You can listen to the podcast of this case from the menu on the right
Our journal has decided that members of the editorial board are allowed to submit manuscripts which will undergo peer-review directed by the present or former editor-in-chief. It can be difficult, and I would like to present one example.
A group of authors (including one member of the editorial board) submitted five manuscripts during a period of 17 days. The handling of some manuscripts was delayed for two reasons. At first, essential forms (such as the conflict of interest statements) were missing and the editor-in-chief received the manuscripts 10–35 days after submission when the administrative checklist was complete. In addition, it was difficult to recruit reviewers who were willing to assess the manuscripts over the summer, and several papers were within a rather narrow research field. The authors were sending numerous e-mails during the review process. The co-author, who was a member of the editorial board, had already contacted the editor-in-chief the day after submission of the first paper where he stated that he would appreciate it if the evaluation (including revision) was completed prior to a specific date since there was a grant application deadline. The same co-author requested a “preliminary verdict” 7–8 weeks after the peer-review process was initiated.
The editor-in-chief apologised that the handling had been delayed and provided information about the current status of the manuscripts. As the research funding deadline was getting closer, the number of e-mails increased and the authors contacted one other member of the editorial board, apparently to influence the handling of their submissions. The authors claimed that “in view of the delay in the handling” they believed that they were “entitled to a positive response about acceptance”. The authors asked if there was anyone on the editorial board who, during the afternoon, could read the manuscript and make a preliminary decision as to whether one specific paper was likely to be accepted, even if a revision was needed afterwards, according to standard procedures. The editor-in-chief felt that such requests were not acceptable for a peer-reviewed scientific journal.
We have the following question for COPE:
Should we specifically state in our author guidelines or editorial policy that authors should not contact the handling editor during the review process? Any information regarding the process can be obtained from the editorial assistant. The role as co-author can be difficult for a member of the editorial board and I wonder if other journals have experienced similar problems?
The Forum agreed that the editor has handled this situation correctly. What is important is to have a specific procedure and clear process for handling papers from editorial board members. The peer review process should be completely transparent. The Forum told the editor to be extremely firm. All agreed that the editorial board member is abusing his position. The editor should keep accurate records and be very firm and not allow himself to be be pushed into making a decision. For the future, new editorial board members should be made aware that they will be treated like any other author. They will not be given special treatment.
Another suggestion was to put in place a procedure stating that a paper must be re-submitted after a certain time limit if all the required documents are not supplied to the journal.
We have clarified the procedure for handling manuscripts from editorial board members. All editorial board members have been informed that all necessary information regarding the progress of the peer review can be obtained from the editorial office. Editors should generally not communicate directly with the authors and that is especially important if a member of the editorial board is among the authors. Thus they will not be given special treatment. Incomplete submissions may now be unsubmitted by our editorial assistant if the required documents are not supplied within 5 days to the journal.
A published paper has been under legal scrutiny due to fabricated data. The court has concluded that the evidence presented undermined the credibility of the study. We have read the COPE guidelines for retracting an article and have checked the flowchart 'What to do if you expect fabricated data'. From reading the guidelines it seems that the editor has the right to retract the paper and to do this promptly. However, because we have not had a case in which a paper has been discredited through a civil court process before, we would like to seek the advice of COPE before we ask for a retraction.
The case in more detail:
• 2006: journal publishes paper that explores the link between two drugs, A and B and vision loss.
• 2006: the drug company responds in a published letter, pointing out flaws in author’s case control study (mainly well known biases of observational studies).
• 2007: author becomes expert witness in case against drug company, based on his paper.
• 2009, June: journal receives letter from author outlining some changes he wants to make to the paper—corrections, and referring to re-contacting people and re-analysing, reaffirming result of link with vision loss in men with a history of MI who have taken drug A (but only drug A now and not B).
• 2009, August: drug company tells journal that author is expert witness and casts doubt on his letter. They want to release source documents to the journal that have been disclosed to them by the author’s university as part of the court case. The university is resisting because it wants the issues argued in court.
• 2009, October: journal consults COPE, who suggest not publishing the letter until the outcome of the court case is known. COPE clearly discussed it as a conflict of interest issue (letter driven by the fact that the author was the expert witness).
