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Jenny White, MSc, MPH, Center for Tobacco Control Research and Education, University of California, San Francisco, 530 Parnassus Avenue, Suite 366, San Francisco, CA 94143-1390, 415-476-1526, jewhite@itsa.ucsf.edu, Mark Parascandola, PhD, MPH, Cancer Prevention Fellowship Program, National Cancer Institute, 6130 Executive Blvd., Suite 3109, Bethesda, MD 20892, and Lisa A. Bero, PhD, Institute for Health Policy Studies, Department of Clinical Pharmacy, and Center for Tobacco Control Research and Education, University of California, San Francisco, 530 Parnassus Avenue, Suite 366, Box 1390, Library, San Francisco, CA 94143.
Companies that conduct research are under no obligation to follow guidelines regarding human subjects in clinical trials -- whereas clinical researchers funded by federal agencies or under FDA authority are required to follow federal regulations, and academics must adhere to their institutions’ standards.
We will provide an overview of tobacco industry human subjects research over time, and describe industry guidelines and several studies in detail. Tobacco industry documents concerning human subjects research were retrieved from the UCSF/Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu/) and from industry websites. Federal human subjects research guidelines were obtained from government agency websites.
R.J. Reynolds formed a human subjects review committee in 1985. Procedures for a number of studies do not appear to have met generally accepted practices of the time regarding confidentiality, disclosure, protection of human subjects and other factors. For example, an R. J. Reynolds study from 1991 did not inform study participants that the study was conducted by industry scientists. In a 1995 Philip Morris study, pregnant women smokers continued smoking during the study and were to be told that participation would pose no risk to themselves or their baby.
Policymakers should consider expanding the regulatory scope of federal human subjects research regulations (45 CFR 46) to cover research undertaken by private firms such as tobacco companies.
Learning Objectives:
Keywords: Tobacco Industry, Tobacco Policy
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.