Bauer David, Orchard Devin A, Day Philip G, Tunzi Marc, Satin David J
University of Minnesota Medical School, 420 Delaware St SE, Minneapolis, MN, 55455, USA.
Department of Family Medicine and Community Health, University of Massachusetts Chan Medical School, Worcester, MA, USA.
BMC Med Ethics. 2025 May 15;26(1):61. doi: 10.1186/s12910-025-01221-5.
Conflicts of interest (COIs) in healthcare research have received substantial attention over the past three decades. Although financial COI (FCOI) has an extensive literature, publications about non-financial COI (NFCOI) are comparatively rare. Disagreements surrounding the importance of NFCOIs in research and publication, including whether competing non-financial interests should even be considered COIs, present significant gaps in the literature. This lack of clarity prompted our literature review's aim to determine the current consensus about how NFCOIs should be treated in healthcare research and publication.
We searched the PubMed database using MeSH terms and keywords to identify articles published before November 6, 2023 about NFCOI in biomedical research and publication. We applied relevance, appropriateness, transparency, and soundness (RATS) criteria to develop a final dataset of 206 publications and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. Qualitative and quantitative analyses revealed major themes and conclusions regarding consensus within the field.
The literature centers around fundamental disagreements about (1) whether competing non-financial interests constitute COIs like FCOIs, (2) whether they need to be addressed in research, and (3) whether they should be managed with disclosure or with other strategies. Despite these disagreements, the balance of evidence and arguments suggests that (1) NFCOIs are meaningful conceptual entities like FCOIs [96%], (2) they require management [76%], and (3) disclosure is necessary but insufficient [55%] or necessary and sufficient [27%] as a management strategy.
The topic of NFCOI enjoys far less attention and consensus compared to FCOI's robust body of literature developed over decades. We found general agreement about the relevance of NFCOIs and the need to address them, but not how to do so. Our results are consistent with Wiersma et al., the first review on this topic. Taken together, these reviews suggest a path forward for researchers, publishers, and healthcare professionals requiring new approaches for NFCOI management.
在过去三十年中，医疗保健研究中的利益冲突（COI）受到了广泛关注。尽管关于财务利益冲突（FCOI）的文献很多，但关于非财务利益冲突（NFCOI）的出版物相对较少。围绕NFCOI在研究和出版中的重要性存在分歧，包括竞争性非财务利益是否应被视为利益冲突，这在文献中存在重大空白。这种缺乏清晰度促使我们进行文献综述，旨在确定目前关于在医疗保健研究和出版中应如何处理NFCOI的共识。
我们使用医学主题词（MeSH）和关键词搜索PubMed数据库，以识别2023年11月6日之前发表的关于生物医学研究和出版中NFCOI的文章。我们应用相关性、适当性、透明度和合理性（RATS）标准来建立一个由206篇出版物组成的最终数据集，并使用系统评价和Meta分析的首选报告项目（PRISMA）流程图进行报告。定性和定量分析揭示了该领域内共识的主要主题和结论。
文献围绕着以下基本分歧展开：（1）竞争性非财务利益是否像FCOI一样构成利益冲突；（2）它们是否需要在研究中得到解决；（3）它们应该通过披露还是其他策略来管理。尽管存在这些分歧，但证据和论点的平衡表明：（1）NFCOI与FCOI一样是有意义的概念实体[96%]；（2）它们需要管理[76%]；（3）披露作为一种管理策略是必要但不充分[55%]或必要且充分[27%]。
与数十年来关于FCOI的大量文献相比，NFCOI这个主题受到的关注和达成的共识要少得多。我们发现对于NFCOI的相关性以及解决它们的必要性存在普遍共识，但对于如何解决却没有共识。我们的结果与Wiersma等人的研究一致，他们是关于这个主题的首次综述。综合来看，这些综述为研究人员、出版商和医疗保健专业人员提出了一条前进的道路，他们需要新的方法来管理NFCOI。
