During review of a manuscript submitted to our journal, a dispute arose over some of the data used in the database that was described in the submitted paper.
The authors listed several preferred reviewers and also one non-preferred reviewer (without giving reasons). The journal’s submission site states that the editors will consider the authors’ preferred suggestions but are under no obligation to use any or all of them and that the editors reserve the right to approach non-preferred referees. Authors are asked to outline in their comments to the editor any particular reasons for requesting exclusion.
The paper was initially positively reviewed by two referees, one of them a preferred referee, and minor revision was requested. Neither of the initial referees responded to the invitation to review the revision (they neither declined, nor agreed, just did not respond) and as the senior author had already published with virtually all important scientists in this small field, the associate editor decided to invite the non-preferred reviewer. The non-preferred reviewer and one new reviewer agreed to review.
Shortly after accepting, the non-preferred reviewer emailed the editorial office asking whether it was journal policy to publish a reference to a database without any scientific study based on these data (the journal answered yes, citing a previously published database description) and stating “I discovered by examining this database that the senior author has used my data without permission. This applies to hundreds of measurements in country 1 and in the mountains, but also to data from country 2”.
The authors state on the database website that the database contains published data and in the manuscript that the “measurements in the database have been collected over the last 20 years from various sites around the world (references given) and are included with permission from the collectors”. The journal informed the non-preferred reviewer that, from what the authors were stating, all data seemed to be in the public domain, but advised him to put his concerns into his review or contact the authors directly, if the reviewer preferred.
By the time the reviewer received this reply he had already submitted his review and informed the journal that he also sent his full review to the senior author. The reviewer also pointed out in an email to the editorial office that the measurements published in one of the cited studies (of which the referee was the senior author) were not published in the form as they appear now in the database, and then accused the senior author of having used information which he collected as a member of the reviewer’s research group a long time ago, and publishing it without the reviewer’s permission. The reviewer thought that the reference to the paper was not sufficient and also stated that the conditions with the mountain data were more serious.
In the review, the referee pointed out three problems: (1) unethical behaviour on the part of the senior author. The reviewer stated that he could not remember having given permission to use the data, but had specifically asked the senior author not to use the mountain data for anything until the reviewer had finished his analysis. He included the original email in the review. (2) potential dual publication. The reviewer stated that because no analysis of the data was presented in the paper, a simple report on the existence of the database was not suitable for publication in a journal and went on to point out that a first version of this database was already published (as cited on the database website, but not in the paper) as a preprint article. As a comparison of the two manuscripts did not reveal any obvious differences in content, the reviewer questioned whether this constituted dual publication. (3) questions over the use of a particular method. The reviewer called the use of this method “scientifically unacceptable”, stating that the problems with this method have been published and concluding that it was unacceptable for the senior author to ignore these arguments (this was not mentioned by any of the other reviewers).
Checking the date of the above mentioned email and the publication date of the preprint article, the journal realised that the reviewer emailed the senior author shortly after the document was posted online. The dispute had thus been going on for over a year by the time the referee was invited to review, but the reviewer had not declared a conflict of interest.
The associate editor, having read both reviews (the second being positive), recommended rejecting the manuscript and inviting a resubmission once the authors either were able to present the permit obtained from the non-preferred reviewer or removed all unpublished data for which no data were available.
In the meantime (and before any action was taken), the senior author, prompted by the reviewer’s email to him, emailed the managing editor and the associate editor, informing them that the non-preferred reviewer used to be the senior author’s PhD supervisor. The senior author rejected as incorrect any claims over the inappropriateness of the method and the statement that the reviewer had not given permission to use what the referee claimed were his data. As the review implies several forms of unethical behaviour on the senior author’s part, he felt the need to clarify.
(1) the criticised method has been used in top tier journals such as Science, Nature and PNAS and has therefore been through rigorous quality control. Since the reviewer’s evaluation of the method did not contain any concrete arguments, the senior author assumed that the reviewer was referring to a polemic about the method by another author, published in the same journal in which the senior author countered these arguments. The method continues to be the most widely used, cited over 90 times (the associate editor points out that it was cited mainly by the senior author’s main group, but that none of the other reviewers have criticised the method). The senior author further points out that this method is not the only one used in the database.
