Author A contacted our journal following publication of a manuscript claiming that he was the rightful author. We asked the author for proof and he said that he had all of the data concerning the patient because he received the operative specimen and made the diagnosis. Author A said he also collaborated in writing the article with author B and hence was surprised that neither his name nor his contribution appeared in the published article.
Author A alleged he gave authorisation to present the case in a conference to author B who later published the article in our journal without his consent.
Question(s) for the COPE Forum
• Who is the owner of this article?
• Is this a case of plagiarism?
• What action can we take regarding authors A and B?
The Forum advised referring the matter to the institution. Journal editors and publishers cannot be involved in adjudicating authorship disputes. Only the institution(s) can determine who is the rightful author. Hence the advice was to contact the institution and request an investigation. If the institution agrees to investigate, the editor may wish to issue an Expression of Concern until the results of the investigation are available.
As this was a case study, was permission granted from the patient to publish the paper? The editor could seek out the patient consent form, and determine if that came from author A or author B. Case reports must not be published without informed patient consent.
Authors Virginia Barbour, Muhammad Irfan, Deborah Poff and Michael Wise on behalf of COPE Council Version 1 December 2016 How to cite this COPE Council. Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports. Version 1. December 2016 https://doi.org/10.24318/cope.2019.1.6
Our COPE materials are available to use under the Creative Commons Attribution-NonCommercial-NoDerivs license https://creativecommons.org/licenses/by-nc-nd/3.0/ Attribution — You must attribute the work in the manner specified by the author or licensor (but not in any way that suggests that they endorse you or your use of the work). Non-commercial — You may not use this work for commercial purposes. No Derivative Works — You may not alter, transform, or build upon this work. We ask that you give full accreditation to COPE with a link to our website: publicationethics.org
A manuscript was submitted to our journal that describes a social media advocacy campaign that was run by an international NGO for the purpose of eliciting public support for a new law in a low-middle income country. The authors are from the NGO and the government department in that country, that together funded and ran the campaign, and also collected and analysed the data used in the manuscript.
Some of the data reported in the manuscript were survey data collected from people who signed the online petition in support of the proposed law. The manuscript provides information that could be useful for others planning similar advocacy campaigns. The data are reported in grouped format (counts and percentages), such that participants are not able to be identified from the results. The nature of the data reported in the manuscript is not of a sensitive nature, and the study would generally be considered a low risk project (answering an online survey about how the participant found out about the campaign and demographics of respondents etc).
The authors state that all respondents agreed to participate in the research. However, the study has not been reviewed or approved by a human research ethics committee.
Question(s) for the COPE Forum • Would retrospective research ethics committee review be appropriate to consider in this situation?
The majority view from the Forum was that the editor should obtain retrospective ethics approval for the study. However, the Forum noted that it is up to the editor, and it is his judgement call; if the editor is happy with the current position, and common sense tells him that the study is sound, then he should publish.
Although low risk, some of the Forum cautioned that the editor should err on the side of caution as the study involves human subjects, and the advice was to go back to the authors and ask them to obtain ethics approval for the study. If retrospective approval is obtained, the Forum advised a note on the paper saying that retrospective approval was obtained, in the interests of full transparency. A poll of the (8AM) audience revealed that the majority were in favour of going back to the authors and asking them to obtain retrospective ethics approval.
Another view from the Forum was that editors should only seek retrospective review under extraordinary circumstances. As a norm, retrospective approval should not be used for any study that has been completed, unless there are exceptional circumstances (research conducted in a war zone for example). A suggestion was for the authors to provide more specific information on the type of consent that was obtained and for this to be published as an appendix to the paper.
The authors were advised by the editor that they needed to address the issue of lack of ethics approval for the study and it was recommended that they seek retrospective ethics approval from an institutional review board. However, the authors resubmitted the manuscript without ethics approval and stated that ethics approval is not required for this type of study (surveys) in the country where the study was conducted. The editor requested they supply further material, such as a letter from the research ethics authority in the country or other official document that confirms this type of study is automatically exempt from requiring ethics approval, and participant information and consent statements.
The journal is waiting on material from the authors to confirm the study meets accepted standards.
Follow up (October 2016): The authors submitted a response to the journal. Rather than evidence of exemption from ethical approval, they obtained retrospective ethics approval from a relevant institutional review board in the country and provided the certificate. The manuscript has now been accepted.
A paper was submitted to our journal. The managing editor was concerned about patient information in the paper and queried the authors. The authors responded that the data were collected from routine samples and so consent was never obtained. The patients were lost to follow-up, and there was no ethics committee approval as it involved the study of existing data, but they did discuss with the institutional review board who said it was exempt.
The cohort was 2500 patients, all with one syndrome, in one hospital. The paper contains two tables that display data from 12 patients: sex, age, presenting symptom, as well as laboratory parameters and outcome.
