workgroup members, etc.) and did not
survey the general TCORS community. It was time-limited to a single epoch,
representing a particularly interesting point at which the TCORS participants have had
time to implement their training programs before any systematic evaluations across sites.
The study has limitations and assumptions that must be considered. First, the
study population was limited to individuals within existing databases managed by the
Center for Coordination of Analytics, Science, Enhancement, and Logistics in Tobacco
Regulatory Science (CASEL), which serves as the administrative coordinating body of
the TCORS. I must assume that these databases were complete, accurate, and up-to-date
at the time of their access. Additionally, while the total number of targeted individuals
was quite large, a substantial portion of possible respondents, specifically the past
program trainees, likely had moved on to positions outside the TCORS network and may
have been unreachable or even unlikely to respond to a survey. The survey tool may
have been limited in its ability to solicit feedback from different perspectives (i.e.,
9
different groups of professionals/stakeholders) in a comparable manner. To minimize
this and other limitations, a focus group was convened to critique and construct the
instrument and provide input from various perspectives. Another possible limitation is
that the survey may have attracted respondents who were more familiar with the
competencies or were more involved with their development; as a result, the findings
may be weighted more toward the views of these individuals. Investigator bias must also
be acknowledged, as I was directly involved in developing the TRS competencies. The
potential for bias was minimized where possible by the experimental design.
1.5 Organization of Thesis
This study is presented in five chapters. Chapter 1 is an overview of the study
and describes the need to evaluate the implementation of tobacco regulatory science
competencies in the TCORS training programs. It discusses the limitations and
delimitations of the research plans. Chapter 2 reviews the relevant literature, largely
focused on: the history of tobacco and associated harms, the current tobacco product
landscape, the regulatory history of tobacco leading up to the Tobacco Control Act, and
the formation of the TCORS and development of the TRS competencies. The latter part
of Chapter 2 provides a background on competencies, summarizes the literature on
implementing competency-based educational models, and describes the research
framework that will help structure and frame the current research. Chapter 3 outlines the
methodologies that were used to investigate the research questions (including the
development and implementation of the survey tool) and discusses the data analysis plan.
Chapter 4 provides an analysis of the data and findings from the study. Chapter 5
provides a discussion of the findings.
10
Chapter 2. Literature Review
2.1 History of the Tobacco Industry
To elucidate how tobacco, more specifically the cigarette, came to be the
“deadliest artifact in the history of human civilization” (Proctor, 2011), it would be
helpful to trace the history of the use of tobacco products, from their discovery during the
era of Colombian exploration and their subsequent spread throughout the world to the
industry’s obfuscation of the dangers of smoking and the emerging evidence of harm
from it. This centuries-old tale is full of controversy and deceit, centered on a deadly
product that was largely unregulated until relatively recently through strong political
influence.
Cultivation of tobacco plants—any plant of the genus Nicotiana—is believed to
have originated around 5000-3000 BC in South America. The practice of smoking
tobacco, which refers to the combustion and inhalation of smoke, probably evolved by
accident or by exploring alternate means of consumption (Gately, 2003). Smoking later
became part of shamanistic rituals of North America, where its indigenous inhabitants
considered the product sacred (Wilbert, 1993). Evidence also exists for medicinal uses of
tobacco as a pain killer, a cure for the cold, and a treatment for tuberculosis and asthma
(Balls, 1962). However, perhaps its most prevalent use was as a social tool (Robicsek,
1978). Early users were creative in their “formulations” that included smoking, chewing,
oral ingestion of the extract as syrup, nasal administration as snuff, and even rectally as
enemas for ailments of the gut (Goodman, 2005).
11
2.1.1 Discovery and Spread of Tobacco Use
Tobacco was introduced to Europe shortly after Columbus discovered the New
World and returned to share its new array of foods and habits. Jean Nicot introduced
tobacco to France (1556-1560) where he described the plant as a panacea and wrote about
its numerous medicinal properties (Charlton, 2004). In 1561, he sent snuff to the Queen
Mother of France, recommending it as treatment for migraine headaches (Goodman,
2005; Charlton, 2004). Not long after, the plant’s popularity spread throughout Europe
and Africa. Nicot’s influence on the role of tobacco in the world is evident even today as
his name is the origin of the word nicotine. As consumption rose, tobacco became a
powerful economic asset that catalyzed European settlement and colonialism in the New
World (Salmon & Salmon, 2013; Goodman, 2005). Tobacco was the most successful
commercial crop in colonial Virginia and soon its cultivation spread throughout the
Chesapeake Bay (Salmon & Salmon, 2013; Goodman, 2005). By 1640, Virginia and
Maryland exported one million pounds of tobacco; this figure rose to 25 million pounds
by 1690 and over 50 million pounds by 1728 (Goodman, 2005). By the time of the
American Independence, exports had reached over 100 million pounds (Goodman, 2005).
The labor-intensive nature of tobacco cultivation coupled with the rapid increase in
demand by Europe fueled the slave trade in the colonies as means for a cheaper, more
plentiful labor source (Gately, 2003; Goodman, 2005).
2.1.2 The Cigarette Century
Prior to the 20
th
century, tobacco was primarily inhaled as snuff, chewed, smoked
in pipes or rolled into cigars (Goodman, 2005), but by the 1960s, cigarette smoking had
outpaced the use of any other form of tobacco product use (Figure 1 and Figure 2). When
12
tobacco use reached its peak in the 1960s, more than 40% of the U.S. adult population
smoked cigarettes (Institute of Medicine, 2007). This remarkable growth in cigarette
consumption was driven largely by technological advances that allowed for the mass
production of cigarettes and made them more convenient by enabling smokers to light up
virtually anywhere. The advent of mass marketing also played an important role in the
rapid rise of cigarette uptake. Combined, these developments led to a period in the U.S.
that some historians have dubbed as “the Cigarette Century” (Brandt, 2007) when the
country experienced a remarkable rise and fall of cigarette consumption.
Figure 1: Per Capita Consumption of Different Forms of Tobacco in the U.S.,
1880-2011
13
Figure 2: Per Capita Consumption of Cigarettes among Adults Ages 18 Years
and Older from 1900 to 2004
2.1.2.1 What’s in a Cigarette?
The first cigarettes, known as “beggars’ smokes” (Heimann, 1960), were created
somewhat fortuitously by beggars in Seville, Spain, who collected discarded cigar butts,
shredded them, and rolled them in scraps of paper. By the 1830s, this habit had crossed
into France, where the product received its name—cigarette (Goodman, 1993). The first
commercial cigarettes were produced in 1843 by the Manufacture Francaise des Tabacs,
the French state-run tobacco monopoly established by King Louis XIV (Kranzler &
Korsmeyer, 2009). In the U.S., the first commercial manufacturer was Washington
Duke, who began production on his farm in North Carolina in 1865 (Figure 3). Over the
next century, cigarettes evolved from mere shredded tobacco leaves rolled up in paper to
one of the most highly engineered products manufactured for mass human consumption,
designed to create and maintain addiction.
14
Figure 3: Duke of Durham Box of Cigarettes, 1892
Tobacco and tobacco smoke contain over 5,000 identified chemical
constituents—some occur naturally in the tobacco plant itself, some arise during farming
or are introduced during the curing and manufacturing process, and thousands more result
during tobacco combustion (Rodgam & Perfetti, 2008). According to the FDA, 93 of
these are known carcinogens and/or toxicants deleterious to health (FDA, 2012). In
addition to these harmful constituents, tobacco companies have further modified their
products to increase their addictiveness and appeal, especially to young and novice
smokers. For example, tobacco companies have increased nicotine levels to create and
sustain addiction (CTFK, 2014). Filters and ventilation holes were added to dilute the
smoke, chemicals, and sugars to disguise the harshness of nicotine, flavorings like
licorice and chocolate to make the products more appealing to young people (CTFK,
2014). “Ammonia technology” was used to promote faster absorption of nicotine into the
15
brain, and chemicals were introduced to mask the smell, reduce irritability, and minimize
visibility of the smoke to non-smokers (CTFK, 2014). Many of these alterations have
been marketed by tobacco companies as design upgrades to decrease health risks from
cigarettes, but most have made them more lethal (CTFK, 2014).
Table 1: Typical Contents of a Cigarette
2.1.2.2 Technological Innovations Leading to the Popularity of the Cigarette
Developments in the 1880s proved significant for the cigarette business in the
U.S. A young man by the name of James Buchanan Duke had set his sights on the
16
emerging cigarette business (Durden, 1975). Duke had grown up working with his father
and brothers at W. Duke & Sons Tobacco Company in Durham, North Carolina. In the
early 1880s, he recruited over one hundred experienced hand rollers and factory workers
from New York and began manufacturing Duke of Durham cigarettes on his family farm
(Durden, 1975). Around the same time, cigarette making became mechanized through
the invention of the Bonsack Machine. Prior to 1880, cigarette manufacturers could roll
about only a few cigarettes per minute, largely by hand. The Bonsack Machine was
capable of producing over 100,000 cigarettes per day, roughly as many as those hand-
rolled by 500 “cigarette girls” (Proctor, 2011). The machine enabled Duke’s company to
crank out hundreds of thousands of cigarettes daily at lower manufacturing costs. As a
result, cigarette prices came down from eighty cents to about eight cents within 15 years
(Durden, 1975), making them accessible to people of all ages and socioeconomic
backgrounds. To attract more users, Duke increased his marketing efforts, spending an
unprecedented sum on print and billboard advertising and growing a sales team that
traveled across the country (Durden, 1975). In 1890, the other four large tobacco
companies joined Duke to form the American Tobacco Company. The American
Tobacco Company expanded its business globally and by 1910, controlled 92% of the
world’s tobacco market (Wipfli, 2015). This market expansion caught the attention of
American legislators, resulting in the company’s 1907 indictment in violation of the
Sherman Antitrust Act (United States v. American Tobacco Co., 1911). Ordered to
dissolve, the monopoly broke into four separate corporations—American Tobacco
Company, RJ Reynolds, Liggett & Myers, and Lorillard—setting the stage for fierce
competition and aggressive marketing in the following decades.
17
Tobacco companies in other countries soon followed with machines of their own
that rivaled the Bonsack, leading to a rise in cigarette use in the rest of the developed
world (Proctor, 2011). The proliferation of safety matches (invented in 1844 in Sweden)
and later, lighters, helped to further promote the cigarette habit by allowing smokers to
light up cigarettes anywhere. Consequently, by the 1940s, smoking had become the norm
for both men and women in the U.S. (Gardner & Brandt, 2006).
2.1.3 The Big Tobacco Marketing Machine
It is well documented in the scientific literature that marketing and advertising are
important determinants to tobacco consumption (DiFranza et al., 2006; Wakefield et al.,
2003); hence, it would be important to review the history of the marketing of tobacco
products, and more specifically, of cigarettes. Figure 4 depicts what may have been the
very first tobacco advertisement in the United States. Appearing in a local New York
daily paper in 1789, the ad was a plain and unadorned announcement of Peter and George
Lorillard’s snuff and tobacco (Petrone, 1996). But by the end of the 19
th
century,
companies had begun using innovative forms of advertisements to entice the public. Ads
started appearing on billboards and at sporting events; products started to appear in
attractive packages (Goodman, 2005). Trading cards, known as “cigarette cards” at the
time, also became a common marketing scheme (Goodman, 2005). Often portraying
seductive women, movie stars or sports personalities, the pictures were part of a series
and were highly desirable as collectibles (Goodman, 2005).
In the 1920s and 1930s, cigarette advertising shifted to newspapers and
magazines, which offered the opportunity to target a greater number and variety of
potential customers (Goodman, 2005). This was also a period that saw the proliferation
18
of national brands, and tobacco companies used the opportunity to lure customers to their
lines of products. They used creative and aggressive tactics to build and maintain brand
loyalty (Goodman, 2005). One of the most notable examples of this is the 1913
introduction of the Camel brand by R.J. Reynolds (Goodman, 2005), which created
considerable interest and anticipation with nothing but a picture of a camel and a series of
mysterious messages released over the period of a few days (Figure 5). The campaign
proved so successful that it made Camels the top-selling brand of cigarette in just a few
years (Goodman, 2005). In fact, for the first half of the 20
th
century, three national
cigarette brands dominated the market—Camel (R.J. Reynolds), Lucky Strike (American
Tobacco Co.), and Chesterfield (Liggett and Myers) (Boyle et al., 2010).
19
Figure 4: First Tobacco Advertisement in the U.S., 1789
20
Figure 5: The Launch of Camel Brand Cigarettes—The First Viral Ad
Campaign
Through print advertisements, cigarette brands employed clever slogans, imagery,
and themes to lure new customers. Some brands praised the healthy virtues of cigarettes
by depicting doctors and nurses clad in white coats and proudly puffing away, others
incorporated testimonials from doctors declaring their brand of choice (Brandt, 2007).
Some infamously used cartoons to attract youth, and still others used sexual themes, or
themes of sophistication, masculinity, and glamour to sell products (Brandt, 2007). The
“Marlboro Man” has been named as the top icon of the 20
th
century by Advertising Age,
and many other advertising campaigns hold positions in the top 100 list of all advertising
campaigns (Ad Age, 1999; Boyle et al., 2010). Figure 6 depicts some of the most iconic
print advertisements.
When public concern began to mount over the health effects of smoking, as
described in more detail in the following sections, ads began to portray images of doctors
and nurses smoking and declaring cigarettes “less irritating” or “fresh”, suggesting safety
(Unknown (SRITA), n.d.). A famous ad by R.J. Reynolds Company declared that “More
doctors smoke Camels than any other cigarettes” (Unknown (SRITA), n.d.). Ads started
21
to target women with false assertions of weight loss; Lucky Strike encouraged women to
“reach for a lucky instead of a sweet” (Unknown (SRITA), n.d.).
Ads also began to target youth more aggressively with attractive pictures and
cartoon-like characters—Winston depicted the Flintstones in its commercials in the
1960s, and the famous Joe Camel ads ran from 1988-1997 (Unknown (SRITA), n.d.).
Tobacco companies have long claimed that their marketing practices are not deceptive,
that they do not increase demand for tobacco products, that they have no impact on the
initiation of tobacco use among young people, and that they are merely used to compete
with other brands. However, extensive research conducted over the past few decades has
shown a causal relationship between tobacco industry advertising and promotional efforts
and the initiation and progression of tobacco use among young people (USDHHS, 2012).
The release of millions of formerly secret tobacco industry documents proves that the
industry intentionally used aggressive and targeted marketing strategies to promote
tobacco uptake among young people, to keep them addicted, and to achieve greater
consumption among addicted users (NCI, 2008).
In the 1980s, Phillip Morris promoted its cigarettes via product placement in
major new film releases and paid actors to smoke its Kool brand of cigarettes—Sylvester
Stallone can be seen smoking in Rambo, and Marlboro vans appear in the background in
Superman II (Goodman, 2005). This form of indirect advertising, often referred to as
“brand stretching”, further flourished after the Public Health Cigarette Smoking Act of
1969 banned the advertisement of cigarettes on radio and television. In fact, the tobacco
industry is notorious for using such creative practices to counteract any effect of
22
advertising bans, including event sponsorships, promotional discounts and sampling, and
other forms of indirect marketing (Aitken, Leathar & O’Hagan 1985).
Figure 6: Iconic Cigarette Advertisements
Tobacco companies also used creative marketing to help diminish public anxiety
over the growing evidence of harm from smoking. For example, tobacco companies
began the marketing of cigarettes labeled as “light” or “mild” based on machine
measurements of tar and nicotine produced by cigarettes under standardized conditions.
Ventilated filters were developed to dilute smoke and reduce the levels of tar and nicotine
as measured by these machines, and results used as the basis for selling “light” or “ultra-
23
light” products, claiming them as “safer”. However, these modifications did not render
cigarettes any safer. They, in fact, appeared to increase the risk of smoking-related
disease (Bialous & Yach, 2001). Scientific evidence and tobacco industry internal
documents subsequently revealed that these machines, also used by the Federal Trade
Commission (FTC), did not accurately reflect the actual amount of tar and nicotine
absorbed by the smokers, a finding that the tobacco companies had known for years
(Bialous & Yach, 2001). Despite having this knowledge, cigarette companies continued
for many decades to misrepresent the test results in their marketing of certain cigarettes
as “light” or “ultra-light” with claims of lower health risks (Pollay & Dewhirst, 2002).
2.2 Emergence of Evidence of Harm from Tobacco Use
It was not long after the introduction of tobacco to the Old World that state and
religious leaders began to draw attention to the unpleasant aspects of smoking habits.
King James, in 1604, published A Counterblaste to Tobacco, stating, “Smoking is a
custom loathsome to the eye, hateful to the nose, harmful to the brain, dangerous to the
lungs…” (James, 1604). His further observations that “The wife must either take up
smoking or resolve to live in a perpetual stinking torment”, alluded to the effects of what
now has been termed “second-hand smoke” (USDHHS, 2000). Concerns about the
health effects of tobacco were not limited to Western cultures. In the 1600s, the Chinese
philosopher, Fang Yizhi, pointed out that too much smoking will scorch one’s lung
(Eriksen et al., 2012). The addictive qualities of the plant were also recognized early on;
probably the first written account of tobacco addiction was Sir Francis Bacon’s account
in 1610, when he noted that trying to quit the bad habit of smoking was quite hard (Bacon
1610; Russo et al., 2011). Concern was also apparent early on with regard to other
24
potential health effects, such as cancer (Russo et al., 2011). However, the objections
against tobacco use were overwhelmed by its growing popularity and its importance as an
economic driver (USDHHS, 2000).
Although tobacco was suspected to cause disease and death even during the period of its
early use in Europe, its threat as a public health hazard of epidemic proportions only became
apparent in the early 1900s when doctors began to see an increasing incidence of lung cancer, a
disease that was previously rare (Goodman, 2005). Other cancers and diseases of the lungs and
heart also increased and seemed to point to smoking as the cause. By the 1950s, several
landmark epidemiological studies provided irrefutable evidence to link smoking with a variety of
diseases, including lung cancer, heart attack, stroke, bronchitis, and emphysema (USDHHS,
2014). Smoking is now known to cause disease in almost every organ of the body (Figure 7 and
Figure 8), supported by the largest literature to date that links a specific human behavior to a
variety of diseases and adverse health effects (USDHHS, 2014; Goodman, 2005).
25
Figure 7: The Health Consequences Causally Linked to Smoking
Figure 8: The Health Consequences Causally Linked to Exposure to
Secondhand Smoke
26
In 1964, when the first Surgeon General’s Report on Smoking and Health
described the dangerous health effects of smoking, 42% of American adults smoked
(USDHHS, 2014). Since that time, estimates suggest that over 20 million Americans
have died from smoking. This number is estimated to include 2.5 million non-smokers
exposed to second-hand smoke (USDHHS, 2014). Tobacco control efforts over the last
few decades, such as restrictions on advertising, tobacco excise taxes, smoking
restrictions, and cessation programs, have helped to reduce smoking rates; however, 18%
of American adults continue to smoke, and smoking remains the leading cause of
preventable death in the U.S. (USDHHS, 2014). Smoking rates are particularly high in
certain parts of the country such as the Midwest and South, among certain ethnic
subgroups such as American Indians, and in less educated and financially disadvantaged
subsectors (USDHHS, 2014). Thus, smoking disproportionately affects certain
vulnerable population subgroups (CDC fact sheet). According to the U.S. Department of
Health and Human Services, if the current rates of smoking continue, 5.6 million children
alive today, or 1 child out of every 13, will die early from smoking (USDHHS, 2014).
Smoking-related illnesses pose a high financial burden on society. The annual costs linked to the
use of tobacco in U. S. are estimated to be more than $300 billion—nearly $170 billion in
medical costs and more than $156 billion in lost productivity (US Department of Health and
Human Services). The 2014 Surgeon General’s report predicted that if each current smoker was
to quit and each young person was to refrain from starting, savings would be staggering—half a
million premature deaths, $130 billion in medical costs and at least $156 billion in losses to the
economy would be saved. However, the business of selling tobacco continues to be a lucrative
one, and the public health and tobacco control community seems to always be a few steps behind
27
the industry, whose creative tactics and unmatched resources continue to entice and addict new
generations of smokers with novel products and targeted marketing.
2.2.1 Industry’s Response
The world’s most widespread, serious infection is purposely spread by its
vector: the tobacco industry. …this vector has economic resources
rivaling those of many of the world’s largest governments... Its spread is
mapped out in mahogany-lined boardrooms; it breeds its resistance to
countermeasures in political backrooms; and it seizes its victims in
adolescent bedrooms.—Eric LeGresley, World Health Organization
(Proctor, 2011, pg. 256)
Eric LeGresley very fittingly describes the critical role that tobacco companies
played in the creation of the current tobacco epidemic. When scientific evidence started
to gather linking smoking to disease, their advertising efforts became more creative and
more aggressive. Tobacco companies joined forces to employ various tactics to interfere
with tobacco control measures (Brandt, 2007; Proctor, 2011). They set up front groups
and paid scientists to criticize the studies as “junk” science and instill doubt among the
public (Brandt, 2007; Proctor, 2011). To a large extent, tobacco’s survival depended on
its active protection by individuals at all levels of government and politics. Through a
combination of campaign contributions and lobbying, the tobacco industry was able to
protect its lucrative product from U.S. federal regulations up to the 21
st
century. Until
2009, tobacco remained the only substance consumed by humans to be exempt from U.S.
federal regulation.
The industry lobbied government officials to stifle regulations, introduced
purported “safer” products, and denied that cigarettes caused any harm or addiction
(Brandt, 2007; Proctor, 2011). To better understand the depth and extent of the
28
industry’s campaign to obfuscate the truth about the harms of smoking, it would be
important to explore some of their activities in more detail.
‘A Frank Statement to Cigarette Smokers’
The December 1952 issue of Reader’s Digest—at the time one of the most widely
read periodicals and sources of medical information (Brownell & Warner, 2009) —
featured an article titled “Cancer by the Carton” that discussed recent studies pointing to
cigarette smoking as a cause of lung cancer (Norr, 1952). The article caused a health
scare and for the first time since the Depression, cigarette sales started to decline
(Brownell & Warner, 2009). To stop the public panic, the tobacco companies launched a
formal conspiracy campaign to obscure the truth about smoking and health. In a now-
infamous meeting at downtown Manhattan’s Plaza Hotel, the CEO’s and heads of the
major tobacco companies, conspiring with public relations firm Hill & Knowlton,
contrived a campaign of public reassurance to mislead the public about the dangers of
smoking (Brandt, 2007). The goal of the campaign was to create uncertainty about the
scientific evidence in the minds of the public and to convince them that the jury on the
dangers of smoking was still out (Brandt, 2007). In 1954, tobacco companies placed a
full-page ad (Figure 9) in over 400 newspapers in which they argued that research linking
their products to cancer was inconclusive and only a theory (TIRC, 1954). In it, the
industry also made promises to safeguard the public health and promised to “cooperate
closely with those whose task it is to safeguard the public health” (TIRC, 1954). With an
estimated circulation of over 43 million (Proctor, 2011), the “Frank Statement” was a
counter-offensive that left the public unsure about how dangerous smoking really was,
and cigarette sales rebounded. For decades following its release, the tobacco industry
29
continued to challenge any scientific evidence implicating smoking as the cause of
adverse health effects, but as secret industry documents from the time would later reveal,
the industry’s own scientists had confirmed the scientific findings linking smoking to
cancer and other adverse health effects and conspired to mislead the public about these
health risks (Cummings et al., 2007).
Promotion of “Safer” Products
The emergence of scientific evidence pointing to the dangers of smoking also led
tobacco companies to mass-market purportedly “safer” cigarettes, including ones with
filters and ventilation holes, and ones with low-tar formulations. None of these changes
in product design or formulation were, in fact, effective at mitigating the health hazards
of smoking, but this did not stop the tobacco companies from perpetuating the notion that
they were (Kozlowski & O’Connor, 2002; Boyle et al., 2010). The number of cigarettes
with filters increased from 2% to more than 50% between 1950 and 1960 (Harris, 2011),
by 1980, over 93% of cigarettes sold had filters (Pauly et al., 2002), and filter-tipped
cigarettes continue to dominate the market today.
