A manuscript was published by journal X and submitted by author A (last author). Author B claims that fraud occurred in relation to authorship for the following reasons.
(1) Author A did not take part in producing the data for the paper and has never been a co-author on any version of the manuscript. (2) A paper with very similar content ,which was part of the PhD thesis of author C (first author), was accepted for publication in journal Y. (3) The figures in the paper published in journal X were identical to the figures in author C’s PhD thesis. (4) The name of author B was misspelt in the paper published in journal X to avoid identification of the article search in PubMed.
The editor of journal X contacted all of the authors by email and they responded as follows: author C (first author), author D and author E agreed with author B (claiming author). Author F did not respond, despite receiving five emails.
In addition, author B sent us a letter signed by the Vice-Rector at his University, agreeing and supporting the point raised by author B.
Author A (last author) disagreed with all of the allegations and pointed out the following. (1) Author A declared that he was the principle investigator of the project in country Z during 2004–2009, and the role of author B was to help in the analysis of the samples in his laboratory, located in country W. (2) Author A submitted an official complaint to author B’s university, alleging that they (authors B, C and D) had no right to use data without notifying or asking his permission. In addition, they did not have any patient consent. (3) The paper published in journal X was the original manuscript and it was circulated to all of the authors. (4) The name of author B was misspelled in journal X by mistake.
Author B requests that the paper must be retracted from journal X, and he also demands that the editors ensure that the paper will disappear from PubMed.
In summary, all of the authors confirm that the data are correct but they disagree regarding the issue of authorship?
Because of the quality of the phone line, it was not possible to discuss this case at the forum. Council instead gave the following advice on this case.
All agreed it was a complicated case and it would be useful to know which paper was submitted and published first, X or Y, although it seems likely it was X. Also what is the role of author F, is he/she affiliated with the institution of author A or authors B, C and D? Before dealing with the authorship dispute, it is essential to confirm whether patient consent was required and obtained. There are grounds for retraction of the paper if the study was not conducted ethically. Is journal Y aware of this dispute? As both parties disagree on the fundamental points, such as whether author A was involved at all in the study, official documentation and, if available, email conversations need to be produced to consider how to proceed. Hence more information gathering and a request for a formal investigation by the institution should be undertaken to find out exactly what the real issues are first. It might be useful for the journal to check or ask for information from both parties on national regulations and institutional policies for transfer of biological material and data sharing in this case of collaborative research.
The paper cannot “disappear” from PubMed, but at this point, most agreed that an “Expression of Concern” should be issued immediately and the editors need to investigate further the issues of (1) patient consent, (2) overlapping content and (3) the roles of each author on both manuscripts. Institutional input is also needed and the editor should clarify if the statements from the university vice rectors resulted from a formal inquiry.
The ethical issue can be compounded by the policy by some universities that if they conduct research outside of their own country, they require dual ethical approval by (1) that university and (2) whatever ethical system is in place in the countries where the research is undertaken.
The editor published an expression of concern in his journal, stating that one of the authors had questioned the authorship of the corresponding author. The submission is on hold and the authors have been all informed of the claim. The investigation by the journal has not yet reached a conclusion. Pending the results of the investigations, the journal decided to publish an expression of concern to alert readers to the fact that serious questions have been raised about the authorship of the paper.
Update (June 2013):
The paper was first submitted in journal Y, but it was first published in journal X.
Author F is affiliated with the institution of author A.
The institutional input from university of author B (Vice-Rector) stated that authors B, C and D are the legitimate owner of the data, and confirmed that authors B, C and D were not informed about the submission to journal X.
Ethical approval by the university in both countries was presented by author B, but not by author A.
Authors B, C and D stated that there has been no contact with author A for more than 7 years, and the research was performed long after author A left the research collaboration.
Further questions to COPE:
Author B stated that author A committed plagiarism and requested that the paper must be retracted. There is considerable evidence that plagiarism may have occurred by author A. What would the COPE suggest we do?
