China has become a formidable global leader in scientific—including medical—research, with the world's largest publication output, a rapid surge in the number of highly cited researchers, and an increasingly unparalleled quality of scientific publications.
This month’s topic is “journal management” and on first blush, it isn’t obvious how the concept of “ethics” applies to this topic. I thought of things like selection and implementation of a manuscript manager, paying bills, identifying reviewers, etc. But when I got past my concrete thinking it’s clear journals must be managed based on fundamental ethical principles. These include: Autonomy, Justice, beneficence, non-malfeasance.
COPE was well represented at two very important meetings this September. The first “Seeking Solutions in Research Integrity: A View from All Perspectives” was a day long Research Integrity Summit hosted by Ohio State University.
At the 2017 COPE European Seminar, Robert Kiley from the Wellcome Trust presented Wellcome's perspective on publication and research integrity.
The event was filmed, which you can watch below, and the slides are also available.
A manuscript was submitted to our journal describing a study of a new drug. The manuscript had only one author who gave their affiliation as a company that we can find no record of online. It describes a study in which they appear to have developed a new drug, carried out a toxicology study in mice and then, because no adverse effects were seen, tested it on one patient and five healthy volunteers. There appear to have be no stages in between. There is no statement of informed consent in the manuscript. There is a statement that says the study was reviewed by the institution’s human subjects committee but we cannot find a record of the institution.
We had ethical concerns about the study so we asked the authors for more information, specifically: the details of the ethics committee that approved the study; whether they had informed consent from the patient and healthy volunteers; whether the trial had been registered before it commenced; how the patient and controls were recruited; what information the patient and controls were given before they agreed to participate; where the study took place; what safety/monitoring was in place in case of any adverse effects; what approval was obtained (eg, from the country’s drug regulatory body) before this drug was injected into a human for the first time; and what other research had already been carried out on this new drug? The author responded to our email asking to withdraw the manuscript but did not answer any of our questions. We responded that we had serious ethical concerns and therefore would not be withdrawing the manuscript at this time. We informed the author that we would be investigating the potential ethical issues and asked again for answers to our questions. We have heard nothing from the author since.
The author is based in a country that does not appear to have a national medical board and is not affiliated to an academic institution or hospital. The affiliation given is the company that we can find no record of. The author’s email address is not an institutional or company email address. We have contacted the professional society for the medical specialty of the author but they have informed us that the author is not a member and therefore they cannot investigate. We have also searched for the author on the registry of the regional medical board for the region in which the author is based, and they are not registered with them either. We do not want to reject the manuscript until an appropriate body has agreed to investigate but we are struggling as to how else to report this.
Questions for the COPE Forum (1) Does the Forum agree that we should continue to try and find someone to investigate this before we reject? (2) Does the Forum have any suggestions on how we can report this?
The Forum agreed that the editor had made a tremendous effort in trying to resolve this case. The Forum reiterated that in instances where a paper is rejected or withdrawn, there is still a responsibility to pursue any suspicions of misconduct. In this case, where the author wishes to withdraw the paper, it was agreed that the editor had probably done as much as he could. In some countries, this type of behaviour might be considered criminal, and a last resort might be to inform the legal authorities in that country.
The Forum advised that there is always the possibility that the paper is a hoax, but the editor has to assume, until otherwise proven, that the author has submitted the paper in good faith and should investigate this as far as possible. This is a particularly difficult case as it is a single author paper. If there had been more than one author on the paper, the journal could have applied the revised criteria of the International Committee of Medical Journal Editors (ICMJE). The fourth criterion states that all authors are accountable for all aspects of the work and are responsible for ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. However, this is not applicable in this case as there is only one author.
The only other suggestion was for the editor to write an editorial on this topic, emphasizing that this type of behaviour is unacceptable.
After the case was discussed at the forum, the journal made one further attempt to report the unethical research. This was successful and the case is now being investigated by the relevant governmental department in the country where the research was carried out. The editor also discovered that while he had been trying to resolve this case, the article had been published in another journal. He informed the editor of that journal of the duplicate submission and his concerns.
Follow up (June 2014):
After the relevant governmental department agreed to investigate, the manuscript was rejected by the journal. The journal did not receive a response from the editor of the other journal in which the article had been published.
Author A submitted a trial comparing the safety and feasibility of two delivery techniques in patients. The trial, which was done at author A’s institution, was assessed by inhouse editors, who decided to send it out for peer review.
During the peer review process, some reviewers pointed out that “this work seems premature, experimental and hard to believe”, and also expressed suspicion about the result (ie, 100% procedure success rate). One of the peer reviewers, reviewer X, who works with author A at the same institute in Europe, and who was also acknowledged in the author’s submission, provided further comment. In his letter to editor, he stated that “I have reviewed some of their manuscripts more than 10 times, and I have refused to be associated with their research, because I had no access to the raw data on which there is an embargo made by the military authority in this country.” He continued that “it is fair to say that the data are unbelievable, without a negative or positive connotation. If the data exist and are correct, they will deserve a Nobel Prize.....as a matter of fact, a fake document has been circulated and the hoax has been disclosed in a very elegant way by a young colleague”.
After discussion among editors at our journal, we decided to reject the manuscript and ask for an investigation by the author’s institute. However, since the European institute already seems to be aware of the likely fraudulent nature of these results, and we cannot find contact details for anyone at the institution, we would welcome your advice on to whom we might best direct the investigation.
The Forum cautioned that it is much more difficult to deal with authors and resolve an issue when you have rejected the paper, as the journal no longer has any say over the paper. It is much easier to obtain information from the authors before you reject the article. However, all agreed that this case should be pursued and the editor needs to give the authors an opportunity to respond to the accusations.
The advice was to give the authors one more chance to reply. The editor should contact all of the authors (not just the corresponding author) and inform them that because of the issues raised in peer review unless he hears back from them by a specified date, he will assume that the reviewer comments are correct and will then contact the author’s institution. The Forum advised contacting the institution if the authors fail to respond or if they respond in an unsatisfactory way. The European institute may be able to provide contact details for the initial institution. Also, the editor could ask the reviewer who works with author A at the same institute in Europe to provide contact details for the author’s present or previous institution. The Forum advised addressing the institution in a non-judgemental way, simply informing them of the facts of the case and asking them to investigate.
The editor continued to contact the institute about this matter, but there has been no response since February. The editor now feels there is little else he can do and considers the case closed.