Question(s) for the COPE Forum • Are these patients identifiable? • If we remove, say, age and sex, would that be sufficient to render the data anonymous? Would we lose clinical significance by removing age and gender for those patients, although the paper does mention that of the 12 patients most were female and gives the median age group? • Should we publish this without patient consent? • The study also mentions controls who underwent biopsy, but what is not clear is whether those controls were also from the same cohort and perhaps underwent biopsy as part of routine screening. Would they need ethics approval for biopsy?
The Forum agreed that the case was concerning. With the sophisticated knowledge and information that can be trawled from the internet, the concept of anonymity is becoming more and more difficult. However, editors have to do their best to protect patients’ identities, and it is has to be an editorial decision on the risk–benefit of publishing.
Journals have different policies on publishing papers without consent or approval, although many of the Forum participants said that they would reject a paper if there was no patient consent and/or no ethics approval.
The advice from the Forum was to contact the authors and ask for the Institutional Review Board (IRB) documentation. The editor should ask the authors to clarify why the study was exempt from ethics approval. If the authors insist the study did not require ethics approval, then the editor should ask for proof—for example, a written statement from the IRB. The editor could also contact the IRB directly with their concerns.
The Forum also advised that the issue of consent should be raised with the authors—both consent to participate in the study and consent to have the data published. Was consent received from the whole cohort? Did the authors receive consent to publish from the patients whose data were published?
Following the discussion at the Forum, the journal asked the authors to provide any information that they had about informed consent at the time of treatment. The authors sent their translated form, which specifically mentioned they had consent for treatment and not for publication explicitly. Hence on these grounds, the editor decided to reject the paper. The editor informed the authors, who did understand and said that they could not find the patients to seek consent as they were lost of follow-up. The journal considers the case closed.
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.
In 2008, our journal published a phase 2 randomised controlled trial of a new medicine. In 2011, the regulatory authority in the country where the study was performed decided to undertake routine monitoring of completed studies and this trial was selected for random inspection. The author informed the journal of the inspection and provided a translation of the report (independently verified as accurate by our journal).
The following concerns were raised by the regulatory authorities: (1) There was no medical involvement in the process for informed consent, which was delegated to a non-medical practitioner. The country’s regulations require that a medical practitioner informs a participant and confirms this. The local ethics committee has been informed by the regulator about this lapse. (2) The integrity of blinding was questioned in an earlier inspection in 2007 and because of comments about the treatment’s efficacy and side effects by one of the investigators while the trial was underway. (3) The recording and assessment of adverse events was incomplete and the inspectors felt that the table of adverse events published in our journal did not reflect the clinical records for product safety.
The manuscript had two rounds of peer-review (seven reviews by four clinicians and a statistician). The only point of relevance to the above concerns was the comment that “the main weakness of the study is inadequate data on safety and adverse effects (in part unsurprising as this was a proof of efficacy study) and a rather overly positive presentation of the data”. The manuscript was revised and re-reviewed by this reviewer and a statistician; both were satisfied that the points had been addressed in the revision. After publication of the research article, our journal published two letters as correspondence. In one, the possibility of certain adverse events was raised, to which the authors replied that these had not been observed.
The authors have submitted a correction that states incorrect instructions by the contract research organisation resulted in under-reporting of adverse events for headache, migraine, stress and depression in people who had experienced these conditions before enrolling in the trial. They also state that comments about the medicine made to local media were based on another study. The editors are concerned that taken in their totality, the issues raised by the regulator question the soundness of our publication. As we gather more information and await the ethics committee’s decision about the process for informed consent, the editors would be interested in learning what actions COPE would recommend.
The Forum advised that if the editor cannot decide what to do, a statement of concern could be published in the interim. If the editor thinks the methodology was insufficient (to detect side effects), then he should consider retracting the paper. Clearly a correction needs to be done. The expression of concern should mention the fact that the table of side effects may not be correct, in addition to the issue relating to consent. The editor told the Forum that he does not believe there has been any misconduct and the authors wrote the paper in good faith. On a show of hands, nine people suggested that the editor should do an expression of concern detailing the chain of events. Only two people thought the paper should be retracted. Hence the consensus was that it would be appropriate to put a statement of concern on the paper.
The journal has received a letter from the author that responds to the expression of concern and the inspection report. At present, the precise wording is being negotiated with the author.
Update (September 2013):
The journal published an expression of concern and a letter from the authors that responded to the expression of concern and the inspection report. Although there was insufficient evidence to retract the publication, the editors felt that uncertainties about the study persisted and therefore decided that the expression of concern should remain part of the published record.