Advice on follow up:
(COPE council provided the following advice.) Publication of an expression of concern was the correct route but this now needs a resolution. It appears to Council that there is sufficient evidence that the paper should be formally retracted at this point.
Provided the editor is confident that the account they have is correct, ie, that there is no further information available from the institution, they could consider retraction on the following grounds according to the COPE guidelines: • “The findings have previously been published elsewhere without proper crossreferencing, permission or justification (ie, cases of redundant publication).” In this case the findings were not published previously but were submitted earlier. • “This constitutes plagiarism.”
However, it would be essential for the editors to do a timeline, listing the issues, so that the retraction statement is clear and accurate and can be agreed by the authors and the institution(s) involved before issuing the retraction, even if it is likely that only authors B, C and D will agree to the retraction notice. The retraction notice much also note who agrees to it.
We reviewed and published a randomised controlled trial in which children’s exposure to parental secondhand smoke (SHS) was either sustained (usual practice control) or parents were asked to avoid smoking around their children (intervention group). The study included more than 400 children averaging 9 years old. Parents provided written informed consent. The study was approved by the ethics committee of the researchers’ institution. Data were collected in a school setting by self-reported questionnaire and interviews. Children were classified according to amount of SHS exposure and baseline data about several types of symptoms were collected. The children with the symptom of interest and exposed to SHS were then randomly divided into two groups. Smoking members of families in group 1 were asked not to smoke in the child’s presence for a period of 6 months while those in group 2 were asked not to change their smoking habits. Parents were told prior to study enrolment that they would not be required to quit smoking as part of participation, rather they would be asked to reduce children’s SHS exposure. After 6 months, data were collected again in order to assess the proportion of children in the two groups who were still displaying the symptom of interest. Following this trial, all parents and children were asked to participate in a 5 month school project related to the risks of SHS exposure. The project included weekly lessons about the risk of SHS, attended by children with their parents to educate children about SHS risks and help parents to either reduce or cease smoking in their children’s presence.
Neither the handling editor nor reviewers raised questions about the study’s ethics during the review process. However, following publication, we received a letter questioning the study’s ethics on the basis that the known risks of SHS exposure outweighed any benefit to be gained by learning about whether SHS was a risk factor for the studied symptom and that the study procedures violated the Helsinki Declaration. The letter’s authors argued that the study’s advising of smoking parents in the control group to not change smoking habits could have unnecessarily exposed their children to additional SHS if parents who would have otherwise quit or reduced their children’s exposure did not do so because of the study. The authors of the letter claimed that they could not think of a single research question that would justify exposing children to SHS.
In discussion, one of the editors argued that the letter missed the important point that after the randomised controlled trial, all participants received the 5 month intervention to promote smoking cessation among parents and/or to reduce SHS exposure, and questioned the letter’s implication that the children would be better off if the study had not been conducted. S/he wrote that the letter seemed to argue against any controlled trial to reduce children's exposure to SHS, but that there were several dozen of these in the published literature.
The questions are twofold: was this an unethical study? And, if so, how should the journal proceed?
The editor told the Forum that questions raised during the review process were answered by the authors. The authors informed the editor that institutional review board (IRB) approval had been obtained but they did not provide evidence of IRB approval. The Forum advised the editor to publish the letter and give the original authors a chance to reply. The editor might also consider publishing the IRB approval statement. Another suggestion was to commission a commentary or write an editorial on this issue.
As advised by the Forum, the editor contacted the study authors to clarify the protocol instructions. In addition, the journal obtained a confidential consultation from an independent ethics body with four experts who summarised relevant ethical concerns. The journal also solicited a letter from the study authors to respond to the issues raised in the letter to the editor and solicited expert opinion from the department of bioethics of a major institution.
The letter to the editor, response from the authors and the expert commentary will be published in an upcoming issue along with a brief introductory statement from the editorial staff. The introduction invites the journal’s readers to review the materials in the interest of furthering reflection on the ethical implications of research on the effects of secondhand smoke and the ethics of the research enterprise more generally.