30
Figure 9: A Frank Statement to Cigarette Smokers
2.2.2 Litigation and the Master Settlement Agreement
Between the 1950s and the 1990s, hundreds of claims were brought against
tobacco manufacturers for damages and suffering incurred from smoking. The industry
lawyers were largely able to prevail in these lawsuits, often raising defenses such as
individual responsibility of smokers and contributory negligence. In 1994, a number of
state governments brought suit against large cigarette manufacturers, on the basis of,
31
among other things, consumer protection and anti-trust laws, in attempts to recover
Medicaid and other health care costs attributed to tobacco-related illness and disability.
In 1998, the largest cigarette manufacturers (including Philip Morris USA, R.J. Reynolds,
Brown & Williamson, and Lorillard) entered into a settlement agreement with the states
in what is known as the Master Settlement Agreement (MSA) (Master Settlement
Agreement [MSA] (NAAG,1998). As the largest civil litigation settlement ever in the
U.S., the MSA helped change the course of tobacco control in the country. With an
estimated payout of over $200 billion to the states, the main goal of the MSA was to help
reduce smoking in the U.S., especially among youth. In addition to the financial
compensation, the companies agreed to finance anti-smoking campaigns, to disband
industry trade groups that had conspired to conceal damaging research from the public,
and to refrain from activities that seek to hide negative smoking-related information from
the public (including lobbying against tobacco control legislation) (NAAG,1998). The
MSA also has some important restrictions on the sale and marketing of cigarettes
(NAAG,1998).
Notably, the MSA required that the settling manufacturers make all non-
privileged industry documents produced during any litigation publicly available
(NAAG,1998). This forced the tobacco companies to release over six million once-secret
documents (over 35 million pages) written by company scientists, consultants,
executives, lawyers, their PR and advertising firms, and others (Glantz et al., 1998).
Most of what we know today about the inner workings of the tobacco companies, their
plans and strategies to delay and obfuscate scientific evidence and obstruct tobacco
control measures and policies are from these documents.
32
2.3 The Tobacco Industry Today: A Dynamic Product Landscape
Despite the overall decline in U.S. tobacco production since the 1980s, the U.S.
currently ranks as the fourth-largest producer of tobacco and tobacco products, behind
China, India, and Brazil (Eriksen, Mackay & Schluger, 2015; CDC, 2019). In 2017, an
estimated 249 billion cigarettes were sold in the United States (CDC, 2019). Four
companies (Philip Morris USA, Reynolds American Inc., ITG Brands, and Liggett) share
approximately 92% of these cigarette sales in the U.S. and dominate the market (CDC,
2019. Individual market shares for specific products can be seen in Table 2 (Miller Lo et
al., 2017). New research indicates that revenues of all tobacco products in the U.S. will
amount to more than $98 billion for 2018, and the market is forecasted to continue
growing by an annual rate of 1.2% through 2021 (Statista, 2018). In an effort to curb
tobacco product consumption, the federal and several state governments have sought to
increase the price of tobacco products—what is thought to be the single most effective
method of reducing consumption (USDHHS, 2012). Research suggests that a 10%
increase in price can reduce overall cigarette consumption by 3-5%, but in large part most
consumers continue to pay increasing prices from taxes and market demand (USDHHS,
2012).
2.3.1 Continuing Demand and Consumption
According to the 2015 National Health Interview Survey (NHIS) data, an
estimated 48.7 million individuals in the US (20.1% of its adult population) currently use
some form of a tobacco product—with 87.4% of these tobacco users currently consuming
combustible tobacco products and 19.5% of all tobacco users using multiple tobacco
products (Phillips et al., 2017). An individual breakdown of the current state of tobacco
33
consumption by product type can be seen in Table 3. Estimates from the 2015 survey
show marked progress towards the Healthy People 2020 goal of ≤12.0% of adult cigarette
smokers, with a significant decrease in the last decade from 20.9% of Americans
smoking cigarettes in 2005 to 15.1% in 2015 (Jamal et al., 2016). Results from this
survey, however, also illustrate ongoing disparities in tobacco consumption with smoking
prevalence being higher among certain groups, such as among lesbian, gay, bisexual, and
transgender (LGBT) persons, people with psychological disorders, American
Indian/Alaska Natives, and those living below the federal poverty level, among others
(Jamal et al., 2016). This highlights the importance of diverse tactics in future tobacco
regulation to continue achieving milestones in reducing tobacco consumption.
Traditional forms of tobacco account for a majority of consumption globally;
however, factors such as growing health awareness, increased disposable income
amongst smokers, and technological advancements in electronic smoking devices (also
known as Electronic Nicotine Delivery Systems (ENDS)) are expected to contribute
significantly to the global expansion of the e-cigarette market (Orbis Research, 2018). In
2015, it was estimated that 3.5% of Americans (7.9 million individuals) used e-cigarettes,
accounting for 16.1% of all tobacco users (Phillips et al., 2017). According to Orbis
Research, this market will see a compound annual growth rate of 22.13% from 2018-
2022 (Orbis Research, 2018).
2.3.2 Electronic Nicotine Delivery Systems (ENDS)
Electronic nicotine delivery systems (ENDS), more commonly knowns as e-
cigarettes, entered the mainstream marketplace largely unregulated and flourished in less
than a decade before the long-term health effects of their use could be evaluated and
34
before any marketing restrictions were imposed (Rigotti, 2018). By 2013, a majority of
the tobacco industry’s largest corporations had begun selling their own e-cigarette
products, some even marketing them as “healthy” alternatives to tobacco smoking
(Grana, Benowitz & Glantz, 2014). For example, in a content analysis of e-cigarette
retail websites, Grana and Ling found that 95% of sites made health benefit claims,
including statements about the absence of tar and carcinogens in the featured products
(Grana & Ling, 2014). The manufacturer of NJOY, for example, implied that its product
reduces the risk of disease with the statement “We are dedicated to the eradication of
tobacco-related illness worldwide” (Klein et al., 2016). As of 2014, there were 466
brands of e-cigarettes in the marketplace with three dominating the market—Blu, NJOY,
and Logic (Giovenco et al., 2015; Zhu et al., 2014).
The popularity of electronic cigarettes is largely due to consumers’ ability to
customize the smoking experience with a diverse choice of products, flavors, and even
modes of vaping (USDHHS, 2016). E-cigarettes have now become so mainstream that
by 2014 the terminology for inhaling e-cigarette vapor—vaping—became an official verb
in the Oxford English Dictionary (Rigotti, 2018).
The lax regulatory environment allowed for widespread Internet and television
promotion of e-cigarettes at a critical time when e-commerce was expanding and social
media platforms were emerging—allowing the industry to reach new audiences with
targeted marketing strategies (Grana, Benowitz, & Glantz, 2013; Rose et al., 2014). In
2011, e-cigarette manufacturers spent $6.4 million on advertising; by 2014 the industry
had grown its marketing budget to $115 million (CDC 2016; Kim, Arnold, & Makarenko,
2014). Research has since shown that these advertisements significantly target youth and
35
vulnerable minority populations (CDC 2016; Duke, 2014). At retail stores, e-cigarette
advertisements reach 14.4 million youths; through Internet advertisements, nearly 10.5
million youths are exposed to e-cigarettes; another 9.6 million youths see e-cigarette
advertisements through television and film; and even in the digital era, e-cigarette
advertisements reach nearly 8 million youths through print newspapers and magazines
(CDC 2016).
While the tobacco industry continues to adapt to the changing regulatory
environment, it is taking advantage of new technology to introduce disruptive products
into the marketplace by diversifying its product portfolio. One such introduction in mid-
2015 is a small product called JUUL that resembles a USB flash drive (Huang et al.,
2019). JUUL is situated amongst tobacco products in a category known as “pod
vaporizer” (Huang et al., 2019). Since its debut in mid-2015, its adoption has grown
rapidly; by 2017, a nationwide survey noted that 8% of American young people (ages 15-
24) had “JUULed” within a month of taking the survey (Huang et al., 2019). By the end
of January 2018, JUUL was the most popular e-cigarette with 49.6% of the market share
(Kavuluru, Han, & Hahn 2019). Much of this market expansion occurred prior to the
introduction of regulatory oversight by the FDA that was initiated in April 2018. Prior to
this date, youth had direct access to JUUL products without age-limits or boundaries
through e-commerce websites like eBay (Laestadius & Wang, 2019). Although JUUL
vendors have since been asked to remove their listing from eBay, the market segment for
this product continues to grow (Laestadius & Wang, 2019).
36
Table 2: Cigarette Brand Market Share in the United States
Brands % Brand Shares Within Markets
Tobacco Flavored Cigarettes 66.1 Total Share in the U.S.
Marlboro 46.7
Newport 11.5
Camel 10.5
Pall Mall 8.5
L&M 4.5
Maverick 1.9
Winston 1.8
Natural American Spirit 1.6
Kool 1.4
All Other Brands (Collectively) 11.6
Menthol Flavored Cigarettes 32.9 Total Share in the U.S.
Newport 29.8
Marlboro 26.1
Camel (All Brands Including Camel Crush) 14.7
Pall Mall 6.8
Kool 4.3
All Other Brands (Collectively) 18.3
Recreated from: Miller Lo, EJ, Giovenco, DP, et al., 2017.
Table 3: Tobacco Consumption by Product Type
Tobacco Product % of Consumption,
US Adults
Estimated Number
of Consumers
Any Tobacco Product 20.1% 48.7 Million
Any Combustible Tobacco Product 17.6% 42.6 Million
Multiple Product Users (≥2
Products) 3.9% 9.5 Million
Cigarettes 15.1% 36.5 Million
E-Cigarettes 3.5% 7.9 Million
Cigars, Cigarillos and Filtered Little
Cigars 3.4% 7.8 Million
Smokeless Tobacco 2.3% 5.1 Million
Pipes, Water Pipes, or Hookahs 1.2% 2.7 Million
Source: Recreated from Phillips, E, Wang, TW, et al., 2017.
37
2.4 Regulation of Tobacco
In the 1960s, when tobacco consumption in the U.S. was at its peak, no federal
statutes regulated tobacco use. Even at the state and local levels, people freely smoked
on public transport, in restaurants, and in airplanes, while industry advertising of tobacco
products went largely unchecked. Efforts to regulate tobacco use, sale, and marketing
started to emerge after the release on the 1964 U.S. Surgeon General’s Report on
Smoking and Health, a landmark public health document that catalyzed tobacco control
action at the local, state and federal levels. Thus, efforts in the U.S. to regulate the use of
tobacco products can be divided into two eras—the period before and after the release of
this report. Prior to its release, opposition to smoking was driven by concerns about the
adverse moral and social impact on smokers and not necessarily by health concerns
(USDDHS, 2014). Public sentiment began to change as scientific evidence on the effects
of smoking on health began to accumulate in the 1950s. The 1964 Surgeon General’s
Report was largely responsible for changing public attitudes. It called for “appropriate
remedial action” (USDHEW, 1964) and led to much of the regulatory action at the
federal level since. To understand how the current tobacco regulatory environment came
about, it would be important to trace the evolution of its history from early anti-tobacco
measures to the release of the 1964 Surgeon General’s Report to broad federal regulation.
2.4.1 The Rise of Anti-Smoking Movements
The first organized anti-tobacco movement developed during the Progressive era
through the efforts of religious leaders, health reformers and temperance advocates who
were concerned about increased rates of smoking by women and youth, a behavior that,
like alcohol and drug use, they deemed immoral (Kluger, 1996; USDHHS, 2014). These
38
efforts led to bans on the sale, manufacture, possession and/or use of cigarettes in 15 U.S.
states (USDHHS, 2014) between 1895 and 1927. Other states and municipalities
imposed smoking regulations, such as restrictions on advertising and smoking near
school buildings. Some even restricted smoking by women in public places (Tate, 1999).
However, most of these bans were weakly enforced, some were immediately overturned
by the courts or state legislatures, and eventually, all but those regarding use by minors
were repealed by 1927 (Alston, Dupre & Nonnenmacher 2002; Tate, 1999).
Historical events of the time—such as the World Wars and the women’s
liberation movement—also hampered the efforts of the rising anti-tobacco movement.
During World War I, cigarettes became an important part of soldiers’ rations. Their use
was encouraged as a means for psychological escape from the stress of combat. Many
leading anti-tobacco crusaders began to alter their stance on cigarettes; some even began
sending collections of cigarettes to troops (USDHHS, 2000; Schudson, 1984). The
cigarette also became a symbol of feminist emancipation and equality during the
women’s liberation movement in the 1920s (USDHHS, 2000). Partly bolstered by the
passage of the 19
th
Amendment extending them the right to vote, women began to
denounce the cultural double standard surrounding smoking (USDHHS, 2000). As
women’s desires for equal status increased, the “elongated and sexy” cigarette became
the symbol of the modern woman, a symbol of equality, independence, beauty, sex, and
glamour.
The tobacco industry was also more powerful and better funded than its
opposition. Tobacco companies were able to lobby legislators through campaign
contributions, often through front groups. Legislators from tobacco-growing states were
39
especially vulnerable to industry lobbying as they relied on tobacco income (Brandt,
2012). Thus, most of the opposition in Congress against enhanced legislative control of
tobacco came from the tobacco farming states. Additionally, the industry employed
creative public relations campaigns to shape and manipulate public perceptions and was
very successful at using the same public relations campaigns to fight both regulations and
litigation. The rhetoric of “personal responsibility” and “freedom of choice” is a perfect
example. On the one hand, when used in public relations campaigns, it helped mobilize
public support against potential regulations and garnered public support that threatened a
perceived “inalienable right to smoke” (Friedman et al., 2015). On the other hand, when
employed as a defense strategy in the courtrooms, it served to shift the responsibility for
any negative consequences of smoking from the tobacco companies and onto their
customers (Friedman et al., 2015). This strategy proved quite successful for the industry
until evidence of the effects of environmental tobacco smoke started to emerge in the
1970s.
2.4.2 The 1964 Surgeon General’s Report—the Tipping Point
Beginning in the 1940s, evidence began to accumulate that linked cigarette
smoking to lung cancer and death (USDHHS, 2000). The first studies documenting this
association were published by German researchers during the 1940s. Landmark
epidemiological studies in the 1950s confirmed this association (USDHHS, 2000). The
first of these came from case-control studies showing that smoking increased the risk of
lung cancer approximately 10-fold in smokers compared to never smokers (USDHHS,
2014; Wynder & Graham, 1950; Doll & Hill, 1950). Within a year, several other studies
reached the same conclusion that smoking, and lung cancer were related (Thun, 2005).
40
As the evidence mounted, the scientific community became increasingly convinced that
smoking caused lung cancer and other diseases. In 1952, Reader’s Digest publicized a
summary of the findings in a famous article “Cancer by the Carton” and with a wide
circulation, the publicity aroused public concerns about smoking (USDHHS, 2000). As
controversy mounted, the U.S. Surgeon General Luther L. Terry convened a committee to
assess all available scientific evidence and make recommendations on smoking and
health (USDHHS, 2000). The 1964 Surgeon General's report concluded that “Cigarette
smoking is a health hazard of sufficient importance in the United States to warrant
appropriate remedial action” (USDHEW 1964, p. 33). The report confirmed earlier
findings that estimated a ten to twenty-fold increase in rates of lung cancer among
average to heavy smokers (USDHEW, 1964). It also concluded that a significant link
existed between smoking and bronchitis, emphysema and coronary heart disease
(USDHEW, 1964). What resulted was a landmark public health document whose
publication “marked the beginning of a revolution in attitudes and behaviors related to
cigarettes” (Brandt, 1990, pg. 156). The release of the report was carefully and
strategically planned. Terry invited over 200 reporters to the press conference, which
was held on a Saturday to ensure coverage in the Sunday paper and to minimize any
effects on the stock market (Parascandola, 1997). Although the report did not change
smoking patterns abruptly, it did start a slow and persistent annual decline (USDHHS,
2000). The report also stopped short of offering any concrete remedies, leaving that
challenge to politicians. Notably, the 1964 report has since been named by the New York
Public Library as one of the top 100 books of the 20
th
century (Diefendorf, 1997).
41
2.4.3 The Emergence of Federal Tobacco Regulations
Despite the almost revolutionary change in smoking sentiments among the
scientific community and public following the 1964 report, the federal government was
both slow and selective in its approach to regulate smoking. Most legislators believed
that the government’s role was to protect consumers from industry abuses—such as
misleading and fraudulent advertising—but not to intervene to change consumer behavior
(USDHHS, 2014). This approach, as well as the general notion of personal freedom and
responsibility, began to shift with growing recognition of the addictive nature of nicotine,
as well evidence on second-hand smoke and the emerging non-smokers’ rights
movement.
The evolution toward broad federal regulation of tobacco products perhaps began
with some of the first cigarette regulations, largely aimed at increasing consumer
knowledge about the harms of smoking and curtailing the effects of aggressive
advertising. The first of these came in 1965 with the Federal Cigarette Labeling and
Advertising Act, which mandated the first Surgeon General's warning—“Caution:
Cigarette Smoking May Be Hazardous to Your Health”—to appear on cigarette packs.
Then, in 1967, the Federal Communications Commission (FCC) ruled to apply the
Fairness Doctrine to cigarette advertising (USDHHS, 2000). The Fairness Doctrine
attempted to ensure that all coverage of controversial issues by a broadcast station be
balanced and fair (USDHHS, 2000) and thereafter that national networks would be forced
to provide free airtime to non-smoking efforts. The Public Health Cigarette Smoking Act
of 1969 later prohibited all cigarette advertising on radio and television (Warner, 1979).
Between 1970 and 2009, various other measures were introduced and adopted that
banned smoking on planes (1973), in workplaces (1994), restaurants, and other public
42
places. Most of them, however, were by state and local governments that have
historically been trailblazers in the tobacco control movement. The evolution of tobacco
control measures and progression to broad federal regulation is depicted in Figure 10.
43
Figure 10: Timeline of Tobacco Control Measures
44
The second development came in the 1970s, when Action on Smoking and Health
(ASH), a non-profit advocacy organization at the forefront of the anti-tobacco movement,
filed a petition demanding the FDA to regulate cigarettes as drugs under its governing
rule, the Food, Drug and Cosmetics Act (FDCA). According to the FDCA, a product is a
drug if it affects the structure and function of the body, and, per the petitioner’s
reasoning, nicotine clearly met this requirement (ASH v. Harris, 1980). The FDA,
however, did not agree and the ASH took the case to court. After a series of appeals, the
court ruled in the FDA’s favor (ASH v. Harris, 1980). In making its ruling, the court
reviewed the legislative history of the FDCA, and concluded that Congress made it clear
that only when a product is marketed by the manufacturer as affecting the structure or
function of the body or having a therapeutic effect is the product considered to be a drug
and subject to regulation under the FDCA. According to then FDA commissioner, “a
chiropractor’s table would not be a drug under the Act unless the manufacturers were to
ship that table into interstate commerce and say that the table would cure various ills”
(ASH v. Harris, 1980).
Developments in the 1990s, however, prompted the FDA to revisit its earlier
decision not to assert jurisdiction over tobacco products. In the decade after ASH v.
Harris, scientific consensus emerged to establish nicotine as an addictive substance on
which the tobacco industry relied to maintain its market. The release of internal tobacco
company documents had revealed that the pharmacologic effects of nicotine were in fact
“intended” by manufacturers to affect the structure and function of the human body
(Kessler et al., 1996). Armed with these new findings, David Kessler, FDA
Commissioner at the time, announced in 1994 that the agency intended to assert
45
jurisdiction over tobacco products, specifically cigarettes and smokeless tobacco (Kessler
et al, 1996). Eighteen months later, after an extensive investigation, the FDA announced
its conclusions that nicotine is a drug “intended” to affect the structure or function of the
body and that cigarettes and smokeless tobacco products were “intended” to deliver this
drug to consumers; hence, they would be regulated as drug delivery devices under the
terms of the FDCA (Kessler et al., 1996). In 1996, with support from President Bill
Clinton, the FDA proposed its first tobacco regulation (Kessler et al., 1996), hereafter
referred to as the “1996 Rule”.
2.4.3.1 The “1996 Rule” and the Court’s Findings
The 1996 Rule was largely shaped by the recognition that smoking is a “pediatric
disease” that begins in childhood and that preventing children and adolescents from
initiating tobacco use would yield the biggest gains in public health (Kessler et al., 1996).
Thus, the 1996 Rule aimed to reduce the use of cigarettes and smokeless tobacco by
young people by limiting their advertising and sale. Other policy considerations, such as
an outright ban, would have been widely unpopular given the level of addiction already
present among millions of U.S. adults.
As expected, several tobacco companies sued the FDA, arguing that, without
therapeutic claims, the FDA had no jurisdiction (FDA v. Brown & Williamson Tobacco
Corp., 2000). The case eventually rose to the Supreme Court, who ruled 5-4 in 2000 that
the FDA did not have jurisdiction to regulate tobacco. The court reached this ruling by
applying the principle of chevron deference, which required the Court to consider the
intent of the U.S. Congress when it passed the Food, Drug, and Cosmetic Act (FDCA).
Justice O'Connor argued that the FDCA mandates the FDA to ensure that any product it
46
regulates is safe. Since tobacco is inherently unsafe, the FDA would be obligated to ban
the sale of all tobacco products (FDA v. Brown & Williamson Tobacco Corp., 2000).
However, according to the United States Code (7 USC § 1311(a), 1997), an excerpt from
which appears below, tobacco products cannot be banned from the market (FDA v.
Brown & Williamson Tobacco Corp., 2000).
The marketing of tobacco constitutes one of the greatest basic industries
of the United States with ramifying activities which directly affect
interstate and foreign commerce at every point, and stable conditions
therein are necessary to the general welfare (7 USC § 1311(a)).
Additionally, the Court believed that the fact that Congress had passed six statutes
regulating tobacco since 1965, demonstrated a clear intent by Congress that tobacco falls
under its own regulatory purview. In the Court’s opinion, if Congress had wanted the
FDA to regulate an industry that was such an important part of the American economy, it
would have done so explicitly and thus the Court was not bound to accept the FDA’s
interpretation of the FDCA (FDA v. Brown & Williamson Tobacco Corp., 2000).
The Supreme Court’s decision signaled Congress to enact new legislation giving
FDA explicit authority over tobacco products. Numerous tobacco bills were introduced
between 2000 and 2009 (Givel, 2007), but all failed to advance until 2009, when
Congress passed the Family Smoking Prevention and Tobacco Control Act (H.R. 1256,
2009), empowering the Food and Drug Administration (FDA) to regulate tobacco
products. Interestingly, the TCA passed with the support of Philip Morris. Internal
documents from the tobacco giant detailed the company’s strategy to support legislation
slanted in its favor. The company understood that some form of regulation was
inevitable and that it was better for the company to “shape the agenda than to stand pat
and fight (Unknown, 1995) Thus, Philip Morris worked with legislators to include two
47
key provisions in the TCA—FDA cannot remove cigarettes from the market and cannot
completely eliminate nicotine in tobacco products (FSPTCA).
2.4.4 The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009
(H.R. 1256, 2009)
The passage of the FSPTCA in 2009 in many ways represented a sea change in
the management of tobacco as a product and an industry in the U.S. It constituted the
most comprehensive federal attempt to regulate tobacco since radio and television
tobacco advertisements were banned in 1971. The law (also known as the Tobacco
Control Act or TCA) amended FDA’s governing law, the Food, Drug & Cosmetic Act
(FDCA), vesting the agency with authority to regulate the manufacture, distribution,
marketing, labeling and sale of “tobacco products” to protect public health. Before the
enactment of the TCA, tobacco products were largely exempt from regulation under the
FDCA. In cases when tobacco products made an explicit health claim, such as nicotine
replacement therapies for tobacco cessation, they were and continue to be regulated as
drugs under FDA Center for Drug Evaluation Research (CDER). All FDA CTP
authorities are specifically defined and outlined in the Act with important limitations.
For example, CTP cannot require prescriptions to purchase tobacco products, require that
nicotine yields be reduced to zero or ban an entire class of tobacco products (H.R. 1256,
2009). The major sections of the FSPTCA can be seen in Table 4 below. To better
understand the Act, it would be important to discuss, as a start, how the Act defines
tobacco products and the new “public health standard” it introduced, and then to provide
an overview of the FDA Center for Tobacco Products and its authorities and activities.