A questionnaire was distributed to knowledge workers in an organisation to investigate the following hypotheses:
— H1.There is a positive and significant relationship between ethics and organizational performance. — H2. There is a positive and significant relationship between ethics and intellectual capital. — H3. There is a positive and significant relationship between intellectual capital and organizational performance.
Partly due to the very high rate of response (148/160), consecutive queries were made to the authors about the procedures for subject consent.
Our most recent (and direct) query was: "What we need to know more about is what was done to protect the interests of the individuals who were surveyed. Was there any inducement for them to take part (for example, a reward, or a punishment for not doing so)? Did you collect any consent forms from those individuals? What did they say (please supply a translation as an additional document)? Were any reassurances made to them, or is there a possibility that giving an answer that managers, the government or religious authorities don't like could result in harm for the individual? If there are possibilities of harm were the 160 individuals surveyed warned about them? How? Were they told what the data would be used for? What were they told? When you have amended the paper to give some indication and can supply a (translated) consent form, please visit the instructions to authors to complete your submission".
In response to these queries the following reply was received. "We have set a cover letter in the first part of questionnaire which included the following items: the questionnaire was developed without any name and individual information. As discussed before during the learning programs within the organization, strong attention and commitment to ethical issues are important to reach organizational objectives. Considering the importance of both ethics and IC, the ultimate goal of this study is to explore the relationship between them, and finally their impact on organizational performance. The result of this research will be published by considering privacy issues. It is important to note that the organization’s management has a strong commitment to the above noted subjects. Besides a non-valuable reward, the most important incentive for employees’ participation is that they are in this believed that their organization should be pioneer in comparison with their competitors. Due to being knowledge-based organization, employees have actively participated in such studies, and also they have perceived their positive outcome well, accordingly involving in such studies was accepted as a common subject in that organization".
It thus appears that no consent forms were collected and nothing was said about possible harm to participants. There is no assurance that they were able to answer freely. Given the wider context of the research, do human research ethics constitute a barrier to publication of this paper?
The Forum confirmed that consent forms are not necessary if the questionnaires are anonymous. Ideally, the authors should produce an “ethical reviewer waiver” so that the editor knows that an expert has looked over the protocol and deemed that ethics approval is not required. If the study was conducted at a university, then there should be a university ethics committee. If the editor decides to publish the paper, he could write a note saying that this paper does not have any ethical oversight. But if the editor still has some concerns, he could consider contacting the authors again for more information, and writing out in a very clear way the questions that he requires answers to.
The editor followed the advice of the COPE Forum. However, when peer-reviewed, the reviewers’ decision was 'reject', so the paper was rejected.
A manuscript underwent peer review and the resulting reviewer comments raised grave concerns about the ethical legitimacy of the study. The reviewer:
questioned the authors’ impartiality, suggesting that there was an undeclared conflict of interest;
raised serious concerns about the extent to which participants gave informed consent;
strongly doubted that the study would have gained ethics committee approval; and
suggested that the study violates the World Medical Association’s 1964 Helsinki Declaration on Scientific Research with Humans, which states that the welfare of the research subject takes precedence over the interests of science and society.
The manuscript described a randomised controlled trial conducted on patients undergoing brain surgery. Participants were recruited between January 2010 and February 2012 in a single hospital.
The stated aim of the study was to establish the effect of varying the time for which blood flow to the brain is substantially reduced during surgery on postoperative function and disability. It is already well established that reducing the blood flow in this manner for a prolonged period of time is likely to lead to poorer postoperative outcomes due to reduced oxygen supply to the brain.
In order to avoid negative outcomes and improve patient safety, there already exists a warning criterion used in surgery of this type, which alerts the surgeon to the extent of oxygen starvation and indicates when blood supply should be restored.
In the manuscript, the authors outline their knowledge of the risks involved with the procedure itself and report that many surgeons feel that this procedure should only be used as a last resort due to the increased risks outlined above. However, if the procedure is deemed necessary, the risks can be reduced by employing the pre-established warning criterion.
The authors outline perceived flaws of the pre-existing criterion and go on to describe a novel warning mechanism —conceived by them—that they intend to test during the study. Testing this new criterion entailed increasing the time that blood supply in the brain is reduced—to the extent that, in some cases, the current recommended threshold was significantly exceeded. Additionally, while the procedure was underway, the authors ensured that the surgeon was blinded to the patient’s status with respect to the established risk threshold, making is impossible for them to gauge the level of danger the patient was being exposed to. This, as is noted within the manuscript itself, poses serious risk to the patients.
Participants were divided into three groups. In the control group risk was assessed using the normal criterion and blood supply was reinstated once this threshold was crossed. In the second group, blood supply was reduced for a longer period of time. In the third group, blood supply was reduced or completely cut-off for significantly longer.