(2) re the inappropriate use of data from country 1, the senior author assures the journal that the referee had been asked and had given permission (an email was attached), but that if the referee wanted to retract the permission, the authors would remove the data in question. Re the data from the mountains and the email sent by the reviewer, the senior author claimed that the email had been taken out of context. The senior author had indeed asked the reviewer about the possibility to perform a separate analysis on the mountain data. According to the senior author it was this request about the separate analysis that the reviewer declined and the request had not referred to making publicly available the data that had already been published in one of the references.
(3) re dual publication, the senior author stated that a beta version of the manuscript, with a completely different code and user interface and only a very reduced set of data, was posted on a preprint server, not a regular journal publication (the associate editor saw no major changes in the number of data entries and that both discuss the database in a similar way, but thought that the submitted manuscript was more detailed than the earlier (preprint) article. Figures are not identical, but basically follow the same scheme. The associate editor left it up to the editor whether he considered a full-length paper that builds upon something that has been published on a preprint server as sufficiently novel).
The senior author finally adds that because of previous similar experiences, the authors had listed the reviewer as non-preferred.
The corresponding author emailed the editorial office offering to remove from the database any data that have been collected with the reviewer’s participation but emphasised that by doing so, the authors do not acknowledge any form of wrongdoing on their part, but seek to make it easier for the journal to make a decision.
After discussions between the editors, the editorial office and the publisher, the decision was to reject the manuscript but to invite resubmission. The letter pointed out (a) the disputed use of data in the database; (b) the question of dual publication; and (c) the scientific criticisms expressed by both referees. It of course included both reviews in full.
The editor confirmed that the journal did not have a policy on whether they will accept material that has already been posted on a preprint server. Preprint servers are not peer-reviewed, so some journals will accept material that has already been posted, but all such prior presentations should be disclosed to the editor in the covering letter. All agreed that the editor should not get involved in an author dispute. The editor could suggest that the authors find an independent adjudicator, that both sides find acceptable, if the authors cannot come to an agreement among themselves. It was suggested that the editor could go to the author’s institution and ask them to adjudicate. The editor should also clarify their policy on preprint servers in the journal’s instructions to authors.
The first author of a paper published in 2004 has submitted a “letter to the editor” (LTTE) offering some corrections, and reaffirming some conclusions. The letter has not been published. A pharma company (whose drug is linked by the paper to a negative side effect) has followed this up claiming that between authoring the original article and the letter, the author has become a paid expert witness in a trial relating to the drug in question (the LTTE was shown to the drug company’s counsel during the trial). The LTTE does not mention this. The drug company also claims that the letter’s corrections are based on its work and cross examination in court (again not stated in the LTTE). It also claims the author does not disclose or correct all the errors and downplays others. The company says its claims are backed up by the original study’s source data, currently embargoed by the author’s institution under a court confidentiality order.
Conflict of interest seems open-and-shut. However, a further question seems to be: can/should anything be done before the drug company is able to supply the original source data to the editors? And what if the source data remain embargoed?
The Forum thought that this was a major conflict of interest and found it difficult to believe that it was an oversight. All agreed that there is little that the editor can do while the court case is ongoing. It was suggested that the editor could consult the flowchart “What to do if a reviewer suspects undisclosed conflict of interest (CoI) in a submitted manuscript”. The editor should point out the seriousness of the CoI to the author. The editor cannot proceed with publication. It was suggested that the editor should make sure that he is not giving in to commercial pressure by not publishing the paper – there were concerns that the author was deliberately trying to influence the court case by publishing the additional data. The harm of not publishing was considered to be minimal. The consensus was that the editor should not publish the letter. It was suggested that the editor should inform the author that he will not publish the letter but if the author has new data, he should submit this in a new paper.
The paper was returned to the authors and will not be published.
