A whistle blower contacted journal A regarding two published articles. The articles focus on the effect of energy healing on an in-vitromodel of disease. The whistle blower raised concerns about the appropriateness and reproducibility of the energy healing methodology used.
The authors were contacted to provide an explanation of the methodology as there was a lack of clarity in the articles. The corresponding author responded with a clear explanation of how they implemented the study but concerns about how this would be reproduced by others persisted.
Consequently, a post-publication peer review was conducted. Unfortunately, the post-publication peer review provided no comment on the energy healing methodology that was implemented. The reviewer focused only on the methodological elements that gave no cause for concern, and summarised that the methods are suitable and valid.
Given this review, the editor who handled the manuscript feels that no editorial action is required. However, concerns surrounding the energy healing methodology and its reproducibility remain. It has been suggested that the reviewer is contacted again for an assessment of the specific energy healing techniques used in these studies.
Question(s) for the COPE Forum
If the reviewer or the handling editor determine that the methodology is sound but not reproducible, how should the journal proceed?
A suggestion from the Forum was perhaps to ask at least one other post-publication peer reviewer to specifically comment on this particular issue.
This is an ongoing problem in this field. Some techniques that people use for healing touch and many other types of hands-on healing are difficult to standardise. People who work in this field and use this technology most likely understand this and so the problem is probably more for people who are uninitiated. A suggestion was that there needs to be commentary in the article by the author about the difficulties of reproducing the techniques if that was not sufficiently addressed in the discussion.
A discussion of the limitations of the study could be addressed in the journal, through the usual post publication discussion process or letters to the editor.
Another view was that in a scientific publication, if the method is not reproducible, then it is not considered science. Reproducibility is the foundation to science and so if it is not reproducible, should it be published? However, the post publication review suggested the methodology is sound.
An article was submitted involving over 200 pregnant patients with a systemic illness (from 2010 to 2015) who were recruited and assigned to a control group or an active intervention group (of their systemic illness). The control group received routine antenatal care while the intervention group had active surveillance and management of their systemic illness during the pregnancy.
There was a significant increase in morbidity and mortality in the non-actively managed control group. We (reviewers and editors) are concerned about the ethics of this study design. Specifically, it seems pregnant patients who were assigned to the non-active treatment/control group did not have their systemic condition managed in what would today be regarded as 'standard of care'.
Question(s) for the COPE Forum • Despite apparent local ethics board approval, and a statement from the authors declaring adherence to the Declaration of Helsinki, is it ethical to include a non-active intervention group for a disease which is known to have negative fetal and maternal outcomes?
The Forum advised that this appears to be unethical research conduct and egregious violation of human ethics.
Withholding known effective treatment for experimental purposes is not ethical in human subjects’ research. If there is a known effective treatment, the study cannot ethically be done, and any institutional review board would raise a question about such a protocol. If the active management (treatment) is not known to be effective, and the researchers are attempting to establish efficacy of the active management, then a rigorous research protocol should be in place. Such a protocol would ensure informed consent of all human subjects, as well as a process for breaking the randomization if it becomes clear that the subjects in the control arm of the research are in any medical jeopardy. If this is not the case in this research, the authors should be reported to a research integrity office at their institution or at the country level.
Editors can reject a paper for ethical concerns despite local ethics approval, and a journal can ask the institution to reassess this approval. If it is known that a treatment/management is effective, withholding it is unethical.
The manuscript was rejected for a variety of reasons, including the concerns regarding the ethics of the study design.
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.
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.
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?
The editor told the Forum that questions raised during the review process were answered by the authors. The authors informed the editor that institutional review board (IRB) approval had been obtained but they did not provide evidence of IRB approval. The Forum advised the editor to publish the letter and give the original authors a chance to reply. The editor might also consider publishing the IRB approval statement. Another suggestion was to commission a commentary or write an editorial on this issue.
As advised by the Forum, the editor contacted the study authors to clarify the protocol instructions. In addition, the journal obtained a confidential consultation from an independent ethics body with four experts who summarised relevant ethical concerns. The journal also solicited a letter from the study authors to respond to the issues raised in the letter to the editor and solicited expert opinion from the department of bioethics of a major institution.
