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1 From SR Strategy LLC, Washington, DC (SR and NA); the University of Massachusetts at Amherst, Food Science Policy Alliance, Amherst, MA (FMC); the Coca-Cola Company, Global Scientific and Regulatory Affairs, Atlanta, GA (RSA); McMaster University, Department of Pediatrics, Hamilton, Canada (SA); Kraft Foods Global Inc, Glenview, IL (RMB); the Frances Stern Nutrition Center, New England Medical Center, Boston, MA (JTD); ILSI North America, Washington, DC (EH and EW); PepsiCo Inc, Scientific & Regulatory Affairs, Valhalla, NY (NAH); Utah State University, Center for Advanced Nutrition, Logan, UT (ML); Texas A&M University, College of Agriculture and Life Sciences, Department of Nutrition and Food Science, College Station, TX (JRL); the University of Maryland Center for Food, Nutrition and Agriculture Policy, College Park, MD (SAM); Cadbury Adams USA LLC, Science & Technology, Whippany, NJ (DLT); Purdue University, Department of Foods & Nutrition, West Lafayette, IN (CMW); and Mars Inc, McLean, VA (CEW).
2 Originally published in: Nutrition Reviews® 2009;Vol. 66(5). DOI: 10.1111/j.1753-4887.2009.00188.x.
3 Supported in part by educational grants from Cadbury Adams USA LLC, the Coca-Cola Company, ConAgra Foods Inc, General Mills, Kraft Foods, Mars Snackfoods US LLC, PepsiCo Inc, Procter & Gamble, Sara Lee, and Tate & Lyle.
4 Address reprint requests and correspondence to E Hentges, ILSI North America, 1156 15th Street, NW, Suite 200 Washington, DC 20005-1743. E-mail: ehentges{at}ilsi.org.
for the International Life Sciences Institute North America Working Group on Guiding Principles
ABSTRACT
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. Whereas 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 article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored research. This article, 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. In the conduct of public/private research relationships, all relevant parties shall 1) conduct or sponsor research that is factual, transparent, and designed objectively, and, 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) ensure, before the commencement of studies, 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; 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; and require that such researchers publish only under the auspices of the CRO.
Received for publication February 8, 2009. Accepted for publication March 5, 2009.
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  L. I Lesser Reducing potential bias in industry-funded nutrition research Am. J. Clinical Nutrition, September 1, 2009; 90(3): 699 - 700. [Full Text] [PDF]
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