We routinely ask for ethics committee approval from every research manuscript submitted to our journal. Sometimes, studies from different countries may not have ethics committee approval and authors may claim that their study does not need approval. In such situations, we consult COPE’s “Guidance for Editors: Research, Audit and Service Evaluations” document and evaluate the study at the editorial board and decide whether or not it needs approval.
However, as an editor, what should I do in the following situation? Any research, be it a retrospective analysis of routine patient data, an in vitro study or a study on bacteria requires institutional ethics committee approval in country A. In country B, ethics committee approval is not required for such studies (this information is provided by the authors). The journal receives two such studies, one from country A and one from country B. Neither has ethics committee approval. The authors of both manuscripts claim that their studies do not need approval.
Question(s) for the COPE Forum • What should best editorial practice be in this situation? —Accept both papers for review. —Accept the paper from country B for review but reject the paper from country A (or ask the authors of the paper from country A to apply for institutional ethical approval). —Reject both papers (or ask the authors of both papers to apply for institutional ethical approval).
The Forum noted that editors cannot be expected to know the national guidelines for the conduct of research in individual countries. It is up to authors to make sure that they comply with their national guidelines. One suggestion was that the national standards where the research was done should apply here, or the editor could make a judgement on his own national standards, in the country where the journal is located, and based on his knowledge of what he thinks requires ethics approval. It is good that the journal has a process for discussing this issue among its editorial board, to uphold minimum standards when the authors declare that they do not need ethical approval.
For country A, where ethics committee approval is required, the Forum suggested that the editor investigate whether the research does need ethics approval. It may be that the research is exempt from approval. But if the editor discovers that the study did require ethics approval and the authors failed to obtain approval, he has a responsibility not only to reject the paper but to follow this up with the author's institution and/or the ethics committee. Otherwise, the authors may just submit the paper to another journal.
For country B, the Forum suggested asking for proof that the study did not require ethics approval—for example, a letter from their ethics committee stating that the study does not require ethics approval.
The editorial board of the journal reviewed the Forum’s recommendations and have decided to continue to ask ethics committee approval for every study submitted to the journal from all countries. If the study requires ethics approval, the authors will be asked to provide this. If they cannot provide ethics approval, the journal will reject the manuscript and contact the institutions or related bodies in the authors’ country, if necessary. If a study does not need ethics committee approval after review, the journal will ask authors for confirmation from an ethics committee or an independent committee indicating that the study does not need ethics committee approval according to the research integrity rules in their country. The journal has updated their instructions to authors with these details.
Our journal publishes case reports describing the evaluation, diagnosis and treatment of unusual cases. Parents must provide written informed consent prior to manuscript submission. No cases are presented with unique identifiers and each is anonymised as much as possible.
A manuscript was submitted with written consent that was accepted for publication and assigned to an issue. Just before the issue was to be folioed, the parents contacted the authors and revoked consent. The journal was able to pull the article prior to publication. The editorial board is concerned about this happening again and what the course of action would be if consent is withdrawn from a case that has already been published.
Question(s) for the COPE Forum • Once written consent is provided, can it be revoked? • If the article was already published, what would be the reasonable course of action? Retraction?
The case provoked much discussion among the Forum and raised many interesting questions. Do people really understand the full implications of giving consent to publish? Do patients really understand what consent means? Do patients/carers understand that once a paper is published online, it is very difficult to remove it? A journal can take down the paper, but it may have already been downloaded and/or printed copies may be in circulation. Hence a paper can never be removed completely from the internet.
The Forum stressed that patients should be made fully aware of this before they provide consent. The fact that a paper can be read by anyone should be made very explicit to patients. In genetic studies on pedigrees for example, a paper may potentially identify not only the patient, but the patient’s family, and therefore it may be difficult and complex to obtain consent in this situation. Hence the Forum advised that a journal should strive to avoid a situation where a patient or carer wants to revoke consent by providing clear instructions on what it means to provide consent in the first place. Also, the journal may wish to have their own consent form which could provide clear and detailed information on consent.