We received a paper which describes genotyping results from a large number of individuals (>50) from five unrelated families, in which family members had various blood and liver conditions. On submission we noted that the paper included specific details regarding the clinical histories of individuals in each family. Some individuals were described in substantial detail, others only briefly. For example, information about probands included age at presentation, sex, ethnicity, clinical history, occupation, clinical complications (some quite specific), clinic attended (for some individuals), history of alcohol consumption, ages of relatives, clinical details for relatives, age at death etc.
The authors responded that when initially obtaining consent to the research project, patients consented that “[t]he results from studies on the research samples may be published, but individual patients will not be identified in the publications”. They claim that details included are not identifying, and that it would be impractical now to trace all living relatives. They asked whether our consent form has been approved by an IRB, and say that before using it they will need to have it reviewed by their IRB.
We are unsure how to proceed but feel that when consenting to the research project the individuals may not have realised they would have been described to this level of detail, and that we should respect their privacy. One option might be to ensure the authors seek consent to publication from all probands, but then remove extraneous detail regarding the relatives. However, it is possible that the IRB may have useful input regarding the publication of individuals’ details from this study.
The editor was asked if the personal information was essential to the study. If it were deleted, would the paper still have value? The editor confirmed that the information was crucial to the study and could not be deleted. All agreed that the editor needs to weigh up the need to publish against any harm that might be caused by publication. Most believed that the harm involved was probably quite severe and so outweighs the need to publish. One test that can be applied is to consider whetheran investigative journalist would be able to identify the patients from the study (in this case, most Forum members felt that they could, therefore the risk of identification is high). The Forum did not believe it was that impractical for the authors to obtain consent and so they thought it was reasonable to ask the authors again to obtain consent. Did the authors make it clear to the patients how much detail and history would be published? Also, some noted that with pedigree studies, it can be very easy to identify patients. As with all such cases, the editor needs to make a judgement concerning the harm that might be caused to the patients in publishing and the benefits of publishing. Most believed that the risk of identification was high and that the editor should not publish without consent. The advice was to go back to the authors and ask them to obtain consent. COPE was asked about whether it could produce a generic consent form for all journals (to avoid problems of having to use multiple forms if a manuscript is reject by one journal and submitted to another). COPE Council agreed to consider this suggestion.
The editor informed the authors that the case had been taken to COPE, and the agreement of those who attended was that patients and family members would need to give consent to publication of the case(s) having read the paper. The authors responded after several weeks to say they had traced the patients and obtained consent to publication. They updated their paper to state this in the revised text, and also updated the text to minimise some details of family members, and to state that details were minimised to maintain anonymity but that further clinical details could be made available to other researchers on request.
We received a manuscript for consideration. The manuscript was assigned to one of our section editors who sent it for review. Subsequently, the editor-in-chief received an invitation from another journal to review the same paper. The editor-in-chief recognised the paper straightaway, declined the invitation to review and alerted the editor-in-chief of the second journal of the duplicate submission.
We subsequently emailed the authors of the paper asking for an explanation, especially considering they had confirmed at the time of submission that their manuscript was not under consideration in any other journal. The authors withdrew their paper from the second journal and responded to us by saying that they were very sorry for their “low-level error” in submission and apologised for the occurrence of duplicate submission. The corresponding author claimed that he had entrusted one of the authors to submit it to our journal. Then the corresponding author was away with no telephone access and on his return he found that the paper had been submitted to two journals. He went on to say that his colleagues have access to his e-mail account and so they used his email account to submit to the different journals but he had no knowledge of this. The corresponding author also stated that because the original idea was to submit the paper to our journal, he had revoked the submission from the second journal and apologised to the editor. He hoped that we would still consider his submission. He agreed to standardise the management of submissions and correspondence between his colleagues so that this would not happen in the future.
We are unsure as to how to proceed. If we go ahead with the review of the manuscript, this sends a message to the authors that there are no consequences for their misconduct (whether or not it was an honest mistake). Therefore, we would like to have COPE’s advice on the best course of action. We have put review of the paper on hold.
