F. M. CLYDESDALE’s research while affiliated with University of Massachusetts Amherst and other places

Organizations with principles on publicprivate partnerships

Summary of NIH/USDA workshop “Nutrition Translation from Bench to Food Supply-Matrix of Prioritization Criteria for Research Questions”

Summary of interview process, including organizations represented, questions asked, and representative comments from interviewees.

The present article articulates principles for effective public-private partnerships (PPPs) in scientific research. Recognizing that PPPs represent one approach for creating research collaborations and that there are other methods outside the scope of this article, PPPs can be useful in leveraging diverse expertise among government, academic, and industry researchers to address public health needs and questions concerned with nutrition, health, food science, and food and ingredient safety. A three-step process was used to identify the principles proposed herein: step 1) review of existing PPP guidelines, both in the peer-reviewed literature and at 16 disparate non-industry organizations; step 2) analysis of relevant successful or promising PPPs; and step 3) formal background interviews of 27 experienced, senior-level individuals from academia, government, industry, foundations, and non-governmental organizations. This process resulted in the articulation of 12 potential principles for establishing and managing successful research PPPs. The review of existing guidelines showed that guidelines for research partnerships currently reside largely within institutions rather than in the peer-reviewed literature. This article aims to introduce these principles into the literature to serve as a framework for dialogue and for future PPPs.

Abstract The demand for safety in the U.S. food supply from production to consumption necessitates a scientific, risk-based strategy for the management of microbiological, chemical, and physical hazards in food. The key to successful management is an increase in systematic collaboration and communication and in enforceable procedures with all domestic and international stakeholders. The enactment of the Food Safety Modernization Act aims to prevent or reduce large-scale food borne illness outbreaks through stricter facility registration and records standards, mandatory prevention-based controls, increased facility inspections in the United States and internationally, mandatory recall authority, import controls, and increased consumer communication. The bill provisions are expected to cost $1.4 billion over the next four years. Effective implementation of the Food Safety Modernization Act's fifty rules, reports, studies, and guidance documents in addition to an increased inspection burden requires further funding appropriations. Additional full-time inspectors and unprecedented foreign compliance is necessary for the full and effective implementation of the Food Safety Modernization Act.

The ever-increasing complexity of the food supply has magnified the importance of ongoing research into nutrition and food safety issues that have significant impact on public health. At the same time, ethical questions have been raised regarding conflict of interest, making it more challenging to form the expert panels that advise government agencies and public health officials in formulating nutrition and food safety policy. Primarily due to the growing complexity of the interactions among government, industry, and academic research institutions, increasingly stringent conflict-of-interest policies may have the effect of barring the most experienced and knowledgeable nutrition and food scientists from contributing their expertise on the panels informing public policy. This paper explores the issue in some depth, proposing a set of principles for determining considerations for service on expert advisory committees. Although the issues around scientific policy counsel and the selection of advisory panels clearly have global applicability, the context for their development had a US and Canadian focus in this work. The authors also call for a broader discussion in all sectors of the research community as to whether and how the process of empaneling food science and nutrition experts might be improved.

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.

There has been substantial 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.

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. Although 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 the industry has played and will continue to play in the research process, the International Life Sciences Institute North America Working Group on Guiding Principles has, in this article, 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 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

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. Although 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 the industry has played and will continue to play in the research process, the International Life Sciences Institute North America Working Group on Guiding Principles has, in this article, 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 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.