Questionable/unethical research

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?

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.

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

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.

A manuscript was published by journal X and submitted by author A (last author). Author B claims that fraud occurred in relation to authorship for the following reasons.

(1) Author A did not take part in producing the data for the paper and has never been a co-author on any version of the manuscript.
(2) A paper with very similar content ,which was part of the PhD thesis of author C (first author), was accepted for publication in journal Y.
(3) The figures in the paper published in journal X were identical to the figures in author C’s PhD thesis.
(4) The name of author B was misspelt in the paper published in journal X to avoid identification of the article search in PubMed.

The editor of journal X contacted all of the authors by email and they responded as follows: author C (first author), author D and author E agreed with author B (claiming author). Author F did not respond, despite receiving five emails.

In addition, author B sent us a letter signed by the Vice-Rector at his University, agreeing and supporting the point raised by author B.

Author A (last author) disagreed with all of the allegations and pointed out the following.
(1) Author A declared that he was the principle investigator of the project in country Z during 2004–2009, and the role of author B was to help in the analysis of the samples in his laboratory, located in country W.
(2) Author A submitted an official complaint to author B’s university, alleging that they (authors B, C and D) had no right to use data without notifying or asking his permission. In addition, they did not have any patient consent.
(3) The paper published in journal X was the original manuscript and it was circulated to all of the authors.
(4) The name of author B was misspelled in journal X by mistake.

Author B requests that the paper must be retracted from journal X, and he also demands that the editors ensure that the paper will disappear from PubMed.

In summary, all of the authors confirm that the data are correct but they disagree regarding the issue of authorship?

We reviewed and published a randomised controlled trial in which children’s exposure to parental secondhand smoke (SHS) was either sustained (usual practice control) or parents were asked to avoid smoking around their children (intervention group). The study included more than 400 children averaging 9 years old. Parents provided written informed consent. The study was approved by the ethics committee of the researchers’ institution. Data were collected in a school setting by self-reported questionnaire and interviews. Children were classified according to amount of SHS exposure and baseline data about several types of symptoms were collected. The children with the symptom of interest and exposed to SHS were then randomly divided into two groups. Smoking members of families in group 1 were asked not to smoke in the child’s presence for a period of 6 months while those in group 2 were asked not to change their smoking habits. Parents were told prior to study enrolment that they would not be required to quit smoking as part of participation, rather they would be asked to reduce children’s SHS exposure. After 6 months, data were collected again in order to assess the proportion of children in the two groups who were still displaying the symptom of interest. Following this trial, all parents and children were asked to participate in a 5 month school project related to the risks of SHS exposure. The project included weekly lessons about the risk of SHS, attended by children with their parents to educate children about SHS risks and help parents to either reduce or cease smoking in their children’s presence.

Neither the handling editor nor reviewers raised questions about the study’s ethics during the review process. However, following publication, we received a letter questioning the study’s ethics on the basis that the known risks of SHS exposure outweighed any benefit to be gained by learning about whether SHS was a risk factor for the studied symptom and that the study procedures violated the Helsinki Declaration. The letter’s authors argued that the study’s advising of smoking parents in the control group to not change smoking habits could have unnecessarily exposed their children to additional SHS if parents who would have otherwise quit or reduced their children’s exposure did not do so because of the study. The authors of the letter claimed that they could not think of a single research question that would justify exposing children to SHS.

In discussion, one of the editors argued that the letter missed the important point that after the randomised controlled trial, all participants received the 5 month intervention to promote smoking cessation among parents and/or to reduce SHS exposure, and questioned the letter’s implication that the children would be better off if the study had not been conducted. S/he wrote that the letter seemed to argue against any controlled trial to reduce children's exposure to SHS, but that there were several dozen of these in the published literature.

The questions are twofold: was this an unethical study? And, if so, how should the journal proceed?

In May 2011 a letter from the Vice-Rector for Personnel of a reputable university was sent to the editor mentioning that two articles published in the journal contained two statements not supported by documented evidence. The two statements related to: (1) approval of the local ethics committee and (2) representation of the experimental evidence.

With regard to point (1), the authors stated in the article that they had approval in 1995 for their research protocols but the authorities state that there is no written documentation of this agreement and that this cannot substitute for formal approval of the research. The journal and the university rules indicate that formal approval of an ethics committee is required.

With regard to point (2), a statement in both articles cannot be sustained for one of three patients in one of the articles and for one case in the second article. Laboratory analysis revealed contradictory evidence from the authors’ statements in the articles. The authors gave three reasons why they ignored this information. Unfortunately, the samples kept in the authors’ laboratory were destroyed in a fire.

According to the letter from the academic authorities, “the authors have been kept informed of these facts, which are in breach of the rules of good scientific conduct”.

