authority of the committee and review and rank applications. The committee and HEI staff often work with the sponsor of the successful application to refine the scope and methods of the research project, examining research design, methods of analysis, and data. When research commences, the research committee oversees the research, reviewing progress reports from the investigators, overseeing quality audits of the project research, and visiting the investigators’ research sites.

There are important limits to the HEI model that must be considered when thinking about it as a possible prototype for a TRGE. Perhaps the most important difference between the HEI and any TRGE is that the HEI does not fund projects in support of marketing applications; rather, it funds projects that contribute to general knowledge. Hence the commercial stakes of the research funded by the HEI may be somewhat less than the kind of research that could be funded by a TRGE. In particular, it may be problematic for individual tobacco companies to contribute funds to a TRGE if those funds will be used to fund research that potentially benefits a competitor’s product more than its own product. As such, it will be important to distinguish between two different types of research: (1) individual product testing and (2) research that contributes to general knowledge, including research on better methods for product testing. Institutions like the HEI may be better suited to develop study methods or standards, rather than individual product evaluation. It should also be noted that the public health standard articulated in the FSPTCA is different from any other existing premarket approval standard. Additionally, the level of public, medical, and academic distrust in the tobacco industry and its research is much greater than any that has ever buffeted the automobile industry. Important issues of trust would need to be confronted in order for any such model to be entertained.

Another possibility for an organizational model lies in the Reagan-Udall Foundation (RUF), which advises the FDA on modernizing regulatory science. It conducts and oversees studies on regulatory science, particularly in the emerging fields of pharmacogenomics and genomic-based prediction of drug response and adverse event risk. The RUF receives grants from independent foundations for its work in advancing regulatory science, ranging from work in systems toxicology funded by the Komen Foundation to work on antitubercular drugs in the critical path to tuberculosis drug regimens. The RUF has a board of directors composed of a diverse mix of consumer representatives, industry representatives, scientific and medical authorities, and government officials; none of these groups accounts for a majority of the board’s members. The foundation has implemented a number of strategies to attempt to ward off conflict of interest and undue industry influence. The RUF prohibits board members from participating in any activity or matter in which they have a financial



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