The Forum agreed that consent can be revoked and that a journal should respect the wishes of a patient if they wish to revoke consent. The journal should then remove the paper from their website but leave a place marker, with a note saying that the paper has been removed and stating the reasons why. The journal should inform the patient that although the paper has been removed, there is little that can be done regarding copies already in circulation.
For consent in children and young adults, some journals use a "minor assent form" along with parental permission, which is tailored to the age of the child. The child can then give their "assent".
The issue of consent forms has been raised at COPE in the past and the suggestion of a universal consent form was put forward. However, it was felt that one consent form could not cover all situations and instead, COPE plans to publish various on the COPE website examples of best practice journal consent forms for others to see and perhaps use for their own journal.
The editor was satisfied with the guidance the Forum provided. Based on feedback from the Forum, the journal is creating a sample parental consent form for authors to use as a template. The journal hopes to clarify what it means to give consent to publish a child’s case in the journal so that the parent is fully aware. The editor would be interested in any formal guidance on consent issues from COPE. The editor considers the case closed.
A paper was submitted to our journal. The associate editor assigned to the paper immediately assigned a reviewer who he knew was well qualified to give a good review, as they had worked with the authors before. The editor did think it odd that the reviewer was not an author on this particular paper, given the close collaboration. However, when invited, the reviewer (R1), did not flag up any conflict of interest or request that they should be an author on the paper.
The reviewer returned a very good review and along with another two reviews (R2/R3), and after revision (where the revision once again was sent to R1) the paper was accepted and published.
A few months later, the journal was approached by another researcher (E1 who is from the same laboratory as R1) who said that this paper had been published with an incomplete author list and that they wanted the paper retracted as they had not been included. After discussions with the editors of the journal, a corrigendum was agreed as the best way forward to amend the author list, as there was nothing scientifically wrong with the paper.
In the course of the conversations with E1, it became clear that R1 was involved in the publication from the beginning (specifically designing the experiment discussed in the paper). In the meantime, the corresponding author supplied the editors with the corrigendum text where a new expanded author list was outlined, which included E1 and R1, and the acknowledgements were also updated to include several other researchers’ contributions. Along with the corrigendum text, the corresponding author also included pdfs of emails they had received from all of the authors (including E1 and R1) in which they agreed to be named as an author.
The editor in chief has written to the corresponding author saying that it is not possible for R1 to be included in the author list as they had been a reviewer on the paper, and did not flag up at any time that they thought that they were an author. The editor in chief suggested that R1 be withdrawn from the author list proposed in the corrigendum. The corresponding author replied that there had been a meeting between the two laboratories affected, the content of the paper was evaluated and those people who should be listed as authors were identified. R1 was identified as an author during this meeting (as well as E1). The corresponding author acknowledged that there was a clear conflict with R1 having reviewed the paper, when they should have been a co-author. The corresponding author suggested that R1’s review be stricken from the record and the other two reviews used as the reason for accepting the paper.
The corresponding author wants to have R1’s contribution to the paper reflected in the author list and has requested that we publish the original corrigendum. The journal editors have discussed this and have come to the conclusion that although there is nothing scientifically wrong with the paper, it will need to be retracted as the peer review process for this paper has been compromised. They are willing to give the authors the chance to resubmit the paper with the full author list and have it re-reviewed (new handling editors and reviewers).
Question(s) for the COPE Forum • Should the editors offer the option of a revise and resubmit following a retraction? • If the authors do revise and resubmit, it is likely the paper will be accepted (as there is nothing scientifically incorrect with it) so there is a possibility that the journal will have a retracted paper and a published paper which look very similar by the same (if expanded) author list. In this happens, would a cross linked editorial be needed to explain the situation? • Is a retraction merited given there is nothing scientifically wrong with the paper? A suggestion has been made to publish the corrigendum with just E1 as author (not include R1).