In May 2011 a letter from the Vice-Rector for Personnel of a reputable university was sent to the editor mentioning that two articles published in the journal contained two statements not supported by documented evidence. The two statements related to: (1) approval of the local ethics committee and (2) representation of the experimental evidence.
With regard to point (1), the authors stated in the article that they had approval in 1995 for their research protocols but the authorities state that there is no written documentation of this agreement and that this cannot substitute for formal approval of the research. The journal and the university rules indicate that formal approval of an ethics committee is required.
With regard to point (2), a statement in both articles cannot be sustained for one of three patients in one of the articles and for one case in the second article. Laboratory analysis revealed contradictory evidence from the authors’ statements in the articles. The authors gave three reasons why they ignored this information. Unfortunately, the samples kept in the authors’ laboratory were destroyed in a fire.
According to the letter from the academic authorities, “the authors have been kept informed of these facts, which are in breach of the rules of good scientific conduct”.
One of the articles is coauthored by three colleagues from another university. They have asked the journal that their names be removed.
The author of the articles, who received a copy of the letter from the Vice-Rector, asked to have some time to send in his rebuttal of the accusations. For both issues the answers provided by the authors were submitted to the university and were judged as unsatisfactory.
Long discussions within the publications committee of the journal with representatives of the publisher and the scientific society led to the decision that an “expression of concern” should be published. Prior to publication, the expression of concern was sent to the authors and the university for their comments. Just before the deadline, a letter arrived from the university (signed by the Vice-Rector and the Rector). The conclusion of the letter was that the university believed an expression of concern was not needed. The university believed that the authors recognized that they made mistakes in relation to both issues but since they acted “in good faith” the university had closed the case and did not consider an expression of concern appropriate.
So the journal was faced with an author admitting two serious “mistakes” in two articles. The institution that originally raised the concerns backed off in the end. After consulting with the editorial team I wrote to the author asking him to send a letter to the editor signed by all authors correcting the serious mistakes in the literature. A confidential draft letter was received from the author, and edited and completed by the editor so that both issues were mentioned. This letter was signed by all authors at this author’s institution. Three authors at a different institution refused to sign the letter as they believed that the letter to the editor did not clarify the situation. These three authors confirm their initial position and encourage the other authors to retract both articles. A copy of the email correspondence between the author and a spokesman for the other institution indicates that the author does not want to do this.
A possible conclusion would be to publish the letter to the editor signed by the authors from the institution of the first author as well as a letter to the editor from the three authors from the other institution. This would be accompanied by an expression of concern or an editorial by the editor, highlighting the necessity of proper ethics approval and reporting all experimental data.
An additional question to COPE: should other editors be informed of this? In a sister journal, an article was submitted mentioning the same very outdated ethics approval.
The Forum agreed that this was a very interesting but complicated case. There are two issues here: (1) approval of the local ethics committee and (2) representation of the experimental evidence.
Regarding the first point, the Forum suggested that if the validity of the ethics approval is not in question, then this may not be an issue. The editor does have a right to expect a higher standard from the authors, but they do not seem to have broken the rules as at the time of submission (in 1995), formal approval was not considered mandatory.
In terms of the data, the Forum agreed that the editor needs to decide whether the basic findings of the study are sound. By leaving out some of the data, were the readers mislead? If the data that have been omitted are incidental and do not change the findings of the study, then the advice was for the editor to issue a correction. If however, the editor feels that the study is flawed and the findings were presented in a misleading way, then the article should be retracted.
Some felt that as the authors at the second institute want the article retracted, then the editor should consider retracting it (since these authors no longer stand by the findings). As these three authors believe there are grounds for removing their names because they were unaware of the lack of ethics approval and the omitted data, then the editor should consider this option too.
In the end, it is up to the editor to decide. If s/he decides to issue a correction, s/he could detail in the correction notice which authors were aware of (or responsible for) the errors that occurred. But if the editor has doubts about the underlying science, then s/he should retract the paper.