• 2009, August: drug company writes to say author has been excluded as expert witness in the trial because errors in the trial call the study’s reliability into question. Provides transcript of relevant court ruling. This makes it clear that the author became an expert witness in February 2007, after publication of paper but before submission of the letter. He clearly became an expert witness on the basis of the study. Transcript says that author acknowledges inaccuracies—11 of 27 patients who originally reported use of the drug before developing vision loss turned out, from original trial forms, not to have started drug A or B until after diagnosis of vision loss. The ‘history of MI’ in some of the men turned out to be a family history of MI. Author also claimed to have re-contacted patients during the trial but court found no evidence of that. Court concluded that these undermined the credibility of the study. The court also ruled out the letter from the author as being similarly inaccurate.
It is clear that the author as an expert witness was arguing that his study showed causation. It was a small observational study: it could never show causation. We have not yet approached the author for his comments.
So, we would like to take this back to COPE to ensure our proposed course of action below is the correct one. We do not think we have had a case in which a paper has been discredited through a civil court process so we want to make sure that the actions taken are still acceptable.
(a) Ask the author whether in the view of the court opinion he wants to retract the paper?
(b) If author says no, refer to his university, asking it to investigate and consider ordering retraction of the paper.
The advice from the Forum was to retract the article and to quote the reasons for retraction verbatim from the civil court ruling, pending any legal appeal. In the event of a legal appeal by the author, the editor should probably publish an expression of concern in the journal. The editor was advised to contact the author’s institution and inform them of the journal’s proposed course of action and ask them if they had anything further to add regarding the case.
Following COPE's advice, the editor wrote to the author informing him that the journal wished to retract the paper. The retraction notice will be published in the next issue of the journal.
A manuscript was submitted to my journal. The author, on his own accord, submitted the manuscript for review to several reviewers under the guise that this was sent by me. The author sent the following explanation:
“In some of our previous encounters, you have indicated that finding sufficient cooperative reviewers has been a problem for you. In order to provide you with some help in this area, I have invented an ad hoc entity, ‘Nominated Reviewer Referral Service’, under which aegis ‘blind’ emails were sent to an assortment of academics and journalists, advising them that they had been ‘nominated’ to provide a brief review and evaluation of the paper, which I attached. I did not identify myself as the author or give any kind of a ‘sales pitch’, nor did I try to give the impression that you had anything to do with the sending of these emails, or were even aware of them. If any of these people choose to respond, it will be directly to you, and I will never see the responses unless you at some point forward them to me.”
I did hear from several people with the assumption that I had invited them to review the manuscript. I understand that I could ignore these reviews. However, I wonder what I can do with a manuscript that has been submitted under these circumstances. What is the best ethical course of action?
The Forum questioned the motive of the author. Did he genuinely believe he was being helpful? Regardless of the answer, the author is being misleading in that recipients would assume that the email came from the editor, whether or not he is doing it intentionally (and whether or not the message mentions the journal name or some other fictional organization). The Forum agreed this is unacceptable behaviour on the part of the author. The editor should write a firm letter to the author telling him his behaviour is unacceptable. The review process should be honest and transparent. On a practical level, the author could also do damage to the editor’s relationship with the reviewers. The author’s behaviour undermines the system and the editor should also point this out to the author in his letter. Other advice was to contact the author’s institution and inform them of the situation. If the editor feels that the trust between the editor and author has been lost he should consider not publishing the paper.
The journal proceeded to let people know that they were contacted not through the editor. However, due to the fact that the editor had selected those who had been contacted (to accept their review), the reviews were considered. The paper was indeed accepted. The author was admonished for his inappropriate behaviour.
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.
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 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.
We received a paper reporting a trial. There has only been one previous trial of this intervention in this condition that we know of (which was also done by these investigators). There were substantial issues with the reporting of that trial but the end result, as reported by them, favoured the intervention.
The trial we received, presumably approved after that result had come out, had the complication that most patients also received another treatment, and on an intention to treat (ITT) analysis of all patients, those given the intervention did no better and there was increased mortality in the intervention arm. The only positive outcome was from a per-protocol subgroup analysis of patients who did not have the other treatment (which they say is the only group comparable to the previous trial, and hence shows that the first trial was correct).
