After a manuscript was accepted, an author passed away before they could complete the conflict of interest statement and copyright transfer documents. The publishing company requires that all authors complete these documents prior to publishing.
The other authors do not want to remove the deceased author from the manuscript.
应对论坛的问题
谁有权力为已故作者完成这些文件？
是否有任何特殊的符号应该在手稿中进行？
Advice:
The Forum asked for clarification from the editor regarding when in the publication cycle the author died and did the author see the final version of the submitted and accepted article? The editor told the Forum that the author had seen the final accepted version. Hence the Forum agreed that it seems reasonable that the author should remain on the byline. It would be possible to ask his next of kin or executor to verify the conflict of interest (COI) statement to obtain a notarized statement, if that is required, if the editor is not comfortable taking an informal statement from the co-authors.
《华尔街日报》,有三个组件:战士fying the COI statement, fulfilling the authorship criteria and signing the copyright agreement. There is still a non-financial aspect to potential COIs, which seems to be difficult to ascertain with certainty.
为了透明度,useful for the editor to add a statement or footnote on the paper, including the date of death in relation to participation in authorship and a statement to the effect that to the best of their ability, the journal has determined there was no COI. It is questionable that the deceased author would benefit from any COI. Further, the Forum agreed that COIs, leading to bias in the work, would have been uncovered at the time of grant funding or peer review of the manuscript.
The Forum applauded the editor’s due diligence in handling this matter.
We published two peer-reviewed articles—one protocol and one paper with the results of a comparative analysis comparing a group of people associated with a specific “complementary medicine health care organization” (CMG), with the general population, which concludes that the group has “unusual health indicators” (more favourable than the general population).
The papers originally contained a conflict of interest (COI) statement stating that the authors were “insiders, in that they attend CMG events. However, they have received no funding, reimbursement, or other consideration from CMG or its stakeholders, and no instructions or directions of any kind from CMG or its stakeholders. No other competing interests exist.”
Our freelance copyeditor edited this statement out, to read “Conflicts of interest: None declared”, because “attending events” is not normally something that would be considered a COI. The authors approved the galleys and did not object to these copyediting changes.
Shortly after publication, we received a 12-page letter from a journalist, detailing extensive undisclosed COIs of the authors. The letter was also addressed to another journal which published another protocol from the group, as well as to the university (the lead author is associated with the university). In the letter, the CMG movement is characterized as a controversial, multimillion dollar international enterprise. The healing modalities promoted by CMG do not appear to be evidence based. In the letter, evidence was provided showing that all researchers are long term public promoters of the CMG enterprise, as well as being spiritual adherents to the CMG ‘religion’. One author is a former CMG company director. The letter also says that the lead researcher is the spouse of a current CMG “company director” (which is disputed by the author). The corporation is owned by another corporation which in turned is owned by the founder of the CMG enterprise.
As alleged in the letter (and confirmed by our own internet searches), all authors are influential persons within the CMG spiritual and business community. We confronted the lead author with these allegations and asked the authors to provide a more detailed COI statement for a possible correction of the original papers. In response, the lead author submitted a 1-page revised COI statement detailing that all four authors have varying degrees of association with the CMG and are members of the “Practitioners’ Association” which is the body regulating practitioners who are qualified to practice CMG modalities. Two authors have “occasionally offered paid private healing sessions”. The revised COI by the author also alleged that “all authors have experienced substantial health benefits since they started visiting CMG events”. In addition, they all have published blogs on CMG associated websites. The wife of the lead author is—according to the revised COI—involved in “voluntary activities around producing content for a CMG associated company and is a “company secretary” of the CMG associated company and “does this in an honorary capacity. She is not a director or shareholder” and “does not receive any financial incentives” from CMG.
We consulted the original peer reviewers, showing them the updated COI. They said they would not have accepted the manuscript had they known about these extensive COIs. We suggested to the authors that we feel that both articles should be retracted, and we would prefer to do this with their consent.
The university has launched an investigation as a result of the journalists’ letter, but the investigation is not complete. Meanwhile, the case has also been picked up by the mainstream media, who is putting pressure on the university to distance themselves from CMG, which is described by the media as a “cult”.
