我分析了随机对照试验的结果,刚刚完成我的一些同事。审判与安慰剂相比一个氧游离基清除剂在急性心肌梗死患者。结果的一个主要措施包括梗塞大小,以核成像。我的分析表明,有这两种参数的组间无显著差异,但从制药公司统计人员得出结论,治疗提供重要的临床益处。主要的区别是,他们会进行分析,显示治疗组显著减少梗塞面积。这项研究已经发表在约定使用这种分析。我认为会促进分析不仅是不恰当的,但误导,甚至是不道德的。我建议由于小样本大小(约60名患者),他们应该快乐,结果倾向于治疗中获益,他们真正需要的是一个更大的试验。不幸的是,这项研究没有药物制造商的许可合同禁止出版。我满足自己认为阻止出版的错误主张,我们继续讲课,有insuf吗?充分证据的使用这种药物在冠状动脉疾病。 To date, the drug continues to be a best seller. The story then hit the headlines, when it was published in a journal. The concession to its publication had been the inclusion of some statements pointing out that the conclusion was based on within-group analysis. I was appalled. How could they purposely publish a misleading claim, and ignore all references to alternative analyses? The problem is compounded by the following: The principal instigator is a senior cardiologist,professor emeritus in our college,and a leading figure in heart associations. He sits on many committees that approve funding for projects (some of which are mine). He has lectured far and wide that the drug is actually effective. The editor is a good friend of his. What should I do?
咨询顾问在公共卫生和临床生物化学家受雇于卫生当局提交了一篇论文。它试图解决的问题是苯二氮卓类药物滥用和转售在黑市上。作者确定了实践与苯二氮平类药物的处方率最高,并要求GPs同意请求患者尿液样本苯二氮卓类药物的处方。论文没有明确患者的选择标准,除了通过全球定位系统(GPs)病例选择根据他们是否觉得确认合规将是有用的。他们发现只有83的158例规定苯二氮卓类有积极的尿液样本,并认为“随机尿液测试是一个好主意。“本文没有明确规定要求是否第一或随后的处方。没提道德委员会批准或病人的同意。当这些问题作者提出了他们的反应很迅速,同意的问题。他们认为,这是一个错误称为这一块的研究工作。他们的背景概述问题导致这一块的工作,并认为,而不是一个研究中,他们的工作代表一个决定延长尿液的可用性测试对苯二氮卓类三个实践受到相当大的压力。他们认为,他们不认为这是一个研究项目,但作为一种应对困难的情况下通过扩展这些实践良好的实践和社区设施可用药物团队。成本考虑,他们说,阻止了开放的全科医生获得尿液测试药物。他们说的是他们为什么没有提出更改提交给伦理委员会批准。也没有具体同意寻求其他病人比标准的同意下获得医生的注意义务。 They argued, however, that the testing of urine for drugs of dependency is standard practice for a community drugs teams, and in general practice, in some cases. The authors requested advice on to how to present such a piece of basic public health work in an ethical manner. They also asked what were the ethics of publishing pieces of work that were never intended as research, but which turn up important information; and conversely, what were the ethical implications of not making available important information arrived at during routine work, and how one should deal with the ethics of obtaining genuine informed consent from patients for a test that is being used to assess their honesty. The responsible editor thanked the authors for their swift reply, but pointed out that on purely scientific grounds the journal did not want to publish the study. What is COPE’s view of the ethics of the authors’ actions? How else might the editors respond to the questions they raise? Should the journal take any further action?
论文发表的作者'contributions如下:A和B有最初的想法和研究计划。也负责收集样品和患者数据。C建立数据库和参与计划的临床试验。D开发酶联immunoabsorbent测定和分析所有的样品。E和F负责数据的统计分析。纸已经由B, G D H A和B和A .担保人的研究。D向丹麦科学不诚实,委员会认为贡献者名单已经改变了从被作者同意。委员会支持了这个申诉和《同意发布修正因素列表,如下:a和D主动调查。一个收集的临床资料。F更新和验证的临床资料,最初登记和安排的F c和D PAI-1合作分析样品。 F and E conducted in cooperation the statistical analysis. F, B, D and A interpreted the statistical results. A and B wrote the first draft of the paper and were in charge of the final manuscript. All authors actively participated in discussions regarding the conduction of the work and in preparation of the final manuscript. The findings of the Committee have subsequently been disputed.
一篇论文发表在1998年1月,七作者认为。在确认部分B是感谢他的贡献。一年后B写信给编辑,本文概述了两个所谓的事件相关。首先,队列在1998年1月报纸报道一个B一直致力于自1990年代初。在1992 - 3他寻求与另一个研究小组合作。资助申请和授予。当时B, co-signatory授予应用程序,迁往海外,但格兰特具体包括钱让他回到他的祖国继续合作。此外,所有的合作者同意,他将是所有后续论文的合著者。随着合作的进行,B组的觉得他被击败。一位资深的同事在他的祖国感到同样的方式,最终辞去了合作。 B was unaware that a paper was being prepared for publication from this study. The first time that he saw the paper was after publication. He only contacted the editor after several colleagues urged him to bring the matter out into the open. Not only was he not included as a full author on the paper, but his permission had not been sought for acknowledgement, in direct contravention of the Vancouver Group guidelines. The second allegation concerning this paper is that the hypothesis subtly shifted between the grant application and the published paper. The hypothesis as stated in the grant application is different in an important way from that stated in the introduction to the paper. The results of the research support the hypothesis as cited in the paper,but directly contradict the hypothesis as cited in the grant application. B alleges that the research group concerned has indulged in post hoc hypothesis generation so that the results reflect their beliefs about the meaning of the data rather than their pre-specifed hypothesis. Another paper from this research group,in which B is cited as an author, again without his permission, is currently being held by the editor of a specialist journal pending the outcome of this particular case. All of the co-signatories and collaborators on the original grant application have been asked (with B’s permission) for their view on the allegations. A further complication is that although the grant awarding body has a procedure for dealing with allegations of misconduct, one of the authors of the paper is one of their unit directors.