The Forum agreed that the peer-review process had been compromised and therefore the paper should be retracted. A correction would not be sufficient, even though there is nothing scientifically wrong with the paper, as the peer process has been corrupted. The Forum agreed it was would be acceptable for the editor to offer the author the option of revising and resubmiting the paper following the retraction. The new paper would have to be considered as a new submission and should be reviewed by a new set of reviewers. It was noted that a recent issue of The Lancet (31 January 2015) contained a re-published article that had originally been retracted. There was also a linked commentary explaining what had happened. It was suggested that the editor may wish to use this as a model if he wished.
The Forum questioned the behaviour of the reviewer. Has the editor asked the reviewer why he did not recuse himself from reviewing the paper? The reviewer does not seem to have conducted himself in an ethical manner.
An alternative suggestion was for the editor to consider whether or not he would have published the paper based on the two reviews of the original paper (excluding the review by R1). If it is the normal policy for the journal to have two reviewers and there were three in this case, but only one was compromised, perhaps the paper could stand? The editor would still need to publish a corrigendum explaining the revised authorship but he could justify publication based on the other reviews. In a similar vein, a suggestion was for the editor to consider post-publication peer review of the article, especially as he believes it to be scientifically sound.
The editor decided to follow the alternative suggestion put forward during the COPE Forum, and publish a corrigendum, where researcher E1 has been included as an author of the article and the reviewer R1 has been mentioned in the acknowledgements section. From the journal’s perspective, the case is now closed.
The author was the subject of his study. He depleted himself of a vital nutrient until he had overt clinical and biochemical signs of the deficiency. He monitored various biochemical parameters as he became more deficient and submitted two manuscripts presenting his results: one detailing the biochemical changes and one detailing the differences in results obtained from different commercially available assays for the nutrient.
Reviewers of the first manuscript raised some concerns about the experimental model used and also concerns about the ethics of the study, particularly the lack of any oversight from an institutional research board. The second manuscript was not reviewed and both were rejected on the basis of the ethical concerns raised by the reviewer and concerns about the scientific validity of the results obtained from one individual.
The author feels very strongly that his experiment was not unethical and argues for the autonomy of researchers. He provided the following arguments for his study: — The author is both experimenter and single subject, so the requirement for informed consent does not apply. — There is no institutional involvement, so there is no possibility of coercion. — The subject was assessed by a psychiatrist and found to be competent to evaluate the risks and benefits and to accept full responsibility for the conduct of the experiment. — The Declaration of Helsinki does not comment on self-experimentation; it is concerned with research in patients and healthy volunteers. The requirement for ethics approval therefore does not apply. The Declaration of Helsinki cannot be cited as a reason for rejecting reports of independent self-experimentation. The Declaration was not intended to prevent autonomous independent humans from performing and reporting self-experimentation — The subject was monitored by a qualified psychiatrist who continually assessed the condition of the subject. It was agreed in advance that the psychiatrist would intervene if, but only if, there was an immediate life-threatening condition. — The motivation for performing the experiment was ethical in that the subject wanted to investigate the gross differences between the immunoassays he found in an earlier experiment because he was aware of the potential severe consequences of such errors in measurement of this nutrient. There was no conflict of interest. — The need for IRB or ethics committee approval would totally exclude from publication any self-experimentation research performed by an independent researcher because they will not have access to any ethics committee or institutional review board. This would have prevented the publication of reports of highly useful reports (http://careers.bmj.com/careers/advice/view-article.html?id=20002566 and http://www.bmj.com/content/341/bmj.c7103.long)
The author appealed the decision to reject his manuscripts. Although the appeal was not upheld, we agreed to bring the author's arguments for self-experimentation to the COPE Forum for wider discussion. It is worth noting that the author’s two papers were eventually published in another peer reviewed journal without any negative response over the ethical issues.