应对论坛的问题
• Should we publish the updated COI statement as a corrigendum, perhaps with a notice of editorial concern, and wait for the outcome of the university investigation to decide on further steps.
• Or should we retract the papers due to non-disclosure of COI (and also due to concerns over the content and practices of the CMG enterprise, the scope of which neither reviewers nor editor were aware of when accepting the paper)?
•我们还有第三种选择吗？
Advice:
The Forum advised that there do not appear to be grounds for retraction. The COPE guidelines on retraction state that “Retraction should usually be reserved for publications that are so seriously flawed (for whatever reason) that their findings or conclusions should not be relied upon.” A conflict of interest is not in itself a reason to retract an article, particularly in an original research paper, unless there are serious concerns with the data. Hence the Forum would agree with the publication of an updated COI statement as a corrigendum, perhaps with an editorial notice. The Forum also suggested collaborating with the institution on their investigation. If the institution finds there are fabricated or serious flaws in the data, then the editor may wish to consider retracting the article. But a retraction at this stage is not appropriate.
Follow up:
The journal published two expressions of editorial concerns and corrections (one for the protocol and one for the final paper, correcting the conflict of interest disclosure as well as correcting the data, as per the corrigendum submitted by the authors). Regarding the third paper, a protocol published by another publisher, to our knowledge they have not taken any action, such as publishing an expression of editorial or updating the conflict of interest. The journal is collaborating with the authors' institution which is currently still investigating this case and will await their recommendation on whether or not the paper should be marked as retracted.
我们的COPE材料可用于根据Creative Commons atjection-noncommercial-noderivs许可使用 https://creativecommons.org/licenses/by-nc-nd/3.0/ Attribution — You must attribute the work in the manner specified by the author or licensor (but not in any way that suggests that they endorse you or your use of the work). Non-commercial — You may not use this work for commercial purposes. No Derivative Works — You may not alter, transform, or build upon this work. We ask that you give full accreditation to COPE with a link to our website:publicationeThics.org.
Full page history
Introduction
Competing interests (also known as conflicts of interests — COIs) are ubiquitous. One definition is as follows:
“A conflict of interest (COI) is a situation in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization. The presence of a conflict of interest is independent of the occurrence of impropriety.”
We received an original article which was accepted and published. The article was written by multiple authors from several centres, and the corresponding author undertook the task of standardising the content, making several corrections to the original text. The author proofs were sent to the corresponding author, who reviewed them.
However, once published, one of the co-authors indicated his disagreement with the changes that had been made by the corresponding author on his part of the article. This author has asked us to publish an erratum to include, under “Conflicts of interest”, his disagreement with the final version, because he wants to respect the original text (the author already expressed their disagreement before the article was published, but we did not know this until now).
The corresponding author disagrees with the addition to the conflict of interest statement because there is no conflict of interest, only a difference of opinion. Moreover, he argues that, as scientists, we must be aware that all of our work has limitations, and recognize that these limitations are part of what drives scientific progress.
应对论坛的问题
What is the procedure we should follow in this case?
Advice:
The Forum agreed with the editor that these are not conflicts of interest, but differences in opinion between the authors. A conflict of interest statement would not be appropriate in this instance. The Forum suggested that the journal could ask the disgruntled co-author to submit a letter to the editor for publication in the journal, outlining his concerns. Raising these concerns in public could be a way of resolving this issue. It is important that the letter is linked to the original article, so that the two items are permanently linked. If the journal does not have a mechanism for publishing letters to the editor, the journal could usePubMed Commonswhich enables authors to share opinions about publications in PubMed. In extreme cases, it has been known to have two different discussion sections in the same paper.
A way to avoid a similar situation in the future would be to ask the authors to provide a contributorship statement, which outlines the contribution of each author to the study. The statement could also include agreement on the final version, so that all authors confirm that they agree with the final version for publication.
Follow up:
The journal decided to invite the disgruntled co-author to submit a letter to the editor and to ask the other co-authors to reply. They have yet to receive the letter.
