A journal published an animal study on the use of drug X for the treatment of clinical condition A. The authors did not declare any competing interests. A few months after publication, a journalist contacted the editors to say that the corresponding author had several patents on drug X, was listed as an inventor of the drug, and that the public charity of which he is the director recently announced that they were seeking approval for clinical trials of drug X in condition B. He also said the corresponding author co-owned a commercial company with whom the charity does business. The authors were asked to clarify any competing interests, and were directed to the journal’s policy, which is posted online as part of the instructions for authors. The corresponding author replied saying that the commercial company was a subsidiary of the charity and had no ownership rights to the drug. He did not specifically say whether there were any competing interests to declare. Instead, he wanted to know how this matter had come to light. During a telephone conversation he confirmed that the charity had applied for a patent for the use of the drug for the treatment of clinical condition A, but it was yet to be approved. He also said that no company had been licensed to develop/manufacture the drug for either condition. However, he also said that if the drug was ever licensed, the charity might choose to pass on some of the royalties to the inventors. 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?
-为了透明起见,提交人本应宣布存在利益冲突。-专利权人应当声明,即使所获得的利润转移到其他地方,他们也应当持有该专利,因为他们将从与该专利有关的活动中获得无形利益。-有利益冲突没有错,但必须声明。这使读者能够自行决定利益冲突与论文结论的相关性。-这是一个很好的做法,期刊,以确保他们有一个明确的政策,对利益冲突。-一些期刊将论文发回给最初的审稿人,让他们评论利益冲突是否会改变他们对论文的看法。-只有在非常严重的情况下才会考虑因未申报的利益冲突而撤回论文,因为这似乎会损害数据的有效性。-公布对未申报的利益冲突的更正通常是最适当的做法。-提到非营利机构是一个危险的鲱鱼,因为作者仍然有可能从该产品中获得财务和非财务利益。-编辑应发表一份更正,说明未声明的利益冲突的性质。-《华尔街日报》还应考虑他们是否需要更清楚地说明自己的利益冲突政策。
起草了一份新的修正案,排除了提交人与非营利组织的联系。编辑们联系了通讯作者,让他知道这一修改,为什么要这样做,并要求他批准修改后的更正。新的更正如下:“在我们最近的文章中,[1]我们没有宣布下列相互竞争的利益:A、B和C是X研究所的雇员,该研究所已经申请了使用药物N治疗出血热的专利。该研究所目前拥有在其他临床条件下使用N的专利,D被列为发明人。“通讯作者说,他不同意没有提到他的机构是一个公共慈善机构的声明。他还说,他认为《作者须知》中关于宣布相互竞争的利益的指导方针不够明确。编辑们回应说,该机构的“非营利性”地位并不相关,潜在的竞争利益可能仍然存在,应该予以宣布。提交人拒绝同意一项没有提及“非营利”的声明,并希望与COPE联系,更详细地讨论此事。作者还威胁说,如果编辑未经他同意就发表更正,将采取法律行动。他建议为修正案的案文起草一份新草案。在我们最近的文章[1]中,我们没有声明与N技术相关的专利权。尽管我们的雇主是一个非盈利的公共慈善机构,但由于他们可能被视为非财务上的竞争利益,我们现在提供以下补充信息:a、B和C是X研究所的雇员,该研究所已申请了使用N治疗出血热的专利。X研究所目前拥有在其他临床条件下使用N的专利,D被列为发明人。”为了澄清杂志的立场,编辑们决定发表以下关于更正的评论,作者还同意:“(出版商)感谢作者澄清了他们相互竞争的利益,并希望阐明自己的观点,即即使是非营利公共慈善机构的雇员也可能有相互竞争的利益(财务或其他方面),最好是在宣布这些利益时出错。然而,在发表原文时,我们的竞争利益政策在这一点上还不够明确。因此,我们将适时更新。”bob官方app