Defining Tobacco Regulatory Science Competencies

Abstract

Introduction: In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel's work to develop core TRS domains and competencies. Methods: The Panel developed the list of domains and competencies using a semistructured Delphi method divided into four phases occurring between November 2013 and August 2015. Results: The final proposed list included a total of 51 competencies across six core domains and 28 competencies across five specialized domains. Conclusions: There is a need for continued discussion to establish the utility of the proposed set of competencies for emerging TRS curricula and to identify the best strategies for incorporating these competencies into TRS training programs. Given the field's broad multidisciplinary nature, further experience is needed to refine the core domains that should be covered in TRS training programs versus knowledge obtained in more specialized programs. Implications: Regulatory science to inform the regulation of tobacco products is an emerging field. The paper provides an initial list of core and specialized domains and competencies to be used in developing curricula for new and emerging training programs aimed at preparing a new cohort of scientists to conduct critical TRS research.

Mentoring for Success in Tobacco Regulatory Science: A Qualitative Study

“…1 Whereas the FDA represents one major source of funding for TRS research, its priorities exclude certain types of policy and intervention research that may potentially impact public health, such as the effects of clean indoor air laws, second-hand smoke, and tobacco cessation.…”

“…1 The competencies emphasize a shared knowledge base that should be demonstrated by future tobacco regulatory scientists across disciplinary backgrounds. Even while the TRS field continues to evolve to meet the FDA’s needs, the TRS core curriculum establishes the foundation of a comprehensive training program that exposes TRS mentees to the broad skills and knowledge necessary for success along this career trajectory.…”

“…Thus, the field of TRS is more expansive than the TRS funding priorities identified by the FDA and National Institutes of Health (NIH). 1 …”

“…The TCORS Training Workgroup developed a curriculum for training TRS researchers, the description of which can be found elsewhere. 1 …”

Implementing and Evaluating a Mentor Training to Improve Support for Early-Career Scholars in Tobacco Regulatory Science

“…Tobacco Regulatory Science (TRS) is a nascent field, and recent years have witnessed an increasing need for training programs that specifically address the conduct of regulatory research as it pertains to both traditional and novel tobacco products, [1][2][3] thus echoing broader recognition regarding the necessity for educational curricula uniquely suited to regulatory science as a whole. 4 In a 2017 study by Russo et al, 3 senior tobacco regulatory scientists serving as mentors were asked to comment on the challenges specific to TRS mentoring.…”