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.
As mentioned many times at the COPE Forum, just because a study has been approved by an institutional review board does not mean that the editor has to consider it to be ethical or to publish it. Also, institutional review board approval does not guarantee that the study is not flawed.
Some questioned what kind of an institution would approve such a study in vulnerable patients. Others argued that they would not publish this study – the population was not fully informed of the study and so the research is misleading. It is unethical research in a vulnerable population.
The advice was not to publish the paper and write to the author telling him why. Another suggestion was to write to the ethics committee and ask why they approved the study.
The editor wrote to the authors with the Forum’s comments and indicated that the journal would not publish their paper and that they should not attempt to seek to publish it elsewhere. The authors have not replied.
Our journal received a manuscript describing a comparison of two different techniques for patients in the intensive care unit. There was no information on ethics committee approval and so we asked the authors if approval was obtained. They replied that they had not applied for ethics committee approval “as it was a clinical comparison of two existing methods, none of them experimental. All patients had an indication for the technique, and the technique was introduced in our intensive care units before the beginning of the study period”.
The study is described in the manuscript as a “prospective, comparative clinical study” conducted in 2009 and that “every other patient” who received the technique during the study period was assigned to “the technique of choice at our institution” or to a technique introduced in 2005. It is not clear whether informed consent was obtained.
We believe that this study was not conducted in accordance with the Helsinki Declaration where it is specified that “The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins".
Regarding informed consent, it is stated that “Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorised representative.”
We have the following question for COPE: should we wait for the authors to apply for approval from the ethics committee at this stage or should we reject the manuscript and forward our concerns to the person responsible for research governance at the institution?
The Forum agreed that the described project was clearly research and not a service audit. It appeared, in fact, to be a prospective randomised trial and so it should have been registered and ethics approval obtained. Retrospective approval would not be appropriate. In addition, all participants should have given their informed consent. The lack of consent suggests a breach of the Helsinki declaration. All agreed that the editor should contact the author’s institution and inform them of the situation and ask them to investigate.
The editor contacted the professor who is responsible for research governance at the authors' institution. He agreed that this case raised significant concerns and an investigation has been initiated. Based on this, he has arranged a teaching programme in the department focusing on research principles and legislation. He has promised to keep us informed about other "whatever measures” that he deems necessary.
Follow Up (March 2011):
A departmental medical ethics programme has been organised in collaboration with the regional ethics board. The need for ethics committee approval has been emphasised and all clinical study protocols must be assessed by the person responsible for research. Violations of the department’s medical ethics program will lead to local manuscript retraction and freezing of intramural research funding and other support. A department publication and manuscript database system will be used for monitoring purposes.
We are seeking guidance on the ethical issues surrounding drug/medicine use evaluation (DUE or MUE) audit cycles, particularly with respect to the publication of findings but also perhaps with regard to the conduct of these audits in general.
DUE is a quality improvement activity that involves data collection and evaluation (usually by audit), followed by ‘action’ or intervention and a repeat or ‘follow-up’ audit to monitor changes in practice. DUE methodology was used for a recent national quality improvement activity overseen across approximately 60 hospitals by an independent organisation funded by the government to promote quality use of medicines. Participating hospital ‘project teams’ were asked to identify a predefined number of patients from their surgical lists for the baseline audit, obtain consent from the patient for inclusion (‘if required by local authorities’), conduct a brief postoperative patient interview regarding pain management and, after discharge, retrospectively collect pain management data from the medical record .
Data were submitted to the national project team for collation and assessment, with individual and combined results fed back to hospitals. An educational intervention was then conducted at each site, attempting to address medical, nursing and pharmacy issues, and utilising a number of tools, including one-on-one ‘academic detailing’, presentations and posters. A follow-up audit (same as the baseline) was then conducted at each institution.
A manuscript was submitted to our journal describing the conduct and outcome of the project in two hospitals, and comparing these with each other and with the national results. The hospitals were not specifically identified but were labelled A and B, although one could be assumed to have been the primary institution of the authors and the other probably one of two smaller institutions in the same area health network. The methods stated that formal patient consent was not required for the inpatient interview component because the questions asked fell within routine postoperative care. Institutional Ethics Committee approval appears not to have been sought for any aspect of the project in either of the hospitals concerned although the overall project appears to have been conducted with the approval of various state health bodies and presumably individual hospital administrations, although this is not clear.
