2008

We received an article at our editorial office in April 2008. One of the referees discovered that a similar article had been published in a surgical journal in 2000. In that article, the authors presented data on the haemodynamics and intestinal blood flow in pigs.

In the article submitted to us, they presented the same results, but only the first three time points (which had been included in the first article). The data were exactly the same but the graphical presentation was different. The language was different; not copied from the first. The article submitted to our journal included three new authors (not on the original paper).

作者承认了所有这些。作者声称第二篇文章是合理的，因为他们在讨论中有一些新的次要元素。他们无法承认并看到这是一个明确的双重出版物的案例。我们告诉他们这是一项严重违反国际出版伦理规则的行为。我们还告诉他们这次包括三个新作者是不可接受的。

The authors admitted to having done all this, but were very offended by our response. I told them I would consult COPE to obtain an objective statement.

一篇论文提交给我们描述》杂志上study in which children received general anaesthesia for a minor operation. The authors chose to induce anaesthesia with a mask and 8% sevoflurane inhalation for 8 minutes. The aim was to study the EEG over various brain areas to see where the epileptogenic activity is located. The reason for doing the study was that it has been shown that sevoflurane can cause epileptogenic activity on the EEG. Clinical convulsions have also been seen but much less often. Hence the authors deliberately gave a high concentration for 8 minutes because they wanted to provoke this epileptogenic activity to study it more closely. I asked them what information they had given to the parents (according to the manuscript, informed consent had been given). They replied that they had not given them the information that this could happen and why the investigation was performed. I also doubt that the ethics committee knew the true reason for doing the study.

This case resembles many I have seen over the years. The study was approved by the authors’ university ethics committee. My question is whether we, as journal editors, always must follow that judgement or whether we have an independent obligation to make our own judgement about whether a study is ethical.

A study was submitted that reported the prevalence of an intestinal infection in a tribal community. The authors did not obtain informed individual consent for stool collection from the study participants; instead they obtained consent from the leaders of each village. The study protocol was approved by the national IRB, but the protocol made no specific mention of stool collection—it referred to a study of a respiratory infection and “interdisciplinary research”, so we are unclear if the IRB knew that such collection would take place. The authors had obtained a permit for research from the country’s “national foundation”.

The handling editors, who work in the country in which this study took place, and who are very familiar with the national laws on conducting health research in tribal communities, state that:

(1) The law makes it clear that while obtaining prior consent from community leaders is very good practice, it should not dispense with efforts to obtain individual consent.

(2) Every individual must give consent; illiterate individuals should give a digital print.

We wrote to the authors to ask why they did not obtain individual consent, and whether the national IRB had approved the stool collection. We asked to see the protocol approved by the IRB.

They explained that they had published nine papers arising from this work, no journal had ever questioned them on ethical oversight (or asked to see the study protocol) and they are the only doctors to have ever offered this tribe any medical treatment. They withdrew their paper in protest.

There was obviously some ethics oversight here—ie, (1) there was national IRB approval of a related study (and perhaps the use of the word “interdisciplinary” gave the researchers license to include stool collection); (2) the village leaders gave consent; (3) the authors had some type of research permit allowing entry to tribal communities. But the editors remain concerned that: (i) national law clearly states that community leaders’ consent should not replace individual consent; (ii) it is not clear whether the IRB specifically approved the stool collection; and (iii) providing a medical service to this community arguably made it even more crucial to obtain individual consent (since provision of care might be coercive in this situation, especially if it was conditional on agreeing to be in the study). On receiving the letter from the authors withdrawing the paper, we wrote to them to share these concerns, but the authors never replied.

Does COPE feel that the editors have any further obligations?

We have recently been alerted to the fact that an article which has been reviewed as part of our service has been retracted. This is the first time this has happened and we are currently developing a guideline on how to deal with reviews of retracted articles.

We have alerted the section editors where the review was published, and we have also informed the reviewer of the article to give her/him the opportunity to comment.

我们打算在本次审查下展示一份编辑笔记，即说这篇文章已被撤回，并且教师已被警告。在本说明下，审阅者将能够显示出现后续评论。

Would you agree with our proposed course of action?

We publish “mini-reviews” of published articles. Our faculty of eminent researchers and clinicians write these evaluations. One of the conditions we insist on from our faculty is that they may not evaluate work on which they are an author. We received a review of a paper, the authorship of which was listed as:

Name A, Name B, Name C; study group X

As the reviewer was a member of “study group X”, we rejected the submission. The reviewer wrote back claiming that:

“我不是”名字“纸上的作者。后者是替代的，它使用“研究组X”数据库。虽然我们进入了一些患者进入主要审判，但绝不能够履行作者标准，因为我甚至没有看到论文的草稿，也不知道它正在提交。“

We published the review with the declaration above listed as a “competing interest”. We then informed the journal in question.

Did we act correctly?

A person named in the acknowledgements of a paper wrote to the editor indicating that they had been in part responsible for the analysis and interpretation of the data and should therefore be named as an author.

I have had extensive correspondence (copies of emails, etc.) from both parties and spoken to both on the telephone. Clearly, earlier there had been an exchange of data between the two parties and some work from the complainant on possible findings to report from the study. This included at least in part one iteration of what was eventually reported in the published paper. At one point in this correspondence, the first author offered the (later) complainant authorship. However, at some later point in time and before the manuscript was submitted to the journal, the first author insisted that they had not in fact used any analysis or interpretation from the complainant but that they were willing to offer “authorship” even though this was the case—this was declined by the complainant as they did not consider their contribution in this case warranted inclusion as an author although the complainant did not, to my knowledge, at this point see the most recent version of the manuscript that went on to be submitted to the journal.

