Defining Tobacco Regulatory Science Competencies

Nicotine Tob Res. 2017 Feb;19(2):222-230. doi: 10.1093/ntr/ntw178. Epub 2016 Jul 14.


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.

MeSH terms

  • Benchmarking*
  • Clinical Competence*
  • Consensus Development Conferences as Topic
  • Governing Board / organization & administration*
  • Humans
  • National Institutes of Health (U.S.)
  • Smoking / legislation & jurisprudence*
  • Smoking Cessation*
  • Smoking Prevention
  • Tobacco Industry / legislation & jurisprudence*
  • United States
  • United States Food and Drug Administration