48
Table 4: Sections of the FSPTCA
Chapter IX – Tobacco Products
SEC. 900 Definitions
SEC. 901 FDA authority over tobacco products
SEC. 902 Adulterated tobacco products
SEC. 903 Misbranded tobacco products
SEC. 904 Submission of health information to the Secretary
SEC. 905 Annual registration
SEC. 906 General provisions respecting control of tobacco products
SEC. 907 Tobacco product standards
SEC. 908 Notification and other remedies
SEC. 909 Records and reports on tobacco products
SEC. 910 Application for review of certain tobacco products
SEC. 911 Modified risk tobacco products
SEC. 912 Judicial review
SEC. 913 Equal treatment of retail outlets
SEC. 914 Jurisdiction of and coordination with the FTC
SEC. 915 Regulation requirement
SEC. 916 Preservation of state and local authority
SEC. 917 Tobacco Products Scientific Advisory Committee (TPSAC)
SEC. 918 Drug products used to treat tobacco dependence
SEC. 919 User fees
According to the Act, a “tobacco product” is “any product made or derived from
tobacco that is intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than tobacco used to
manufacture a component, part, or accessory of a tobacco product) (H.R. 1256, 2009).
Cigarette paper is a good example of a tobacco product “component” that is regulated
under the Act, while the raw materials used to manufacture the cigarette paper are not
regulated.
The FSPTCA gave the FDA immediate authority to regulate cigarettes, roll-your-
own tobacco, and smokeless tobacco products and empowered the agency to extend this
jurisdiction to other tobacco products. As such, through a formal rule-making process
49
called the “Deeming Rule”, in 2006, the FDA extended its jurisdiction to other categories
of tobacco products including Electronic Nicotine Delivery Systems (ENDS)—better
known as e-cigarettes, cigars, hookah, and any future tobacco products. FDA jurisdiction
also applies to components and parts of newly deemed products (i.e. cartridges and
atomizers) but not to accessories (i.e. lighters and matches, ashtrays, cigar clips). Table 5
summarizes all FDA-regulated tobacco products.
Table 5: Regulated Tobacco Products
Products Under Immediate
Regulatory Authority
“Deemed” Products
Cigarettes
Cigarette tobacco
Roll-your-own tobacco
Smokeless tobacco
Components, parts, and
accessories of these products
Electronic Nicotine Delivery Systems (ENDS)
Pipe tobacco
Cigars
Hookah
E-liquid
Any future products developed that meet the
definition of “tobacco product” per the TCA
Components and parts of these products
Accessories of these products are not included
FDA’s traditional “safe and effective” standard used to evaluate pharmaceuticals
and medical devices would not apply to tobacco products, because these are inherently
dangerous when used as intended. Hence, when evaluating tobacco products or
considering new tobacco product regulations, the FDA must use an approach that
considers the risks and benefits of the tobacco product or regulatory action on the
population as a whole, not just on individual users. For example, a regulation restricting
the availability of flavored e-cigarettes could help to restrict use by youth who, in the
absence of flavors, would likely not initiate tobacco product use. At the same time, e-
50
cigarette flavors may encourage adults to switch from combustible tobacco products to e-
cigarettes in the interest of harm reduction.
2.4.4.1 FDA Center for Tobacco Products
To oversee the implementation of the new law, the TCA mandated the
establishment of a new FDA Center—the Center for Tobacco Products (CTP). The CTP,
as is written in the Act, is funded solely through user fees collected from tobacco product
manufacturers and importers. The goal of the CTP is to reduce harm from tobacco
product use by (1) preventing individuals, especially youth, from initiating the use of
tobacco products, (2) encouraging those who use tobacco products to quit, and (3)
reducing the adverse health impact for those who continue to use tobacco products. In
the decade since its inception, the CTP has grown to over 600 staff across various offices
with a budget of over $700 million in 2019. Figure 11 shows the organizational structure
of the CTP.
Described in more detail below, the CTP’s activities can be grouped into four
major categories—(1) Compliance and Enforcement, (2) Policy, Rulemaking, and
Guidance, (3) Public Education Campaigns, and (4) Regulation through Research.
Figure 11: FDA CTP Organizational Structure
51
One of CTP’s major activities is to monitor and enforce the tobacco industry
(including manufacturers, distributors, importers, and retailers) compliance with
regulations. The agency has authority to issue warnings, civil penalties, seizures and
injunctions and to stop sales with the power to pursue criminal prosecution for violations
(FSPTCA). The agency supports industry compliance by issuing guidance documents,
conducting trainings and conferences, and even providing technical assistant for small
businesses. The CTP monitors compliance by conducting inspection checks at venues
where tobacco products are sold (i.e., age verification, provision of free samples, etc.),
monitoring manufacturing and marketing practices (i.e., inspection of manufacturing
sites, monitoring of advertisements and labeling), and ensuring annual registration of
tobacco business and disclosure of product ingredients, among other activities.
Another CTP responsibility is setting policy and developing regulations and
guidance documents to help operationalize the Act. For example, the CTP has set a
national minimum age of purchase of 18 for cigarettes and smokeless tobacco and
established a list of Harmful and Potentially Harmful Constituents (HPHCs) in tobacco
products. The CTP can also establish tobacco products standards related to the
composition, design, labeling, or marketing of tobacco products. For example, the FDA
can issue a product standard for nicotine levels or other chemicals in cigarettes and
prescribe the form and language of product labels (FSPTCA, 2011).
To support the CTP in these activities, the TCA mandates the establishment of a
12-member Tobacco Products Scientific Advisory Committee (TPSAC). The committee
is composed of 9 voting members—seven representing the scientific community, one
employee or officer of a local, state or the federal government, and one representative of
52
the general public. An additional three non-voting members represent the interests of the
tobacco industry (TPSAC). The TCA includes specific mandates for TPSAC. For
example, it requires the committee to review all applications for Modified Risk Tobacco
Products and requires the committee to prepare a report on the impact of mentholated
cigarettes on the public’s health.
The Act also authorizes the CTP to invest directly in campaigns that will help to
educate the public on the dangers of tobacco use. The first national public education
campaign released by the FDA was “The Real Cost” campaign (2014), which
discouraged youth smoking. Other campaigns have targeted current smokers and LGBT
young adults. The campaigns are delivered via television, radio and online video ads,
through social media, as well as through print material (fda.gov).
2.4.4.2 Focus on Tobacco Regulatory Science
The Tobacco Control Act and the new public health standard it introduced gave
birth to the new scientific discipline of tobacco regulatory science. As defined by Ashley
and colleagues (2014), tobacco regulatory science (TRS) is the “scientific discipline that
supports the evaluation of the risks and benefits of tobacco regulatory decisions and
provides a robust scientific foundation for regulatory policies.” As used in the context of
the current study, TRS refers to research specifically intended to inform the FDA’s
regulation of tobacco. However, TRS can be defined more broadly. For example, TRS
research can help inform local and national policies that are outside the scope of CTP’s
authorities, such as laws governing tobacco product taxes and clean indoor air laws. It is
important to understand that the field of TRS is distinct from the broader field of tobacco
control. While tobacco control is intended to advance knowledge about smoking
53
prevention or treatment of tobacco-associated disease, the goal of TRS is scientific
research that is specifically intended to inform regulation. TRS requires an
understanding of the regulatory process and how research evidence can inform FDA’s
work. Conducting such research became an immediate priority on CTP’s agenda.
Important to the work of the CTP is scientific evidence that can support its
interpretations of the law and development of risk-based strategies for regulatory action.
To advance this scientific base, the FDA CTP both funds and conducts its own research
to better understand the variety of tobacco products and their characteristics, disease
mechanisms, and how to reduce harm from tobacco products (Table 6). The centerpiece
of FDA’s funded research is the Tobacco Centers of Regulatory Science (TCORS),
funded through a partnership with the National Institutes of Health (NIH) and intended to
integrate and invigorate the sciences underlying a broad range of tobacco-associated
issues from basic mechanisms of addiction and nicotine action to cultural and behavioral
factors fueling tobacco use.
Table 6: CTP Research Priorities
54
2.4.5 Tobacco Centers of Regulatory Science
In addition to conducting its own research relevant to tobacco regulatory science,
CTP supports other relevant research through a competitive grant-making process. Since
the FDA lacked the infrastructure for grant-making (solicitation, review, and
management of scientific research), it formed an inter-agency partnership with the NIH—
the Tobacco Regulatory Science Program (TRSP)—to help establish a comprehensive
research agenda in tobacco regulatory science. The first awards made through this
funding mechanism were fourteen Tobacco Centers of Regulatory Science (TCORS) that
would help generate scientific evidence to guide the FDA in designing regulations to
reduce the public health impact of tobacco use. For example, one area of research that
the TCORS could explore is how various tobacco products are used and by whom.
Another is better understanding the effects of product labeling and advertising on
perceptions and use. The TCORS could help generate evidence in support of product
standards; for example, since the TCA prohibits the FDA from reducing nicotine levels to
zero, scientific data could help to support a product standard that reduces nicotine levels
to non-addictive levels. The total amount of the 14 awards was more than $273 million
for the period 2013-18. In 2018, the second generation of TCORS (TCORS 2.0) was
awarded—a total of nine TCORS 2.0 research centers received more than $151 million
for the period 2018-23 to conduct research to inform the regulation of tobacco products.
Among the nine second-generation TCORS were two newly created centers and seven
carried over from the inaugural TCORS. Maps showing the geographic distribution of
the TCORS and the areas of focus for each Center can be found in Appendix E and
Appendix F. Appendix A provides more detail on the focus of each TCORS and their
55
research projects. In 2022, the FDA issued a Requests for Applications (RFA) to fund
the third installment of TCORS awards, with expected funding in September 2023.
Table 7: TCORS Research Areas
2.4.5.1 TCORS Training Program
The investment in the TCORS training programs is significant. As of March
2019, the FDA has invested over $30 million into the programs. This sum reflects the
total effort required to develop and carry out the training programs, with allocations for
trainee recruitment, trainee stipends, supplies, travel support, and development of
educational and training material, for example. According to data collected in January
2018, there were 205 self-identified trainees across the TCORS between 2015 and 2017.
Of these, 109 self-reported as post-doctoral trainees, 55 as pre-doctoral trainees, and
41 unknowns. It is important to note that this data is a snapshot in time and continued to
grow significantly as more and more trainees progressed through their training
trajectories.
56
An emphasis on the training of tobacco regulatory scientists was not something
that might have been predicted even 5 years before the passage of the TCA. It gave rise
to the question: What is a tobacco regulatory scientist? What exactly are the skills,
knowledge, and abilities that would be central to training young professionals with the
necessary competencies to fit this description? Given the scope of the TCORS training
programs and the immediacy of the call for such educational activities, a need to define
competencies and then incorporate them into the educational enterprise became part of
the immediate agenda across the TCORS network.
2.4.5.2 Defining Competencies in Tobacco Regulatory Science
In 2014, as part of the cross-TCORS training effort, a panel was established to
define tobacco regulatory science (TRS) competencies that could guide the emerging
educational programs of the 14 TCORS. The panel had the overall goal of “facilitating
the sharing of training materials and approaches and developing a common core set of
competencies in Tobacco Regulatory Science” (Samet & Anderson, 2014). The panel
consisted of TCORS faculty and staff responsible for leading their respective training
programs; NIH and CTP representatives; and Center for Evaluation and Coordination of
Training and Research (CECTR) members. Representation included expertise from
different centers and disciplines—epidemiology, toxicology, health behavior,
communications, law, policymaking, and basic sciences. The panel used a semi-
structured Delphi method—a systematic method of collecting opinions from a panel of
experts through several rounds of surveys/questions—to produce a final list of
79 competencies divided across two domains that they defined as core (51) and specialty
(28) domains. For example, understanding the health consequences of tobacco use,
57
understanding the Tobacco Control Act, and development of general research skills were
determined to be core areas for which each TCORS had to have training modules,
irrespective of its area of focus. These competency domains were deemed essential for
the successful development of all trainees. Five additional training areas, including
addiction and toxicology studies and the economics of tobacco use, were determined to
be “specialized” domains. The understanding is that not all the TCORS would have to
develop training modules in these areas and each Center could focus training curricula in
their Center’s area of expertise. For example, the USC TCORS has a large focus and
research portfolio in Marketing and Communications. Hence, it is natural that it would
develop its trainees in this area, instead of focusing its training program and curricula in
the area of toxicology, for example. The full list of the core and specialized competency
domains can be found in Table 8 and Table 9. Table 10 andTable 11 provide an example
of the competencies developed for a specific core and specialized domain, respectively.
For example, in the specialty domain of addiction, one competency is identifying the
physical and psychological effects of substance dependence. The full list of
competencies, in core and specialized domains, developed in four phases between
January 2014 and August 2015, can be found in Appendix C.
Table 8: Core Competency Domains
1 Health Consequences of Tobacco Use and Population Health Impact
2 Tobacco Control Act/ FDA Regulatory Framework
3 Tobacco Control Policies and Programs
4 Tobacco and Nicotine Product Diversity
5 Vulnerable Populations
6 Skills—Research, Dissemination, Testimony
58
Table 9: Core Specialized Domains
1 Addiction
2 Toxicology
3 Litigation and Disclosure
4 Marketing/ Communication
5 Economic: Cost/ Benefit
Table 10: Example of Competencies in Core Domain
Domain: Health Consequences of Tobacco Use and Population Health Impact
• Identifying the health consequences of active and passive smoking
• Epidemiology of health consequences of tobacco and nicotine use and exposure: person,
place, and time
• Recounting the history of tobacco industry efforts to discredit the scientific evidence base
linking tobacco use to death and disease
• Communicating the health consequences of tobacco use to diverse groups
• Applying findings of scientific analyses addressing the public health impact of regulatory
measures
• Applying health impact assessment tools to understand potential regulatory effects on
population health
59
Table 11: Example of Competencies in Specialized Domain
Domain: Addiction
• Identifying the physical and psychological effects of substance dependence
• Understanding methods of product manipulation to enhance addictive properties in tobacco
products
• Understanding the basis of addiction in biology, learning, and culture
• Using medical literature, highlighting human vulnerability to quick onset of addiction from
tobacco use
• Proposing regulatory policies and standards to counter manipulation of products that enhance
addiction
• Describing the neural pathways that are involved with addiction in the brain, brain reward
system, and mechanisms of addiction
• Understanding the cognitive, physical, social, and brain development of addiction throughout
the lifespan youth
• Describe tobacco industry tactics to fight classification of tobacco (and nicotine) as addictive in
the past and present
The development of these initial set of competencies was only a first step in the
effort to educate and train the over 200 current trainees of the TCORS, as well as
subsequent generations of trainees, in a more defined and harmonized way. However,
simply defining competencies is only a first step in developing and assuring
competencies. It is necessary to put into place the system to implement and then assess
the training that is designed to assure those competencies in the targeted individuals. The
research goal of this dissertation is to explore the extent and success of the transition
from the development of competencies to their implementation into the TCORS training
programs.
2.5 Competency-based Education
To better understand the importance of the current study, it would be important to
first provide some background on the competency-based education model and why it has
become favorable to many educational and training programs, especially those offering
60
degrees in higher and professional education. I will also explore the literature
surrounding the actual implementation of a competency-based educational model and
discuss the issues surrounding its development, implementation, and assessment. This
will help provide context for the current research investigating the implementation of the
TRS competencies in the TCORS programs.
2.5.1 Competency-based education models
Competency-based education (CBE), sometimes also referred to as outcomes- or
performance-based education, as well as “mastery learning”, is a model of training where
students advance upon demonstrated mastery of certain pre-determined competencies. In
more traditional education programs, student advancement is typically based on time
spent in a classroom or credits earned for courses. The CBE movement in the U.S. can
be traced to the 1920s and 1930s. This period is marked by many developments in the
field of education, such as the application of scientific management to work roles and the
development of mastery learning models (Ford, 2014). The field of psychology, largely
the work of B.F. Skinner, also had a large influence on education reforms and
instructional design at the time (Ford, 2014). Competency-based education, a novel
paradigm, started to gain momentum with the teacher educator reforms of the 1960s
(Hodge & Harris, 2012) when the word “competency” began to be widely used to
describe the new model of instruction and learning. This is also when key competency-
based learning concepts emerged; for example, measurable behavioral objectives were
used to assess what a learner should be able to do following training and at what level
(Ford, 2014). These reforms in education were largely a result of the social efficiency
movement of the early twentieth century, which encouraged better preparation of learners
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for careers and called for educational practices that were efficient and effective (Schilling
& Koetting, 2010; Curry and Docherty, 2017).
At the core of CBE is the idea of “competence”, which is manifest as a complex
mix of the knowledge, skills, and attitudes that are needed to perform the activities of a
specified occupation to acceptable standards (Gervais, 2016). The background literature
review conducted in preparation for the current study indicates that there seems to be no
standard definition across disciplines on the definition of competence or competency-
based education. There also seems to be no consensus on the criteria and components
that encompass this model of education. Despite this, the educational approach has
become popular in recent decades, and many professional degree programs, such as those
in the medical and health fields, have attempted to implement CBE, albeit with various
degrees of success. For the current research, I will attempt to provide an overview of the
components that encompass a CBE model based on prior experience from the medical
disciplines.
Jennifer Gervais (2016) conducted a comprehensive review of the available
literature on CBE and conducted interviews with key informants from various disciplines
to gain further insight. Based on this review, the following definition of CBE was
constructed:
CBE is an outcome-based approach to education that incorporates modes of
instructional delivery and assessment efforts designed to evaluate mastery of
learning by students through their demonstration of the knowledge, attitudes,
values, skills, and behaviors required for the degree sought.
Although it is now well-accepted that competencies are important for developing
and selecting individuals with certain capabilities for specific job categories, what is
often less clear is how to define and develop those competencies as part of an effective
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training program. In most of today’s professions, competency definition and curriculum
development to assure competencies are key to the development and accreditation of
educational programs in that discipline. However, how the discipline goes about
accomplishing these common goals is somewhat different. By exploring examples of
competency development in various medical disciplines, common themes can be
identified. This may help to frame the approaches that might be used for the
development of competency-setting exercises in tobacco regulatory science.
2.5.2 Implementing CBE
In the last few decades, accountability and responsibility to the public for the
competency of practicing physicians, dentists and professionals in various medical
disciplines have become the driving force behind reforms in medical education
(Carraccio et al., 2002). For example, the Accreditation Council for Graduate Medical
Education (ACGME) and the American Board of Medical Specialties (ABMS) have
pushed for the establishment of competency-based training for all physicians. Despite
the dearth of strong scientific evidence evaluating the outcomes of competency-based
medical education, what evidence there is generally favors CBE over traditional teaching
models. Carraccio and colleagues (2002) reviewed the medical literature in hopes of
providing practical insight into how full implementation of this new educational model
can be accomplished. The authors found that while much attention was given to the need
for and development of professional competencies for many medical disciplines since the
1970s, widespread adoption is not yet a reality. The evidence suggests that certain
activities are key to the successful implementation of CBE programs. For example, the
first phase of developing such a program is identifying and defining the desired
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competencies. How this process is carried out can be critical to the program’s success
(Carraccio et al., 2002). For example, stakeholder buy-in and engagement are critical in
this phase of program development, as well as throughout the entire planning and
implementation phases. Stakeholders include student learners, faculty, administrators,
and others. Another critical activity at this stage of program development is the clear
delineation of the benchmarks for defining competency and the thresholds for attaining
competence. These will be important for later assessment of student success. Relevant
coursework should be identified early in the process and competencies should be mapped
on to course curricula. Successful implementation also requires strong administrative
infrastructure and support for developing, managing, and assessing the curriculum and
assuring that the planning process is clearly linked to an assessment plan (Carraccio et al.,
2002). Assessments are an integral component of CBE and should be created and
implemented programmatically across the curriculum.
According to the literature on past experience in implementing CBE models, it is
apparent that some activities are especially critical to effective implementation. For
example, faculty development programs for the clinician-educators who teach the
trainees are critical (Carraccio et al., 2002; Hawkins et al., 2015). In addition, the
development of advisory councils, consisting of all stakeholders, to provide input and
feedback to help curriculum development is also critical, as well as accreditation councils
to assess the implementation process. The use of technology can be an important tool in
supporting student learning in a CBE model, and an “open system” that allows for
iterative program modification based on feedback from stakeholders is important.
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While the available literature is not all-encompassing, it provides a good overview
regarding the key aspects of program development that, according to the literature, are
regarded as critical for the successful implementation of CBE programs. Accordingly,
effective implementation of a training program can be largely grouped into five areas—
administrative infrastructure, curriculum development, stakeholder engagement, faculty
training and development, and other supportive resources. Surveying and exploring these
areas could provide insights into how different TCORS have implemented the TRS
competences and the areas of challenge they are facing in the process.
2.5.3 Assessment of Implementation
Reliable numbers on fully operating competency-based programs in higher
education are difficult to confirm. However, according to Fain (2015), around 600
institutions are attempting to engage CBE in some way with efforts to restructure
curricula, retrain faculty, and reframe assessment of student learning outcomes. This
shift to competency-based training has implications for program accreditation. Such
shifts in the method of content delivery and program offerings are considered to be a
“substantive change” by accreditors and warrant review by accrediting agencies (Eaton,
2016), who set and assure the standards for accreditation. In some cases, and likely
increasingly so as the CBE approach becomes more and more favorable, the accrediting
bodies may themselves promulgate program competencies. Such is currently the case
with some graduate programs in Public Affairs and Health Administration (Rissi &
Gelmon, 2014).
Because the TCORS training programs do not have an associated accrediting
body, it is unclear as to who will assess the TRS competencies or the process of
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implementing the competencies throughout the TCORS network. Lack of program
evaluation by an accrediting body may, in fact, hinder successful program
implementation. Since almost seven years have passed from the time that the TRS
competencies were developed, it would be important to now survey stakeholders to gain
insight into the status and process of implementation throughout the TCORS network.
Findings can help assess, in part, the success of implementation and help future attempts.
2.6 Research Frameworks
A systematic framework of defined competencies is considered important to
ensure the effective achievement of well-trained experts. Thus, most educational
approaches in other disciplines have relied on competencies to assess the appropriateness
of their educational programs. This study will survey stakeholders to identify how the
TCORS have addressed the development of defined competencies in their curricula and
training programs. It will also help identify some barriers and enablers to effective
implementation. To help guide the development of the survey instrument for this
research, it would be valuable to apply a framework or model that would help to ensure
that the survey is comprehensive and balanced and ultimately ensure that the findings are
meaningful. One such framework selected for this purpose is the implementation
framework proposed by Fixsen and colleagues (Fixsen et al., 2005).
2.6.1 Implementation Framework
To help inform this study, it would be important to become familiar with the
literature concerning implementation science and how successful implementation of new
programs or innovations comes about. In the current study, the innovation is the list of
competencies in tobacco regulatory science developed by the TCORS network. Fixsen
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and colleagues (2005) provide a synthesis of the implementation science literature and
introduce a framework that provides a foundation for understanding the components of
implementation and factors that promote its effectiveness. Fixsen and colleagues (2005)
define implementation as “a specified set of activities designed to put into practice an
activity or program of known dimensions”. Of the numerous components of Fixsen’s
framework, the following would be helpful to the current study: 1) the implementation
framework, 2) stages of implementation and 3) implementation drivers.
Implementation Framework
Fixsen and colleagues (2005) offer a conceptual systems framework for
implementation consisting of five essential components, which, according to the authors,
exist in all successful implementation scenarios. The framework is depicted in Figure 12
and described in more detail below. When applied to the current study, the framework
can help illustrate the implementation “system”—the differing roles of the key
stakeholders, the important components of implementation, and how these interact and
influence one another. This system's view of the framework helps focus attention on the
essential components and processes necessary to effectively implement the TRS
competencies into the TCORS training programs and successfully train and develop the
first practitioners of tobacco regulatory science. For the current research, this would be
useful in developing survey questions and identifying potential survey participants.
1. The Source – the set (or portion of) the program/innovation being implemented. In
the current study, the source would be the new TRS competencies, or a subset of the
competencies implemented at one or more TCORS sites.