The letter to the editor, response from the authors and the expert commentary will be published in an upcoming issue along with a brief introductory statement from the editorial staff. The introduction invites the journal’s readers to review the materials in the interest of furthering reflection on the ethical implications of research on the effects of secondhand smoke and the ethics of the research enterprise more generally.
A letter was sent to the chief editor of our journal in response to a recently published article in our journal. The author had serious concerns about the ethics and consent obtained as a result of this study and the follow-up by the researchers.
The author explained that he was the physician of two of the “volunteers” who participated in this study and was concerned about informed consent procedures in the trial. Specifically, workers never provided informed consent that their tests, mandated by a company medical monitoring program, be used in any “research” study. His concerns were in four areas. (1) The researchers failed to inform both the company and the injured workers that they should have been removed from further exposures when their test results showed severe impairment. (2) The researchers failed to report abnormal findings to the workers in a timely and appropriate manner, a failure that placed these workers’ health in jeopardy. (3) The researchers failed to fully inform the workers of the known risks of exposure. (4) The timing and location that the researchers used to obtain signatures on the informed consent forms did not permit the workers to adequately question the researchers and become informed. One of the author’s patients who was studied was a previously (pre-employment) healthy 40-year-old woman who was found after a period of time at work to have abnormal results. However, no doctor contacted her to explain the results and written communication did not describe them as serious, and so she did not seek further medical attention. Her tests were repeated again one and two years later. The two year test indicated more severe disease. These findings were reported to her 10 months later by one of the researchers who failed to mention their significance in his cover letter to the radiologist’s report. Given the patient’s history, she should have been removed from work immediately, and the researchers should have reported this case of occupational disease to the state authorities. The following year, she sought care from a non-corporate physician and was removed from work the same day.
Another patient of the author’s had abnormal test results in 2005, which were markedly worse on repeat tests conducted in the same year. The researchers wrote to her in September of 2005 and advised her to have a CT scan and repeat testing. A year later, a member of the researcher’s group ordered a CAT scan. In November 2006, the CAT scan revealed moderately severe disease. The patient requested that these results be forwarded to her personal physician. At the time of the author’s first visit with her in late August 2008, she had never seen the results, and neither the company nor the researchers had communicated with her about her condition or continued occupational risk. The author requested that the researchers send him her complete medical records, including communications with the company and the research protocol. However, only incomplete records were sent, omitting the research protocol and including none of the communications with the company.
In October 2008, the author wrote to the IRB Director and filed a formal complaint concerning these matters informing them that one of the researchers was both a paid consultant advising on occupational health procedures while simultaneously conducting the research/monitoring program. This researcher based his published paper on a mandated monitoring program in which the “volunteer” workers had to participate as a “condition of work” in order to keep their jobs. The “research” was based on test results for which full consent had not been obtained. The Director of the Office of Research Compliance and Regulatory Affairs responded in February of 2009, stating that although the committee’s investigation determined that “no misconduct occurred” with respect to any violation of IRB policies, their findings prompted them to institute “modifications to our processes that will help us to continue to raise that bar.” The author concluded that “IRB protocol modifications” were based on an acknowledgment that the researcher’s study violated patient rights, even if the study did not violate IRB rules. The author believes that journal editors have a responsibility to investigate allegations like these.
All agreed that this was a very serious matter and possibly of criminal concern and were surprised that the complainant had not taken any more action or taken the matter up with the medical authorities or the police. If medical staff are aware of abnormal test results and they do not tell their patients, the staff should be reported to the GMC in the UK or to a similar authority in the country where the research took place. The editor should contact the authors and ask for a detailed copy of the ethics approval. The editor should explain that he has had a complaint about the paper but he should not divulge the name of the whistleblower. The editor should also ask for copies of the consent forms.
It was suggested that the editor might want to consult the flowchart on “What to do if you suspect an ethical problem with a submitted manuscript”. All agreed that this case has wider implications than ethics or patient consent and that the whistleblower should pursue other avenues. There is little that the editor can do other than to contact the authors and request an explanation. All agreed that the journal cannot offer due process to investigate the concerns itself but must leave this to the institution involved or the committee that gave ethical approval for the research.
Advice on follow up:
Following the advice from COPE, the chief editors wrote to the authors of the paper to mention that we had received a complaint regarding the ethics of the paper. The chief editors asked for proof of approval of the study from the authors’ university and also the patient consent forms. These were both received from the authors and the chief editors were happy with the documents provided and have therefore taken no further action.