There was conflicting advice from the Forum. Some suggested rejecting the paper, while others thought it was more appropriate to write a firm letter to the authors explaining that their behaviour was unacceptable. If the author is very junior then sometimes this behaviour is excusable based on inexperience. However, this was not the case in this instance. Some questioned whether the instructions to authors in the editor’s journal make it clear that papers should only be submitted to one journal. Most agreed that a firm letter to the authors and a letter to journal B would be sufficient. The letter to the authors should state that this behaviour is not acceptable and will not be tolerated in the future. It was also suggested copying the letter to the dean of the author’s institution so that the institution could put in place guidelines on submission of papers so that this does not occur again.
The editor continued with the review of the paper and sent the authors a firm letter (copying in the editor-in-chief of journal B and the head of the authors’ institution) stating that their behaviour was unacceptable and will not be accepted in future. In the meantime, the manuscript has been reviewed, and the editor recommended it be revised. The authors have now submitted a revised version which is still under review.
A letter was sent to the chief editor of our journal in response to a recently published article in our journal. The author had serious concerns about the ethics and consent obtained as a result of this study and the follow-up by the researchers.
The author explained that he was the physician of two of the “volunteers” who participated in this study and was concerned about informed consent procedures in the trial. Specifically, workers never provided informed consent that their tests, mandated by a company medical monitoring program, be used in any “research” study. His concerns were in four areas. (1) The researchers failed to inform both the company and the injured workers that they should have been removed from further exposures when their test results showed severe impairment. (2) The researchers failed to report abnormal findings to the workers in a timely and appropriate manner, a failure that placed these workers’ health in jeopardy. (3) The researchers failed to fully inform the workers of the known risks of exposure. (4) The timing and location that the researchers used to obtain signatures on the informed consent forms did not permit the workers to adequately question the researchers and become informed. One of the author’s patients who was studied was a previously (pre-employment) healthy 40-year-old woman who was found after a period of time at work to have abnormal results. However, no doctor contacted her to explain the results and written communication did not describe them as serious, and so she did not seek further medical attention. Her tests were repeated again one and two years later. The two year test indicated more severe disease. These findings were reported to her 10 months later by one of the researchers who failed to mention their significance in his cover letter to the radiologist’s report. Given the patient’s history, she should have been removed from work immediately, and the researchers should have reported this case of occupational disease to the state authorities. The following year, she sought care from a non-corporate physician and was removed from work the same day.
Another patient of the author’s had abnormal test results in 2005, which were markedly worse on repeat tests conducted in the same year. The researchers wrote to her in September of 2005 and advised her to have a CT scan and repeat testing. A year later, a member of the researcher’s group ordered a CAT scan. In November 2006, the CAT scan revealed moderately severe disease. The patient requested that these results be forwarded to her personal physician. At the time of the author’s first visit with her in late August 2008, she had never seen the results, and neither the company nor the researchers had communicated with her about her condition or continued occupational risk. The author requested that the researchers send him her complete medical records, including communications with the company and the research protocol. However, only incomplete records were sent, omitting the research protocol and including none of the communications with the company.
In October 2008, the author wrote to the IRB Director and filed a formal complaint concerning these matters informing them that one of the researchers was both a paid consultant advising on occupational health procedures while simultaneously conducting the research/monitoring program. This researcher based his published paper on a mandated monitoring program in which the “volunteer” workers had to participate as a “condition of work” in order to keep their jobs. The “research” was based on test results for which full consent had not been obtained. The Director of the Office of Research Compliance and Regulatory Affairs responded in February of 2009, stating that although the committee’s investigation determined that “no misconduct occurred” with respect to any violation of IRB policies, their findings prompted them to institute “modifications to our processes that will help us to continue to raise that bar.” The author concluded that “IRB protocol modifications” were based on an acknowledgment that the researcher’s study violated patient rights, even if the study did not violate IRB rules. The author believes that journal editors have a responsibility to investigate allegations like these.
All agreed that this was a very serious matter and possibly of criminal concern and were surprised that the complainant had not taken any more action or taken the matter up with the medical authorities or the police. If medical staff are aware of abnormal test results and they do not tell their patients, the staff should be reported to the GMC in the UK or to a similar authority in the country where the research took place. The editor should contact the authors and ask for a detailed copy of the ethics approval. The editor should explain that he has had a complaint about the paper but he should not divulge the name of the whistleblower. The editor should also ask for copies of the consent forms.
It was suggested that the editor might want to consult the flowchart on “What to do if you suspect an ethical problem with a submitted manuscript”. All agreed that this case has wider implications than ethics or patient consent and that the whistleblower should pursue other avenues. There is little that the editor can do other than to contact the authors and request an explanation. All agreed that the journal cannot offer due process to investigate the concerns itself but must leave this to the institution involved or the committee that gave ethical approval for the research.
Advice on follow up:
Following the advice from COPE, the chief editors wrote to the authors of the paper to mention that we had received a complaint regarding the ethics of the paper. The chief editors asked for proof of approval of the study from the authors’ university and also the patient consent forms. These were both received from the authors and the chief editors were happy with the documents provided and have therefore taken no further action.
A review paper (paper 1) was published in journal A. A review paper on the same subject (paper 2) by a different author was published in my journal (journal B) later in the same year. The authors of paper 1 and the editor of journal A informed me that paper 2 had in part been plagiarised from paper 1.
I as editor of journal B looked to the COPE flowchart for guidance and I wrote to the author of paper 2 for an explanation. Although I did not consider the author’s explanation satisfactory, I felt uncertain whether this was a case of “minor” or “major” plagiarism based on the fact that the paragraphs copied verbatim from paper 1 constituted only a small fraction of paper 2 and because this was a review paper and not original data.
I then contacted COPE and the chair of COPE gave me some personal advice. I was advised that plagiarism is not a matter of percentages but of principle and to take another look at the flowchart and decide if the author had given a satisfactory explanation for the “overlap”. If there was no satisfactory explanation, I should consider a retraction and informing the author’s institution.
In considering what to do, I was advised to take account of COPE’s guidelines and code of conduct under the headings of encouraging integrity of the academic record and pursuing misconduct..
Based on the advice communicated to me, the journal decided to retract the paper and to inform the dean of the author’s institution about this incident. The retraction note has been published online (and will also be printed in the next possible print issue).
The authors’ institution has established a high-ranking committee to look into this matter, consisting of the dean, the rector and representatives from the Academy of Sciences.
This case is for information only and was not discussed at the COPE Forum.
The editor of an international journal is bothered: he has received a gift that looks expensive, though it might not be.
The sender is an author of a paper submitted to the journal; he has just received a “major revisions necessary” decision. In previous emails, the author has suggested hosting the editor in “his native beautiful city”, an invitation the editor has acknowledged, saying he had already visited the city, and it was indeed beautiful! The author identified himself as a student in further emails, thanking the editor in flattering tones for the reviews.
The editor needs of course to acknowledge the gift (no letter was included), or perhaps to return it, but feels very uncomfortable with the situation. The possibilities for this gift range from an innocent gesture of a proud citizen, to one expecting something in return.
The publisher’s code of ethics and business conduct does cover this subject, but its provisions apply to the publisher’s employees, officers and directors, and not to its editors.
The editor therefore asks his publisher, and through him, COPE, for comments, advice and guidance.
There was general agreement from the Forum that the author should return the gift with a polite note. Although there are no general rules on the acceptance of gifts, some believe that the apparent value of the gift should be considered and whether or not it would be deeply offensive to return it. Often there are cultural issues and the editor should avoid causing offence. However, in this instance, all agreed that it would be wrong to accept any gift while a paper is still in the process of being reviewed. One option would be for the editor to say that his company has a policy that he would have to declare a conflict of interest at the bottom of the paper if he accepted the gift so he thinks it is better to return it.
The editor concurred with the Forum's recommendation, and felt that while returning the gift after an unavoidable delay might lead to offence, the guidance would be invaluable for any future occurrences.
We have received threats of legal action from the authors of a manuscript rejected by our journal, henceforth referred to as journal A. These “aggrieved” authors claim that their manuscript was unfairly reviewed by a close competitor, who then used some of their findings in a paper subsequently published in journal B, without either attribution or citation.