2. The Destination – the organization that will be adopting and using the new program
or innovation, or the practitioner who works directly with the consumer of the
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service/program. In the current study, the destination would be the individual
Tobacco Centers of Regulatory Science, and more specifically, the faculty mentors
who will most directly interact with the TCORS trainees.
3. The Communication Link – refers to the set of implementation drivers (i.e., program
evaluation, facilitative administrative supports, etc.) provided within the organization
that assure core program/intervention components are implemented competently. The
communication link can also refer to the individual(s), called “purveyors”, who
actively work to implement the new program or innovation. In the current study, the
purveyors would be the directors of the individual TCORS programs and members of
the National TCORS Training Workgroup who worked to develop the TRS
competencies. For the current study, it would be useful to identify the implementation
drivers perceived to be important to the successful implementation of the TCORS
competencies, such as mentor training and coaching. This will help us explore the
range of factors that may have hindered or facilitated program implementation.
4. The Feedback mechanism – flow of information about the performance of
individual(s) and organizations that can be acted upon by relevant purveyors, such as
those who are actively working to implement the program/innovation. In the current
research, this might be internally generated information about the implementation
process itself, or about program outcomes (such as trainee performance, etc.), or
findings from various evaluation studies undertaken by purveyors. For example,
findings from the study by Russo et al. (Russo et al., 2017) on the experiences of
TCORS early career scientists regarding mentorship and career trajectories in
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tobacco regulatory science (TRS) could provide useful information on program
outcomes.
5. Influence – the entire implementation process, according to Fixsen and colleagues
(2005), is influenced by outside factors (i.e., social, economic, political, etc.) that may
directly or indirectly affect the people, organizations, and systems described above.
Figure 12: Conceptual Framework for Key Components of Implementation
Stages of Implementation
Fixsen’s framework (2005) can also be used to systematically study and
characterize implementation activities, which occur in roughly 6 stages described as 1)
exploration (or adoption), 2) installation, 3) initial implementation, 4) full
implementation, 5) innovation and 6) sustainability. As described, the stages may seem
to occur in a linear, sequential fashion, but in practice, the implementation process is
more iterative, and the stages can overlap (Figure 13).
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The goal of the Exploration Stage is to assess the needs of the
stakeholders/organization and the feasibility of implementing and sustaining the new
program. The requirements for potential enablers and barriers to implementation of the
program must be identified at this stage. At this stage, an important activity for the
TCORS training working group would have been to identify all key stakeholders and
involve them in the implementation process. Once the decision to proceed with
implementation of the program is made, the Installation Stage begins. In this stage, the
organization/group must start preparing for the new program/innovation by building the
infrastructure to support effective implementation. This can include assuring practical
needs, such as physical space, equipment, technology, or financial and human resources.
It should also include human resource development. For example, when adopting new
competencies and/or developing training programs, such as is the focus of this research,
at this stage, it would be important to ensure that those expected to implement the new
competencies receive training and support to be able to carry out the expected activities.
The next stage, Initial Implementation, is when the new program/innovation is first
introduced into practice and where weaknesses and barriers to implementation are
identified to help inform decision making. At this stage, it would have been important
for the TCORS training working group to give special attention to coaching and training
of directors and staff of the individual TCORS. The fourth stage described in this
framework—Full Implementation—is when the processes and procedures to support the
new program are in place, the program is being implemented, outcomes are being
achieved, and the program is being monitored and evaluated for success. Sustainability
isn’t necessarily a separate stage, but rather an active part of each of the four stages. This
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requires that at each stage, attention is paid to financial, programmatic, and human
resources requirements and to ensuring that policies and procedures adequately support
the implementation process.
The Stages of Implementation outlines the specific types of activities that are
important in the various phases of program implementation in order for the process to
progress successfully. For the current study, survey questions that probe respondents in
these areas can inform us about the types of activities that the Centers have undertaken
and help us better understand the forces that either helped or hindered full
implementation of the training competencies. The framework can also provide
information on the extent of implementation of the TRS training competencies across the
TCORS.
Figure 13: Stages of Implementation
Implementation Drivers
In addition to describing the stages of implementation, Fixsen and colleagues
propose that effective implementation requires a commitment of resources and people, or
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what the authors describe as core components (Fixsen et al., 2005). Based on Fixsen’s
2005 framework, Bertram suggests a modified grouping of core implementation
components they call implementation drivers, or forces that affect implementation
(Bertram, 2015). Grouped into three main categories—competency, organization, and
leadership—these drivers essentially function as pieces of the infrastructure that are
necessary for effective and sustainable implementation of programs or practices.
Competency drivers can be described as activities that develop, improve, and sustain the
competence and confidence of practitioners. The four competency drivers are selection,
training, coaching, and performance assessment/fidelity. Organization drivers help build
a supportive infrastructure to facilitate the success of new programs; these include a
supportive administrative structure or a friendly funding and policy environment. They
also assure improvement of outcomes through routine monitoring, evaluation, and
improvement. The third group of implementation drivers, leadership drivers, are perhaps
the most critical as they’re the strategies employed to establish, monitor, and adjust
competency and organization drivers throughout the stages of implementation (Bertram,
2015). In this framework, adaptive and technical leadership strategies are specifically
emphasized. Finally, it is important to note that the implementation drivers are integrated
and compensatory in nature. For example, if a certain skill is deemed to be an important
element of the innovation or program being implemented, then assessment and
development of this particular skill will be expressed in each of the implementation
drivers, and if not acquired or supported through one driver, can be compensated for by
the use of another driver.
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Fixsen’s implementation framework provides a good basis for understanding
implementation science and how effective implementation of new programs and
innovations comes about. Using the framework to guide the development of the research
instrument for the current study will help assure that the study survey is comprehensive
and balanced. The framework will help guide the development of the survey research
tool, which will probe respondents with questions that will help better identify any
weaknesses or enablers to effective implementation, extent or maturity of implementation
across the TCORS sites, etc. Findings will help inform future decision making as the
TCORS continue to innovate and refine TRS training programs.
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Chapter 3. Methodology
3.1 Introduction
This study examined the implementation of the tobacco regulatory science
competencies across the TCORS training programs with the use of an online survey. The
survey instrument was developed based on information obtained from the literature
review described in Chapter 2 and guided by Fixsen’s Implementation Framework
(2005). A focus group of subject matter experts was convened to review a preliminary
survey draft; feedback was used to refine and finalize the survey instrument. The survey
was distributed to individuals from the TCORS network identified as mentors (faculty,
staff) or trainees. Responses were collected and analyzed through the Qualtrics platform.
Participants were assured of the anonymity of their responses.
3.2 Development of the Survey
The survey was designed, distributed, and analyzed using Qualtrics
(www.qualtrics.com), a well-recognized web-based survey platform. The survey
contained 34 questions of mixed-format, including multiple-choice, Yes/No, Likert scale,
matrix, rank-order and open-ended. The estimated completion time was under 15
minutes. The response recorded for certain questions determined which subsequent
questions would be displayed to the respondent. This was pre-determined and automated
through the display logic and skip logic functions of the survey tool. The survey was
organized into four sections. The first set of questions were demographic in nature and
established respondent profiles and roles within the TCORS network. The remaining
sections, guided by Fixsen’s implementation framework (2005), assessed stakeholder
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views on the level of implementation of the TRS competencies into the TCORS training
program, challenges and enablers to implementation, and utility of competencies.
3.2.1 Survey Refinement by Focus Group
A focus group was convened to help refine and finalize the survey. Six
individuals were recruited to participate in a 90-minute focus group. These individuals
had prior experience in developing or implementing educational programs and curricula
in various disciplines and had diverse professional roles, such as faculty, administrator,
program director, trainee, etc. The charge to the focus group was to review and critique
the quality, content, and clarity of the questions, as well as provide feedback on
formatting, length, etc. Participants received an electronic copy of the survey prior to the
meeting and were presented with a hard copy during the focus group. The focus group
met at the University of Southern California Health Sciences Campus; two participants
joined via video conference. The meeting began with a brief presentation on the purpose
of the current study, followed by a review and discussion of the survey questions and the
proposed respondent pool. Dr. Eunjoo Pacifici, Ph.D. facilitated the meeting to ensure
that adequate time was devoted for discussion to each part of the survey (including
selection of respondents, comprehensiveness of the survey, survey sections and
individual questions, formatting, clarity, and other).
Prior to dissemination, the survey was distributed to a small group of test subjects
from the USC TCORS and USC Regulatory Science doctoral program. Validation
confirmed that email flow was as intended, notifications functioned properly, and
responses were being accurately captured for proper analysis.
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3.3 Data Collection and Analysis
Invitations for study participation were distributed to individuals identified as past
and current mentors (faculty, staff) and trainees (predoctoral, postdoctoral, other) of the
TCORS program. Names and email addresses of potential participants were obtained
from a database of contacts maintained by the Center for Coordination of Analytics,
Science, Enhancement, and Logistics (CASEL)—the TCORS coordination center. In
some cases, this information was obtained directly from representatives of individual
TCORS. Individuals were initially contacted via email with a message explaining the
purpose of the study, length of survey, and assurance of confidentiality. Those declining
to participate were not sent survey links or follow-up emails. Those accepting the
invitation to participate—312 individuals—were sent a private link to the survey. Two
reminder emails were sent to individuals who either had not initiated the survey or had
initiated but not completed it. The survey was open for approximately 12 weeks. The
distribution of invitation letters, thank you notes for participation, and reminder notes
were all managed utilizing the Qualtrics Insights Platform software. Participants had the
option (and were encouraged) to forward the survey to other individuals or colleagues
who they felt may be appropriate participants in the survey based on their status and
relationship to the TCORS training programs. Respondents were informed that a
summary of study results would be made publicly available.
The target response rate for this study was 80 surveys (40 from each of two
stakeholder groups—mentors and trainees) with 75% or more completion. Respondents
were allowed to skip questions. All responses were collected, electronically saved, and
analyzed via Qualtrics. The Qualtrics program provided statistical data—such as
percentages, counts, minimums, maximums, and means for all questions—displayed in a
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tabular or graphical format. Responses to open-ended questions were analyzed by the
researcher for content, including patterns or recurring themes. Cross tabulation per
stakeholder group or cohort association was performed where appropriate to further make
clear any differences or similarities between groups of respondents.
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Chapter 4. Results
4.1 Survey Logistics
The survey was distributed as described in Chapter 3 starting on September 15,
2021 and was closed on December 8, 2021. Three-hundred-twelve personal survey links
were sent to direct email recipients; of these, 100 surveys were initiated, yielding an
overall response rate of 32% (100/312). Ninety-four of these respondents completed the
survey and 6 partially completed the survey. Of the 6 partially completed surveys, 3
respondents answered over 40% of the questions and were included in the total count; 1
respondent answered less than 40% of the questions and thus was excluded from the total
count; the other 2 respondents answered only questions that were demographic in nature
and thus were excluded from the total count. The overall completion rate for the survey
was 97% (97/100). The number of responses received for each question is provided with
the results, as appropriate.
4.2 Profiles and Backgrounds of Respondents
The study survey was developed with various stakeholder groups in mind—
loosely categorized here as mentors and trainees. Since it was important to understand
the views of the different stakeholder groups, the respondents were asked a series of
questions regarding their TCORS association and role. Close to half of all respondents
(46/97, 47%) were associated with both TCORS 1.0 and 2.0; a large number of
respondents were associated only with TCORS 2.0 (32/97, 33%). A small number of
respondents (13/97, 13%) were associated with TCORS 1.0 only or selected “I don’t
know” (6/97; 6%) (Figure 14).
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Figure 14: TCORS Association
To characterize the role of respondents within the TCORS, the survey asked
respondents to select the function that best described their current role (Figure 15). Of
the 97 respondents, 42 (43%) identified as TCORS faculty, 28 (29%) as a past trainee, 20
(21%) as current trainees and 2 (2%) as staff. Five respondents selected “Other” and
described their role as: retired faculty (2); past trainee and current faculty; staff who
functions like early career investigator/trainee; TCORS-associated faculty.
Qualtric’s survey display logic function was used to present different sets of
questions to the five different groups of respondents specified above. For some of the
following questions, however, the five groups of respondents were categorized into two
stakeholder groups—mentors and trainees. This was accomplished by using the
bucketing variable creation tool in Qualtrics. Faculty were bucketed under the “mentor”
variable while past and current trainees were bucketed into the “trainee” variable. The
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seven respondents who self-identified as staff or “other” were bucketed in the “mentor”
category. This was a reasonable approach since these respondents were treated like
faculty respondents with regards to the survey display logic (i.e., they were presented the
same questions that were presented to the faculty survey participants). In the following
sections, data for some questions is presented in aggregate, for other questions, data is
cross tabulated and presented for each of the two stakeholder groups. For some
questions, cross tabulation was performed against TCORS cohort association to delineate
any differences or similarities between respondents from the different TCORS cohorts.
Figure 15: Current TCORS Role
Survey display logic and skip logic functions were used to display a different set
of questions to respondents who characterized as faculty, staff, or other vs those who self-
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identified as trainees in order to help further characterize the groups of stakeholders and
to determine whether any respondents should be taken to the end of the survey.
Respondents who identified as faculty, staff, or “other” were further probed to determine
if any were previous TCORS trainees. Of the 49 respondents, about 1 in 3 (14/49, 29%)
reported previously being a TCORS trainee (Figure 16).
Figure 16: Previous Trainee Status
4.2.1 Characterizing Faculty, Staff and “Other”
Respondents who identified as faculty, staff, or “other” were asked to select the
level of their involvement in the training and career enhancement program/activities at
their TCORS (Figure 17). Of the 42 respondents who had self-identified as faculty, half
(21/42, 50%) reported being somewhat involved, a little less than half (17/42, 40%)
reported being very involved and a few (4/42, 10%) reported not being involved
(Figure 17). All 7 respondents who identified as “staff” or “other” reported being either
very involved (3/7, 43%%) or somewhat involved (4/7, 57%) and thus were allowed to
proceed through the survey (Figure 18).
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Figure 17: Involvement in Training Activities, Faculty Respondents
Figure 18: Involvement in Training Activities, Staff/Other Respondents
The same respondents (who self-identified as faculty, staff or other) were also
asked to describe the level of their current or past involvement in the National Training
Working Group. As shown in Figure 19, more than half of respondents (32/49, 65%)
reported not being involved and only a small number of respondents reported being very
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involved (4/49, 8%) or somewhat involved (8/49, 16%). A small number of respondents
(5/49, 10%) selected the choice “I don’t know” (Figure 19).
Figure 19: Participation in National Training Working Group
4.2.2 Characterizing Trainees
The survey included a series of questions to understand better the characteristics
of the study participants who identified as current or past trainees. Of the 20 current
TCORS trainees, about half (11/20, 55%) were postdoctoral trainees; the other half were
roughly split between predoctoral trainees (5/20, 25%) and faculty-level trainees (4/20,
20%) (Figure 20). As shown in Figure 21, among the 28 respondents who were past
TCORS trainees, half (13/28, 46%) were postdoctoral trainees, followed by predoctoral
trainees (12/28, 43%), then faculty-level trainees (2/28, 7%). The one respondent (1/20,
4%) who selected “Other” further reported being “all of the above”.
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Figure 20: Trainee Type, Current Trainees
Figure 21: Trainee Type, Past Trainees
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More than two-thirds of past trainees (19/28, 68%) indicated that they currently
hold a position in the field of tobacco regulatory science, tobacco control or other
tobacco-related field (Figure 22). A third of respondents (9/28, 32%) indicated that their
current position is not in any of the fields noted above; 8 respondents specified their
current field of work in the open text comment box as displayed in Figure 22.
Figure 22: Current Employment Field
Is your current position in the field of tobacco regulatory science, tobacco control, or other tobacco-
related field? (N=28)
Yes 19 (68%)
No: please specify the field
In medical school
Residency in Internal Medicine
I am an assistant professor and willing to continue working on toxicants emissions
from electronic cigarettes
gut-brain biology
I am a public health associate professor.
Clinical Microbiology
Investigator for a population based epidemiology study
I’m a data analyst at the BHCOE, an organization that provides accreditation for
behavior analysis providers.
9 (32%)
The past trainees were also asked to indicate the industry they are in currently;
responses are shown in Figure 23. The majority of respondents (19/28, 68%) indicated
that they were employed in academia, a few reported being employed by the federal
government (2/28, 7%) or tobacco products industry (1/28, 4%), and three respondents
(3/28, 11%) indicated that they were still in training. The remaining respondents (3/28,
11%) selected “other” and described their current employer as: Independent Research
Institute; Autism/Behavior Analysis Industry; and Non-Profit.
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Figure 23: Current Employer
All respondents who identified as trainees (current or past) were asked about their future
career aspirations (Figure 24). More than half of all respondents (31/48, 65%) indicated
they wanted a future career in academia while only one respondent (2%) indicated
wanting a career in the tobacco products industry. A small number of respondents (5/48,
10%) reported wanting a future career in federal government and 11 (23%) selected
“other” and specified the following: current medical student; physician-scientist; unsure;
clinical; clinical practice and academia.
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Figure 24: Future Career Goals
4.3 Level of Implementation of Competencies into Training Programs
The next section of the survey included a series of questions regarding
respondents’ views on the level of implementation of the competencies into the training
programs at their respective TCORS. In order to present the views of each of the main
stakeholder groups, data for some questions was cross-tabulated against respondent
function/role and not reported in aggregate. For some questions, data is presented
separately for respondents who identified as past trainees or current trainees; for other
questions, data from these two groups of respondents is presented in aggregate. When
asked if they knew that the TCORS had identified a list of competencies in Tobacco
Regulatory Science (TRS), the responses were split. Exactly half of participants (49/98)
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said “yes” and half (49/98) said “no”. Results were similar when broken down by
respondents’ current roles within the TCORS (Figure 25). Of respondents who identified
as faculty, about half (22/42, 52%) were aware of the TCORS competencies and half
(20/42, 48%) were not. Among current trainees, 9 (9/20, 45%) were aware and 11
(11/20, 55%) were not. Among past trainees, 14 respondents (50%) were aware and 14
(50%) not aware. Both respondents (100%) who identified as staff were aware of the
competencies. Of the 6 respondents who selected “other” as their current TCORS role, 2
(33%) were aware and 4 (67%) were not.
Figure 25: Awareness about TCORS Competencies per TCORS Role
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This question was also analyzed by stratifying responses according to association
with TCORS 1.0, TCORS 2.0 or both (Figure 26). Results show that respondents who
were associated with both TCORS cohorts were more likely to be aware of the
competencies—30 out of 46 respondents (65%) were aware and 16 out of 46 respondents
(35%) were not. Of the 13 respondents representing only TCORS 1.0, about half (7/13,
54%) were aware of the competencies and half (6/13, 46%) were not. In contrast,
respondents that were only a part of TCORS 2.0 were less likely to be aware of the
competencies (11/33, 33% were aware and 22/33, 67% were not aware).
Figure 26: Awareness about Competencies Per Cohort Association
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Respondents who reported being aware of the existence of the competencies were
then asked to report how they learned about them; respondents were offered five choices
and were allowed to make multiple selections (Table 12). The choice selected most often
by respondents was “Through leadership in my TCORS institution” (31 selections),
followed by “Through presentation at national TCORS meetings” (15 selections),
“Through manuscript published by Wipfli et al. in TRS journal” (12 selections) and
“Through participation in national Training Working Group meetings (9 selections). The
“Other: please describe” choice was selected 4 times and open-ended text responses are
shown below in Table 12.
Table 12: How did you learn about TRS competencies?
The next few questions sought to understand how the stakeholder groups
perceived implementation activities to be progressing in their respective centers.
Respondents were presented with a list of the six TRS Core Competency Domains and
asked to select the level of focus that best described their respective TCORS in their
efforts to develop trainees in each of these domains. The responses across the six
domains were fairly similar (Figure 27). More than half of all respondents believed that
their TCORS places a strong level of focus on all 6 core competency domains. In
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contrast, only 1-2 respondents believed that their TCORS places no focus toward
developing trainees to be competent in these same 6 core competency domains.
Specifically, for the domain “Health consequences of tobacco use and
population health impact”, 61 (62%) believed their TCORS places a “strong” level of
focus, 24 (24%) selected “modest”, 8 (8%) selected minimal, 2 (2%) selected “none” and
3 (3%) selected “I don’t know”. For the domain “Tobacco Control Act/FDA
Regulatory Framework”, 57/98 respondents (58%) selected “strong”, 27 (28%) selected
“modest”, 8 (8%) selected “minimal”, one (1%) selected “none” and 5 (5%) selected “I
don’t know”. For the domain “Tobacco Control Policies and Programs”, respondent
selections were: 60/97 (62%) “strong”, 24/97 (25%) “modest”, 10/97 (10%) “minimal”,
1/97 (1%) “none” and 2/97 (2%) “I don’t know”. For the domain “Tobacco and
Nicotine Product Diversity”, respondent selections were: 62/97 (64%) “strong”, 25/97
(26%) “modest”, 6/97 (6%) “minimal”, 1/97 (1%) “none” and 3/97 (3%) “I don’t know”.
For the “Vulnerable Populations” domain, respondent selections were 50/97 (52%)
“strong”, 32/97 (33%) “modest”, 11/97 (11%) “minimal”, 2/97 (2%) “none” and 2/97
(2%) “I don’t know”. For the “Skills – Research, Dissemination, Testimony” domain,
respondent selections were 61/97 (63%) “strong”, 23/97 (24%) “modest”, 6/97 (6%)
“minimal”, 2/97 (2%) “none” and 5/97 (5%) “I don’t know”.
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Figure 27: Level of Focus on Core Competency Domains
Responses were less consistent when the questions inquired about the level of
focus placed on developing trainees in the Specialized Competency Domains (Figure 28).
For the domain “Addiction”, over half of respondents (57/98, 58%) selected “strong”,
one in five respondents (20/98, 20%) selected “modest”, 14/98 (14%) selected
“minimal”, 4/98 (4%) selected “none” and 3/98 (3%) selected “I don’t know”. For
“Toxicology”, respondent selections were more evenly distributed: 31/98 (32%) selected
“strong”, 22/98 (22%) selected “modest”, 22/98 (22%) selected “minimal”, 15/98 (15%)
selection “none” and 8/98 (8%) selected “I don’t know”. For “Litigation and
Disclosure”, respondent selections were: 8/98 (8%) “strong”, 20/98 (20%) “modest”,
37/98 (38%) “minimal”, 22/98 (22%) “none”, and 11/98 (11%) “I don’t know”. For the
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“Marketing and Communication” domain, 44% (43/98) of respondents selected
“strong”, 22% (22/98) selected “modest”, 18% (18/98) selected “minimal”, 9% (9/98)
selected “none” and 6% (6/98) selected “I don’t know”. For the “Economic:
Cost/Benefit” domain, 15% (15/98) of respondents selected “strong”, 30% (29/98)
selected “modest”, 27% (26/98) selected “minimal”, 18% (18/98) selected “none” and
10% (10/98) selected “I don’t know”.
Figure 28: Level of Focus on Specialized Competency Domains
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Figure 29: Emphasis on Implementing Competencies into Training Programs
Respondents were asked whether they believe their TCORS places an emphasis on
incorporating the competencies into its training and career enhancement program
(Figure 29). Over half of all respondents (64/98, 65%) said “yes” while only a handful
(6/98, 6%) said “no”. A significant number of respondents (28/98, 29%) selected “I
don’t know”.
The six respondents who said they don’t believe their TCORS emphasizes the
implementation of the competencies were further probed to understand why they thought
this was the case. Five of the six respondents provided comments in the open text
comment fields, which are displayed in Table 13.
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Table 13: Open Text Comments
Why do you think your TCORS does NOT place an emphasis on incorporating
the established competencies into its training programs? (N=5)
No idea
There was no training
Not sure that they know that TCORS competencies exist. Also, not everyone is
required to develop competencies in all areas. One can be highly competent in one
areas because it’s area of their expertise without developing high competencies in
other areas, and that’s completely acceptable.
I think they put emphasis on certain competencies more than others.
