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Patricia A. McDaniel, PhD, Gina Solomon, MD, MPH and Ruth E. Malone, PhD, RN, FAAN

Patricia A. McDaniel is with the Center for Tobacco Control Research and Education, University of California, San Francisco. Gina Solomon is with the Natural Resources Defense Council and the Division of Occupational and Environmental Medicine, Department of Medicine, University of California, San Francisco. Ruth E. Malone is with the Department of Social and Behavioral Sciences, School of Nursing, University of California, San Francisco.

Correspondence: Requests for reprints should be sent to Patricia A. McDaniel, PhD, Center for Tobacco Control Research and Education, University of California, San Francisco, 530 Parnassus Ave, Suite 366, San Francisco, CA 94143–1390 (e-mail: patricia.mcdaniel{at}ucsf.edu).

In the United States, companies that use their own funds to test consumer products on their employees are subject to few regulations. Using previously undisclosed tobacco industry documents, we reviewed the history of that industry’s efforts to create internal guidelines on the conditions to be met before employee taste testers could evaluate cigarettes made from tobacco treated with experimental pesticides.

This history highlights 2 potential ethical issues raised by unregulated industrial research: conflict of interest and lack of informed consent. To ensure compliance with accepted ethical standards, an independent federal office should be established to oversee industrial research involving humans exposed to experimental or increased quantities of ingested, inhaled, or absorbed chemical agents.