After the COPE Forum discussion, a decision was taken to correct the literature by publishing two letters to the editor. The first letter from all of the authors recognises the errors made and explains the reason why the omission of the experimental evidence did not put into question the validity of the work. The letter was signed by all of the authors except the three authors from the other institution; they had asked that their names be removed as authors and they explain in a letter to the editor why they requested this. An editorial was written in relation to these two letters, reiterating the facts and insisting that proper ethical approval is required and that all experimental evidence needs to be reported. The conclusion of the editorial is that the journal decided not to retract the paper but to publish a correction. Both letters to the editor and the editorial will be linked to the two articles in the literature.
As editor-in-chief of a journal (journal A), I was contacted by an individual (N) who indicated the following: authors of an article published in journal A were questioned as to the similarity of a figure and a table appearing in both journal A and in another journal (journal B). N noted that reanalysis of the data of the published work by the authors suggested errors and inconsistencies of the similar data across journal A and journal B.
Subsequently, N provided additional details, including notice of a third journal (journal C) that appeared to have published a table similar to those in journals A and B. The editor of journal B responded to this saying that although the authors had been contacted by the editor of journal B and a response from the authors was pending, they agreed that retraction from journals A, B and C was required. Of note, journal B had previously resolved a challenge from N with respect to the study in question as a letter to the editor regarding data interpretation with a response from the authors. The editor of journal B shared both of these publications with the other journals involved at the request of journal A.
Although the authors referenced journal B in the article they published in journal A and stated that it was an extension of the study published in journal B, they only indirectly referenced the figure and table. The figure and table did not include a reference or acknowledgment to indicate where they were initially accepted/published or submitted elsewhere. Hence it appears that a very similar figure and table appeared in three publications and a figure in two publications without appropriate assigning credit.
This appears to journal A to be a possible case of overlapping publications by the authors. Taking the first publication dates (including Epub dates) on PubMed, it appears all three articles were published at around the same time, with the article in journal C publishing first as an Epub article.
It should be noted that the authors retained the copyright to their article published in journal B. I am not sure about journal C.
Most recently, N sent another email to all three journals questioning the housing conditions of the animals used in the study and whether the statement indicating that the authors had received approval from their ethics committee of experimentation on animals is actually true.
As editor of journal A, I forwarded all the information to my publisher. I plan to contact the authors on review and after discussion with COPE. My publisher has also informed journals B and C of our plans to contact COPE before taking any initial action.
As well as asking for guidance on how best to handle this case, we would like COPE’s opinion on which journal should be taking the lead to resolve these concerns, as it involves multiple journals.
The advice from the Forum was to follow the COPE flowchart on redundant publication. Initially the editor should contact the authors and ask for a full explanation. If the editor feels that the explanation from the author is not satisfactory, he can then retract the paper, if his is the second journal which published the paper. If a paper is published online it should be considered as being published, so the epublication date is the date to go by. The first version of the paper should remain and the others should be retracted.
However, if the editor feels that there is only partial overlap and readers would benefit from the availability of new data, then the editor could issue a notice of redundant publication.
Another scenario would be if the editor accepts the explanation of the authors that they made a genuine mistake. In this instance, the editor could issue a correction (for example, figure 7 has appeared in a previous publication).
The Forum stressed it is important to contact all of the authors, not just the corresponding author. The Forum also agreed that regardless of whether or not N is acting in good faith, the editor should investigate the accusations by contacting the authors and asking for an explanation.
The Forum advised liaising with the other editors if possible, and jointly contacting the institution.
The Forum also suggested looking at the copyright issues (e.g. the date on which copyright was transferred to a journal, if applicable).
The editor retracted the paper. To the best of his knowledge the other papers in question have also been retracted.
I received a submission that had asked a series of questions of visitors to a website about a mental health issue. It was reviewed by a senior colleague and myself. While the science was fine we were both concerned that no mention had been made of any ethics approval. I raised this issue with the authors, especially given that deception was involved.
The authors then appear to have sought ethics approval from their institutional committee. The committee appears to have granted approval with the proviso that a notice be placed on the website indicating that the material from the questionnaires was to be employed in research, not in supporting the activities promoted by the website, as first indicated. The notice was to remain up for 3 weeks so that any of the participants could ask for their responses to be deleted from the study. No one asked that this be done.
We have discussed this issue 'in-house'. It has been suggested that publication is not necessarily precluded given that the institutional review board has approved the study and required the authors to notify participants of their intentions. Of course, the institutional review board and the authors would need to be able to produce full documentation relating to the submission and approval of the project.
We would be grateful for COPE's advice on this issue.
As mentioned many times at the COPE Forum, just because a study has been approved by an institutional review board does not mean that the editor has to consider it to be ethical or to publish it. Also, institutional review board approval does not guarantee that the study is not flawed.
Some questioned what kind of an institution would approve such a study in vulnerable patients. Others argued that they would not publish this study – the population was not fully informed of the study and so the research is misleading. It is unethical research in a vulnerable population.
The advice was not to publish the paper and write to the author telling him why. Another suggestion was to write to the ethics committee and ask why they approved the study.
The editor wrote to the authors with the Forum’s comments and indicated that the journal would not publish their paper and that they should not attempt to seek to publish it elsewhere. The authors have not replied.
Our journal received a manuscript describing a comparison of two different techniques for patients in the intensive care unit. There was no information on ethics committee approval and so we asked the authors if approval was obtained. They replied that they had not applied for ethics committee approval “as it was a clinical comparison of two existing methods, none of them experimental. All patients had an indication for the technique, and the technique was introduced in our intensive care units before the beginning of the study period”.
The study is described in the manuscript as a “prospective, comparative clinical study” conducted in 2009 and that “every other patient” who received the technique during the study period was assigned to “the technique of choice at our institution” or to a technique introduced in 2005. It is not clear whether informed consent was obtained.
We believe that this study was not conducted in accordance with the Helsinki Declaration where it is specified that “The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins".
Regarding informed consent, it is stated that “Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorised representative.”
We have the following question for COPE: should we wait for the authors to apply for approval from the ethics committee at this stage or should we reject the manuscript and forward our concerns to the person responsible for research governance at the institution?
The Forum agreed that the described project was clearly research and not a service audit. It appeared, in fact, to be a prospective randomised trial and so it should have been registered and ethics approval obtained. Retrospective approval would not be appropriate. In addition, all participants should have given their informed consent. The lack of consent suggests a breach of the Helsinki declaration. All agreed that the editor should contact the author’s institution and inform them of the situation and ask them to investigate.
The editor contacted the professor who is responsible for research governance at the authors' institution. He agreed that this case raised significant concerns and an investigation has been initiated. Based on this, he has arranged a teaching programme in the department focusing on research principles and legislation. He has promised to keep us informed about other "whatever measures” that he deems necessary.
Follow Up (March 2011):
A departmental medical ethics programme has been organised in collaboration with the regional ethics board. The need for ethics committee approval has been emphasised and all clinical study protocols must be assessed by the person responsible for research. Violations of the department’s medical ethics program will lead to local manuscript retraction and freezing of intramural research funding and other support. A department publication and manuscript database system will be used for monitoring purposes.
We are seeking guidance on the ethical issues surrounding drug/medicine use evaluation (DUE or MUE) audit cycles, particularly with respect to the publication of findings but also perhaps with regard to the conduct of these audits in general.
DUE is a quality improvement activity that involves data collection and evaluation (usually by audit), followed by ‘action’ or intervention and a repeat or ‘follow-up’ audit to monitor changes in practice. DUE methodology was used for a recent national quality improvement activity overseen across approximately 60 hospitals by an independent organisation funded by the government to promote quality use of medicines. Participating hospital ‘project teams’ were asked to identify a predefined number of patients from their surgical lists for the baseline audit, obtain consent from the patient for inclusion (‘if required by local authorities’), conduct a brief postoperative patient interview regarding pain management and, after discharge, retrospectively collect pain management data from the medical record .
