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Funding food science and nutrition research: financial conflicts and scientific integrity^1,2,3,4

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.

See Fuglie et al (3). Also see Lesser et al (4), which asserts that roughly 29% of beverage research was fully or partially funded by industry. A study by Thomas et al (5) concluded that roughly 60–65% of long-term (1 y) weight-loss trials were funded by industry.

For industry-funded research that enhanced the microbiological safety of food, see Tanaka et al (6). This research, which concerns the safety of cheese products, was the precursor to the field of microbiological predictive modeling, which is now widely used by food processors and regulatory agencies to predict the safety of formulated foods.

For beneficial food-industry toxicological research (ie, research promoting better public health), which was incidentally shared with the US Food and Drug Administration (FDA) prior to journal publication, see Velasco (7) and Pittet (8). For FDA aflatoxin information, see the Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (9).

^ll Case in point: the FDA's refusal in the early 1960s to approve the drug thalidomide, which was marketed in Europe as a tranquilizer for use in pregnant women, despite the German manufacturer's "scientific" assurances of its safety. See Burkholz (16) and Silverman (17) for a case history.

^¶ For a discussion of bias and the distinction between bias and conflict of interest, see publications by the National Academy of Sciences (26) and the Federation of American Societies for Experimental Biology (FASEB) (27).

^# The sample may not be representative of the population—may be too small. The data may be inaccurate because of self-reporting or inaccurate recording, the sample groups may be inappropriately grouped for analysis, the confounding variables may be misjudged or unidentified, or the journals may refuse to publish null or negative results or research on issues judged unpopular—all of these issues may result in biased conclusions, without the researchers even being aware. For a more complete discussion, see Bulgar et al (28).

^** Pressure to publish can also lead to journal-promoted biases, as cited in a recent article by Butler (31).

For an organizational example of applied peer review, visit the website of the National Institutes of Health (NIH) Office of Extramural Research (33), where the process is used to sift through the many funding applications received by the NIH.

Note the issues raised in the public health research community over a perceived disproportionate influence of one foundation's funding, documented in recent media coverage (38).

This guideline, separating the science from the funding of it, will be fulfilled in a variety of ways, depending on the specific funding mechanism used in a given research project. For descriptions of the significant variety of research arrangements currently used, see guidance offered by the NIH (39); an excellent analysis of conflict of interest management with respect to the varied research funding mechanisms is also offered by FASEB (40–42).

^llll For the purposes of this guideline, the investigative team may include employees of the sponsoring entity; researchers should agree or commit to publish findings on the key questions/hypotheses they investigate in their studies.

^¶¶ This guideline is intended to apply to investigators not associated with the funding entity and appropriate scientific auditors; it is not intended to guarantee availability of research data to the general public.

for the International Life Sciences Institute North America Working Group on Guiding Principles

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.

This article has been cited by other articles:

				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]