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. 2016 Jul 14;19(2):222–230. doi: 10.1093/ntr/ntw178

Table 3.

Final Core Domains and Competencies

No. 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 nontobacco 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
• 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 among 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 subgroups
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 individual’s 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