Although the trial was investigator led, it seemed to us that the authors were trying very hard to make something positive out of this actually rather worrying result. We sent the paper for review, including to a statistician; the reviewers raised a number of issues about the interpretation (eg, the overemphasis on subgroup analysis) and the analysis and reporting.
We felt that this was an important trial that needed to be reported, mainly because of the excess mortality in the intervention arm, but we had the rather odd situation that the authors wanted to emphasise the positive, and the need for further trials of this intervention, whereas the reviewers and editors saw the paper as delivering a negative message and feel actually that the paper will be the death knell for this treatment.
We therefore rejected the paper but offered to see a revised version if it was written more in line with our concerns.
The authors revised and the paper was re-reviewed. The paper was felt to be more balanced, but not yet completely satisfactory (ie, there was still too much emphasis on the positive result in one subgroup and not enough on the mortality).
A further issue then arose in that a reviewer spotted (on re-review) that three of the authors were noted as being on the DSMB for this trial. In their author contributions all are listed as having been involved in “analysing the data” and one, X, as “supervising the statistical analysis”
We asked the authors about these points and they replied: "(1) We are fully aware that it is unusual for members of the DSMB to be listed as authors, as independence is obviously important for such boards. In our case, the DSMB’s independence was not affected for the following reasons:
(a) Members of the DSMB worked for the entire study period (ie, between 2003 and 2008) completely independent and without any promises or expectation that they would be credited later by a coauthorship.
(b) My personal decision to include three of the four DSMB members in the list of authors was made a significant time after the final database lock. This decision was long after completion of the clinical study and its analysis. It credited three members of the board who made some significant advisory contributions to the present manuscript. Only for this reason they were included as coauthors, and it was quite unexpected for them. This decision from December 2008 has in no way influenced their independence and objectivity at the time when the study was running.
(2) As to the contribution of X (one of the members of the DSMB), we have to admit a simple language problem. In our use of the word “supervision”, the word meant that he took a final comprehensive look at our data analysis before the paper was submitted for publication. Importantly, he never supervised (like an academic supervisor) data analysis at any time point before database lock and processing of the data by the clinical research organization. We will change the terminology accordingly.”
We subsequently found that X was also an author on the previous trial.
Finally, the authors did not declare initially any competing interest but after we enquired specifically, they declared that the corresponding author “holds a patent on the use of t[he intervention] for treatment of [the condition]”.
Our concerns overall therefore were that this paper not only reports the outcomes in a way that is not appropriate, but also the composition of the DSMB and the presence of some DSMB members as authors means that the trial may not have had adequate independent oversight.
We felt we had two possible options with regard to publication:
(1) We reject the paper because it was inappropriately conducted and not appropriately reported.
(2) We publish the trial after further revision to ensure it is reported appropriately and publish alongside it an editorial that lays out our concerns with the conduct of the trial, but notwithstanding those, our reasons why we think it should be published.
We also discussed whether we needed to raise the issue of the DSMB with the authors’ institution.
We discussed the paper with our internal ethics board and they unanimously agreed we should reject the paper (mainly because of the concerns over the DSMB) and inform the authors' institution. We have as yet heard nothing from the institution.
We are bringing this to COPE as this paper raised a number of serious issues we had not come across before. We would appreciate the Forum’s opinion on whether we handled this correctly.
Some of the members of the Forum suggested that perhaps the journal should have a formal policy that DSMBs should be independent and not involved in the study in any way. The Forum questioned whether these authors fulfil the criteria for authorship, as outlined in the ICJME guidelines. One opinion was that perhaps the paper should not have been rejected until the outcome of the investigation was known. However, most agreed that rejecting the paper was the correct decision and the editor might consider contacting the ethics committee who approved the study if no response is received from the authors’ institution.
The editor reported the case to the author’s institution but no response has been obtained. The editor is pursuing the case.
During peer review of a manuscript submitted to journal Y, one of the referees indicated a belief that at least one of the authors had not declared a relevant conflict of interest (CoI). The article indicated that the authors had no relevant CoIs. The referee provided a URL to a press release that supported the allegation. It appears that one of the authors is the discoverer of a series of compounds that are the subject of the article. The compounds have been licensed to a company.