A paper was submitted to our journal describing a study in which children received general anaesthesia for a minor operation. The authors chose to induce anaesthesia with a mask and 8% sevoflurane inhalation for 8 minutes. The aim was to study the EEG over various brain areas to see where the epileptogenic activity is located. The reason for doing the study was that it has been shown that sevoflurane can cause epileptogenic activity on the EEG. Clinical convulsions have also been seen but much less often. Hence the authors deliberately gave a high concentration for 8 minutes because they wanted to provoke this epileptogenic activity to study it more closely. I asked them what information they had given to the parents (according to the manuscript, informed consent had been given). They replied that they had not given them the information that this could happen and why the investigation was performed. I also doubt that the ethics committee knew the true reason for doing the study.
This case resembles many I have seen over the years. The study was approved by the authors’ university ethics committee. My question is whether we, as journal editors, always must follow that judgement or whether we have an independent obligation to make our own judgement about whether a study is ethical.
The Forum were unanimous in their view that this appears to be unethical behaviour on the part of the authors. The editor should ask to see copies of the information given to parents and the consent forms as it was felt that this information was probably inadequate. Further advice was to write to the authors’ institutions and inform them of the authors’ actions, and also to contact the ethics committee. It was suggested that, if receipt of the documents confirms lack of transparency or failure to obtain informed consent, the editor may wish to report the authors to the GMC or other equivalent regulatory authority.
In answer to the editor’s initial question, the Forum agreed that an editor does not always have to follow the judgement of an ethics committee and he does have an obligation to make his or her own judgement about whether or not a study is ethical.
The editor has written to the authors of the article and awaits their answer. The editor is considering perhaps consulting some international experts on this topic for their advice.
Update (February 2009)
This was an investigation which was accepted by the local ethics committee, and a professor of anaesthesiology was among the committee members. So the committee must have known what they were doing. However, the editor is absolutely confident that the patients/parents were not given the all of the information about the objective of the investigation.
The editor contacted a few eminent international people within this field asking privately for their opinion but none answered. For the editor, it was a difficult decision ethically as well as diplomatically. The article was accepted but the editor did inform the authors that this article would be used for future discussion around research and publishing ethics. In fact the editor has already included this story in a lecture which he gave in New York and Pittsburgh about publication ethics. The article was published in the February 2009 issue of the journal. The editor is not very proud of his decision but felt he had to choose diplomacy over confrontation.
Professor A and professor B has been in a dispute over a certain type of treatment for over 15 years. Professor A has accused professor B of killing a patient while he was (in professor A’s view) doing research on the patient without consent. Professor B has accused professor A of research and publication misconduct because he published a paper in journal X in 1994 that included a selected group of patients from a paper already published and a selected group of patients from professor A’s hospital that had not given consent to be part of a research project. Professor A has claimed that his patients were not part of a research project, since the treatment he gave them was available to all at that time. Both cases were handled by the national board of research misconduct at the time (in 1996). The conclusion (briefly) was that none of them had behaved unethically, but that they could have done it differently.
Last year this debate “reopened” when professor A published a book were he portrayed himself as a whistleblower and told about how the hospital and the medical community had tried to “hide” the fact that professor B had in fact killed a patient while he was doing research on the patient without consent. In the debate that followed, several things were written from both “sides”. In professor B’s opinion, professor A has throughout this last debate actually admitted that the patients he included in his 1994 paper were part of a research project and that they had not given consent. He now asks the editor of journal X to retract this paper. What should the editor do?
The Forum agreed that there were no grounds for retraction of the paper. Given the very public nature of this case and the fact that it has been thoroughly aired in the public domain, the advice was to do nothing. The editor should consider the case closed. The Forum also advised against publishing any more letters of correspondence.
We have just had a paper submitted as an ethical debate in which the author details ethical concerns about a study previously published in another journal. The study involved complementary/alternative therapy for an infectious disease in children. The author alleges that the study gave insufficient protection to vulnerable subjects, who were exposed to unwarranted risks and discomfort; and that the study had violated the accepted tenets of human studies ethics and national regulations.