Question(s) for the COPE Forum • Do other editors at the COPE Forum consider manuscripts on self-experimentation without formal IRB approval? • What criteria do editors use to determine whether such studies are acceptable?
The Forum suggested there are two issues here: the ethical issue of self-experimentation and whether the study warrants publication with an n of 1.
The Forum agreed that the author has the right to perform the experiments on himself, but he does not the right to have his findings published. There have been some highly publicised cases of self-experimentation, which in one case led to a Nobel prize for Barry Marshall after he infected himself with Helicobacter pylori (the causative organism of peptic ulcers). There was also the case of Spurlock’s documentary, Super Size Me, a social experiment in fast food gastronomy.
Regarding the second issue, the Forum agreed that this has to be a judgement call for any editor. Does the study warrant scientific publication? The author has the option of blogging about his experiments if he wants to disseminate his results.
The editor told the Forum that they were interested in learning if any journals had a specific policy on this issue, but among the Forum audience, no journal had such a policy. The discussion ended in agreement that this is a topic that needs further debate.
In 2014 we received a communication from the Research Integrity Officer of an academic institution informing us that a paper, published in our journal in 2013, included falsified or fabricated data. We were informed that, following an investigation, they had determined that scientific misconduct had occurred.
Within a few days we received a communication from one of the authors of the paper (who is no longer at the institution) reiterating this assertion and providing some further explanation; that a former student had fabricated data and that it affected the paper (but providing no specifics).
Over the next week or so, other journals by the same publisher received similar notifications from the same author. Initially, we were presented with no information regarding who the perpetrator was or the specifics of the affected data. We were therefore unable to determine how severely affected the validity of the overall paper was and whether a retraction or correction was necessary.
Our initial response was to request further information from the institution and the author. Initially, we were informed by both parties that, as a result of Federal privacy laws, they were unable to divulge any details pertaining to the investigation, aside from what they had already told us. In the meantime, we decided to publish an expressions of concern on all four papers affected by our publisher with identical notices detailing what we knew for certain and stating that we would seek further details from the institution.
Sometime later we heard back from the institution providing further specific information (ie, outlining the fabricated data) for three of the four papers. Of these three papers, two are now in the process of being retracted, while an academic editor has been consulted to advise on whether the third should be retracted or corrected, based on the additional scientific information now available.
However, in regard to the fourth paper, published in our journal, we were told by the institution that no further information was available. The author who contacted us has not provided any specific information either. Therefore, we find ourselves unsure of how to proceed next, as we still do not know to what extent the conclusions in the paper are valid.
Question(s) for the COPE Forum • Should we proceed with a retraction but simply state that we cannot provide further information (something we feel is unsatisfactory for our authors)? • Should we instead leave the expression of concern online but update it to say that we will not be able to provide any further information? • Does the Forum have any other suggestions?
The Forum asked the editor if the paper had been handled through the Office of Research Integrity (ORI) in the USA, as they post their findings on cases on their website. However, the laws related to the ORI are very strict and do not allow sharing of information, even with institutions, and so the only way of finding out any information is to look at what has been published in the federal registry. The editor told the Forum that there was no information on the ORI website.
One view was that, given the history of all of these papers, and the concerns about the data on this particular paper, the editor should err on the side of caution and retract the paper.
However, a more cautious approach was also suggested. COPE would advise that a retraction statement should be as informative as possible; a journal needs to give its readers a reason for the retraction. Hence, in the absence of further information, the editor may consider not retracting at the moment, but instead updating the Expression of Concern. The editor may want to explain that other papers have been retracted as a result of the same investigation but no further information is available on the current paper.
Another suggestion was to go back to the institution and insist that they provide further information on the validity of the data.
Advice on follow up:
Following the discussion at the Forum, the editor decided that there was insufficient information available to support a retraction. Therefore, the current Expression of Concern remains on the record pending further communication from the institution concerned.
We received a review paper and it was accepted and published on our website. We then noticed that one of the figures had been copied from a paper published in another journal.
