Tobacco industry research and protection of human subjects: a case study of R. J. Reynolds.

Companies that conduct research are under no obligation to follow guidelines regarding treatment of human subjects in clinical trials. By contrast, clinical researchers funded by federal agencies or under U.S. Food and Drug Administration authority are required to follow federal regulations, and academics must adhere to their institutions' standards. We examined how one tobacco company, R. J. Reynolds, treated human subjects in internal research conducted from 1985 to 2000. We then compared this treatment with standards of the time. We focused on R. J. Reynolds because the company conducted a significant amount of research using human subjects. Tobacco industry documents were retrieved from the UCSF/Legacy Tobacco Documents Library, Tobacco Documents Online, and industry Web sites. Materials from 73 research projects, including informed consent forms, were analyzed. The U.S. Code of Federal Regulations, Title 45 Part 46, Protection of Human Subjects (the Common Rule) was the primary source for human subjects research guidelines and standards. R. J. Reynolds formed a human subjects review committee in 1985. The committee's structure and procedures did not meet generally accepted practices of the time regarding community representation, written procedures for adverse events, and other factors. In all 73 studies, consent procedures failed to meet five or more human subjects research standards. Policymakers should consider expanding the scope of federal human subjects research regulations to cover research undertaken by private firms such as tobacco companies.