The authors were asked to clarify the situation and have provided a revised declaration that acknowledges the CoI.
Journal Y recently (September 2007) published another article by this group on the same subject that contained a declaration indicating no relevant CoI. Journal Y is in the process of indicating to the authors that a correction to the published article with the correct CoI declaration will be necessary.
Journal Y is also aware that another article by this group was published in journal Z six months earlier and did not reveal the CoI. Journal Z has a stated policy on declaring CoIs that we strongly suspect was in place when this article was submitted. Journal Y is intending to contact Journal Z to inform them.
Does the Forum recommend that other affected articles should be sought out and other affected journals be alerted in this way? If so, perhaps the question “Are other articles affected?” might be added to the flowcharts.
Does the Forum consider that the seriousness of this omission is compounded by its repetition? If so, should there be any additional sanction (other than publishing multiple corrections) in this and similar cases?
The Forum questioned whether it is the editor’s role to police all journals and so rejected the idea that other affected articles should be sought out and other affected journals be alerted. Editors should spend their time editing not policing. However, most agreed that the author’s institution should be informed, asking it to investigate, but warned about making any allegations. The Forum believed that the seriousness of omission of a CoI was compounded by its repetition but only if it had been done knowingly and if the omission occurred after it had been made clear to the author that this was not good behaviour. Some warned that this may not be so clear cut. Instructions to authors can vary widely and often CoI statements are not requested.
The journal brought the previously published article lacking a declaration of the potential conflict of interest to the attention of the authors of that article and requested that they supply a corrected declaration for publication as an rrratum. The authors agreed and the erratum has been published. It appears this was a case of omission rather than anything else and the journal has not informed the affected author’s department.
After peer-review, a general medical journal published a household survey of violence following a coup against the country’s elected President. The survey revealed high levels of violence and human rights abuses, only a small minority of which were attributed to supporters of the deposed regime. The manuscript stated that none of the interviewers had political affiliations and the authors declared that they had no conflict of interest.
Within days of publication the Editor was contacted by an expatriate from the country and by a local aid worker who expressed incredulity over the fact that the findings attributed so little of the violence to supporters of the deposed President’s political party, It was also pointed out that one of the authors was acquainted with the deposed President and had previously published pieces under a different name which were supportive of him. Some of these pieces were cited in the manuscript.
The author admitted that she had done this and the co-author, her thesis supervisor, stated that he was aware of these facts and did not consider them a conflict of interest.
Not satisfied by the responses from the authors, the Editor asked the Dean of the authors’ institution to undertake an internal investigation to verify that the data had been coded accurately. Results are expected by the end of 2006.
This interesting case prompted much discussion. The committee felt that the conflict of interest should have been identified in the peer-review process and were surprised by the reviewers’ responses and their failure to pick up on the political bias. The committee agreed that the editor has a duty to his readers to inform them that an investigation is ongoing. He should tell his readers that there have been allegations made about the paper but that it is not possible to establish the truth as yet. Hence the advice was to issue a statement of concern in the journal or possibly write an editorial highlighting all sides of the issue.
Following discussion of the case, a statement was published in the journal, a summary of which is given below.
In response to credible allegations that one author’s former activities might constitute an undisclosed conflict of interest, the journal began an inquiry. The authors’ institution was asked to investigate the matter, and the issue was referred to the Committee on Publication Ethics (COPE).
The institution audited 100 questionnaires selected by computerised randomisation. Outcome details on the original handwritten records corresponded with the project’s computerised database. The overall distribution of rapes and murders were re-analysed according to alleged perpetrators, and the results agreed with the published findings. Outcomes were then compared by political affiliation of the interviewer and for the author’s own data (as an interviewer). Again, there was no evidence of systematic bias. On the basis of this investigation, the journal has confidence in the authors’ findings as published.
COPE recommended that readers should be made aware that the author had published as a reporter under another name, and that failure to disclose a separate name, under which relevant material had been published and cited in her paper, constitutes an undeclared conflict of interest. The journal’s position on transparent disclosure of potential conflicts of interest is in accordance with guidelines established by the International Committee of Medical Journal Editors. The journal has made this position prominently available to readers and to authors, and stated clearly that incomplete disclosures will be amended in a published statement in the Department of Error section, which will also be linked electronically to the publication in electronic databases. Such a correction for this study appears in today’s journal.