Don’t know
Respondents were then asked to identify the ways in which their TCORS had
used the competencies in its training and career enhancement program. The survey
question offered five answer choices, including an “other: please describe” choice and
respondents were allowed to make multiple selections (Figure 30). The choice selected
most often by respondents was “External resources are offered to address competency
areas in which my TCORS does not have expertise” (55/170), followed by “New
coursework” (39), “Individual Development Plans” (36), and “Coursework was revised to
address the competencies” (29). Additionally, 5 respondents selected “other: please
describe” and their additional comments are shown in Table 14.
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Figure 30: How Have Competencies Been Used?
Table 14: Additional Comments - How Have Competencies Been Used?
The TRS competencies were developed to help guide the development of the
TCORS training programs. To understand the extent to which these have been utilized
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for the intended purpose, the survey asked all respondents to select the statement that
most accurately describes the readiness of their TCORS in implementing the TRS
competencies into their respective training programs (Figure 31). More than half of all
respondents (52/96, 54%) indicated that they do not know. About 23% (22/96) of
respondents indicated that their center has implemented the competencies; about 13%
(12/96) indicated they had implemented the competencies and conducted or planned to
conduct program evaluation. Comparatively, a smaller number of respondents suggested
that their centers had initiated activities and acquired resources in preparation for
program implementation (8/96, 8%) or were only exploring the feasibility of
implementation and fit with their existing training program (2/96, 2%). The answer
choice “we have decided to pursue implementation but have not started the process” was
not selected.
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Figure 31: Stage of Implementation
To better characterize the perceived stage of implementation of the competencies
per the respondents, the survey inquired about the extent to which the TCORS had
mapped competencies to coursework (Figure 32). Again, the most common response,
selected by more than half of all respondents (56/96, 58) was “I don’t know”. More than
a quarter of respondents indicated that their centers had either begun to map the
competencies to existing curricula (7/96, 7%) or had completed the process (18/96, 19%).
Some respondents (8/96, 8%) indicated that they were in the process of developing new
curricula that would address the defined competencies. A very small number of
respondents suggested their centers were exploring how to do this (4/96, 4%) or had
decided to forgo the process altogether (3/96, 3%).
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Figure 32: Mapping of Competencies to Coursework
It was also important to characterize respondent satisfaction with the level to
which their respective TCORS had accomplished certain activities, such as acquiring
necessary human and technology resources, providing opportunities for mentor training,
mapping competencies to curricula, developing trainee assessment tools or program
evaluation tools/methods. These activities were derived from the literature review as
discussed in section 2.6.1.
As displayed Table 15, a majority of respondents (70/97, 72%) were very satisfied
with the level to which their TCORS had acquired necessary resources, 17 of 97
respondents (18%) were somewhat satisfied and a couple of respondents (2/97, 2%) were
not satisfied. Additionally, 8 respondents indicated that they did not know. Regarding
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opportunities for mentor training, more than half of respondents (60/96, 63%) were very
satisfied and about a quarter of respondents (26/96, 27%) were somewhat satisfied.
About 10% indicated being either not satisfied (4/96, 4%) or did not know (6/96, 6%).
Respondents were again probed on their level of satisfaction with the extent to
which the competencies had been mapped to curricula. Responses were about equally
split between very satisfied (27/96, 28%) and somewhat satisfied (28/96, 29%) with a
smaller number of respondents indicating they were not satisfied (11/96, 11%). Almost a
third of respondents (30/96, 31%) indicated that they did not know.
Regarding the development of trainee assessment tools, the majority of
respondents indicated being either very satisfied (36/97, 37%) or somewhat satisfied
(30/97, 31%) with some respondents stating they were not satisfied (11/97, 11%). A
significant number of respondents (20/97, 21%) selected “I don’t know”.
The distribution of responses concerning the development of program evaluation
tools/methods closely echoed those concerning the development of trainee assessment
tools—the majority were either very satisfied (33/96, 34%) or somewhat satisfied (30/96,
31%). Ten percent of respondents (10/96) selected being not satisfied and 24% (23/96)
selected “I don’t know”.
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Table 15: Level of Satisfaction with Implementation Activities
How satisfied are you with the level to which your TCORS has accomplished the following activities?
Very
satisfied
Somewhat
satisfied
Not
satisfied
I don’t
know
Total
responses
Acquired necessary resources (i.e.
technology, human resources)
70, 72% 17, 18% 2, 2% 8, 8% 97
Provided opportunities for mentor
training
60, 63% 26, 27% 4, 4% 6, 6% 96
Mapped the competencies to
existing curricula
27, 28% 28, 29% 11, 11% 30, 31% 96
Developed trainee assessment
tools
36, 37% 30, 31% 11, 11% 20, 21% 97
Developed program evaluation
tools/methods
33, 34% 30, 31% 10, 10% 23, 24% 96
It was important to understand the extent to which the TCORS had provided
training resources (such as courses, lectures, workshops, or other) in each of the
competency domains, and whether these were balanced across the eleven competency
domains (Table 16). For the six core competency domains, responses were fairly
balanced. Over two thirds of respondents believed that training resources were already
developed or offered in these core domains, with the following specific breakdown:
Health Consequences of Tobacco Use and Population Health Impact - 71/97, 73%;
Tobacco Control Act/FDA Regulatory Framework - 63/96, 66%; Tobacco Control
Policies and Programs - 64/96, 67% ; Tobacco and Nicotine Product Diversity - 67/96,
70%; Vulnerable Populations - 63/96, 66%; Skills – Research, Dissemination, Testimony
- 69/96, 72%.
A small number of respondents reported that their TCORS was planning to
develop or offer resources in these competency domains: Health Consequences of
Tobacco Use and Population Health Impact – 5/97, 5%; Tobacco Control Act/FDA
Regulatory Framework - 9/96, 9%; Tobacco Control Policies and Programs - 7/96, 7% ;
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Tobacco and Nicotine Product Diversity - 6/96, 6%; Vulnerable Populations - 7/96, 7%;
Skills – Research, Dissemination, Testimony - 2/96, 2%. For all six of these domains,
only 2-3 respondents (2-3%) reported that their Center was not planning to develop or
offer resources. Nineteen to 23 respondents (20-24%) reported “I don’t know” for all six
domains.
For the five specialized competency domains, responses were not so balanced. As
detailed in Table 16, the Addiction domain was the most developed (55/95, 58%)
according to survey respondents, followed by Marketing & Communication (51/96,
53%), then Toxicology (39/96, 41%). The domain Litigation and Disclosure was the
least developed (18/96, 19%), followed by Economic: Cost/Benefit (25/96, 26%).
Between 8-12% of respondents believed that their Centers were planning to develop these
domains (8% for Addiction, Marketing & Communication, 9% for Toxicology, 10%
Litigation/Disclosure, and over 12% Economic: Cost/Benefit Analysis).
While only 3-5% stated their Centers did not plan to develop the domains of
Addiction (3/95, 3%) and Marketing/Communications (5/96, 5%), a slightly larger
number stated the same for the other 3 domains (10/96, 10% for Toxicology; 12/96,
12.5% Economic: Cost/Benefit; and 15/96, 16% for Litigation/Disclosure). Between
one-third and one-half of respondents did not know the status of or plans surrounding the
development of these five specialized domains at their respective TCORS.
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Table 16: Extent of Development of Competency Domains
Describe the extent to which your TCORS has provided training resources in the following competency
domains.
Developed
and/or offered
Planning to
develop/offer
Not planning to
develop/offer
I don't
know
Total
Resp.
Health Consequences of
Tob. Use and Population
Health Impact
71, 73% 5, 5% 2, 2% 19, 20% 97
Tobacco Control
Act/FDA Regulatory
Framework
63, 66% 9, 9% 2, 2% 22, 23% 96
Tobacco Control
Policies and Programs
64, 67% 7, 7% 3, 3% 22, 23% 96
Tobacco and Nicotine
Product Diversity
67, 70% 6, 6% 2, 2% 21, 22% 96
Vulnerable Populations 63, 66% 7, 7% 3, 3% 23, 24% 96
Skills - Research,
Dissemination,
Testimony
69, 72% 2, 2% 2, 2% 23, 24% 96
Addiction 55, 58% 8, 8% 3, 3% 29, 31% 95
Toxicology 39, 41% 9, 9% 10, 10% 38, 40% 96
Litigation and
Disclosure
18, 19% 10, 10% 15, 16% 53, 55% 96
Marketing and
Communication
51, 53% 8, 8% 5, 5% 32, 33% 96
Economic: Cost/Benefit 25, 26% 12, 12.5% 12, 12.5% 47, 49% 96
4.4 Understanding Implementation Components and Drivers
Another research area of this study was to explore what challenges the TCORS
encountered when attempting to implement the competencies and whether there were any
enablers to implementation.
4.4.1 Challenges to Implementation
Respondents were asked to rate a set of statements according to level of challenge
(very challenging, somewhat challenging, not challenging, I don’t know) (Table 17). The
six statements were derived from the literature review for this study as presented in
section 2.6.1. The majority of respondents (39/94, 41%) didn’t believe that a lack of
knowledge about the existence of the competencies was a challenge to implementation;
slightly less than a quarter of respondents (20/94, 21%) believed it was somewhat
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challenging and only 4 (4/94, 4%) found it very challenging. A third of respondents
(31/94, 33%) selected “I don’t know”.
For the second statement, “lack of communication across the TCORS regarding
the implementation of the competencies”, again the majority of respondents (32/94, 34%)
did not find it challenging, about a quarter (22/94, 23%) found it somewhat challenging,
10 respondents (10/94, 11%) found it very challenging, and about a third (30/94, 32%)
selected “I don’t know”.
The third statement asked respondents to rank the level of challenge that was
posed by the lack of adequate administrative infrastructure support. Responses were
quite similar to the two previous statements—40% (38/94) selected not challenging, 23%
(22/94) found it somewhat challenging, 5% (5/94) found it very challenging and 31%
(29/94) did not know.
The fourth statement inquired about the time constraints of faculty and mentors.
Over half of all respondents found this to be either very challenging to implementation
(23/93, 25%) or somewhat challenging (30/93, 32%) as opposed to a smaller number of
respondents (16/93, 17%) who found it not challenging. About a quarter of respondents
(24/93, 26%) did not know.
For statement 5, close to half of all respondents (45/93, 48%) did not believe that
a lack of faculty/mentors trained in TRS was a challenge, a fifth of respondents (19/93,
20%) believed this was somewhat challenging, and only 5% (7/93) found this to be a
major challenge. About a quarter of respondents (24/93, 26%) did not know.
The last statement was about the lack of faculty/mentor development programs.
A large number of respondents (44/94, 47%) did not find this to be a challenge, some
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(16/94, 17%) found it somewhat challenging, and only a few (7/94, 7%) found it very
challenging. Again, over a quarter of respondents (27/94, 29%) did not know.
Table 17: Challenges to Implementation
What do you think are the challenges faced by your institution during its attempt to incorporate the
competencies into your training program? Rate the following according to level of challenge.
Very
challenging
Somewhat
challenging
Not
challenging
I don't
know
Total
Resp.
Lack of knowledge about the
existence of competencies
4, 4% 20, 21% 39, 41% 31, 33% 94
Lack of communication across
TCORS regarding the
implementation of the competencies
10, 11% 22, 23% 32, 34% 30, 32% 94
Lack of adequate administrative
infrastructure support
5, 5% 22, 23% 38, 40% 29, 31% 94
Time constraints of faculty/mentors 23, 25% 30, 32% 16, 17% 24, 26% 93
Lack of faculty/mentors who are
trained in TRS
7, 5% 19, 20% 45, 48% 24, 26% 93
Lack of faculty/mentor development
programs
7, 7% 16, 17% 44, 47% 27, 29% 94
Respondents were then asked to share (in open-text-entry format) what they
believed was the most significant barrier/challenge to fully implementing the TRS
competencies into the training program at their TCORS. A total of 29 respondents shared
their views; 16 of these responses were from mentors and 13 from trainees. The
responses are presented in Table 18 and Table 19 below with two minor redactions (first
instance mentioned a specific TCORS and another a specific individual). The responses
were analyzed for content, to the degree possible, noting any patterns or repetitions.
Across both stakeholder groups, a challenge cited often (7 instances) was
inadequate communication and/or awareness about the existence of the competencies or
curriculum design process. Another common theme that emerged was faculty resources,
more specifically, time constraints of faculty (8 instances). A significant number of
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respondents shared that they weren’t directly involved in their respective training
program or weren’t involved in the competency development process and hence didn’t
have any feedback to share (5 mentors, 1 trainee). Three mentors shared that didn’t
identify any barriers to implementation (2/16) or were unsure if any existed (1/16). The
wide range in competency domains/topics and their relevancy trainees at various levels
was another challenge that was cited numerous times (6 instances). A couple of mentors
noted the importance of CASEL’s or the NIH’s involvement in this process and/or the
coordination of efforts across the TCORS. Other individual comments are displayed in
Table 18 and Table 19 below.
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Table 18: Significant Barriers to Implementation (Mentor Feedback)
In your view, what is the most significant barrier/challenge to fully implementing the TRS
competencies into the training program at your TCORS?
I didn’t realize that such competencies existed. If having competencies in these areas are a training goal
then then CASEL of the NIH should emphasize that each TCORS should be addressing them.
Communication from the National Training Working Group to coordinate efforts across TCORS
Time and commitment.
Resources. Faculty time.
I have other competing priorities (e.g., writing more grants to fund my salary and my team's salaries,
writing papers, administrative tasks such as trying to find out how much money we have and how to get it
allocated correctly, doing human resources work, writing recommendation letters, teaching, responding to
student crises, etc., etc., etc.)
If some of those tasks were done efficiently and correctly by other people, I would have more time to
learn what the TCORS competencies are and teach them. However, we are evaluated by how much
money we bring in and what journals we publish in, and we don't have a functional administrative staff to
help (grants people, HR, student services staff, nonexistent administrative assistants). Therefore, I spend
most of my day putting out other fires rather than mentoring.
Lack of faculty expertise in TRS and focus on this as part of the training program.
Trainees across TCORs are at various stages of their careers (from undergrads to junior faculty). It's
difficult to come up with plans/curricula that would be appropriate and useful for everyone.
Most competencies are not relevant to the purpose of our center.
None noted.
Unaware of any barriers.
I really can't comment as I have limited involvement in the TCORS over the past few years.
I have not been involved in developing the competencies and am having a hard time answering these
questions.
This is a bit outside my expertise as I am not officially TCORS faculty, as associated faculty I am not
directly involved in the training program at my TCORS.
I recently transitioned to being a TCORS faculty and can not speak to the barriers/challenges to fully
implementing the TRS competencies into the training program.
I have not been involved in the receipt of or planning for any competency trainings so unfortunately I
don't have the information needed to answer many of these questions.
Not sure
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Table 19: Significant Barriers to Implementation (Trainee Feedback)
In your view, what is the most significant barrier/challenge to fully implementing the TRS
competencies into the training program at your TCORS?
The lack of knowledge about the core competencies
Ensuring the trainees know there are TRS competencies and how they can be effectively trained and
assessed. There should be contingencies tied to providing adequate opportunities for trainees to develop
these competencies.
I was not aware that the TRS competencies existed. So I would expect that awareness will be a major
barrier. Two additional substantial barriers that I see are relevance and availability, convincing extremely
busy trainees that they should take the time to build up competency in areas that are not directly related to
the research that they are conducting will be a challenge.
TCORS communication and administration is very hierarchical by Default from the FDA/NIDA- I think
the top down approach is fueled by the manner with which the FDA is managing TCORS anyway, so not
sure how the trainees can actively contribute in policy or planning if this is the case!
The training for these competencies specifically seemed a bit lackadaisical. Some competencies were far
more comprehensive than others. For example, training in research and dissemination was exemplary in
my training program. However, training in FDA disclosures and other FDA-specific topics was lacking. It
seems that the training on topics that are easy and natural to do for the faculty members is what was
emphasized, with little thought about formal training in other competency areas. Staff/Faculty can only
teach what they know.
I am not aware of the processes used to design the curriculum at my TCORS, however I do know that
faculty running the career enhancement core engaged in regular and rigorous evaluations of the program,
which they then used to make improvements to the training program regularly. I imagine that the biggest
barrier may be that the competencies span a wide range of substantive topics (i.e., economics, product
diversity, toxicology, litigation/policy), and so comprehensively mapping these diverse competencies into
a 1 or 2 year training program may be difficult.
The willingness of faculty to formalize the process.
TCORS faculty members already have a full schedule, I think it was difficult to prioritize TRS
competencies into the training program given the emphasis on research, publications, project-specific
TCORS meetings and the department level TCORS meetings
Faculty/mentors in a soft money environment are so busy with other grants that there was insufficient
opportunity/time to devote to the training program. Some faculty were co-I's on TCORS and much more
focused on the grants on which they were PI's. To my knowledge there's 2-4 other center grants at my
institution, meaning faculty are just too busy.
I did not receive adequate support as a postdoc. I was new to the research field and felt that I had been
thrown into a pool and expected to swim. My research training was provided largely by undergraduate
and graduate research assistants. I had weekly meetings with my faculty mentor, but very little training
was conducted in these meetings. Most of my "training" was done via observation in meetings and by
seeking out the expertise of other postdocs. I was used to an academic environment with cordial
collaboration and high congeniality among colleagues. I experienced neither of these at XYZ.
Additionally, there was a lot of pressure from faculty to publish frequently. I understand the modern
academic publishing requirements, but to meet these criteria I should have received more adequate
supervision and direction from faculty in the program. I decided to quit my postdoc after one year as I
was quite depressed and unhappy in the role.
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In your view, what is the most significant barrier/challenge to fully implementing the TRS
competencies into the training program at your TCORS?
The TRS competencies cannot be fully implemented unless diversity and inclusion are also a priority.
Trainee challenges and performance differ widely and in part due to systemic barriers in academia.
The pandemic posed some challenges and was a major barrier in getting the most out of the training
opportunities.
I'm not sure, I'm not part of this process
4.4.2 Enablers to Implementation
To better understand stakeholder views regarding implementation drivers, we
presented a list of five resources and asked, “How helpful would it be to have the
following resources centralized and accessible in advancing the implementation of the
competencies in your TCORS training programs?” Respondents were asked to select very
helpful, somewhat helpful, or not helpful. Respondents also had the option to select “I
don’t know” and to share additional resources that were not listed.
As can be seen in Table 20, the majority of respondents believed that having an
implementation toolkit, evaluation tools, and benchmarks for attaining competency
would have been very helpful (51/91, 56%; 48/91, 53%; 51/91, 56%, respectively). A
little less than half of respondents believed that having curriculum mapping or assessment
tools would have been very helpful (curriculum mapping tools: 40/90, 44%; assessment
plan: 45/91, 49%). Close to a third or more of respondents selected somewhat helpful for
all five resource categories (implementation toolkit/guidelines: 27/91, 30%; curriculum
mapping tools: 34/90, 38%; assessment plan: 34/91, 37%; evaluation tools: 29/91, 32%;
and benchmarks for attaining competency: 26/91, 29%). Very few respondents selected
not helpful for any of the five categories (1-4, 1-4%). Roughly the same number of
respondents selected “I don’t know” for any of the five categories (11-12, 11-12%).
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Additionally, two respondents provided comments in the open text comment box; these
are displayed below in Table 21.
Table 20: Centralized and Accessible Resources
How helpful would it be to have the following resources centralized and accessible in advancing the
implementation of the competencies in your TCORS training programs?
Very helpful Somewhat
helpful
Not helpful I don't know Total
Implementation toolkit or guidelines 51, 56% 27, 30% 2, 2% 11, 12%
91
Curriculum mapping tools 40, 44% 34, 38% 4, 4% 12, 13%
90
Assessment plan 45, 49%
34, 37% 1, 1% 11, 12%
91
Evaluation tools 48, 53% 29, 32% 2, 2% 12, 13%
91
Benchmarks for attaining competency 51, 56%
26, 29% 3, 3% 11, 12%
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Table 21: Affiliated Comments: Centralized and Accessible Resources
How helpful would it be to have the following resources centralized and accessible in
advancing the implementation of the competencies in your TCORS training programs?
Additional Comments
“Other: please describe”
As I was a predoctoral trainee, I don’t know much about this part.
Salary support for mentoring activities.
Respondents were then provided a list of five resources considered to be potential
enablers to implementation—derived from literature review as discussed in section
2.5.2—and asked to rank order in order of importance, with one being of highest
importance and 5 being of lowest importance (Table 22). To understand how the
respondents collectively viewed the importance of each of the resources, a weighted
mean score—provided by Qualtrics—is provided for each resource (Table 22).
The weighted mean results of all respondents revealed that additional funds was
ranked as the most important resource (weighted mean: 2.46) and supportive technology
was ranked as the least important resource (weighted mean: 3.76). The weighted means
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for the other three resources were fairly close: additional faculty/mentors or more faculty
with relevant expertise in TRS (weighted mean: 2.76), additional centralized/shareable
resources (weighted mean: 2.80), and additional supportive personnel (weighted mean:
2.85).
A cross tabulation was performed of the five presented resources for the two main
stakeholder groups—mentors and trainees (Table 22). Responses from the trainees
(n=45) were similar to those of the overall respondents in that the resource ranked as
most important was additional funds (weighted mean: 2.42), followed by additional
faculty/mentors (weighted mean: 2.56), additional centralized/shareable resources
(weighted mean: 2.67), additional supportive personnel (3.00), and supportive
technology (3.82).
In comparison, the mentors (n=40) had slightly different views on the order of
importance of the resources. They also ranked additional resources as the most
important resource (weighted mean: 2.50) but followed by additional supportive
personnel (weighted mean: 2.70), additional centralized/shareable resources (weighted
mean: 2.95), additional faculty/mentors with TRS expertise (2.97), and supportive
technology (weighted mean: 3.69).
Table 22: Importance of Resources as Enablers to Full Implementation
How important do you consider the following resources to be in enabling full implementation of the
TRS competencies into the training program at your TCORS? Rank in order of importance.
Resources All respondents
(n=85)
Mentors
(n=40)
Trainees
(n=45)
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Rank Order
(weighted mean)
Rank Order
(weighted mean)
Rank Order
(weighted mean)
Additional funds 1 (2.46)
1 (2.50) 1 (2.42)
Additional faculty/mentors or more
faculty with TRS expertise
2 (2.76) 4 (2.97) 2 (2.56)
Additional centralized/shareable
resources
3 (2.80) 3 (2.95) 3 (2.67)
Additional supportive personnel
4 (2.85) 2 (2.70) 4 (3.00)
Supportive technology
5 (3.76) 5 (3.69) 5 (3.82)
Respondents were further probed on their perspectives around the helpfulness of
certain items/resources in advancing the implementation of the competencies at their
respective TCORS. Respondents were presented with a list of eight items/resources and
asked whether each of these would be very helpful, somewhat helpful, neither helpful nor
unhelpful, or to report “I don’t know” (Table 23).
For Increased communication from the Training Working Group, almost half of
respondents selected “very helpful” (41/92, 45%), followed by “somewhat helpful”
(32/92, 35%), “neither helpful nor unhelpful” (8/92, 9%), “not helpful” (2/92, 2%), and “I
don’t know” (9/92, 10%).
For Opportunities to share experiences across TCORS, half of respondents
selected “very helpful” (47/92, 51%), followed by “somewhat helpful” (35/92, 38%),
“neither helpful nor unhelpful (4/92, 4%), “not helpful” (2/92, 2%) and “I don’t know”
(4, 92, 4%).
For Evidence of effectiveness in preparing trainees for future careers, over half of
respondents selected “very helpful” (52/92, 57%), followed by “somewhat helpful”
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(27/92, 29%), “neither helpful nor unhelpful” (5/92, 5%), “not helpful” (1/92, 1%) and “I
don’t know” (7/92, 8%).
For Availability of implementation guidelines, 40 respondents (40/92, 43%)
selected “very helpful”, over a third of respondents selected “somewhat helpful” (34/92,
37%), a smaller number selected “neither helpful nor unhelpful” (7/92, 8%) and about
one in ten selected “I don’t know” (11/92, 12%).
For Availability of tools to help map competencies to curricula, most respondents
selected “somewhat helpful” (38/92, 41%), followed by “very helpful” (32/92, 35%),
“neither helpful nor unhelpful” (14/92, 15%), and “I don’t know” (8/92, 9%).