In the results section, the authors state that in the control group one patient became severely disabled, and that all patients in the third group experienced negative outcomes. Of the patients in the third group, three were severely disabled as a result of the procedure and all of the others suffered some neurological deficit. As the reviewer points out, the pattern of outcomes raises serious ethical concerns about the study. The reviewer questions whether this was (and even should have been) tested on animals first, as this would have provided an upper limit and ‘red flag’ for testing.
The reviewer believes that this study violates the Helsinki Declaration on Scientific Research with Humans in that it appears that subjects randomly included in the third experimental group were subjected to an experimental condition that caused three of them to be severely disabled, and nine of them to be moderately disabled by the experimental manipulation. Because patients were assigned to intervention and control groups randomly and the outcomes between the groups differed significantly, it is highly unlikely that the negative outcomes among group 3 patients are attributable to technical surgical problems in one group only.
It appears that the negative outcomes found in group 3 patients were due to the blood supply being reduced or occluded for long periods of time. The reviewer also suggests that for the control group, there was an omission of a standard of care practiced by most modern medical centres that perform this procedure. The reviewer suggests these findings cannot be generalised to other procedures of this type and he wonders why the original warning criterion was not utilised in this study to further protect these patients.
Furthermore, the study raises serious concerns about the extent to which patient consent (for which consent forms were obtained from the patients) was properly informed. There is no indication that the risks to the participants inherent in an experiment such as this were properly conveyed to the individuals before participation was agreed.
Finally, the Declaration of Helsinki also states that “Physicians must immediately stop a study when the risks are found to outweigh the potential benefits…”; the authors did not stop this study for over a year. And, an unproven intervention should only ever be carried out if “it offers hope of saving life, re-establishing health or alleviating suffering” and that in the nature of research it is “designed to evaluate its safety and efficacy” not to establish a benchmark
The Forum were in agreement that this was very dangerous and very unethical research and that the editor should act quickly. The advice was for the editor to contact the authors informing them that there are substantial concerns with the content of the paper. The editor should copy in all of the authors, giving them a specific and short deadline in which to respond. The editor should tell the authors that he will contact the authors’ institution if no response or an unsatisfactory response is received.
The editor can ask to see proof of the ethics approval of the study, as well as the patient consent forms. Was the trial registered? If no response is received, the editor should contact the institution, copying in all of the authors. If there is no response from the institution, the editor should contact the general medical council or equivalent, or the funding body. For this form of potential misconduct, it is the editor’s responsibility to bring it to the attention of the institution or authority body that can investigate the case.
This single author manuscript describes the treatment of 300 women with psychological problems. The women were randomised to either therapy or pharmacological intervention, and this study reports the relative effectiveness of these strategies.
At submission, the manuscript did not contain any mention of ethics approval, consent or trial registration. When the author was queried on these issues, he claimed that the study was performed ethically, but that he did not have ethical approval because he did the study privately, and is not associated with any organization or institution. Since he had listed his affiliation with university X, we questioned how he had access to these patients. The author responded that he runs a private practice, and that he wanted to mention university X out of “personal interest”, and to please remove the name of the institution from his submission.
This author does not have a Scopus or PubMed record, or an institutional email address. Upon searching for his email address in Google, we identified two papers that appear to have been published by this author in journal A and journal B, neither of which is indexed in Scopus or PubMed.
We have contacted university X through their general email address to alert them of this individual, since he appears to be using their name in an unauthorized context, but have not received a response. We contacted the author to express our concerns and inform him that we would keep his file open until the issue has been resolved, but received no response. We attempted to contact the author’s medical council to report this individual, but were unable to find contact information as their website is not in English. We also contacted journal A and journal B to notify them of our concerns, in the event that they also wished to investigate this author; neither journal has responded.
Two months later, we re-sent the notification to university X general email address and received an out of office response.
We would greatly appreciate any suggestions on whether there is anything further we can do other than to reject the manuscript.
The Forum suggested that the editor has a duty to pursue this further and to continue to try and make contact with the author and the institution. Suggestions were to send an email to a specific person or department at the institution, not just use the general institution email; find out the name of the vice-chancellor or head of the department; locate a phone number or email contact for the secretariat in charge of the department; find someone to translate the information on the website. The university needs to know that their name is being used in this context by this author, and they need to start an investigation. The Forum also advised contacting journals A and B again. Are there any co-authors on the other papers? If so, the editor should try to contact them. Does the journal have any editorial board members in this country who could tell the editor the relevant person to contact?
If the editor still gets no response, another suggestion was for him to write an editorial on this issue.
Based on advice from the COPE forum, we have again attempted to contact the institution through their general email address—we have still not been successful in identifying a personal contact at the institution. Our next step will be to find someone to help us translate the website or an editorial board member who may be able to help us identify a committee or other point of contact in the author’s region.