The manuscript was rejected on a number of grounds, mainly relating to questions of methodology and partly related to the question of publishing a small subset of a much larger set of data (also to be published eventually according to the website of the national project). The submission did, however, raise other ethical questions that remain a matter of some debate among the editors concerned, and we seek the help of COPE in addressing these since it appears this sort of situation is likely to come up again with increasing regularity. Our first question relates to the study subjects study. In the submitted paper, the assumption appeared to be that the patients were the subjects and their ‘recruitment’ was discussed. However, we feel that the subjects of the investigation were the staff of the participating hospitals since it was their drug prescription administration and documentation behaviour that was being examined before and after a behavioural intervention.
Our second question regards the nature of the project. Is it a quality assurance/improvement activity that does not require ethics approval for its conduct and/or publication of results? Or is it actually a research study examining the behavioural effect of an educational intervention on hospital staff, and as such does require ethics committee consideration, approval and possibly individual participant (staff) consent?
This case prompted a discussion on the differences between a study and an audit. Most agreed that if there is an intervention, then it is a study, but it was pointed out that there are regional differences, and different countries have different policies on what type of studies need ethics approval. The Helsinki declaration discusses “human subjects” and so does not make a distinction between patients and staff. The advice from the Forum was for the journal to develop their own policy on this issue and to perhaps commission an ethical debate around the subject for publication in their journal. The Forum also reiterated the fact that even if a study has ethics approval, the editor does not have to publish it if s/he is unhappy about any of the aspects of the study.
COPE suggested we develop internal policies regarding situations like these, and this was discussed at our subsequent editorial board meeting. The Committee's advice was found to be very helpful by the board, and in particular the agreement with our assessment that the staff, not the patients, were the subjects of this particular “experiment”, and some discussion occurred surrounding this and other cases discussed at the COPE Forum meeting involving conflict of interest issues (new ICMJE guidelines) and Clinical Trial Registration.
Notices regarding conflict of interest and trial registration are being considered for inclusion in our instructions for authors and also for a new set of editorial guidelines.
The more difficult ethical question is yet to be fully resolved. However, we will continue to deal with such cases on a case by case basis and hopefully reach consensus among the editors.
This research article investigated the effect of the widespread administration of a homeoprophylactic preparation against a bacterial zoonotic disease in a developing country after a period of particularly heavy rainfall. The authors claim to have given this oral preparation to all members of the population over 1 year of age, in three provinces of the country where this disease is prevalent (over 2 million people). This was done in parallel to the country’s conventional vaccination and surveillance programme. The authors claim that this intervention significantly reduced the incidence of the disease in the treated provinces compared with the non-treated provinces.
We asked the authors to provide more information on how they had addressed the ethical aspects of this study and to provide supporting documentation. They stated they would include a paragraph on ethical considerations in the text, but argued that the principle aim of the study was to report the results of a healthcare intervention as a response to an emergency situation and was not classical clinical trial research. They further argued that the product used in the intervention is a registered product of common use on the public health system of the country in question and all the administration was approved and regulated by the “National Regulatory Agency” and “Competing Health Authorities”. They also claimed that they had obtained ethics committee approval from four different ethics committees.
Despite repeated requests from us, the authors failed to provide documentation from the ethics committees or the National Regulatory Agency or to explain how they had obtained consent. They eventually did supply a document in Spanish purporting to be “approval from the National Regulatory Agency for the intervention that was granted after the analysis of proposals by ethic committee and meeting National Regulations from the Minister of Public Health”. However, on translation by one of our Spanish speaking members of staff, it turned out to be a statement of their intention to obtain ethics approval and consent.
We contacted the CDC to enquire whether such an intervention was known to be in use in this country. We were told that they were not aware that this intervention is in use in any official capacity. We rejected the manuscript on ethical grounds explaining to the authors why we were not prepared to consider it. All authors are affiliated to a private institute. The last author is its founder.
We would welcome advice from the committee on whether and how we should take this further, given the scale of the study and the conflicting statements of the authors and the CDC.
The Forum was told that this study was funded privately. The Forum questioned whether it was in fact a study? From the description, it seemed to be a report of a public health intervention. If that is indeed the case, then consent is not needed. The advice from the Forum was to seek confirmation that these interventions actually took place (since the numbers involved are so large and because of the discrepancy with the information from the CDC). Did the government introduce it? The Ministry of Health could be contacted. If the editor discovers that the whole event was fraudulent, then he should bring the case back to COPE.