For Availability of trainee assessment plan, the choice selected most often was
“very helpful” (39/92, 42%), followed by “somewhat helpful” (29/92, 32%), “neither
helpful nor unhelpful” (15/92, 16%), “not helpful” (2, 92, 2%), and “I don’t know” (7/92,
8%).
For Availability of program evaluation plan, about the same number of
respondents selected “very helpful” (36/92, 39%) and “somewhat helpful” (37/92, 40%),
followed by “neither helpful nor unhelpful” (8/92, 9%), “not helpful” (2/92, 2%), and “I
don’t know” (9/92, 10%).
For Mentor development modules, about half selected “very helpful” (45/92,
49%), a third selected “somewhat helpful” (30/92, 33%), followed by “neither helpful nor
unhelpful” (7/92, 8%), “not helpful” (2/92, 2%) and “I don’t know” (8/92, 9%). The
results are presented in detail in Table 23.
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Table 23: Helpful Resources
How helpful would it be to have the following items in advancing the implementation of the
competencies in your TCORS training programs?
Very
helpful
Somewhat
helpful
Neither
helpful nor
unhelpful
Not
helpful
I don't
know
Total
Increased communication from
the Training Working Group
41, 45% 32, 35% 8, 9% 2, 2% 9, 10% 92
Opportunities to share
experiences across TCORS
47, 51% 35, 38% 4, 4% 2, 2% 4, 4% 92
Evidence of effectiveness in
preparing trainees for future
careers
52, 57% 27, 29% 5, 5% 1, 1% 7, 8% 92
Availability of implementation
guidelines
40, 43% 34, 37% 7, 8% 0, 0% 11, 12% 92
Availability of tools to help map
competencies to curricula
32, 35% 38, 41% 14, 15% 0, 0% 8, 9% 92
Availability of trainee assessment
plan
39, 42% 29, 32% 15, 16% 2, 2% 7, 8% 92
Availability of program
evaluation plan/methods
36, 39% 37, 40% 8, 9% 2, 2% 9, 10% 92
Mentor development modules 45, 49% 30, 33% 7, 8% 2, 2% 8, 9% 92
4.4.3 Stakeholder Engagement
To better understand stakeholder engagement in the competency development
process, respondents were asked to rank their agreement with a set of four statements on
a three-point scale—Agree, Somewhat agree, Do not agree. Respondents also had the
option to select “I don’t know” (Table 24).
For the statement Communication from the National Training Working Group
was adequate, about a quarter of respondents selected “Agree” (24/91, 26%), followed by
“Somewhat agree” (18/91, 20%) and “Do not agree” (10/91, 11%). The majority of
respondents selected “I don’t know” (39/91, 43%).
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For the statement The process of developing the competencies was transparent,
about a fifth of respondents selected “Somewhat agree” (20/91, 22%), followed by
“Agree” (15/91, 16%) and “Do not agree” (12/91, 13%). Again, the majority of
respondents stated “I don’t know” (44/91, 48%).
For the statement I was provided the opportunity to participate in the competency
development process, over a third of respondents selected “Do not agree” (32/91, 35%),
followed by “Agree” (12/91, 13%), and “Somewhat agree” (10/91, 11%). Again, the
largest number of respondents selected “I don’t know” (37/91, 41%).
For the last statement, All stakeholders groups were involved throughout the
process, over half of respondents selected “I don’t know” (49/92, 53%), followed by “Do
not agree” (21/92, 23%), “Somewhat agree” (12/92, 13%), and “Agree” (10/92, 11%).
Table 24: Stakeholder Engagement in Competency Development Process
Thinking about how the competencies were developed and shared, please rank your agreement with the
following statements.
Agree Somewhat
agree
Do not
agree
I don't
know
Total
Communication from the National Training
Working Group was adequate
24 , 26% 18 , 20% 10 , 11% 39 , 43% 91
The process of developing the competencies
was transparent
15 , 16% 20 , 22% 12 , 13% 44 , 48% 91
I was provided the opportunity to participate in
the competency development process
12 , 13% 10 , 11% 32 , 35% 37 , 41% 91
All stakeholder groups were involved
throughout the process
10 , 11% 12 , 13% 21 , 23% 49 , 53% 92
4.5 Modification of Competencies for future efforts
The final set of survey questions explored stakeholder perceptions regarding the
usefulness of the competencies and if and how they should be modified for future efforts.
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When asked how useful the competencies were in guiding the development of training
programs in TRS (Figure 33), the overwhelming majority of respondents collectively
found them to be at least somewhat to very helpful (71/94, 76%) while less than a quarter
said they didn’t know (23/94, 24%). None of the 94 respondents found the competencies
not useful. When broken down by stakeholder group, it appears that a larger number of
trainees found the competencies to be at least somewhat useful (25/94, 53%) as compared
to mentors (16/94, 34%).
Figure 33: Usefulness of Competencies
Respondents were also asked to rate the usefulness of the competencies in guiding
Curriculum development, Trainee assessment, Mentor/faculty training and development,
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and Development of training resources (Figure 34). Collectively, over 60% of all
respondents found the competencies were useful in the development of all four areas.
Comparatively, only a handful believed the competencies were not useful for the
development of any of the four areas (Curriculum: 1/94, 1%; Trainee assessment: 5/94,
5%; Mentor Training: 2/94, 2%). A cross tabulation of stakeholder group is not shown as
it did not yield any noticeable difference in opinion on any of the four training areas.
Figure 34: Utility of Competencies
Respondents were asked about their views regarding the relevancy of the
competencies during the time of the study, considering that a number of years had passed
since they were developed. As detailed in Table 25, more than half of all respondents
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believed the competencies were either adequate in their current form (Mentors: 12/94,
26%; Trainees 6/94, 13%) or should be revised slightly (Mentors: 16/94, 34%; Trainees:
24/94, 51%). Comparatively, only four mentors (4/94, 9%) and four trainees (4/94, 9%)
believed the competencies should be revised extensively and none believed they should
be eliminated. About a third of respondents (Mentors: 15/94, 32%; Trainees: 13/94,
28%) selected “I don’t know”.
Table 25: Views on Relevancy of Competencies
Considering that a number of years have passed since the competencies were developed, what are
your views on the relevancy and adequacy of the competencies today?
Mentors Trainees
Competencies are adequate in their current forms 12, 26% 6, 13%
Competencies should be revised slightly 16, 34% 24, 51%
Competencies should be revised extensively 4, 9% 4, 9%
Competencies should be eliminated 0, 0% 0, 0%
I don't know 15, 32% 13, 28%
Total 47 47
When asked who should be tasked with monitoring and assessing the
implementation of the competencies (Figure 35), the option selected most often was
Individual TCORS (31/91, 34%), followed by NIH or FDA CTP (19/91, 21%), National
Training Working Group (18/91, 20%), Advisory council consisting of all stakeholders
(16/91, 18%), and Accrediting body (4/91, 4%). Of the three respondents who selected
“Other: please describe”, one wrote CASEL in the open-text-entry field, and another
wrote ‘I don’t know’. The third did not provide further a description.
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Figure 35: Oversight Bodies
The final survey question invited respondents to share any additional thoughts
regarding the competencies, the implementation process, future directions, or other.
Comments were received from fourteen respondents (14/97, 14%). Responses were
analyzed for content and grouped into four general groups: awareness and
communication regarding the competencies, competencies, implementation process,
other. Full responses are presented in Table 26.
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Table 26: Additional Thoughts from Respondents
Please share any additional thoughts you may have regarding the competencies, the implementation
process, future directions, or other.
Comments related to: lack of awareness or communication about competencies
As I was just a predoctoral trainee, I don't know much about how the program had been developed based
on competencies. Still, I can say all day that the training that I received during the TCORS 1.0 was really
wonderful; I have no doubt that it was the one of the best training programs in the field.
I can't speak to the competencies. I had no idea they existed. I was not made aware of any competencies
when I joined the XYZ program. As mentioned in my previous comment, I spent the greater part of that
year by myself with no direction. It was quite common for me to come into work and leave without
interacting with a single other individual in the office.
I marked TCORS faculty at the beginning of this survey. I am a faculty member, but not heavily involved
in our TCORS so I think I did not have adequate answers to some of the questions.
I have been in this TCORS from the start, but I admit that I don't know much about the competencies. I
know that XYZ and a workgroup developed them, that they sound good, and that students are probably
learning them. But that probably happens organically, between students and their committees, and the
rest of the TCORS doesn't really see the process or the outcomes. But I'm glad there are
competencies. However, on a day-to-day basis, I'm more concerned about the research getting done and
the students making progress toward their Ph.D.s, not necessarily specific TCORS competencies.
I think it's problematic that after six years in the TCORS training program, I didn't even know there were
competencies that I should have been working towards. I thought these "competencies" at TCORS
meetings were just general groupings of research abstracts, not benchmarks for me to gauge whether I
was getting the intended training from this program.
It felt odd to be considered a "TCORS trainee" when I felt like that didn't really mean anything as far as
training. I went to conferences, attended seminars, worked in research labs, did my coursework for my
degree, and finished my thesis and dissertation. But these all seem like things that are related to getting a
PhD, not things directly related to the TCORS trainee program.
Why is this survey being targeted to trainees? Trainees don't necessarily know about the development,
barriers, and implementation of competencies. This survey should be being directed to TCORS directors.
Comments related to: competencies
Competencies in basic research need to be developed further. For example, animal studies have been
extremely informative in the analysis of behavioral effects of tobacco product flavors, and their toxicity.
Analytical chemistry should also be more emphasized.
One competency area that is desperately needed is job preparedness training in tobacco control and
beyond (resume building, job searching, interview practice, etc.). It is the one area that I felt the least
prepared for as I finished my degree.
Comments related to: implementation process
Could be helpful to map the competencies to the current FDA TRS research priorities, as they have
shifted since the competencies were developed. There is still alignment between the two, but it may be
helpful to specifically address how these two intersect.
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Please share any additional thoughts you may have regarding the competencies, the implementation
process, future directions, or other.
Make it open for comments and input from all tobacco control researchers (even those with no TCORS
affiliation).
Monitoring and assessment of the competencies should occur at the trainee, mentor and TCORS center
levels.
As far as developing these competencies into training for students, it would be great to have an
understanding of the TCORS training program, as a whole, at the very start of initiation into the training
program. Topics to be covered would be: competencies, benchmarks for success, what it means to be a
TCORS trainee, expectations in the program, advantages to being in the program, etc.
Other comments
I had difficulties answering some of the questions. I had entered that I am a former TCORS Post-doc, but
questions were asked in present and not in past tense.
None noted.
Our Center lacked expertise in some of the competencies. We have found investigators from the first and
second round generous with their time in speaking with our fellows.
Use and refer to Wipfli repeatedly in our fellowship, grants, and manuscripts.
please support HBCUs. At an HBCU, I do not have access to many resources. My U is so small and the
resources are much more limited than UM, USC, etc.
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Chapter 5. Discussion
5.1 Overview
In 2014, the FDA partnered with the National Institutes of Health (NIH) to fund a
national network of Tobacco Centers of Regulatory Science (TCORS). The mission of
the TCORS is two-fold—help generate the scientific base to inform FDA’s tobacco-
related policy and develop and train scientists in the new field of tobacco regulatory
science. Collectively, the TCORS have demonstrated significant impact in developing
the science surrounding tobacco products. Based on these successes, a third TCORS
cohort is anticipated to be funded in Fall 2023 (NIH, 2022), again with a strong emphasis
on training and career enhancement of tobacco regulatory scientists. However, despite a
significant investment into these training programs, this component of the centers has
remained understudied. This dissertation provides beginning information on the current
state of these initiatives.
Given the nascency of TRS, there was an immediate need for training programs
that specifically addressed the conduct of regulatory research pertaining to tobacco
products, and the first activity that the TCORS immediately undertook as a collective
body was the development of competencies in tobacco regulatory science. A list of 79
competencies were developed across 11 domains and presented to the TCORS
community. But while the individual TCORS were encouraged to adopt these
competencies into their own training programs, no formal mechanisms were put in place
to ensure the implementation or evaluation of the competencies. This study examined the
adoption and implementation of these competencies through a survey of stakeholders
including faculty mentors, program directors, staff, and trainees. The development of the
study survey was guided by the implementation framework proposed by Fixsen and
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colleagues (Fixsen et al., 2005). Study findings suggest that while stakeholders find
utility in the competencies, they, largely, have not been fully implemented at most of the
TCORS. Findings also identify challenges and enablers to implementation. Findings
from the study should help inform the upcoming TCORS cohort in further developing
and refining the training programs.
5.2 Methodological Considerations
Data collection for this study was delimited to a specific time span—September-
December, 2021—thus, study findings reflect the views of stakeholders held during this
specific time epoch. However, the TCORS continued to expand and develop their
training programs beyond this period, and it’s expected that activities related to the
implementation of the TRS competencies also continued. Thus, it is unclear if
stakeholder views will be maintained over time. Fixsen and colleagues (2005) suggest
that full implementation of new programs may take 2-4 years, hence, capturing this data
when we did—6 years after the competencies were presented to the TCORS—seems
timely. Enough time had passed to allow us to gauge implementation maturity, both
within the initial and second TCORS cohorts.
Another limitation of this survey is that the data is not segmented based on the
TCORS center that respondents represent. This anonymity shades individual centers from
any criticism and scrutiny; however, at the same time, it limits our ability to evaluate
successful implementation and strategies that may have been adopted differentially across
the TCORS centers. In this respect, this was a missed opportunity to identify successful
implementors and activities that facilitated implementation and hence diminishes the
value of our data.
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The study proposed to survey stakeholders identified as faculty, administrative
staff, past program trainees, and current program trainees. Hence, a potentially low
response rate for any one of the four groups was a concern. An appropriate sample of
respondents per stakeholder group is necessary to be able to generalize findings for that
group (Kelley et al., 2003), and to be able to adequately perform cross tabulations across
various groups. The recruitment of past trainees was particularly concerning, for
numerous reasons. First, it was unclear if the contact information for past program
trainees obtained from CASEL would be up-to-date. Second, because this stakeholder
group has moved on from the training program, it was possible that they would no longer
be motivated to participate in such a study. However, response rate from this group was
acceptable. In fact, 28 survey respondents identified as past trainees versus 20 who
identified as current trainees. One factor that directly correlates to high survey response
rate is the total number of invitations sent, use of personal salutations, and sending
reminder notices (Cook et al., 2016), all strategies that were used in this research.
For this study, my goal was to survey two main stakeholders—TCORS mentors
and trainees. However, while identification of trainees was straightforward,
identification of mentors required some thought. For one, it was important to define a
“mentor”.
A mentor is an individual with expertise who can help develop the career
of a mentee. A mentor often has two primary functions for the mentee. The
career-related function establishes the mentor as a coach who provides
advice to enhance the mentee’s professional performance and
development. The psychosocial function establishes the mentor as a role
model and support system for the mentee. Both functions provide explicit
and implicit lessons related to professional development as well as
general work–life balance (APA, 2012).
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After careful thought, I selected to extend a study invitation to TCORS program
administrators and staff who were involved in training-related activities. The expectation
was that, despite not being faculty, these individuals had opportunity to affect the
implementation of the training programs, with often direct interactions with the trainees.
When asked to self-identify to one of five respondent categories (TCORS faculty, staff,
current trainee, past trainee, other), seven survey respondents self-identified as Staff (i.e.,
Center Director, Administrator, Core Director, Manager, etc.) or “Other”. These
respondents were ultimately bucketed under the “mentor” variable since they were
treated like faculty respondents with regard to the survey display logic (i.e., they were
presented the same questions that were presented to the faculty survey participants).
Perhaps a potential weakness in the survey design was the inclusion of questions
that contained “I don’t know” as an answer choice. Ten of the 34 survey questions
contained this answer choice, and selection of this answer choice by respondents was
fairly significant for some questions, ranging from 4% to 55%. It’s important to think
about why a respondent may select “I don’t know” as an answer choice. One reason is
that the respondent genuinely does not know, or “lacks the necessary information and/or
experience with which to form an attitude” (Krosnick & Presser, 2010). By explicitly
offering a “don’t know” option, these answer choices tell the respondent that it is
acceptable to say they have no information with which to answer a question (Krosnick
and Presser, 2010). For this reason, some researchers have recommended that the “don’t
know” option routinely be included in questions (Converse & Presser, 1986; Krosnick &
Presser, 2010). On the other hand, there is often a reluctance to allow these answer
choices as they reduce the effective sample size and representatives for the item. Often,
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respondents overuse them not from genuine lack of opinions, but rather from
ambivalence, question ambiguity, satisficing, survey fatigue, etc. (Krosnick & Presser,
2010). In the case of this study, the “don’t know” answer choice serves as a good proxy
for demonstrating awareness, which can denote, for example, poor or lack of stakeholder
engagement or lack of obvious or observable implementation activity. For this reason, it
was routinely and intentionally included as an answer option for certain questions.
5.3 Consideration of Results
The TRS training programs are an essential component across the TCORS
network and support the fundamental mission of this educational and research enterprise.
The TRS competencies not only are intended to provide a broad and comprehensive
education on tobacco regulation and control, but also to more uniformly train a
generation of TRS researchers. Given the important timing of this project, in anticipation
of the upcoming 2023 TCORS cohort, this study provides important context for
understanding stakeholder views of the existing training programs with respect to the
established TRS competencies.
According to Strifler et al. (2020), “over 100 theories, models and frameworks
exist to guide effective implementation and sustainability of evidence-based interventions
or programs.” The implementation science literature largely groups these into three
bins—process models, determinant frameworks, and implementation theory (Strifler et
al., 2020). I combed through many of these in order to identify one that would provide a
good frame of reference for this study. Because of its wide scope and applicability to the
current study, the Implementation Framework proposed by Fixsen and colleagues seemed
appropriate to guide the development of the study survey. The framework provided a
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basis for exploring the level or stage of program implementation, described as a “process
model” by the literature surrounding implementation science. It also helped identify
some of the systemic issues that could have hindered or influenced the implementation
process—often described as determinant frameworks. Lastly, it helped provide context
for predicting or explaining implementation success—described in the implementation
science literature by implementation theories (Strifler et al., 2020).
Study findings indicate that the TCORS have largely not reached full
implementation of the competencies. Potential influences on the implementation
process—such as stakeholder engagement and mentor development—are also identified.
The discussion of results presented below is organized according to the elements of the
study framework: 1) the stages of implementation and the 2) implementation framework.
5.3.1 Stages of Implementation
A central objective of this study was to identify the extent of implementation of
the TRS competencies into curricula and training programs across the TCORS. Hence,
survey questions were specifically developed to help identify activities that could be
associated with the various stages of implementation. Study findings indicate that while
the TCORS have begun implementation activities, collectively, they have not typically
gone past the beginning stages of implementation as defined by Fixsen’s Stages of
Implementation. One indicator of this is respondent answers directly inquiring about the
extent of implementation of the competencies at their respective TCORS. Only a third of
respondents indicated that their sites had implemented the competencies, and of these,
only about a third had initiated any activities aimed at program evaluation. This indicates
that implementation is largely at the Installation Stage. Implementation at some Centers
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seemed to be even less mature. For example, about 10% of respondents indicated that
their Centers were in the early “exploration phase” of preparing and acquiring resources
and exploring feasibility and fit with their program.
While disappointing, these findings can perhaps be partly explained by the lack of
a centralized and comprehensive implementation strategy, at least at the inter-TCORS
level. The majority of study respondents believed that having had access to centralized
resources—such as an implementation toolkit, curriculum mapping tools, assessment
plans and evaluation tools—would have been helpful in advancing the implementation of
the competencies. In the absence of these, implementation efforts were limited and
implementation across the TCORS may not be uniform. Respondent views seem to be in
agreement with the scientific literature on implementation science, which regards a well-
designed toolkit as an important facilitator to successful implementation (Thoele et al.,
2020). Kelli and colleagues share a case study on the development and use of a toolkit to
facilitate implementation of an intervention among several stakeholders in 14 acute care
hospitals, making a case for toolkits as effective strategies to foster adoption and
implementation of innovations (Thoele et al., 2020).
Fixen and colleagues describe a key feature of the Implementation Framework to
be the “feedback mechanism”, whereby findings from program evaluation are used to
guide decision-making. Unfortunately, in the absence of a broad and centralized
evaluation strategy, it will be difficult for the TCORS to assess how successfully the TRS
competencies were adopted/implemented, as well as how effective the competencies
themselves have been in developing TRS researchers. While individual TCORS may
have developed an evaluation plan, no such resources exist at the inter-TCORS level.
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5.3.1.1 Curriculum Mapping as Demonstration of Program Implementation
Curriculum mapping refers to the process of indexing a curriculum in order to
help identify academic gaps, redundancies, and misalignments for the purpose of
improving the overall coherence of a course of study, and its effectiveness (Suvin, 2023).
It provides a clear documentation of what is taught, when and how it is taught, and how it
aligns with the desired competencies and learning outcomes. The importance of
curriculum mapping in the implementation of a competencies-based education model is
well established in the literature, and to a degree, can serve as a proxy or demonstration
of effective implementation. To better characterize the perceived stage of
implementation of the TRS competencies, the study survey asked respondents about the
degree to which the TCORS had mapped competencies to coursework. The fact that
more than half of respondents were unaware of activities related to this can be a clear
indication that most TCORS have not begun to map the established TRS competencies
into their curricula or training plan. Surprisingly, this finding was evenly distributed
between faculty mentors and trainees. In fact, three respondents actually indicated that
their Centers were not planning to take on this exercise at all and about just as many were
only exploring how to do this. On the other hand, the number of respondents to confirm
that their TCORS had initiated any activities related to curriculum mapping was small—
only about a third of respondents. While this study did not directly explore the possible
reasons for the lack of activities related to curriculum mapping, we can make certain
inferences from study findings. For example, a majority of respondents indicated that
having had tools to help with mapping competencies to curricula would have been
helpful in advancing implementation, suggesting again, as discussed above, that the lack
of centralized resources and tookits impeded more successful implementation of the TRS
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competencies. Another reason, as indicated through further questioning, could be the
lack of faculty/mentor time or motivation to formalize such a process, as stated by
Respondent #75. This viewpoint was shared by a few respondents, some of whom shared
the following:
“TCORS faculty members already have a full schedule, I think it was difficult to
prioritize TRS competencies into the training grogram given the emphasis on research,
publications, project-specific TCORS meetings and the department level TCORS
meetings.”
“Faculty/mentors in a soft money environment are so busy with other grants that
there was insufficient opportunity/time to devote to the training program. Some faculty
were co-I's on TCORS and much more focused on the grants on which they were PI's. To
my knowledge there's 2-4 other center grants at my institution, meaning faculty are just
too busy.”
These findings point to a key element featured in Fixsen’s framework that has
been largely ignored in the implementation of TCORS training programs—the
“Influence” of the academic environment in which the TCORS operate. Without
consideration of these influences, training programs may fail to fully implement because
they do not take into account the various forces that are exerted on faculty at different
levels and their different motivations for participating in these programs altogether.
Keyser and colleagues suggest incentivizing and motivating faculty to serve effectively
as mentors:
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Institutional recognition and support of faculty contributions to mentoring
are important mechanisms for encouraging faculty members to serve as
mentors and for ensuring that mentors dedicate the requisite amount of
time and energy to the tasks involved. For example, willingness,
experience, or success serving as a mentor may be considered as part of
the annual review process for faculty members, or it may be required for
promotion or tenure. In some cases, institutions or departments will give
awards for excellence in mentoring or designate time and financial
resources for mentoring. In others, discussions about the importance of
mentoring may be incorporated into regular faculty meetings or other
faculty events (e.g., orientations, retreats). Although facing fiscal
constraints, some institutions may be able to institute financial incentives
for mentorship in faculty compensation plans. (Keyser et al., 2008 ).
5.3.2 Components of Implementation
In addition to exploring the maturity of implementation of the TRS competencies
across the TCORS network, this study also sought to identify challenges the TCORS may
have faced with the implementation process. “Distinguishing implementation
effectiveness from intervention effectiveness is critical for transporting interventions
from laboratory settings to real-world and or community settings” (Naccarella, 2022).