从我读的信件好像那t the primary author may have used the ideas of the “complainant” to some extent in that the focus of the published paper does take one of the lines of interpretation that the complainant had suggested (a line of interpretation that was not given prominence in the very first outline manuscript from the author that was originally shared with the complainant and that I have seen). The analysis presented in the published paper was slightly but not substantially different from one of a number that the complainant had earlier performed. The author insists that neither of these points is correct and that the complainant had no role in the formation of the paper but rather had suggested a different focus for the analysis/paper that they did not go on to take up.

I have not been able to broker an agreement between the two parties and I am not able to square their two separate accounts of what has happened over time, including claims that some emails pasted into Word documents and forwarded to me had been altered. As such, this leaves me unable to confidently either reject or accept the complaint.

The journal feels unhappy with the situation. Given that both accounts as currently being presented cannot be true and that this makes arbitrating between the two accounts very difficult, we are considering retracting the paper if this dispute cannot be resolved. We envisage publishing some note regarding a dispute between the authors and a complainant that could not be resolved by the editors. We would welcome the Forum’s experience of retraction in such circumstances.

A preschool boy had a biopsy to confirm a condition from which he subsequently made a complete recovery. Later, he and his younger brother were reported by their female carer to have developed a possible recurrence and this looked likely on near-patient testing. At each review their carer urged us to undertake further biopsies on them both, but we did not feel that this was necessary.

他们的照顾者还报告说，他们正在接受另外三种不同条件的治疗，并且患有第四个不愉快的症状。

During a hospital admission the near-patient test we were performing repeatedly was always abnormal when his carer was on the ward, and normal when she was not. Further testing of the samples in question showed contamination with female genetic material. The carer admitted to deliberately contaminating the samples to achieve a positive test.

While this condition is well described, it has not been identified by karyotyping in this way before. This probably accounted for us being slow to diagnose it. There are extremely important reasons for diagnosing fabricated illnesses.

Unsurprisingly, the carer was not prepared to give consent for publication. Despite anonymising the case, editors of medical journals are unprepared to publish it without her consent. As a result of this decision, this new diagnostic information will not be disseminated to other paediatricians, which may contribute to other children being unnecessarily exposed to undiagnosed abuse. There will be many other similar examples.

The authors carried out a randomised single blind controlled trial on the effects of a pain relieving intervention in pregnant women for pelvic girdle pain. Participants were recruited between 2000 and 2002 and the results were published in 2005. The trial had not been registered at the time.

The authors now want to publish the adverse effects of the same intervention during pregnancy and delivery. The data in the new manuscript were gathered from 2000 to 2002 and is from the same study population. On submission of the manuscript we enquired about a trial registration number and the authors indicated that the trial had not been registered. Their interpretation of the International Committee of Medical Journals Editors (ICMJE) statement is that this trial does not need a number because enrolment was completed before 2005.

Given that the authors wish to publish data from the original trial after 2005, should we insist on a trial registration number?

ICMJE的也t states the following for trials that began before 1 July 2005:

Investigators should register trials that began enrolling patients any time before July 1, 2005 as soon as possible if they wish to submit them to a journal that follows the ICMJE policy. While the ICMJE hoped that all such trials would be registered by September 13, 2005, the committee understands that the policy statement was not entirely clear. Thus, ICMJE journals will consider trials that began before July 1, 2005 that were not registered prior to September 13, 2005. However, beginning on September 13, 2005, ICMJE journals will consider such trials only if they were adequately registered before journal submission. The ICMJE journals will accept “retrospective registration” of trials that began before July 1, 2005 (retrospective meaning registration occurs after patient enrolment begins).

We received a paper reporting on the outcomes of treatment of an individual with obsessive–compulsive disorder and body dysmorphic disorder, which seemed not to respond to standard treatment. Following ethical review and approval, and individual consent, the individual was treated with several distinct courses of an experimental therapy. The individual’s clinical and family history, and their outcomes in response to the experimental therapy, were detailed in the paper. The editors felt that sufficient details were included to potentially identify the patient, so as outlined in our editorial policies, we asked the authors to obtain signed consent to publication from the patient.

作者回答说,他们曾试图remove all identifiers from the paper (although the editors felt that very substantial and identifying details remained), and that revealing the patient’s identity to the editorial office would violate their clinical protocol, and the principle of patient anonymity. The editors discussed this and felt that it was still very important that the patient have read the paper and agreed to its publication; secondly however, we were concerned about the journal having access to (and our ability to keep confidential) the patients’ names. We also wondered whether under HIPAA law it would even be legal for the authors to give us the patient’s identity.

Therefore, the editors proposed that we would ask the author to have the patient (or patient’s parents) sign our consent-to-publication form, and then include in the paper a statement that they had done so, but that we stop asking authors to send us copies of these forms and simply rely on the authors’ word instead. Is this acceptable?

We received a paper with potentially important results. After review and revision, we accepted the paper. On further reflection, and asking more of the authors, we became concerned. It is an RCT and the only protocol available was slim but appeared authentic. There were two protocols: one for a pilot trial and, if that was positive, a second protocol aimed to randomise more people. One residual concern was that there was an imbalance in the two randomised arms. The authors’ statistical advisor has explained that such an imbalance, although large, is not necessarily unexpected when using older versions of random number allocation programs.

We present this case to the COPE Forum for discussion as we had not identified a numerical imbalance that might be unacceptable. We also ask for advice: since the pilot trial showed a significant difference (p<0.001), might it be considered unethical to recruit many more participants before publishing? Furthermore, should the unpublished data from the pilot trial be included in the final analysis?