While the industry currently acknowledges the health risks of smoking, this history continues to affect the legitimacy of self-sponsored research associated with their products. To provide confidence in the face of the history of tobacco industry-sponsored and tobacco industry-conducted research, additional measures may be required beyond what otherwise might be expected of industries.

The mandate to advise the FDA on the conduct of studies presented a unique challenge to the committee. The committee concluded that it would be neither helpful nor adequate to simply rearticulate minimum standards for research conduct; the basic standards for the ethically and socially responsible conduct of science are well established. The committee felt strongly that mechanisms to enforce or otherwise affirm minimum standards for the conduct of studies should be addressed, and would be of much greater relevance to the FDA. As such, in this chapter the committee addresses not only the principles for ethical and proper conduct of research, but also the governance mechanisms to ensure the ethical and proper conduct of research as well.

This chapter begins with a brief retelling of the history of tobacco research. The next section explores how the absence of governance and a history of improper conduct have resulted in a situation where the tobacco industry currently lacks the ability to independently produce and disseminate comprehensive and credible data about tobacco products. The chapter concludes with a discussion of one or more independent organizations that may be needed for the governance of tobacco industry studies in support of applications to market MRTPs.


To provide proper context for the committee’s recommendations regarding the design and conduct of studies to support the marketing of MRTPs, it is necessary to briefly review the history of, and lessons learned from, research conducted, funded, or supported by the tobacco industry and its affiliate organizations. An earlier report from the IOM provides a more thorough review of the history of tobacco harm reduction approaches and products (IOM, 2001), so the current section is designed to briefly review the major issues.

Historical Overview of Tobacco Harm Reduction

The issue of reducing the harm associated with tobacco use emerged very early in the growth of the cigarette market in the United States. In the 1930s and 1940s, before smoking-related health effects began to

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