We attempted to contact the Ministry of Health without success. We have contacted the director of PAHO (the Pan American Health Organization) and are awaiting a response.
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.
The authors carried out a study. A homeopathic treatment was given to people with HIV/AIDs. The outcome was quality of life, as measured by a questionnaire after 1 month and 18 months of treatment. Participants were selected for inclusion if they had a HIV seropositive status at the time of study and were not taking any other kind of HIV/AIDs treatment.
The participants were stratified into severely ill (including those who could not walk and were cachectic) and not severely ill. The authors said that they had obtained ethics approval for this study from their own institution in their country of origin and that the Ministry of Health in the country where the trial was conducted had “authorised” the study.
We asked the authors whether the participants had been offered antiretroviral treatment at any time and if not why not? The authors confirmed that the study protocol did not include antiretroviral therapy because “There is no obligation of the ARVs use and conventional medicine is expensive. Many patients...were afraid of white people and of the side effects”.
We asked what the participants were told when they gave consent. The participants were given details of the homeopathic treatment but no mention was made of the existence of antiretroviral treatment. We asked to see copies of the protocol submitted to their ethics committee and the actual approval. The document, which was translated by a member of our staff, did not mention antiretroviral treatment. We asked to see documentation of “authorisation” from the Ministry of Health of the country in which the trial was conducted. There was no written documentation. It was verbal.
We asked why they sought approval from their native country and not the country where the study was carried out. The authors told us that once they had approval from their country, the authorities in the country where the trial was conducted did not require local approval.
We asked how the study was funded and what the authors’ relationship was with the funding body. They provided the names of two funding bodies but no documentation (funding came from funding for a Master’s degree of one of the authors). They did not clarify whether they had any relationship with the funding bodies.
We felt that all participants should have received standard care with antiretroviral therapy, that ethics approval should have been sought from a local ethics committee and that the participants should have been informed about antiretroviral therapy when consent was sought. We were also concerned that this protocol apparently was approved by an ethics committee. We rejected the manuscript and wrote to the authors’ institution expressing our concerns and requesting they investigate further and keep us updated on their progress.
Is there further action we should take?
The Forum questioned whether in fact there was a local ethics committee, which may be a reason why the authors obtained approval in their own country. However, the Forum was unanimous in their view that the authors had behaved unethically. All agreed that the editor had done all he could and there is little more action that he can take, although some advised contacting the ethics committee or the licensing body of the authors. If there is no response from the institution, the editor could consider contacting the ministry of health in that country (he should copy in the authors in this communication if he does).
We contacted the authors’ institution, ethics committee and the Ministry of Health but have not received a response from any of them.
The issue here is whether formal ethics approval has been granted in order to satisfy publication criteria. By way of some background information, a lot of screening data are collected on many athletes in many sports, both nationally and internationally. Historically, clubs and associations have disclaimers whereby athletes sign consent for their data to be used for audit purposes on the proviso they will not be identified individually. This study appears to do exactly that, except that this is not a retrospective audit, this is an interventional study whereby these players have been subjected to a specific regimen.
In my opinion, there are several issues here. (A) A blanket proforma that these players were asked to sign does not constitute formal ethics approval for this interventional study. (B) These players are under age and therefore warrant additional protection. (C) These players are vying for selection and there is no obvious protection from them being coerced into participation
Whilst new training regimens are being introduced into clubs all the time, if the findings are intended to be disseminated through formal publication, then ethics approval should be sought beforehand. I would be very grateful for the Forum’s opinion on this matter.
The Forum was concerned that the volunteers involved were under age and so coercion may have been a problem. The Forum were unanimous in their view that ethics approval and informed consent should have been sought specifically for the study and that the study should not be published without these. The authors may also have contravened the Declaration of Helsinki, which covers all human trials. The Forum agreed that blanket consent is not sufficient and that the specific treatment needs to be detailed and consent obtained from individual subjects. The ICJME guidelines state that procedures followed should be approved by an ethics committee and be in line with the Helsinki Declaration. There is also a European directive on obtaining ethics approval and informed consent. A suggestion was for the editor to write an editorial in their journal highlighting this problem in general.