The submitted manuscript summarizes (with full names of people involved, their affiliations and positions) various correspondence between the author and the investigators of the published study, the Institutional Review Board that approved the study, the office for the protection of human subjects in research of the associated medical school, the country’s regulatory authority for the protection of human subjects in research and the editors of the journal that published the paper.
The country’s regulatory authority for the protection of human subjects in research found that the author’s allegations were unsubstantiated. The author claims in reaching this decision, the authority had misinterpreted aspects of the study, prompted by false statements from the Principal Investigator and the presiding IRB. The authority, the IRB and the investigators all asserted (with reasons) that certain usual human subject protections did not apply in this study. The author gives rebuttals for these assertions.
The medical school stated it would not pursue the matter because of the conclusions already reached by the reviews conducted by the IRB and the country’s regulatory authority for the protection of human subjects in research.
The journal that published the study declared that no purpose would be served to its readers by publishing further correspondence (letter from our author), again citing the conclusions of the country’s regulatory authority.
The author lists as failing in their duty all the above-mentioned people/authorities, including the editors of the journal that published the paper.
Questions:Should we consider this for peer-review?
If we ultimately publish, are there legal issues surrounding perceived defamation of character when the regulatory bodies above have found the allegations unsubstantiated?
Presumably we would have to inform the investigators/authorities involved about our plan to publish and be prepared to publish a response from them?
Would it be acceptable to publish it in an anonymised format if the author agreed to this?
The editor provided further clarification on the case pointing out that the accusations include, the editors of the journals, the institutional review boards, and members of the national agencies involved in reviewing the case. The author also alleges that the principal of the study lied to the authorities. The medical school involved is not pursuing the case as it defers to the national authority. The committee commented that what ever the editor does, they will be in trouble and added to the authors list! It was pointed out that the complaint had been taken to the highest level in the country and it is difficult to see why the editor should join in the debate and there was speculation if the material should be published. It sounded like the author wants all those involved with their heads on the block.
It was asked if the author had completed a competing interest statement, they have not. The editor thought that the author seemed to be investigating and doesn’t seem to have a personal interest. Though the author requested that no-one on the editorial board with any interest in complimentary medicine be involved in peer reviewing the paper.
The committee commented that the first port of call should be the editors lawyers, as the legal issues would take precedence. It was also pointed out that there was a contradiction in the author’s account, as since the issue had gone to the countries regulatory authority, the author would have had chances to air their view and correct the misleading statements. Apparently the author had written to the regulatory authority. Also probably the first legal advice the editor will be given is to check to see that ALL the facts in the article can be substantiated, and probably no-lawyer will advise the editor to publish as they are risk adverse.
Also it was suggested the editor should do a pubmed search on the author, as this perhaps seemed like an author who had a bee in their bonnet about complementary medicine.
The advice was for the editor to seek legal advice. The committee was unenthusiastic on taking further action. This is the sort of paper that should be sent to the press. The editor should reject the paper citing legal advice.
We took legal advice. It was felt that the risk of publishing allegations which respected bodies had already found to be unsubstantiated was too high, laying us open to a claim for defamation from the people the allegations were made about.
We rejected the manuscript, stating that the decision had been made after taking legal advice.
An internet search revealed the author to have previously been involved in various anti-complementary/alternative therapy campaigns.
To date we have not had any further correspondence with the author following rejection of the manuscript.
In a paper detailing a physiological study of healthy human volunteers the authors stated that ethics committee approval had been granted and that the participants had given informed consent. After peer review the paper was revised and accepted.
During the production phase the journal received an email from a researcher who was reviewing another paper from the same authors for a different journal. The reviewer had been sent the draft of the “paper in press” to provide additional information for the submission being reviewed. The reviewer was concerned that both studies were unethical on the grounds that the preparation being administered to the volunteers was insufficiently pure and had not been previously tested thoroughly in animals.
The editors asked for clarification and also sought a translation of the consent form. The authors provided further verification from the ethics committee, and argued that the animal testing was not a legal or ethical requirement at the time of their study. The reviewer and authors still disagree. The consent form seems to lack information on potential side effects, but the authors’ previous preliminary research had not revealed any adverse reactions.
This warrants further investigation.
It may be helpful to find more referees in this area and subject the paper to further peer review.
The Editors’ Code of Conduct emphasises that even with ethical approval, a study may not be ethical.
Write to the editor of the other journal outlining the concerns.