Follow up (February 2016): 失语的合作者向编辑提交了一封信。原始文章的相应作者有机会回复。这两个字母都被发布并永久链接到原始文章。
The manuscript described a randomised controlled trial conducted on patients undergoing brain surgery. Participants were recruited between January 2010 and February 2012 in a single hospital.
The stated aim of the study was to establish the effect of varying the time for which blood flow to the brain is substantially reduced during surgery on postoperative function and disability. It is already well established that reducing the blood flow in this manner for a prolonged period of time is likely to lead to poorer postoperative outcomes due to reduced oxygen supply to the brain.
In order to avoid negative outcomes and improve patient safety, there already exists a warning criterion used in surgery of this type, which alerts the surgeon to the extent of oxygen starvation and indicates when blood supply should be restored.
In the manuscript, the authors outline their knowledge of the risks involved with the procedure itself and report that many surgeons feel that this procedure should only be used as a last resort due to the increased risks outlined above. However, if the procedure is deemed necessary, the risks can be reduced by employing the pre-established warning criterion.
The authors outline perceived flaws of the pre-existing criterion and go on to describe a novel warning mechanism —conceived by them—that they intend to test during the study. Testing this new criterion entailed increasing the time that blood supply in the brain is reduced—to the extent that, in some cases, the current recommended threshold was significantly exceeded. Additionally, while the procedure was underway, the authors ensured that the surgeon was blinded to the patient’s status with respect to the established risk threshold, making is impossible for them to gauge the level of danger the patient was being exposed to. This, as is noted within the manuscript itself, poses serious risk to the patients.
参与者被分成三个小组ps. In the control group risk was assessed using the normal criterion and blood supply was reinstated once this threshold was crossed. In the second group, blood supply was reduced for a longer period of time. In the third group, blood supply was reduced or completely cut-off for significantly longer.
In the results section, the authors state that in the control group one patient became severely disabled, and that all patients in the third group experienced negative outcomes. Of the patients in the third group, three were severely disabled as a result of the procedure and all of the others suffered some neurological deficit. As the reviewer points out, the pattern of outcomes raises serious ethical concerns about the study. The reviewer questions whether this was (and even should have been) tested on animals first, as this would have provided an upper limit and ‘red flag’ for testing.
It appears that the negative outcomes found in group 3 patients were due to the blood supply being reduced or occluded for long periods of time. The reviewer also suggests that for the control group, there was an omission of a standard of care practiced by most modern medical centres that perform this procedure. The reviewer suggests these findings cannot be generalised to other procedures of this type and he wonders why the original warning criterion was not utilised in this study to further protect these patients.
Finally, the Declaration of Helsinki also states that “Physicians must immediately stop a study when the risks are found to outweigh the potential benefits…”; the authors did not stop this study for over a year. And, an unproven intervention should only ever be carried out if “it offers hope of saving life, re-establishing health or alleviating suffering” and that in the nature of research it is “designed to evaluate its safety and efficacy” not to establish a benchmark
Advice:
The Forum were in agreement that this was very dangerous and very unethical research and that the editor should act quickly. The advice was for the editor to contact the authors informing them that there are substantial concerns with the content of the paper. The editor should copy in all of the authors, giving them a specific and short deadline in which to respond. The editor should tell the authors that he will contact the authors’ institution if no response or an unsatisfactory response is received.
The editor in chief received a letter to the editor criticising a paper published earlier in the journal. The editor first told the author of the letter that he would publish the commentary after he had given the authors of the criticised paper a chance to respond. When asked by the author of the letter, he later added that he would also publish the letter if the authors failed to respond.
The corresponding author of the paper explained that the same person had attacked every single article from his group for about 5 years, that they had responded to the critics adequately in the past and declined doing so again in this instance. He portrayed the letter as a disingenuous and fraudulent commentary and asked that we do not publish the letter, which in his view would be a disservice to science.
At this stage, the editor of our journal contacted me as managing editor to ask if he could reject the letter outright. I advised that he could, but only based on the scientific merit of the letter, and not on the history of its author. He sent the letter for review to the associate editor who handled the criticised paper, and who briefly concluded that the commentary was probably not worth publishing. The editor then rejected the letter, initially mentioning various peer reviewers, when in fact there was only one short set of comments.