The “accused” scientist had indeed reviewed the paper for journal A, and the date on which he/she had first been sent the paper preceded that of his/her own submission to journal B. The steps of our investigation were as follows:
The aggrieved author was asked to provide additional details on which aspect of his work he/she suspected of being unethically used, and he/she identified a particular paragraph in journal B’s paper, which named two genes which our authors claimed to have identified for the first time in the particular bacterial genus studied in both papers.
Meanwhile, the “accused” scientist was asked to respond to the accusation. His response identified the paragraph in question as being a small area of overlap between the two papers, however, he categorically denied that the content of this paragraph drew in any way on the information presented in the manuscript which he had reviewed for journal A. The accused backed up this denial by sending us a copy of an earlier version of the paper, which had been submitted to and rejected by a previous journal (journal C) months before he had first reviewed the complainant’s paper in journal A.
We confirmed this by contacting the editors of journal C who, after obtaining permission, provided us with an independent copy of the manuscript that had been submitted to his journal. On examination we found that the paragraph in question had remained unchanged, and that the description of the two genes was indeed present before any submission to journal A took place.
We agreed with the accused that this data analysis was a very minor part of the paper published in journal B.
Questions for COPE • At this point, we feel that our investigation has exonerated the accused reviewer of one allegation (unethically using information obtained during the peer review process in his/her own publication). Does COPE agree?
• If the manuscript submitted to journal C (providing independent confirmation of the accused’s defence) had not been available, how would such a case be investigated?
• The other allegation (of the reviewer causing the authors’ manuscript to be unfairly rejected) remains unresolved. The reviewer denies misconduct, but there is at least the appearance of misconduct on the basis of conflict of interest. However, we do not think that any further investigation can resolve this issue. Does COPE agree?
• The aggrieved authors have asked for a correction to acknowledge their work (which was published in yet another journal one month before journal B published its article). While the reviewer did not “steal” any data or ideas, he may have unfairly “squashed” the authors’ publication. However, the data analysis in question is a very minor point in the article published in journal B, and the authors’ work may simply be independent corroboration. At this time we do not feel a correction is warranted because we have no evidence of wrongdoing. Does COPE agree?
• Are there other options that might be used in place of a correction?
The Forum agreed that the accused reviewer had been exonerated. The advice from the Forum was that the editor should obtain permission from the reviewer to contact the authors, tell them that their allegations were unfounded and explain the situation to them. The authors should be informed that the reviewer has given his permission for this disclosure as the editor is not obliged to reveal the names of reviewers if the journal operates a closed peer review system. The editor might also suggest that the authors may like to consider an apology to the reviewer. However, some Forum members voiced concerns that the reviewer did have a conflict of issue and that he should have declared this initially.
The reviewer was notified (as were the editors of the other journals) that he had been exonerated, with thanks for his patience and for his cooperation throughout the investigation. The author was also contacted and told that the reviewer had been exonerated. The authors did not formally apologise to the reviewer.
A paper published in one of our journals (paper A) provoked the submission of a correspondence article claiming that a minor conclusion of the paper was a misinterpretation and erroneous. The point in contention was a question of zoomorphology and our paper’s conclusions were based on analysis using a non-invasive technique while the rebuttal relied on more traditional techniques. We are bringing this case to COPE because although it appears to be in the process of being amicably resolved, with a clear resolution of the scientific issues, it has highlighted an area of confusion about the use of privileged information.
The authors’ of the correspondence article (rebutting authors) originally expressed anger and surprise that the paper A contained this error, because they thought they had clearly laid the issue to rest in an earlier rebuttal of a previously published paper making similar errors (paper B). Although this first rebuttal had not yet appeared in print, it had been considered and accepted for publication by the one of the authors of paper A, in his/her capacity as the editor of another journal. Furthermore, this first rebuttal not only challenged the findings of paper B, it also specifically called into question the interpretation of some website data which was included (unmodified) in paper A.
