Rowe, Sylvia, Alexander, Nick, Clydesdale, Fergus, Applebaum, Rhona, Atkinson, Stephanie, Black, Richard, Dwyer, Johanna, Hentges, Eric, Higley, Nancy, Lefevre, Michael, Lupton, Joanne, Miller, Sanford, Tancredi, Doris, Weaver, Connie, Woteki, Catherine, and Wedral, Elaine
There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. While biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, set out proposed conflict-of-interest guidelines, regarding industry funding, for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The paper, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. The Guiding Principles are as follows. In the conduct of public/private research relationships, all relevant parties shall: 1) conduct or sponsor research that is factual, transparent, and designed objectively; according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) prior to the commencement of studies, ensure that there is a written agreement that the investigative team has the freedom and obligation to attempt to publish the findings within some specified time-frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; and 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; require that such researchers publish only under the auspices of the CRO. [ABSTRACT FROM AUTHOR]