Data were submitted to the national project team for collation and assessment, with individual and combined results fed back to hospitals. An educational intervention was then conducted at each site, attempting to address medical, nursing and pharmacy issues, and utilising a number of tools, including one-on-one ‘academic detailing’, presentations and posters. A follow-up audit (same as the baseline) was then conducted at each institution.
A manuscript was submitted to our journal describing the conduct and outcome of the project in two hospitals, and comparing these with each other and with the national results. The hospitals were not specifically identified but were labelled A and B, although one could be assumed to have been the primary institution of the authors and the other probably one of two smaller institutions in the same area health network. The methods stated that formal patient consent was not required for the inpatient interview component because the questions asked fell within routine postoperative care. Institutional Ethics Committee approval appears not to have been sought for any aspect of the project in either of the hospitals concerned although the overall project appears to have been conducted with the approval of various state health bodies and presumably individual hospital administrations, although this is not clear.
The manuscript was rejected on a number of grounds, mainly relating to questions of methodology and partly related to the question of publishing a small subset of a much larger set of data (also to be published eventually according to the website of the national project). The submission did, however, raise other ethical questions that remain a matter of some debate among the editors concerned, and we seek the help of COPE in addressing these since it appears this sort of situation is likely to come up again with increasing regularity. Our first question relates to the study subjects study. In the submitted paper, the assumption appeared to be that the patients were the subjects and their ‘recruitment’ was discussed. However, we feel that the subjects of the investigation were the staff of the participating hospitals since it was their drug prescription administration and documentation behaviour that was being examined before and after a behavioural intervention.
Our second question regards the nature of the project. Is it a quality assurance/improvement activity that does not require ethics approval for its conduct and/or publication of results? Or is it actually a research study examining the behavioural effect of an educational intervention on hospital staff, and as such does require ethics committee consideration, approval and possibly individual participant (staff) consent?
This case prompted a discussion on the differences between a study and an audit. Most agreed that if there is an intervention, then it is a study, but it was pointed out that there are regional differences, and different countries have different policies on what type of studies need ethics approval. The Helsinki declaration discusses “human subjects” and so does not make a distinction between patients and staff. The advice from the Forum was for the journal to develop their own policy on this issue and to perhaps commission an ethical debate around the subject for publication in their journal. The Forum also reiterated the fact that even if a study has ethics approval, the editor does not have to publish it if s/he is unhappy about any of the aspects of the study.
COPE suggested we develop internal policies regarding situations like these, and this was discussed at our subsequent editorial board meeting. The Committee's advice was found to be very helpful by the board, and in particular the agreement with our assessment that the staff, not the patients, were the subjects of this particular “experiment”, and some discussion occurred surrounding this and other cases discussed at the COPE Forum meeting involving conflict of interest issues (new ICMJE guidelines) and Clinical Trial Registration.
Notices regarding conflict of interest and trial registration are being considered for inclusion in our instructions for authors and also for a new set of editorial guidelines.
The more difficult ethical question is yet to be fully resolved. However, we will continue to deal with such cases on a case by case basis and hopefully reach consensus among the editors.
We have been contacted by a reviewer after he spotted a paper he had reviewed for us (journal 1) now published in a second journal (journal 2). Both journals are members of COPE. The reviewer had advised we reject the paper when it was sent to him to review in September 2008. This was based on his assessment of the paper and also the supplementary material he was sent by us: protocol, CONSORT statement and trial registration details. Seeing the paper now published in journal 2 (April 2010), he still has the same concerns about the conduct of the trial and validity of the data presented—for example, the study was not really randomised (subjects were allocated alternately to treatment or control and participants’ trial numbers were known to the outcome assessors)—and reporting of the outcomes was inconsistent with scores given in the raw data.
Following the original rejection from journal 1, the authors appealed against our rejection and we declined their appeal. The letters from us made it clear that we had concerns about the methods and reporting, and both external reviewers’ reports were available for the authors to see.
So in spite of making it clear that there were problems with their paper, the authors still went ahead and submitted to journal 2.