We sent the correspondence article for peer review, and the reviewers supported the soundness of the rebuttal data presented and the alternative morphological interpretation. The reviewers appeared inclined towards the view that the perpetuation of the “wrong” interpretation in paper A was surprising and did not reflect well on the authors of paper A. However, they also indicated that given the close chronology of the various publications, this was a grey area, and not germane to the scientific case for publishing the second rebuttal. We therefore asked the correspondence authors to revise their text to keep the focus on resolving the scientific questions.
Having decided we should, in principle, accept and publish the correspondence article, the authors of paper A were invited to submit a signed response. In this they have clearly acknowledged that the data presented by the authors in both their rebuttals fully support the conclusions reached in these rebuttals and that some of their own data had been misinterpreted in paper A. They also explained that they were already convinced by the first rebuttal which one author had seen in his/her capacity as an editor, and the other had reviewed. However, they had felt it would not be ethical to make use of this privileged information to modify their own paper (paper A) shortly before final acceptance.
We are inclined to accept this as the personal view of the authors of paper A but question whether they adopted the best ethical course.
Questions for COPE • What is COPE’s view? • How should editors and reviewers proceed when they have access to privileged information which suggests that their own work should be modified or corrected? • Is there an ethical responsibility to avoid letting known errors into the scientific literature which was transgressed in this case?
The Forum questioned the authors’ use of the term “privileged information”. The Forum agreed that the authors had acted wrongly. They could have delayed publication of their paper until after the information was in the public domain. The authors should have contacted the publisher and asked them to hold back on publication, explaining the reasons why. Although there was no major misconduct, a correction should appear in the journal (in addition to the correspondence) so that the article will be permanently linked to it.
The case was successfully and amicably resolved. All parties found the advice from COPE very helpful.
The authors carried out a study. A homeopathic treatment was given to people with HIV/AIDs. The outcome was quality of life, as measured by a questionnaire after 1 month and 18 months of treatment. Participants were selected for inclusion if they had a HIV seropositive status at the time of study and were not taking any other kind of HIV/AIDs treatment.
The participants were stratified into severely ill (including those who could not walk and were cachectic) and not severely ill. The authors said that they had obtained ethics approval for this study from their own institution in their country of origin and that the Ministry of Health in the country where the trial was conducted had “authorised” the study.
We asked the authors whether the participants had been offered antiretroviral treatment at any time and if not why not? The authors confirmed that the study protocol did not include antiretroviral therapy because “There is no obligation of the ARVs use and conventional medicine is expensive. Many patients...were afraid of white people and of the side effects”.
We asked what the participants were told when they gave consent. The participants were given details of the homeopathic treatment but no mention was made of the existence of antiretroviral treatment. We asked to see copies of the protocol submitted to their ethics committee and the actual approval. The document, which was translated by a member of our staff, did not mention antiretroviral treatment. We asked to see documentation of “authorisation” from the Ministry of Health of the country in which the trial was conducted. There was no written documentation. It was verbal.
We asked why they sought approval from their native country and not the country where the study was carried out. The authors told us that once they had approval from their country, the authorities in the country where the trial was conducted did not require local approval.
We asked how the study was funded and what the authors’ relationship was with the funding body. They provided the names of two funding bodies but no documentation (funding came from funding for a Master’s degree of one of the authors). They did not clarify whether they had any relationship with the funding bodies.
We felt that all participants should have received standard care with antiretroviral therapy, that ethics approval should have been sought from a local ethics committee and that the participants should have been informed about antiretroviral therapy when consent was sought. We were also concerned that this protocol apparently was approved by an ethics committee. We rejected the manuscript and wrote to the authors’ institution expressing our concerns and requesting they investigate further and keep us updated on their progress.
Is there further action we should take?
The Forum questioned whether in fact there was a local ethics committee, which may be a reason why the authors obtained approval in their own country. However, the Forum was unanimous in their view that the authors had behaved unethically. All agreed that the editor had done all he could and there is little more action that he can take, although some advised contacting the ethics committee or the licensing body of the authors. If there is no response from the institution, the editor could consider contacting the ministry of health in that country (he should copy in the authors in this communication if he does).
We contacted the authors’ institution, ethics committee and the Ministry of Health but have not received a response from any of them.