To realise their full potential to benefit populations, research findings must influence practice. Intelligent debate is part of that process. The journal encourages genuine debate, and will always consider seriously allegations of scientific misconduct. It is unfortunate, however, that in this case much of the debate was aimed at exploiting historical divisions in the country in question. That process has obscured the message of the authors’research and detracted from the real issue—the welfare of civilians in that country—to whom attention should now turn.
We have just had a paper submitted as an ethical debate in which the author details ethical concerns about a study previously published in another journal. The study involved complementary/alternative therapy for an infectious disease in children. The author alleges that the study gave insufficient protection to vulnerable subjects, who were exposed to unwarranted risks and discomfort; and that the study had violated the accepted tenets of human studies ethics and national regulations.
The submitted manuscript summarizes (with full names of people involved, their affiliations and positions) various correspondence between the author and the investigators of the published study, the Institutional Review Board that approved the study, the office for the protection of human subjects in research of the associated medical school, the country’s regulatory authority for the protection of human subjects in research and the editors of the journal that published the paper.
The country’s regulatory authority for the protection of human subjects in research found that the author’s allegations were unsubstantiated. The author claims in reaching this decision, the authority had misinterpreted aspects of the study, prompted by false statements from the Principal Investigator and the presiding IRB. The authority, the IRB and the investigators all asserted (with reasons) that certain usual human subject protections did not apply in this study. The author gives rebuttals for these assertions.
The medical school stated it would not pursue the matter because of the conclusions already reached by the reviews conducted by the IRB and the country’s regulatory authority for the protection of human subjects in research.
The journal that published the study declared that no purpose would be served to its readers by publishing further correspondence (letter from our author), again citing the conclusions of the country’s regulatory authority.
The author lists as failing in their duty all the above-mentioned people/authorities, including the editors of the journal that published the paper.
Questions:Should we consider this for peer-review?
If we ultimately publish, are there legal issues surrounding perceived defamation of character when the regulatory bodies above have found the allegations unsubstantiated?
Presumably we would have to inform the investigators/authorities involved about our plan to publish and be prepared to publish a response from them?
Would it be acceptable to publish it in an anonymised format if the author agreed to this?
The editor provided further clarification on the case pointing out that the accusations include, the editors of the journals, the institutional review boards, and members of the national agencies involved in reviewing the case. The author also alleges that the principal of the study lied to the authorities. The medical school involved is not pursuing the case as it defers to the national authority. The committee commented that what ever the editor does, they will be in trouble and added to the authors list! It was pointed out that the complaint had been taken to the highest level in the country and it is difficult to see why the editor should join in the debate and there was speculation if the material should be published. It sounded like the author wants all those involved with their heads on the block.
It was asked if the author had completed a competing interest statement, they have not. The editor thought that the author seemed to be investigating and doesn’t seem to have a personal interest. Though the author requested that no-one on the editorial board with any interest in complimentary medicine be involved in peer reviewing the paper.
The committee commented that the first port of call should be the editors lawyers, as the legal issues would take precedence. It was also pointed out that there was a contradiction in the author’s account, as since the issue had gone to the countries regulatory authority, the author would have had chances to air their view and correct the misleading statements. Apparently the author had written to the regulatory authority. Also probably the first legal advice the editor will be given is to check to see that ALL the facts in the article can be substantiated, and probably no-lawyer will advise the editor to publish as they are risk adverse.
Also it was suggested the editor should do a pubmed search on the author, as this perhaps seemed like an author who had a bee in their bonnet about complementary medicine.
The advice was for the editor to seek legal advice. The committee was unenthusiastic on taking further action. This is the sort of paper that should be sent to the press. The editor should reject the paper citing legal advice.
We took legal advice. It was felt that the risk of publishing allegations which respected bodies had already found to be unsubstantiated was too high, laying us open to a claim for defamation from the people the allegations were made about.
We rejected the manuscript, stating that the decision had been made after taking legal advice.
An internet search revealed the author to have previously been involved in various anti-complementary/alternative therapy campaigns.
To date we have not had any further correspondence with the author following rejection of the manuscript.