The author of the letter was quite irate as, based on the editor’s initial replies, he expected his letter to be published in any case (with or without a response from the authors) and found the peer review process and decision letter that he received unsatisfactory. A first clarification of our position resulted in a long threatening point-by-point response, to which the editor responded by reasserting his position and clarifying again why the letter had been reviewed by a referee and himself and subsequently rejected.
我们的出版商通知他，她正在认真对待他的担忧，并会要求我按照应对的指导方针进行调查，特别是关于我们的披露政策。bob官方appAlthough the author of the letter accused us of being in breach of the COPE policy on fair peer review in an earlier correspondence, he then replied that in this case COPE’s ‘concepts’ are meaningless and, for example, anonymous peer review or impartiality are impossible, since he is the only researcher “who has exposed a long series of frauds” on the topic. He went on to reiterate his request that we (a) do not contact the authors of the paper he criticised (he was initially fine with the authors responding to his critique), (b) ask referees specifically if they belong to the advocacy group discussed above and (c) send, if needed, his blinded manuscript to ‘independent’ (from the advocacy group mentioned and industries) reviewers, of which he proposes three names.
我们没有回复最后一封电子邮件，并决定寻求应对如何最佳关闭的建议以及我们应该更先做的事情。特别是，我对您的意见感兴趣： — how the editor should have communicated with the author of the letter in the first place? What are the main weaknesses in our handling of the case? - 如果批评文件的作者属于宣传群体，他们是否应该在他们的利息宣言中披露这一点？ — how to respond to the author of the letter about allegations of unfair peer review, and his rejection of a blinded peer review system? — should we, and how could we, check whether the author of the letter is genuinely trying to make valid points against prevalent opinion? — on the other hand, should he have an undisclosed agenda, should we take any action against him?
His letters and emails are often unconvincing, based on assumptions, defamatory and threatening, and he seems to belong to an opposite advocacy groups without disclosing it. In addition, the bulk of his contributions to the literature is made of commentaries criticising articles but he does not appear to publish any original research himself.
Advice:
The COPE Code of Conduct states that editors must be willing to consider cogent criticisms of work published in their journal. However, the editor needs to decide if this is “cogent criticism” or not. The Forum suggested there were three issues here: (1) whether the editor should publish the letter; (2) the undisclosed conflict of interest of the authors; and (3) the defamation of the editor on websites.
Regarding whether the editor should publish the letter, the Forum noted that editors have a duty to publish letters unless they are factually incorrect or libellous, and it is the responsibility of the editor to make that decision. Some of the members of the Forum argued that an editor should veer towards publishing everything, while others noted that there are different types of letters in different journals and it is not always appropriate to publish. However, all agreed that the editor should not make false claims (saying that the letter would be published with or without a response from the authors and then going back on that decision) and that the journal needs to tighten its editorial processes. The journal should have a clear process for handling letters. Are they peer-reviewed? The decision to publish a letter should be based solely on its academic merit.
Regarding the undisclosed conflict of interest of the authors, the editor should contact the authors directly and ask them to respond to this accusation and emphasise that non-financial conflicts of interest are also very important. If it transpires that the authors do have a conflict of interest, the editor could publish a correction. The editor should also check the journal’s policy on this issue.
我联系了博士C,这封信的作者,让him know that his case had been discussed at the COPE Forum and to reiterate our decision not to publish his letter. Most members present, if not all, supported the view that the editor in chief can reject a letter or commentary at his discretion. I sent a brief overview of the discussion and explained that the COPE Forum was of the opinion that declarations of interest should relate only to direct potential conflicts of interest. That meant that the disclosure in the criticised paper was satisfactory and appropriate.
The remaining question concerned the author’s role within an ‘advocacy group’.
I said we would contact the author and ask him to clarify the purpose of the group, their involvement in it and whether they think it might be a conflict of interest. We would then assess their response against our current requirements regarding declarations of interest.
Dr C quickly sent a couple of inflammatory emails in his usual style, where he repeated that there is a “universal conflict of interest that must be disclosed” because 90% of authors, editors and reviewers belong to the same bias ‘advocacy group.’ He then went on to contradict himself and, in my view, invalidate his only claim which may have had some merit: