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管理行业资助研究中的冲突和提高透明度。

Managing Conflicts and Maximizing Transparency in Industry-Funded Research.

机构信息

GSPsquared LLC, Newton, Massachusetts, USA.

Wisconsin Surgical Outcomes Program, Univeristy of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.

出版信息

AJOB Empir Bioeth. 2020 Oct-Dec;11(4):223-232. doi: 10.1080/23294515.2020.1798562. Epub 2020 Aug 18.

DOI:10.1080/23294515.2020.1798562
PMID:32808880
Abstract

BACKGROUND

Industry funding of research comes with important conflicts of interest, especially when research findings have financial implications for funders. When considering industry funding, academic investigators seek ways to mitigate and manage conflict to ensure integrity of research design, analysis, interpretation, and to protect researchers' and their institutions' credibility. This qualitative study's purpose was to conduct semi-structured interviews with expert stakeholders to gain insight into industry funding of research focused on nutrition and obesity, and determine the feasibility of developing a transparent process using an advisory board to help govern industry funding and manage conflict.

METHODS

We conducted seven semi-structured interviews with a purposive group of expert stakeholders representing varied perspectives. We distributed a summary of the advisory board concept to interviewees; developed and used a 16-question interview guide; and analyzed the interviews using open coding, manifest content analysis, axial coding, and code list reviews to identify and refine themes.

RESULTS

Most interviewees agreed that managing conflicts between industry funders and researchers was possible but difficult. They believed a carefully constructed advisory board empowered with specific responsibilities could help facilitate this process. They posited that strict guidelines are required to protect research quality and reporting, researcher(s)' and research institution(s)' reputations, and subsequent policy influenced by the research findings. They recommended specific guidelines and a framework for developing and administering the advisory board.

CONCLUSIONS

A carefully constructed advisory board empowered with specific responsibilities could be useful to manage actual and perceived conflicts of interest, and increase transparency of research processes, funding, and results for industry-funded research. Stricter guidelines than those previously proposed in existing frameworks are needed to instill confidence in industry-funded nutrition and obesity research. A possible next step could include a pilot study of the advisory board concept to determine specific requirements for execution and to develop rigorous guidelines.

摘要

背景

产业界对研究的资助伴随着重要的利益冲突,尤其是当研究结果对资助者具有财务影响时。在考虑产业界的资助时,学术研究者寻求减轻和管理冲突的方法,以确保研究设计、分析、解释的完整性,并保护研究人员及其机构的信誉。本定性研究的目的是对关注营养与肥胖的研究领域的专家利益攸关方进行半结构访谈,以深入了解产业界资助的情况,并确定使用咨询委员会制定一个透明的流程来帮助管理产业界资助和冲突的可行性。

方法

我们对一组具有不同观点的专家利益攸关方进行了七次半结构访谈。我们向受访者分发了咨询委员会概念的摘要;制定并使用了 16 个问题的访谈指南;并使用开放式编码、显式内容分析、轴向编码和代码列表审查对访谈进行分析,以识别和精炼主题。

结果

大多数受访者一致认为,管理产业资助者和研究人员之间的利益冲突是可能的,但很困难。他们认为,一个拥有具体职责的精心构建的咨询委员会可以帮助促进这一过程。他们认为,需要严格的指导方针来保护研究质量和报告、研究人员和研究机构的声誉,以及随后受研究结果影响的政策。他们建议制定具体的准则和框架来开发和管理咨询委员会。

结论

一个拥有具体职责的精心构建的咨询委员会可以有助于管理实际和感知的利益冲突,并提高产业资助研究的研究过程、资金和结果的透明度。需要比现有框架中先前提出的更严格的准则来增强对产业资助的营养和肥胖研究的信心。下一步可能包括对咨询委员会概念进行试点研究,以确定执行的具体要求并制定严格的准则。

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