One of the articles is coauthored by three colleagues from another university. They have asked the journal that their names be removed.

The author of the articles, who received a copy of the letter from the Vice-Rector, asked to have some time to send in his rebuttal of the accusations. For both issues the answers provided by the authors were submitted to the university and were judged as unsatisfactory.

Long discussions within the publications committee of the journal with representatives of the publisher and the scientific society led to the decision that an “expression of concern” should be published. Prior to publication, the expression of concern was sent to the authors and the university for their comments. Just before the deadline, a letter arrived from the university (signed by the Vice-Rector and the Rector). The conclusion of the letter was that the university believed an expression of concern was not needed. The university believed that the authors recognized that they made mistakes in relation to both issues but since they acted “in good faith” the university had closed the case and did not consider an expression of concern appropriate.

So the journal was faced with an author admitting two serious “mistakes” in two articles. The institution that originally raised the concerns backed off in the end. After consulting with the editorial team I wrote to the author asking him to send a letter to the editor signed by all authors correcting the serious mistakes in the literature. A confidential draft letter was received from the author, and edited and completed by the editor so that both issues were mentioned. This letter was signed by all authors at this author’s institution. Three authors at a different institution refused to sign the letter as they believed that the letter to the editor did not clarify the situation. These three authors confirm their initial position and encourage the other authors to retract both articles. A copy of the email correspondence between the author and a spokesman for the other institution indicates that the author does not want to do this.

A possible conclusion would be to publish the letter to the editor signed by the authors from the institution of the first author as well as a letter to the editor from the three authors from the other institution. This would be accompanied by an expression of concern or an editorial by the editor, highlighting the necessity of proper ethics approval and reporting all experimental data.

An additional question to COPE: should other editors be informed of this? In a sister journal, an article was submitted mentioning the same very outdated ethics approval.

As editor-in-chief of a journal (journal A), I was contacted by an individual (N) who indicated the following: authors of an article published in journal A were questioned as to the similarity of a figure and a table appearing in both journal A and in another journal (journal B). N noted that reanalysis of the data of the published work by the authors suggested errors and inconsistencies of the similar data across journal A and journal B.

Subsequently, N provided additional details, including notice of a third journal (journal C) that appeared to have published a table similar to those in journals A and B. The editor of journal B responded to this saying that although the authors had been contacted by the editor of journal B and a response from the authors was pending, they agreed that retraction from journals A, B and C was required. Of note, journal B had previously resolved a challenge from N with respect to the study in question as a letter to the editor regarding data interpretation with a response from the authors. The editor of journal B shared both of these publications with the other journals involved at the request of journal A.

Although the authors referenced journal B in the article they published in journal A and stated that it was an extension of the study published in journal B, they only indirectly referenced the figure and table. The figure and table did not include a reference or acknowledgment to indicate where they were initially accepted/published or submitted elsewhere. Hence it appears that a very similar figure and table appeared in three publications and a figure in two publications without appropriate assigning credit.

This appears to journal A to be a possible case of overlapping publications by the authors. Taking the first publication dates (including Epub dates) on PubMed, it appears all three articles were published at around the same time, with the article in journal C publishing first as an Epub article.

It should be noted that the authors retained the copyright to their article published in journal B. I am not sure about journal C.

Most recently, N sent another email to all three journals questioning the housing conditions of the animals used in the study and whether the statement indicating that the authors had received approval from their ethics committee of experimentation on animals is actually true.

As editor of journal A, I forwarded all the information to my publisher. I plan to contact the authors on review and after discussion with COPE. My publisher has also informed journals B and C of our plans to contact COPE before taking any initial action.

As well as asking for guidance on how best to handle this case, we would like COPE’s opinion on which journal should be taking the lead to resolve these concerns, as it involves multiple journals.

I received a submission that had asked a series of questions of visitors to a website about a mental health issue. It was reviewed by a senior colleague and myself. While the science was fine we were both concerned that no mention had been made of any ethics approval. I raised this issue with the authors, especially given that deception was involved.

The authors then appear to have sought ethics approval from their institutional committee. The committee appears to have granted approval with the proviso that a notice be placed on the  website indicating that the material from the questionnaires was to be employed in research, not in supporting the activities promoted by the website, as first indicated. The notice was to remain up for 3 weeks so that any of the participants could ask for their responses to be deleted from the study. No one asked that this be done.

We have discussed this issue 'in-house'. It has been suggested that publication is not necessarily precluded given that the institutional review board has approved the study and required the authors to notify participants of their intentions. Of course, the institutional review board and the authors would need to be able to produce full documentation relating to the submission and approval of the project.

We would be grateful for COPE's advice on this issue.