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资助食品科学与营养研究:财务冲突与科学诚信。

Funding food science and nutrition research: financial conflicts and scientific integrity.

作者信息

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, Wedral Elaine

机构信息

SR Strategy LLC, Washington, DC 20036, USA.

出版信息

Nutr Rev. 2009 May;67(5):264-72. doi: 10.1111/j.1753-4887.2009.00188.x.

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. 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.

摘要

关于研究易受各类偏差影响这一问题,公众展开了激烈辩论。这场讨论已延伸至同行评审文献、科学会议、大众媒体、政府咨询机构等诸多领域。虽然偏差可能源自无数种来源,但迄今为止,讨论的压倒性焦点一直是行业资助的科学研究。鉴于行业在研究过程中已经并将继续发挥关键作用,国际生命科学研究所(ILSI)北美指导原则工作组在本文中针对行业资助制定了拟议的利益冲突准则,以保护科学记录的完整性和可信度,尤其是在健康、营养和食品安全科学方面。文中列举了八项原则,明确了行业资助研究的基本规则。本文向更广泛的科学界发出挑战,要求其解决所有偏差问题,这只是第一步;该文件旨在保持动态性,促使持续讨论和完善。指导原则如下。在开展公共/私人研究关系时,所有相关方应:1)开展或资助基于事实、透明且客观设计的研究;根据公认的科学探究原则,研究设计应提出恰当表述的假设,研究应回答恰当的问题,而非偏向特定结果;2)要求研究设计和研究本身的控制权保留在科学研究人员手中;3)不提供或接受与研究项目结果挂钩的报酬;4)在研究开始前,确保有书面协议规定调查团队有在特定时间框架内尝试发表研究结果的自由和义务;5)要求在出版物和会议报告中全面披露所有经济利益并签字;6)不参与行业资助的出版物或报告中未公开的有偿署名安排;7)保证研究人员、合适的审计人员/评审人员能够获取所有数据并控制统计分析;8)要求学术研究人员在为合同研究组织(CRO)工作或担任合同研究人员时,明确声明其所属关系;要求此类研究人员仅在CRO的支持下发表成果。

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