When these efforts fail, it becomes important to understand if the failure occurred due to
an ineffective intervention/program (intervention failure), or if the intervention/program
was implemented poorly (implementation failure). To better understand the latter, Fixen
and colleagues, as well as the broader implementation science literature, suggest that
there are common practices that drive implementation. In the absence of these
“implementation drivers”, successful implementation is hindered. One important
component to successful implementation identified in Chapter 2, as well as featured
prominently throughout Fixen’s framework, is stakeholder engagement. Another is
mentor/staff development and training.
131
5.3.2.1 Stakeholder Engagement
Fixsen’s conceptual framework for key components of implementation helps
portray the entire implementation “system”, consisting of five essential components,
which, according to the authors, exist in all successful implementation scenarios (Fixsen
et al., 2005). The iterative process is driven by the “communication link” and the
“feedback mechanism”, both of which are inherently tied to the key stakeholders that
should be actively engaged in the implementation process. For TCORS training
programs, these stakeholders are mentors that are developing or providing the training
and the trainees who are to develop their future careers on the basis of obtaining
competence in specified TRS competency areas. For successful implementation to occur,
both groups of stakeholders are to be engaged with all stages of program development,
implementation, and sustainment.
However, study findings point to a general lack of awareness about the existence
of the TRS competencies or the competency-based approach of the TCORS training
programs. Collectively, exactly half of respondents were aware that the TCORS had
developed such competencies, and half were unaware. However, a couple of details are
worth noting. As the newest and most unfamiliar participants in the TCORS network and
its training programs, current TCORS trainees had the greatest proportion of respondents
who were unaware of the existing competencies. Although past trainees were more
familiar with the competencies compared to current trainees, they were evenly split in
their awareness of the competencies. This indicates perhaps that trainees become more
aware of them as they obtain greater familiarity with the programming. This conclusion is
further supported by the disaggregated data analyses (Figure 26) that looked at awareness
of these competencies at a cohort level. Respondents that were only a part of TCORS 2.0
132
were disproportionately more likely to be unaware of the competencies (67%), while
those who had been a part of both cohorts were far more likely to be aware of the
competencies (65%). Given that the trainees are actively involved in the TCORS’
training programs as recipients of the training and mentoring, these findings indicate
insufficient stakeholder engagement in the implementation and evaluation of these
competencies across the TCORS network and individual cohorts.
These challenges with stakeholder engagement were also seen with TCORS
faculty, although at first glance the results appeared to be more positive. Unlike the
trainee populations, a greater proportion (52%) of TCORS faculty were aware of the
competencies, regardless of cohort association (Figure 25). These 42 individuals
indicated that they have current roles as TCORS faculty, meaning that they have either
participated in both cohorts TCORS 1.0 and 2.0 or have been recently introduced to the
network as a part of the second cohort. Although these results indicate that a significant
proportion were aware of the competencies, it is equally important to note that the
number of TCORS faculty who were still unaware of the competencies (n=20) is far
greater than what is seen in any other stakeholder group. This indicates that although
faculty may be involved in other aspects of the TCORS research programs, there may be
significant differences in their individual involvement in training and education activities,
or activities concerning the development and implementation of the competencies.
Characterizing the faculty respondents, a majority (60%) indicated that they are only
somewhat involved in the training and career enhancement activities in their TCORS, if
at all (Figure 17). And perhaps more noteworthy was that an even greater majority (75%)
of faculty and staff were either not involved with or not aware of the TCORS National
133
Training Working Group (Figure 19). These findings suggest that these faculty may not
be actively engaged in all aspects of their TCORS’ activities, and that despite their role as
faculty mentors, not all faculty are implementing these competencies in their training.
This underscores a significant need not only for greater stakeholder engagement within
the TCORS network, but also for additional training activities focused on providing
faculty mentors with the resources and knowledge needed to successfully implement,
monitor, and evaluate these competencies in their trainee populations.
5.3.2.2 Mentor Development and Training
Previous research suggests that mentorships are important in the development of
professionals in a range of academic fields (Johnson et al., 2012), and that structured and
purposeful mentorship is considered essential for professional development and career
success (Ellis, 1992; Pfund et al., 2006). As discussed earlier in this paper, mentor
development is also critical to effective implementation of competency-based training
programs (Carraccio et al., 2002; Hawkins et al., 2015) and should be a critical activity at
every stage of program implementation.
Mentorship in TRS has its unique challenges, and recognition of this led some
TCORS to explore this area early on. In 2017, Russo and colleagues, representing
various TCORS institutions across the nation, conducted a qualitative study investigating
the views and experiences of early career and senior scientists around mentorship in TRS
(Russo et al., 2017). The authors were interested in identifying the characteristics of TRS
that make it distinct from other research areas and understanding the challenges of
mentoring within TRS, with the goal of making recommendations for best practices in
TRS mentoring (Russo et al., 2017). The study found that the majority of tobacco
134
regulatory scientists serving as mentors did not participate in formal ongoing mentor
training to maintain or enhance their mentoring skills. The study also concluded that a
mentor training program specific to TRS would be valuable. The findings led to the
development and implementation of a training program for mentors that is specific to the
needs of TRS scientists (Di Frances et al., 2020). The number of TCORS who
subsequently implemented this mentor training program at their own centers is not
known, and this study did not attempt to identify that. But considering the favorable
responses from this study’s participants pertaining to the availability and opportunities
for mentor training across the TCORS, we may be able to infer that perhaps there was a
fair amount of uptake of the piloted mentoring training education.
When asked to rate their level of satisfaction with certain implementation
activities, 86% of respondents were satisfied with the opportunities provided for mentor
training. Responses to follow up questions seems to validate this finding. When asked
about perceived challenges to implementation of the TRS competencies, only 5% of
respondents believed that the lack of mentors trained in TRS posed a challenge, and 7%
believed that lack of mentor development programs was a challenge. Close to half of all
respondents did not find these to be a challenge at all. It is important to note here that the
study findings indicate that the biggest challenge to the implementation process was time
constraints of mentors, but this is discussed elsewhere in this paper.
5.4 Future Directions and Concluding Thoughts
According to the latest funding opportunity announcement for the Tobacco
Centers of Regulatory Science (TCORS), given the continued need for TRS researchers
that are capable of conducting cutting-edge research, all “TCORS are required to have a
135
Career Enhancement Core that will provide exposure to and experience in Tobacco
Regulatory Science” (NIH, 2022). Internally to each of the TCORS, these career
enhancement cores are intended to focus on research experiences and other training
activities that will enhance development of TRS expertise across all necessary
competencies. Across the TCORS network, these cores are also intended to promote
inter-programmatic collaborative efforts with regards to research, training, education, and
career development. In addition, they are also intended to contribute to existing curricula,
courses, research projects, symposia, and even the expertise of established faculty
investigators. The expectation is that the TCORS will actively develop networks for
sharing resources for development of TRS expertise and harmonize efforts across the
TCORS network (NIH, 2022).
While these require that TCORS collaborate and develop new training, education,
and career development programs specifically focused on TRS apart from their
institutional programs, further resources and strategic planning are necessary to ensure
the implementation of these competencies and consistent training across the TCORS
network. Simply requiring that these programs be put in place does not necessarily
facilitate the processes and mechanisms required for implementation. For example,
without developing uniform processes for program evaluation and coordination between
the TCORS, there is no guarantee that these efforts will be successful or sustained. And
without taking into consideration the complex academic/institutional environments in
which these Centers must operate, the needs and challenges of key stakeholders may be
largely ignored.
136
It is worth noting that while the funding agencies require TCORS to establish
Career Enhancement Cores to aid in the implementation of TRS-specific competencies,
the funding announcement itself does not mention the competencies nor existing training
resources that may exist across the TCORS network. This indicates that strategic
planning for implementation does not take place before the TCORS are funded and active
and are instead created on an ad hoc basis.
Findings from this study indicate that TCORS mentors and trainees find value and
utility in the established TRS competencies and suggest that general lack of awareness
stemming from poor stakeholder engagement and a lack of centralized resources and
toolkits likely contributed to less than effective adoption of the TRS competencies. Any
intentional efforts for cross-TCORS program development, such as the development of a
mentor training program, may facilitate better program outcomes. Study findings can
serve as a valuable resource to the FDA and the NIH Tobacco Regulatory Science
Program (TRSP), who, as important stakeholders, can serve as facilitators to more
successful program implementation in the next round of TCORS. There already exists a
mechanism that can serve as a facilitator to the coordination and communication of
training and career enhancement activities across the TCORS—the Center for
Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) in Tobacco
Regulatory Science. CASEL serves as the administrative coordinating body for the
TCORS network and can be tasked with assessing program offerings TCORS-wide,
identifying any curricular or content gaps, and more systematically facilitating training
opportunities so that they are harmonized across the TCORS sites.
137
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147
APPENDIX A.
Tobacco Centers of Regulatory Science 1.0: Areas of Focus and Project Descriptions
Institute Projects
American
Heart
Association
• Project 1: Cardiovascular Toxicity of Tobacco Products
• Project 2: Cardiovascular Injury Due to Tobacco Use
• Project 3: Cardiovascular Effects of Tobacco Products in Community-Based
Cohorts
University of
Michigan
• Project 1: Comparative Modeling of the Impact of E-Cigarettes Use on Smoking
and Long-Term Health Outcomes
• Project 2: Modeling the Impact of Nicotine Regulation on Smoking and
Smoking-Related Mortality
• Project 3: Modeling the Impact of Tobacco Control Policies on Polytobacco Use
and Associated Health Disparities
Virginia
Commonwealth
University
• Project 1: Using Toxicity Testing Data to Test Hypotheses About Advanced-
Generation ECIGs and Generate Population-Level Predictions Regarding
Potential Regulatory Action
• Project 2: Using User Behavior Data Collected in the Clinical Lab to Test
Hypotheses About Advanced-Generation ECIGs and Generate Population-Level
Predictions Regarding Potential Regulatory Action
• Project 3: Using Abuse Liability Data to Test Hypotheses About Advanced-
Generation ECIGs and Generate Population-Level Predictions Regarding
Potential Regulatory Action
• Project 4: Using a Prospective Cohort Survey to Test Population-Level
Predictions Generated by Projects 1-3
University of
Pennsylvania
• Project 1: The Effects of Cigarette Package Color on Smoking Behavior,
Exposure and Risk Perception When Using Low Nicotine Content Cigarettes
• Project 2: The Effects of Advertising and Correctives for Reduced Harm
Tobacco Products
• Project 3: Influence of Cigarillo Packaging and Labeling on Young Adults
• Project 4: Examining Product Descriptors in Natural American Spirit Cigarette
Marketing
UCSF • Project 1: Impact of Different E-Cigarette Characteristics on Acute Lung Injury
• Project 2: Short-Term Cardiovascular Effects of E-Cigarettes: Influence of
Device Power and E-Liquid pH and How E-Cigarettes Compare with Heat-Not-
Burn Products
• Project 3: Cardiovascular Health Effects of Emerging Heat-Not-Burn Tobacco
Products
• Project 4: Current and Emerging Tobacco Products in a Rural Context:
Influences of Product Characteristics on Perceptions, Behaviors, and Biologic
Exposures
• Project 5: Impact of Changing Tobacco Product Use on Healthcare Costs for
General and Vulnerable Populations
USC • Project 1: Effects of Social Media Marketing and Messages on Tobacco
Transitions
• Project 2: Influence of Tobacco Product Characteristics and Marketing on
Diverse Populations of Vape Shop Customers
• Project 3: Product Characteristics, Marketing, and E-Cigarette and Cigarette Use
Across Adolescence and Young Adulthood
148
Institute Projects
• Project 4: Human Laboratory Research to Inform Precision Regulation of E-
Cigarettes Across Populations
University of
Vermont
• Project 1: Low Nicotine Content Cigarettes in Vulnerable Populations:
Economically Disadvantaged Women (Non-Pregnant)
• Project 2: Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid
Abusers
• Project 3: Low Nicotine Content Cigarettes in Vulnerable Populations: Affective
Disorders
• Project 4: Low Nicotine Content Cigarettes in Vulnerable Populations: Pregnant
Women
Roswell Park
Comprehensive
Cancer Center
• Project 1: In Vitro and In Vivo Assessment of Flavorant Toxicity
• Project 2: Human Thresholds for Characterizing Flavors and Impact on Behavior
• Project 3: Respiratory Health Effects of Flavors
• Project 4: Evaluating Effects of Packaging and Market Availability of Flavored
Tobacco Products on Consumer Perception and Behavior
Yale University • Project 1: Effects of Sweet and Coolant Flavors on Nicotine Choice,
Consumption, and Seeking
• Project 2: Sweet and Cooling Flavors and Nicotine: Examinations in New and
Established Tobacco Product Users
• Project 3: Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
149
APPENDIX B.
Focus and Descriptions of TCORS 1.0 Training Programs
Center Name Institution Focus of Center Training Elements
American
Heart
Association
Tobacco
Regulation
and
Addiction
Center (A-
TRAC)
American Heart
Association
The adverse consequences of
cardiovascular disease from
diverse tobacco uses
• Mentorship of the next generation of investigators with
expert health education, health advocacy, and
translational tobacco-related cardiovascular research to
inform FDA tobacco-related regulation
• Development of a formal, competency-based education
and mentored training program with a unique core of
experiential training modules in interactive courses and
seminars - specifically designed to nurture talents of post-
doctoral trainees, clinical cardiology Fellows, and early
career Faculty
• Teach “academic survival skills”- include strategies for
effective literature searching and reference managing,
scientific and grant-writing skills, effective scientific
communication and responsible conduct of research
GSU Center
for the Study
of Tobacco
Products
(GSU CSTP)
Georgia State
University
Social, behavioral, economic,
and legal forces that shape
the actions of individuals with
a regard to traditional
tobacco products, as well as
novel and alternate products
• 3-tiered training program that recruits post-doctoral
fellows, provides specialty training for established
faculty, introduces pre-doctoral and doctoral students to
tobacco regulatory science
• Ensemble of education modalities (traditional, online,
and blended instruction; practicum experiences;
symposium and colloquium exchanges; apprenticeship;
and mentoring)
• Fellows work with an individual mentor from the
department or discipline in which he/she wishes to focus
Pennsylvania
State
University
Tobacco
Center of
Regulatory
Science (PSU
TCORS)
Penn State
University
Specialty-focused education
and research ranging from bio
behavioral models of
addiction, pharmacology to
public health models of
tobacco-related harm and
policy, tobacco control
interventions, and community
engagement
• Training pre-doctoral students, post-doctoral fellows/
junior faculty and professionals using a step-wise
individualized program in the field of tobacco regulatory
science
• Career development with a full-range of college and
university-wide relationships, resources and experiences
with individually mentored research or training project for
selected fellows
• Online World Campus that bridges both PSU campuses
(Hershey and University Park) and available to all TCORS
sites
Tobacco
Center of
Regulatory
Science on
Youth and
Young Adults
(TCORS
YaYA)
University of
Texas Health
Sciences Center
Youth and young adult use of
nicotine & tobacco products
and marketing methods
targeted to this population
• Enrollment and matriculation of two master’s level and
two pre-doctoral level student appointees in which
students attend weekly seminars, conduct projects, and
present on new tobacco products
• Recruitment of two postdoctoral appointees to conduct
research in the regulatory science arena
• Continued education for professionals using webinars,
short courses, online classes, social media, continuing
education units (CEUs), and TCORS cross-site training
opportunities
OSU Center
of Excellence
in Regulatory
Tobacco
Science
(OSU-CERTS)
The Ohio State
University
The reasons for underlying
tobacco-product preferences,
especially dual and poly-use,
and how these reasons
influence use, toxic exposure
and dependence/cessation, in
an environment of ever-
changing diverse types of
tobacco products
• Development of a postdoctoral multidisciplinary training
program in tobacco regulatory science research that
includes a specialized curriculum of instruction, mentored
research experiences, and development of an NIH grant
proposal
• Creation of opportunities for pre doctoral trainees and
junior faculty at OSU to participate in OSU-CERTS research
projects and special program initiatives
Center for
Tobacco
Control
University of
California- San
Francisco
The development of improved
models to inform tobacco
product regulatory strategies
• Interdisciplinary coursework related to health policy,
biostatistics, tobacco control policy, tobacco-related
addiction, tobacco-induced disease (including
150
Center Name Institution Focus of Center Training Elements
Research and
Education
(CTCRE)
secondhand smoke), smoking cessation and cancer
prevention and control
• Fellows with backgrounds in medical, biological, social,
behavioral and policy sciences pursue interdisciplinary
research projects directed by mentors from two different
disciplines drawn from 30 participating faculty members
with active research programs in tobacco control
regulatory science
• Fellows will be taught how to prepare, submit, and
review grant proposals in order to possibly secure third
year funding
University of
Maryland
Tobacco
Center of
Regulatory
Science
(UMD
TCORS)
University of
Maryland
Testing new and modified
tobacco products using
approaches that examine
health risks from the
molecular to the whole
human level
• Expansion of a trans disciplinary research focused training
program at the University of Maryland College Park to
post-doctoral appointees
• Cross-disciplinary collaborations that facilitate exposure
to different theories, methods, approaches and research
traditions, which will result in increased innovation and
the acceleration of the evidence translated into science-
based regulation of nicotine/tobacco products
• Facilitation in the continued production of trainees that
are comfortable working across disciplines, to become
the next generation
Center for
Tobacco
Regulatory
Science and
Lung Health
University of
North Carolina
Assessing the impact of new
and emerging tobacco
products on the lung's innate
defense system
• Mentorship of new trainees demonstrate interdisciplinary
approaches that result in the understanding and
translation of how the environment influences human
disease
• Collaborative research environment with postdoctoral
trainee colleagues and senior investigators to provide a
multidisciplinary experience
• Building of competencies and skills on how to write up
results for publication in high quality peer reviewed
journals, as well the ability to write competitive grant
applications to national agencies
Center for
Regulatory
Research on
Tobacco
Control
(CRRTC)
University of
North Carolina
(UNC) and
Wake Forest
School of
Medicine
(WFSM)
Explores the perceptions,
attitudes and beliefs of
tobacco products and the
development of messages
that effectively communicate
the risk of using such
products
• Individualized mentoring plans under the guidance of a
multidisciplinary team of mentors
• Attainment of research expertise by mastering a content
area (e.g., health communication) related to tobacco
regulatory science
• Development of professional skills required for successful
research careers (e.g. presenting research findings,
writing for publication, grant writing, and working in
collaborative teams across disciplines)
Penn
Tobacco
Center of
Regulatory
Science
(Penn
TCORS)
University of
Pennsylvania
Understanding the complex
public communication
environment to inform
tobacco product regulation
• Development and support doctoral level trainees in
tobacco regulatory science research to prepare them for
successful careers in this field
• Implementation of programs in research career
development and interdisciplinary collaboration for these
trainees
• Educational resources in the area of tobacco product
marketing and communication that can be disseminated
across the TCORS
USC Tobacco
Center of
Regulatory
Science for
Vulnerable
Populations
(USC TCORS)
University of
Southern
California
Generate new research and
training for regulatory science
of tobacco with emphasis on
its use, marketing, and
messaging in vulnerable
populations
• Recruitment of pre- and post-doctoral trainees, giving
emphasis to candidates from vulnerable populations, as
well as transitioning several established investigators into
tobacco regulatory science
• Training model based around the core knowledge and
competencies needed for researchers in tobacco
regulatory science and evidence-based policies that
includes a core curriculum and a career development
program
• Use distance-based approaches for collaboration across
the TCORS in education and training
Vermont
Center on
University of
Vermont
Tobacco products in
vulnerable populations,
• The training program will be primarily located at the
University of Vermont (UVM), but will also include
151
Center Name Institution Focus of Center Training Elements
Tobacco
Regulatory
Sciences
(VCTRS)
including women of
childbearing age/pregnant
women, individuals with
comorbid other substance use
disorders, and individuals with
comorbid serious mental
illness
postdoctoral training positions at collaborating
institutions, Brown University and Johns Hopkins
University
• Focus on regulatory science related to pre- marketing
studies on the addictiveness and adverse health effects of
new tobacco products among vulnerable populations
• Training model will serve to assure that fellows receive
thorough training in regulatory science and addictions
research while also creating the opportunity to introduce
other fellows within these larger training programs to the
fundamentals of tobacco regulatory science
VCU Center
for the Study
of Tobacco
Products
(VSU CSTP)
Virginia
Commonwealth
University
Uses an integrated, iterative
model of modified risk
tobacco product (MRTP)
evaluation that uses analytic
lab, human lab, randomized
controlled trial (RCT), and
quantitative/qualitative
methods to inform tobacco
product regulation
• Pre-doctoral and Postdoctoral training in areas of abuse
liability assessment, nicotine and safety pharmacology
• Development of a Tobacco Product Regulatory Science
graduate course through the Institute of Drug and
Alcohol Studies focused on trans disciplinary methods for
evaluating tobacco product health effects
• Training of faculty with experience in tobacco research to
become most familiar with regulatory science, as well as
attract other faculty researchers whose involvement in
the Center will enhance their capabilities in tobacco
regulatory science
Yale Tobacco
Center of
Regulatory
Science
Yale University Programmatic research to
examine the influence of
flavors, and related factors,
on preference for and
addiction to tobacco products
• Post-doctoral and junior faculty trainees focus specifically
on the regulation of tobacco products as it pertains to
reducing addiction, as well as other priorities outlined by
the FDA
• Lecture series on Regulatory Science of Tobacco and
Models of Addiction will be incorporated into courses
• Opportunities provided for scientific exchange through
small travel grants for appointees to attend conferences
relevant to reducing addiction and understanding tobacco
regulatory science
152
APPENDIX C.
Core TRS Domains and Competencies
Final Core
Domains
Competencies
1. Health
Consequences
of Tobacco Use
and Population
Health Impact
• Identifying the health consequences of active and passive smoking
• Epidemiology of health consequences of tobacco and nicotine use and
exposure: person, place and time
• Recounting the history of tobacco industry efforts to discredit the
scientific evidence base linking tobacco use to death and disease
• Communicating the health consequences of tobacco use to diverse
groups
• Applying findings of scientific analyses addressing the public health
impact of regulatory measures
• Applying health impact assessment tools to understand potential
regulatory effects on population health
2. Tobacco
Control
Act/FDA
Regulatory
Framework
• Describing the roles of the various regulatory agencies in the context of
public health
• Understanding the basics of FDA regulatory science, including safety
and efficacy principles
• History of FDA regulation, regulatory science, and the regulatory
process
• Defining the scope of the FSPTCA, the key elements of the final text,
and specifically what is not covered through the federal law
• Recalling the core mission and responsibilities of the FDA’s Center for
Tobacco Products
• Outlining major regulatory decisions made by the FDA since the
FSPTCA came into effect
• Describe how scientists can engage in regulatory decision making
• Describing how the tobacco industry engages with the FDA and in the
regulatory process
• Offering effective tobacco specific rules and guidelines relevant to
public health standards within the legal context
• Identifying the points (from production to product use) at which
regulatory interventions can be implemented to impact tobacco use
• Summarizing how non-tobacco nicotine products are regulated
differently than tobacco products
• Understanding the process of submitting comments to the FDA docket
3. Tobacco
Control
Policies and
Programs
• Identifying and differentiating tobacco regulatory science from the
broader field of tobacco control
• Providing examples of successful tobacco control initiatives including
legislative, policy, media, community and partnership building
• Justifying the public health response to tobacco use and exposure to
tobacco smoke domestically and abroad
• Providing examples of efforts by the tobacco industry to defeat, delay,
or co-opt tobacco control policies
• Identifying the diverse organizations that have engaged in tobacco
control programs beyond traditional tobacco control agencies.
