期刊的一位编辑委员会成员提交了一个未经请求的审查文章。编辑表示，该期刊将考虑这篇文章，但怀疑这篇文章已被委托或甚至由毒品公司撰写。他/批定提交人必须在可以接受这篇文章之前提供金融披露声明。该期刊发表了审查条，这些条款被两个独立审稿人归因。他的竞争利益披露的作者，他一直是销售该药物的公司的付费顾问。出版后几个月，药物公司的代理商订购了这篇文章的重印。该代理要求措辞：“此文献审查由[x]支持”被包含在每个重印的封面上。该代理商被告知，由于提交人没有披露，因此无法增加此声明。代理人坚持，所以期刊联系了作者。提交人问：“最后一篇文章是否有这些词语或某种东西，这些词或某种东西指出了[x]的部分支持？” A copy of the agent’s wording and the competing interest statement from the published article were sent to the author, who replied that he was fine with it as long as the publisher was. The author was then asked to explain the extent of the drug company’s involvement in writing the review article. The author replied that the competing interest statement in the article was accurate; the review had been written independently of any pharmaceutical company, and that the requested statement from the agent was inappropriate. The author was contacted again to point out the contradiction in his two replies. At the same time the agent was asked to question the drug company as to whether it had paid the author to write the review, and to confirm the extent to which the drug company had been involved in preparation of the manuscript. The agent did not reply; neither did the drug company. Eventually, the agent cancelled the reprint order. The author finally replied to confirm that he had been confused by the original request, thinking that clarification of whether he was a paid consultant to the drug company was required. He said that when it became apparent in a follow-up email that the drug company wanted the extra statement added, he realised it was inappropriate. The author assured the editors that the drug company would write a letter of explanation soon. The letter has yet to arrive.
一个新的编辑被任命为少数民族医学专业的社会期刊。该社会的一名官员立即向他递给他一封来自抱怨的读者的匿名信，该文章最近发表的一篇文章是不道德的。编辑是一个个人朋友，他们接受了这篇文章，以及本文的作者。本文由一个作者提供对学术组织没有隶属度的作者。该报告描述了对他在前几年进行治疗X的患者的群组研究。在世界文学中，据报道，治疗X在少数患者中导致心内膜炎，其中大多数有风险因素。提交人邀请他的患者与心内膜炎和超声心动图的标志物一起恢复临床检查和尿液试验。他没有寻求从道德委员会的研究许可，并且没有从患者中正式获得知情同意，但这些研究的目的是与他们讨论的。该报告具有相当大的科学和临床重要性，是系统寻求治疗X后心内膜炎的存在的第一个，其结果（未发现任何病例）提供一些支持的证据表明治疗X后心内膜炎的风险低。提交人表示，该项目突出了他对患者的福祉的最初关注，他没有意识到他已经通过了要求道德批准的门槛。 The Editor’s close personal involvement at several levels makes it very difficult for him to make a decision on what action should be taken.
一家杂志发表了一项关于使用X药物治疗临床病症A的动物研究。作者没有宣布任何相互竞争的利益。发表几个月后，一名记者联系编辑说，通讯作者拥有X药物的多项专利，被列为该药物的发明者，他担任董事的公共慈善机构最近宣布，他们正在寻求批准在条件为b的情况下进行药物X的临床试验。他还表示，通讯作者与慈善机构共同拥有一家商业公司。这些作者被要求澄清任何相互竞争的利益，并被导向该杂志的政策，该政策作为对作者的指导的一部分发布在网上。通讯作者回复说，该商业公司是该慈善机构的子公司，对该药物没有所有权。他没有具体说明是否有任何相互竞争的利益需要申报。相反，他想知道这件事是怎么曝光的。在一次电话交谈中，他证实该慈善机构已经为该药物用于治疗a型临床症状申请了专利，但尚未获得批准。他还说，目前还没有任何一家公司被授权研发或生产治疗上述两种疾病的药物。不过，他也表示，如果该药物获得许可，慈善机构可能会选择将部分版税转给发明者。 It was suggested that the following competing interest statement should be published: “Authors 1, 2 and 3 are employees of the not for profit institute, which has applied for a patent for the use of drug X in the treatment of clinical condition A. The institute is a public charity that currently holds patents for the use of drug X in other clinical conditions, with Author 1 listed as an inventor.” - Should the authors have included a competing interest declaration on the manuscript? - If so, should it be any different to what was suggested? - In general, what should be done about studies on drugs that are potentially lucrative? Should the authors declare if they “might” make money? - In this case, what does “not-for-profit” really mean? - And what does all this mean for researchers at universities that make money through spin-off companies?
建议：
- 为了透明度的利益，提交人应该宣布利益冲突。- 专利的持有人应声明他们暂时申请了这样的专利，即使任何地方取得任何地方，因为他们站立从与该专利相关联的无形益处。- 患有利益冲突没有错，但必须被宣布。这使读者可以自己决定利益与论文结论的相关性。- 期刊是良好的做法，以确保他们有明确的利益政策。- 一些期刊将纸张发送回原始审核人员，并要求他们评论利益冲突是否会改变他们对论文的意见。- 仅在非常严重的情况下审议未征得利益冲突的纸张的缩回只会被认为是破坏数据的有效性。- 关于违约的利益冲突的纠正的出版通常是最适合的行动方案。- 对非营利性机构的参考是一个红鲱鱼，因为作者仍有潜力仍然从产品中获得财务和非经济利益。- 编辑应发布修正，说明未征得的利益冲突的性质。 - The journal should also consider whether they need to state their conflict of interest policy more clearly.
跟进：
起草了一个新的修正，其中排除了向非营利组织的作者隶属关系。编辑联系了相应的作者，让他知道改变，为什么已经完成，并要求他批准重新修正。新修正如下：“在我们最近的文章中，我们未能宣布以下竞争利益：A，B和C是X研究所的员工，该员工申请了用于使用药物的专利治疗出血热。该研究所目前拥有在其他临床条件下使用N的专利，其中D作为发明人。“通讯提交人表示，他不同意没有提到他的机构是公共慈善机构的宣言。他还表示，他认为，宣布发布的竞争利益的准则，提交人的说明书没有足bob官方app够明确。编辑答复说，该机构的“非营利性”状况不相关，潜在的竞争利益可能仍然存在，并且应该宣布它。提交人拒绝同意宣言，没有提到“非营利”，并希望联系应对要求更详细地讨论此事。如果编辑在未经他的同意下发布修正，提交人也会威胁法律诉讼。 He suggested a new draft for the text of the correction. In our recent article [1], we did not declare the patent rights related to N technology. Since they may potentially be viewed as non-financial competing interests, despite the fact our employer is a non-profit public charity, we are now providing the following supplemental information: A, B and C are employees of X Institute, which has applied for a patent for the use of N in the treatment of haemorrhagic fever. X Institute currently holds patents for the use of N in other clinical conditions, with D listed as an inventor.” To clarify the journal’s position, the editors decided to post the following comment on the correction, which the author also agreed to: “[The publisher] thanks the authors for clarifying their competing interests and wishes to make clear its view that even employees of non profit public charities may have competing interests (financial or otherwise) and that it is always best to err on the side of declaring these. However, at the time of publication of the original article, our competing interests policy was not sufficiently explicit on this point. We will, therefore, be updating it in due course.”