Before publication, we asked the authors if the figures were original or if they needed references, and the authors responded that they were original. After confirmation of the similarity of one figure to a published figure, we contacted the corresponding author again and he/she said they had not seen the paper and it was submitted by a student.
As the paper was “in press”, we thought that we may be able to withdrawn it. We contacted the research deputy of our university and the author’s university but we have received no reply.
Question(s) for the COPE Forum • Is this major plagiarism? Can the authors remove the figure and publish this paper or should the paper be withdrawn? • Should we contact the author’s university again?
The Forum agreed that there are two issues here: the authorship issue and the plagiarized figure. Regarding the plagiarized figure, there may be copyright issues, so the editor may like to consider contacting a Copyright Clearance Centre to obtain permission to publish the figure in a review article. The editor may decide that the use of one figure is not a major plagiarism issue and he may wish to educate, rather than punish, the author. The editor should emphasize to the author that having permission to use the figure is not the same as having permission to publish it. It is acceptable to re-use a figure if the author has permission and if the original figure is cited. But the potential copyright issue may be more serious than the plagiarism issue. This can sometimes depend on the nature and complexity of the figure itself and whether the author has made an honest attempt to redraw the figure.
Regarding the authorship issue, the Forum suggested contacting the institution. It is up to the institution to resolve the author dispute.
The Forum advised that the paper cannot be withdrawn—if it is available online, it is considered already published, and therefore it has to treated as published material.
A paper was submitted to a medical journal reporting original research on human subjects. Two corresponding authors, author A (first in authors’ list) and author B (last in the list) were listed. The paper was sent to external referees but while it was under review, the editor received an email from author A stating that s/he had not read the paper, was not aware of the submission and did not agree with the submission. Author A did not provide any specifics of the disagreement.
The editor immediately contacted author B, who admitted that s/he had submitted the paper after many failed attempts to contact author A. The authors performed the work in the same institution but author A had left the institution prior to the submission and his/her current address/institution was unknown to author B.
The editor immediately contacted the external referees asking them to halt the reviewing process, pending resolution of the conflict. On the editor’s request, author B asked the leadership of the institution to contact author A in order to get input that would allow the submission to proceed but author B informed the editor that no response had been received after 2 months. The editor was also informed that author A had taken legal action against the institution over an unrelated matter, and author B suspected that the refusal to authorize the submission was being used as a weapon in that dispute.
The editor further suggested contacting the leadership of author A’s new institution. However, neither author B nor the institution leadership are aware of author A’s current employment. A web search by the editor found several entries on author A, none of which was indicative of a current academic position. Author A’s email to the editor was from a non-institutional provider (gmail).
The paper reports important work, in which human subjects volunteered to participate. It would, therefore, be very unfortunate for it not to be published.
Question(s) for the COPE Forum • Is there anything more than the editor can do? • Should the editor contact author A directly? • Would it be possible to publish the paper against author A’s objections if author A refuses to provide a scientific basis for his/her objection after a reasonable attempt has been made to obtain it?
The Forum advised contacting the institution directly, rather than relying on author B to liaise between the journal and the institution. COPE advice would normally be that author disputes should be resolved by the institution. In addition, the Forum advised that the editor should consider contacting author A directly, and asking for his explanation of the events. The Forum advised against publishing the paper in the absence of author A’s agreement, unless the authorship issue is resolved by the institution. There may also be legal issues to consider if the editor were to go ahead and publish, as author A may have issues related to their intellectual property.
Papers are sometimes held hostage by authors and COPE’s advice would always be to ask the institution to resolve the issue. However, sometimes the editor has to make a judgement call. One way forward, if the editor really wants to publish the paper, is to have a clear statement on the published paper, explaining the circumstances around the paper, acknowledging there was a problem and explaining the issues.
Following the advice from the Forum, the editor contacted the disputing author and convinced her to participate in the publication. She promptly provided her feedback on the manuscript, which was submitted. It is now in revision for the journal.