• Analyzing the economics of tobacco control
153
Final Core
Domains
Competencies
• Describe the major policies and programs known to impact tobacco use
in the United States
4. Tobacco and
Nicotine
Product
Diversity
• Contrasting the factors to consider when regulating diverse products to
benefit the public health
• Synthesizing how products differ in term of health effects
• Describing the process through which a product can make a harm
reduction claim
• Describing how diverse products are used in isolation and in
combination to retain tobacco dependence
• Preparing a map of the range of tobacco products on the market and
their regulatory status
• Differentiating between cognitive and affective factors associated with
new and emerging nicotine products versus traditional cigarettes
amongst youth and young adults
• Analyzing the history of industry-sponsored research on tobacco
products
• Describe the youth tobacco and nicotine adoption process and how it
varies by diversity of products and subgroup
5. Vulnerable
Populations
• Defining the characteristics of a vulnerable population in regards to
tobacco use
• Summarizing where vulnerable populations are mentioned within the
FSPTCA and FDA's priorities
• Understanding the history of youth tobacco prevention,
multicomponent interventions, and critiquing related literature
6. Skills -
Research,
Dissemination,
Testimony
• Formulating a research question and research methods that result in
evidence applicable to tobacco regulation
• Preparing and executing a pilot grant and using date to compete for an
NIH grant related to TRS
• Identifying research gaps related to the tobacco regulatory environment
• Analyzing existing evidence relevant to the tobacco regulatory
environment
• Appraising how study methods and results in terms of their regulatory
aims
• Ability to search and analyze tobacco industry documents
• Disseminating research finding to diverse regulatory stakeholders
• Identifying potential cases of ethical misconduct and conflict of interest
that could impact an individuals’ ability to engage in the regulatory
process
• Understanding the role of scientific testimony in regulatory and judicial
processes
• Generating public comments to the FDA based on research findings
• Preparing an accurate conflict of interest disclosure
• Articulating the role of organization, practice, and individual in
affecting tobacco policy
• Conducting policy analysis to identify regulatory weakness and gaps
• Developing working relationships across disciplines and learning how
to integrate the work of others outside your field into your work
• Being able to conduct a risk-benefit analysis
154
APPENDIX D.
Final Specialized Domains and Competencies
Domain Competencies
1 Addiction • Identifying the physical and psychological effects of substance
dependence
• Understanding methods of product manipulation to enhance
addictive properties in tobacco products
• Understanding the basis of addiction in biology, learning, and
culture
• Using medical literature, highlighting human vulnerability to quick
onset of addiction from tobacco use
• Proposing regulatory policies and standards to counter
manipulation of products that enhance addiction
• Describing the neural pathways that are involved with addiction in
the brain, brain reward system, and mechanisms of addiction
• Understanding the cognitive, physical, social, and brain
development of addition throughout the lifespan youth
• Describe tobacco industry tactics to fight classification of tobacco
(and nicotine) as addictive in the past and present
2 Toxicology • Describing the general mechanisms through which exposure to
tobacco products elicit a toxic response
• Characterizing the utility of bio-markers of toxicity for regulation
• Creating a toxicological risk assessment of tobacco products by
applying the principles used to manage risks associated with the
exposure to tobacco products
• Understanding the legal and regulatory basis for determining
constituent "safety limits" or "generally recognized as safe"
3 Litigation and
Disclosure
• Recommending approaches that the FDA could use to help ensure
that its regulations withstand legal review
• Predicting potential scenarios that could result in legal challenges
• Outlining the process through which a regulation can be challenged
in federal court
• Recounting past court decision resulting from legal challenges to
regulatory measures
• Knowing the history of tobacco-related litigation
4 Marketing /
Communication
• Discussing the beneficial effect of marketing regulation
• Describing how technology and social media is shifting the
delivery of tobacco product marketing
• Providing examples of marketing practices that influence risk
perception and use behavior among diverse populations
• Explaining how point-of-sale marketing affects the sale of tobacco
and the , including how economics and policies affect tobacco
product use
• Proposing a communication strategies to combat tobacco industry
marketing
• Conducting content analyses of current marketing techniques
aimed at youth, young adults, and other vulnerable populations
155
Domain Competencies
• Developing research studies to demonstrate how communication
and marketing tools can be used to reduce tobacco use
• Understanding how to tailor and target campaigns that will improve
the well-being of tobacco users
6 Economic:
Cost/Benefit
• Explaining how assumptions from traditional economic theory
apply/do not apply to the analysis of tobacco products
• Discussing and estimate the economic cost of tobacco use
• Critically evaluating cost-effectiveness analysis used to inform
tobacco regulatory decision-making
156
APPENDIX E.
Geographic Distribution of TCORS 1.0 and TCORS 2.0 Centers
157
APPENDIX F.
Overview of TCORS 1.0
Organization Title Investigator(s)
American Heart
Association (AHA)
AHA Tobacco Regulation and Addiction
Center (A-TRAC)
Aruni Bhatnagar,
Rose Marie Robertson
Georgia State University
(GSU)
GSU TCORS - The Science of Decision-
Making: Connecting People and Policy
Michael Erikson
Ohio State University
(OSU)
OSU Center of Excellent in Regulatory
Tobacco Science (CERTS)
Peter Shields,
Mary Ellen Wewers
Pennsylvania State
University
PSU Tobacco Center of Regulatory
Science
Joshua Muscat,
Jonathan Foulds
University of California,
San Francisco (UCSF)
UCSF TCORS – Improved Models to
Inform Tobacco Product Regulation
Stanton Glantz
University of
Pennsylvania
UPenn TCORS - Tobacco Product
Messaging in a Complex
Communication Environment
Robert Hornik,
Caryn Lerman
University of North
Carolina
Center for Regulatory Research on
Tobacco Communication – Effective
Communication on Tobacco Product
Risk and FDA Authority
Kurt Ribisl
University of North
Carolina
UNC TCORS - The Impact of Tobacco
Exposure on the Lung’s Innate Defense
System
Robert Tarran
University of Maryland Rapid Response Characterization of
New and Manipulated Tobacco Products
Pamela Clark
University of Southern
California (USC)
USC TCORS for Vulnerable Populations Jonathan Samet,
Mary Ann Pentz
University of Texas UT Texas on Youth and Young Adults Cheryl Perry
University of Vermont Vermont Center on Tobacco Regulatory
Science
Stephen Higgins
Virginia Commonwealth
University
Center for the Study of Tobacco
Products
Thomas Eissenberg,
Robert Balster
Yale University Yale TCORS Suchitra Krishnan-
Sarin,
Stephanie O’Malley
158
Overview of TCORS 2.0
Organization Title Investigator(s)
American Heart
Association (AHA)
AHA Tobacco Center of Regulatory
Science (A-TRAC) 2.0
Aruni Bhatnagar,
Rose Marie
Robertson
Roswell Park Cancer
Institute Corporation
WNY Center for Research on Flavored
Tobacco Products
Richard O’Connor,
Maciej Goniewics
University of California,
San Francisco (UCSF)
Integrated Health, Behavioral and
Economic Research on Current and
Emerging Tobacco Products
Stanton Glantz
University of Michigan Center for the Assessment of the Public
Health Impact of Tobacco Regulations
Rafael Meza,
David Levy
University of Pennsylvania Examining the Effects of Advertising,
Packaging and Labeling on Perceptions,
Use and Exposure of Combustible
Tobacco Products
Andrew Strasser,
Christine Delnevo
University of Southern
California (USC)
Tobacco Regulatory Science Investigating
the Intersection of Products with Diverse
Populations
Mary Ann Pentz,
Adam Leventhal
University of Vermont Vermont Center on Tobacco Regulatory
Science
Stephen Higgins
Virginia Commonwealth
University
Center for the Study of Tobacco Products Thomas
Eissenberg,
Alison Breland
Yale University Yale Center for the Study of Tobacco
Product Use and Addiction: Flavors,
Nicotine and Other Constituents
159
APPENDIX G.
Implementation of TRS Competencies in
the TCORS: Stakeholder Views
Start of Block: Demographics
Q1
Thank you for taking part in this survey and sharing your views on the implementation of
the Tobacco Regulatory Sciences competencies across the TCORS training programs.
This survey is part of research associated with the Doctor of Regulatory Science degree
at the University of Southern California. Your candid answers are important to the
success of this study and are anonymous. A summary of survey results will be
published and shared TCORS-wide once the study is complete. I hope you will find the
study findings valuable.
The survey should take approximately 12-15 minutes to complete.
Q2
The TCORS with which you are associated was funded as part of:
○ TCORS 1.0 (2013-2018) (6)
○ TCORS 2.0 (2018-2023) (2)
○ Both TCORS 1.0 and 2.0 (3)
○ I don't know (4)
160
Q3 What function best describes your current role within TCORS?
○ TCORS Faculty (1)
○ Staff (i.e., Center Director, Administrator, Core director, Manager) (2)
○ Current TCORS trainee (3)
○ Past TCORS trainee (4)
○ Other: please describe (5) __________________________________________
Skip To: Q9 If What function best describes your current role within TCORS? = Past TCORS trainee
Skip To: Q8 If What function best describes your current role within TCORS? = Current TCORS trainee
Q4 Were you previously a TCORS trainee (predoctoral, postdoctoral or other)?
○ Yes (1)
○ No (2)
Display This Question:
If What function best describes your current role within TCORS? = TCORS Faculty
Q5
How involved do you consider yourself to be in the training and career enhancement
program/activities at your TCORS?
○ Very involved (1)
○ Somewhat involved (4)
○ Not involved (5)
161
Display This Question:
If What function best describes your current role within TCORS? = Staff (i.e., Center Director,
Administrator, Core director, Manager)
Or What function best describes your current role within TCORS? = Other: please describe
Q6 How involved do you consider yourself to be in the training and career enhancement
program/activities at your TCORS?
○ Very involved (1)
○ Somewhat involved (4)
○ Not involved (5)
Skip To: End of Survey If How involved do you consider yourself to be in the training and career
enhancement program/activi... = Not involved
Q7 How would you describe the level of your current or past involvement/participation in
the National Training Working Group?
○ Very involved (2)
○ Somewhat involved (4)
○ Not involved (5)
○ I don't know (6)
Display This Question:
If What function best describes your current role within TCORS? = Current TCORS trainee
Q8 Which of the following best describes your current trainee title/status:
○ Predoctoral trainee (1)
○ Postdoctoral trainee (2)
○ Faculty-level trainee (4)
○ Other: please describe (3) ___________________________________________
162
Display This Question:
If What function best describes your current role within TCORS? = Past TCORS trainee
Q9 Which of the following best describes your past training title within TCORS:
○ Predoctoral trainee (4)
○ Postdoctoral trainee (5)
○ Faculty-level trainee (7)
○ Other: please describe (6) ___________________________________________
Display This Question:
If What function best describes your current role within TCORS? = Past TCORS trainee
Q10 Is your current position in the field of tobacco regulatory science, tobacco control, or
other tobacco-related field?
○ Yes (1)
○ No: please specify the field. (2) _______________________________________
Display This Question:
If What function best describes your current role within TCORS? = Past TCORS trainee
Q11 Where are you currently employed?
Academia (4)
Federal Government (5)
Tobacco Products Industry (6)
Other: please describe (7) _____________________________________________
I am still in training (8)
163
Display This Question:
If What function best describes your current role within TCORS? = Current TCORS trainee
Or What function best describes your current role within TCORS? = Past TCORS trainee
Q12 I want my future career to be in one of the following settings:
○ Academia (1)
○ Federal Government (2)
○ Tobacco Products Industry (3)
○ Other: please describe (5) ___________________________________________
End of Block: Demographics
Start of Block: Level of implementation of competencies into training programs
Q13 Do you know that the TCORS identified a list of competencies to help develop
training programs in Tobacco Regulatory Science (TRS)?
○ Yes (1)
○ No (2)
Display This Question:
If Do you know that the TCORS identified a list of competencies to help develop training programs in...
= Yes
Q14 How did you learn about the TRS competencies developed by the National TCORS
Training Working Group in 2016? Mark all that apply.
▢ Through manuscript published by Wipfli, H. et al, 2016 in TRS journal. (1)
▢ Through participation in National Training Working Group meetings (2)
▢ Through presentations at national TCORS meetings (3)
▢ Through leadership in my TCORS institution (4)
▢ Other: please describe (5) _____________________________________
164
Q15 Tobacco Regulatory Science competencies were identified in 6 core competency
domains (listed below).
Select the level of focus that best describes your TCORS in its effort toward developing
trainees in each of the core competency domains.
Strong (1) Modest (2) Minimal (3) None (4)
I Don't Know
(5)
Health
Consequences
of Tobacco
Use and
Population
Health Impact
(1)
○ ○ ○ ○ ○
Tobacco
Control Act /
FDA
Regulatory
Framework (2)
○ ○ ○ ○ ○
Tobacco
Control
Policies and
Programs (3)
○ ○ ○ ○ ○
Tobacco and
Nicotine
Product
Diversity (4)
○ ○ ○ ○ ○
Vulnerable
Populations (5) ○ ○ ○ ○ ○
Skills -
Research,
Dissemination,
Testimony (6)
○ ○ ○ ○ ○
165
Q16
Competencies were also identified in 5 specialized competency domains (listed below).
Select the level of focus that best describes your TCORS in its effort toward developing
trainees in each of the specialized competency domains.
Strong (1) Modest (2) Minimal (3) None (4)
I Don't
Know (5)
Addiction (1)
○ ○ ○ ○ ○
Toxicology (2)
○ ○ ○ ○ ○
Litigation and Disclosure
(3) ○ ○ ○ ○ ○
Marketing/Communication
(4) ○ ○ ○ ○ ○
Economic: Cost/Benefit
(5) ○ ○ ○ ○ ○
Q17 To your knowledge, does your TCORS place an emphasis on incorporating the
competencies into its training and career enhancement activities/program?
○ Yes (1)
○ No (2)
○ I don't know (4)
166
Display This Question:
If To your knowledge, does your TCORS place an emphasis on incorporating the competencies into its
t... = No
Q18 Why do you think your TCORS does not place an emphasis on incorporating the
established competencies into its training programs?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Q19 To your knowledge, in what ways has your TCORS used the competencies in its
training and career enhancement program/activities? Mark all that apply.
▢ New coursework was developed to address the competencies (1)
▢ Coursework was revised to address the competencies (2)
▢ External resources (courses outside of your TCORS, workshops,
seminars, etc.) are offered to address competency areas in which my
TCORS does not have expertise (3)
▢ Competencies are incorporated as part of Individual Development Plans
(IDP's) (4)
▢ Other: please describe (5) _____________________________________
167
Q20 Which of the following statements most accurately describes the readiness of your
TCORS in implementing the TRS competencies into your training programs?
○ We are exploring the feasibility of implementation and fit with our existing training
program (1)
○ We have decided to pursue implementation but have not started the process (2)
○ We have initiated activities and acquired resources in preparation for program
implementation (3)
○ We have implemented the competencies into our training program (4)
○ We have implemented the competencies and have conducted (or are planning to
conduct) program evaluation (5)
○ I don't know (7)
Q21 In your view, to what extent has your TCORS mapped competencies to
coursework?
○ We are exploring how to do this (1)
○ We have begun to map competencies to existing curricula (2)
○ We are in the process of developing new curricula that will address the defined
competencies (3)
○ We have completed the process of mapping competencies to various coursework
(4)
○ We will not be mapping the defined competencies to any coursework (5)
○ I don't know (6)
168
Q22 How satisfied are you with the level to which your TCORS has accomplished the
following activities?
Very satisfied
(1)
Somewhat
satisfied (2)
Not satisfied (3) I don't know (4)
Acquired
necessary
resources (i.e.
technology,
human
resources) (2)
○ ○ ○ ○
Provided
opportunities for
mentor training
(3)
○ ○ ○ ○
Mapped the
competencies to
existing curricula
(4)
○ ○ ○ ○
Developed
trainee
assessment tools
(5)
○ ○ ○ ○
Developed
program
evaluation
tools/methods (6)
○ ○ ○ ○
169
Q23 Describe the extent to which your TCORS has provided training resources (such as
courses, lectures, workshops, or other) in the following competency domains.
Developed
and/or offered
(1)
Planning to
develop/offer (3)
Not planning to
develop/offer (4)
I don't know
(5)
Health
Consequences of
Tobacco Use and
Population Health
Impact (1)
○ ○ ○ ○
Tobacco Control
Act/FDA
Regulatory
Framework (2)
○ ○ ○ ○
Tobacco Control
Policies and
Programs (3)
○ ○ ○ ○
Tobacco and
Nicotine Product
Diversity (4)
○ ○ ○ ○
Vulnerable
Populations (5) ○ ○ ○ ○
Skills - Research,
Dissemination,
Testimony (6)
○ ○ ○ ○
Addiction (7)
○ ○ ○ ○
Toxicology (8)
○ ○ ○ ○
Litigation and
Disclosure (9) ○ ○ ○ ○
Marketing and
Communication
(10)
○ ○ ○ ○
Economic:
Cost/Benefit (11) ○ ○ ○ ○
End of Block: Level of implementation of competencies into training programs
170
Start of Block: Challenges and enablers to implementation
Q24 What do you think are the challenges faced by your institution during its attempt to
incorporate the competencies into your training program? Rate the following according
to level of challenge.
Very challenging
(1)
Somewhat
challenging (2)
Not challenging
(3)
I don't know (4)
Lack of
knowledge about
the existence of
competencies (1)
○ ○ ○ ○
Lack of
communication
across TCORS
regarding the
implementation of
the competencies
(6)
○ ○ ○ ○
Lack of adequate
administrative
infrastructure
support (8)
○ ○ ○ ○
Time constraints
of faculty/mentors
(3)
○ ○ ○ ○
Lack of
faculty/mentors
who are trained in
TRS (4)
○ ○ ○ ○
Lack of
faculty/mentor
development
programs (7)
○ ○ ○ ○
Other: please
describe (5) ○ ○ ○ ○
171
Q25
How helpful would it be to have the following resources centralized and accessible in
advancing the implementation of the competencies in your TCORS training programs?
Very helpful (1)
Somewhat
helpful (2)
Not helpful (3) I don't know (4)
Implementation
toolkit or
guidelines (1)
○ ○ ○ ○
Curriculum
mapping tools (2) ○ ○ ○ ○
Assessment plan
(3) ○ ○ ○ ○
Evaluation tools
(4) ○ ○ ○ ○
Benchmarks for
attaining
competency (5)
○ ○ ○ ○
Other: please
describe (6) ○ ○ ○ ○
Q26 How important do you consider the following resources to be in enabling full
implementation of the TRS competencies into the training program at your TCORS?
Please rank in order of importance with "1" being the most important.
______ Additional funds (1)
______ Additional supportive personnel (2)
______ Additional faculty/mentors or more faculty with relevant expertise in TRS (3)
______ Supportive technology (4)
______ Additional centralized/shareable resources (implementation guidelines, mapping
tools, assessment plans, etc.) (6)
172
Q27 How helpful would it be to have the following items in advancing the implementation
of the competencies in your TCORS training programs?
Very helpful
(1)
Somewhat
helpful (2)
Neither
helpful nor
unhelpful (3)
Not helpful
(4)
I don't know
(5)
Increased
communication
from the
Training
Working Group
(6)
○ ○ ○ ○ ○
Opportunities
to share
experiences
across TCORS
(8)
○ ○ ○ ○ ○
Evidence of
effectiveness
in preparing
trainees for
future careers
(2)
○ ○ ○ ○ ○
Availability of
implementation
guidelines (3)
○ ○ ○ ○ ○
Availability of
tools to help
map
competencies
to curricula (7)
○ ○ ○ ○ ○
Availability of
trainee
assessment
plan (4)
○ ○ ○ ○ ○
Availability of
program
evaluation
plan/methods
(5)
○ ○ ○ ○ ○
Mentor
development
modules (9)
○ ○ ○ ○ ○
173
Q28 Thinking about how the competencies were developed and shared, please rank
your agreement with the following statements.
Agree (1)
Somewhat agree
(2)
Do not agree
(3)
I don't know (4)
Communication
from the National
Training Working
Group was
adequate (2)
○ ○ ○ ○
The process of
developing the
competencies
was transparent
(5)
○ ○ ○ ○
I was provided the
opportunity to
participate in the
competency
development
process (6)
○ ○ ○ ○
All stakeholder
groups were
involved
throughout the
process (1)
○ ○ ○ ○
Q29 In your view, what is the most significant barrier/challenge to fully implementing the
TRS competencies into the training program at your TCORS?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
End of Block: Challenges and enablers to implementation
174
Start of Block: Modification of Competencies for future efforts
Q30 How useful are the competencies in guiding the development of training programs
in TRS?
○ Very Useful (1)
○ Somewhat Useful (2)
○ Not Useful (3)
○ I Don't Know (4)
Q31 How useful are the competencies in guiding the following?
Very useful (1)
Somewhat useful
(2)
Not useful (3) I don't know (4)
Curriculum
Development (1) ○ ○ ○ ○
Trainee
Assessment (2) ○ ○ ○ ○
Mentor/Faculty
Training and
Development (5)
○ ○ ○ ○
Development of
Training
Resources (6)
○ ○ ○ ○
Q32 Considering that a number of years have passed since the competencies were
developed, what are your views on the relevancy and adequacy of the competencies
today.
○ Competencies are adequate in their current forms (1)
○ Competencies should be revised slightly (2)
○ Competencies should be revised extensively (3)
○ Competencies should be eliminated (5)
○ I don't know (4)
175
Q33 Who do you think should be tasked with monitoring and assessing the
implementation of the competencies?
○ Accrediting body (1)
○ Advisory council consisting of all stakeholders (2)
○ National Training Working Group (3)
○ NIH or FDA CTP (4)
○ Individual TCORS (5)
○ Other: please describe (6) ___________________________________________
Q34 Please share any additional thoughts you may have regarding the competencies,
the implementation process, future directions, or other.
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Q35
End
Thank you for your completion of this survey. Survey results will be shared with the
general TCORS community upon study completion.
End of Block: Modification of Competencies for future efforts
Abstract (if available)
Abstract
Regulatory science to inform the regulation of tobacco products is a scientific discipline that emerged from the 2009 passage of the Family Smoking Prevention and Tobacco Control Act (H.R. 1256, 2009), which gave the U.S. Food and Drug Administration (FDA) broad authority to regulate tobacco products. The FDA funded a network of Tobacco Centers of Regulatory Science (TCORS) to conduct research that would inform tobacco-related policy and train new graduates in the new field of tobacco regulatory science (TRS). To guide the TCORS in the development of their training programs, an inter-center panel was formed to identify and establish a set of competencies. The panel, however, did not include a formal process for reviewing the programs and there was no clear strategy on how the implementation of the competencies would be assessed. By applying a well-recognized implementation science framework, this study surveyed stakeholders to evaluate the implementation of the TRS competencies across the TCORS, identified challenges and enablers that may have influenced the implementation process, and examined the perceived usefulness of the competencies. Findings indicate that, collectively, the TCORS are at the initial stages of implementation and point to certain deficiencies that likely challenged implementation, such as the lack of stakeholder engagement. Respondents found utility in the competencies and suggest that they be slightly revised for future training programs. Findings should help inform the TCORS, the NIH Tobacco Regulatory Science Program, and the FDA as they embark on the next iteration of the TCORS, slated for Fall 2023.
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Asset Metadata
Creator
Aladadyan, Lilit
(author)
Core Title
Implementation of tobacco regulatory science competencies in the tobacco centers of regulatory science (TCORS): stakeholder views
School
School of Pharmacy
Degree
Doctor of Regulatory Science
Degree Program
Regulatory Science
Degree Conferral Date
2023-12
Publication Date
09/11/2023
Defense Date
08/03/2023
Publisher
Los Angeles, California
(original),
University of Southern California
(original),
University of Southern California. Libraries
(digital)
Tag
implementation of competencies,OAI-PMH Harvest,tobacco regulatory science,tobacco regulatory science competencies,training competencies,TRS,TRS competencies
Format
theses
(aat)
Language
English
Contributor
Electronically uploaded by the author
(provenance)
Advisor
Pacifici, Eunjoo (
committee chair
), Bain, Susan (
committee member
), Pfeiffer, Joann (
committee member
), Richmond, Frances (
committee member
)
Creator Email
aladadya@usc.edu,aladal01@hotmail.com
Permanent Link (DOI)
https://doi.org/10.25549/usctheses-oUC113304689
Unique identifier
UC113304689
Identifier
etd-AladadyanL-12332.pdf (filename)
Legacy Identifier
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Document Type
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Format
theses (aat)
Rights
Aladadyan, Lilit
Internet Media Type
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Type
texts
Source
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(batch),
University of Southern California
(contributing entity),
University of Southern California Dissertations and Theses
(collection)
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Tags
implementation of competencies
tobacco regulatory science
tobacco regulatory science competencies
training competencies
TRS
TRS competencies