When contacting us, the reviewer wanted to know if he could contact the editor of journal 2, make it known that he had seen supplementary material when he had reviewed the paper and explain his concerns to the editor. We advised him to write to the editor of journal 2 in confidence, explain what had happened and say that we had reservations about breaching confidentiality in this way but thought that the benefits of doing so outweigh the risks.
The editor of journal 2 has now contacted us asking to see the supplementary material. Unfortunately, we no longer have the files available (we do not archive them that long) but we do have the reviews. Questions for COPE • Should we share with journal 2 the reviews we still have? • In principle, could we have shared the supplementary files and original submission (although they are no longer available)?
The Forum’s advice was that the journal should not share reviewer comments with another journal without first asking the reviewer’s permission. However, it is quite acceptable for the reviewer him/herself to decide to send their comments to another journal if they think this is the right thing to do (since the review belongs to the reviewer). Most people felt that the material submitted by the author to the journal (ie, the protocol) should not be sent to another journal, as this is privileged/confidential information. It is up to the second journal to contact the author and ask for this material. If the author does not respond, then the journal that had actually published his work (journal 2) should contact the author’s institution.
The editor of journal 2 contacted the author of the paper who provided some, but not all, of the answers which he sought. So, after discussions with the reviewer and a member of the editorial board, they decided not to dig deeper with the author but instead publish the letters that had been sent to the journal about the paper.
The editor of journal 2 published six letters in total: two letters about the paper with replies from the author, and a further letter about the commentary accompanying the paper, together with a reply from the author of the commentary.
This research article investigated the effect of the widespread administration of a homeoprophylactic preparation against a bacterial zoonotic disease in a developing country after a period of particularly heavy rainfall. The authors claim to have given this oral preparation to all members of the population over 1 year of age, in three provinces of the country where this disease is prevalent (over 2 million people). This was done in parallel to the country’s conventional vaccination and surveillance programme. The authors claim that this intervention significantly reduced the incidence of the disease in the treated provinces compared with the non-treated provinces.
We asked the authors to provide more information on how they had addressed the ethical aspects of this study and to provide supporting documentation. They stated they would include a paragraph on ethical considerations in the text, but argued that the principle aim of the study was to report the results of a healthcare intervention as a response to an emergency situation and was not classical clinical trial research. They further argued that the product used in the intervention is a registered product of common use on the public health system of the country in question and all the administration was approved and regulated by the “National Regulatory Agency” and “Competing Health Authorities”. They also claimed that they had obtained ethics committee approval from four different ethics committees.
Despite repeated requests from us, the authors failed to provide documentation from the ethics committees or the National Regulatory Agency or to explain how they had obtained consent. They eventually did supply a document in Spanish purporting to be “approval from the National Regulatory Agency for the intervention that was granted after the analysis of proposals by ethic committee and meeting National Regulations from the Minister of Public Health”. However, on translation by one of our Spanish speaking members of staff, it turned out to be a statement of their intention to obtain ethics approval and consent.
We contacted the CDC to enquire whether such an intervention was known to be in use in this country. We were told that they were not aware that this intervention is in use in any official capacity. We rejected the manuscript on ethical grounds explaining to the authors why we were not prepared to consider it. All authors are affiliated to a private institute. The last author is its founder.
We would welcome advice from the committee on whether and how we should take this further, given the scale of the study and the conflicting statements of the authors and the CDC.
The Forum was told that this study was funded privately. The Forum questioned whether it was in fact a study? From the description, it seemed to be a report of a public health intervention. If that is indeed the case, then consent is not needed. The advice from the Forum was to seek confirmation that these interventions actually took place (since the numbers involved are so large and because of the discrepancy with the information from the CDC). Did the government introduce it? The Ministry of Health could be contacted. If the editor discovers that the whole event was fraudulent, then he should bring the case back to COPE.
We attempted to contact the Ministry of Health without success. We have contacted the director of PAHO (the Pan American Health Organization) and are awaiting a response.
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.