The editor wrote to the authors conveying the decision of COPE and they responded that they did after all have approval. The editor requested to see this approval and it was dated after the study had been completed. The editor then wrote to the authors explaining in no uncertain terms that retrospective approval was not acceptable and that he was extremely concerned that throughout the submission process they had failed to demonstrate any insight into research governance. The editor suggested lessons to be drawn for the future and rejected the paper.
A was a researcher in C’s lab for 1 year, during which time they published a joint research paper in a third party journal (journal S). After leaving C’s institute (henceforth called institute X), A published in the journal (journal T as a sole author). The affiliation provided by A on the paper was institute X. All of the data reported in this paper were obtained while A was still employed at institute X, of which C is a senior faculty member and in whose laboratory A was a research associate.
C contacted journal T with several allegations regarding A’s paper in journal T. These were: (1) A submitted the paper after having left institute X (2) A never discussed with C his intention to publish these data from C’s laboratory (3) Material published in journal T is “fully based” on data they had previously published together (4) A did not have approval to use material published in journal T (5) Questions two of A’s methods/techniques and the data that resulted (6) A never acknowledged a funding body
An editor on journal T reviewed these allegations and believes that A’s paper was a follow-up paper, and that it appears to take further the research A and C had previously published in journal S. The paper had undergone peer review on journal T by one specialist referee, who provided a full and penetrating report.
A admits to claims: (1) The work was conducted at institute X (6) A admits to a mistake here
A disputes points: (2) A claims to have raised publication multiple times with C, C’s role in generating the “results were almost non-existent” but indicates that C claimed the data were C’s for C to decide (3) The paper is a follow-up to their previously published work (4) A personally analysed the material with the material produced by a technician (5) A claims that the materials are different images of different samples
Journal T submitted relevant correspondence to the dean at institute X and asked them to investigate. Institute X’s dean responded 4 working days later endorsing C’s position on the basis that A had duplicated material, had misrepresented its novelty and did so both without permission or agreement from C.
The investigation by institute X failed to communicate with A or ask for A’s response to the matter. When the findings were presented to A by journal T, A strongly refuted its key points.
Journal T’s position has been to ask institute X to investigate fully the above allegations (including communicating with A) and to make an official statement linked to the case.
However, we seek COPE’s recommendation whether this should be our position or whether they would advise a different approach.
The Forum acknowledged that the institute failed to handle this case correctly and that their investigation is of little value. However, there is little that the editor can do about the institutional failing other than reporting it to someone more senior than the Dean of the institute. The Forum believed that there was a case for asking institute X to carry out an unbiased independent investigation. In the absence of an independent review, the editor could publish a “notice of dispute”, informing readers of the situation and explaining that it is not for the editor to decide the rights and wrongs of the case. All agreed that the editor had handled the case very well and agreed with his course of action.
The editor requested an independent investigation from the institute. It is the editor’s belief that once he asked for an independent investigation, one that is truly independent and would have taken some effort on their part, that the institute decided it was not worth the trouble. The editor suspects that he will not hear from them again.
We would appreciate COPE Forum’s advice with regard to consent and confidentiality in the publication of case histories.
Our journal is published three times a year and has a relatively small circulation but also goes to some postgraduate medical libraries, so is potentially available to a much wider audience.
Our subscribers are doctors working with patients presenting with sexual difficulties in a variety of settings. Training is experiential, through the presentation of cases in seminar groups with a designated leader. Case presentation at our meetings and in the journal articles also provides learning opportunities and peer review.
As well as addressing (in an ordinary medical way) the physical aspects of the sexual problem presented, our work explicitly uses the study of the doctor–patient relationship to shed light on the presenting difficulties. In other words, the doctor–patient relationship is one of our key treatment ‘tools’ allowing connections to be made between the body and the mind in relation to the sexual problem.
These consultations almost always include intimate and sensitive information. Therefore, it had previously been felt that asking for permission to present cases would disrupt the very doctor–patient relationship on which our work depends. As a result, we have tended instead to seek to ensure anonymity by disguising personal details in presentations at meetings and in the journal rather than asking for consent from the patient.
We recognise that this practice is out of line with that recommended by the BMA and the GMC.
Our main concern relates to the possibility of limiting the availability of suitable case material for teaching purposes in presentations and in the journal if doctors felt unable to comply with a requirement to obtain patient consent. This would seriously interfere with the training.
We would prefer to continue using our current guidance where consent is recommended rather than mandatory. Indeed, we would like to suggest that where the doctor is satisfied that the information can be anonymised, he/she does not need to try to obtain consent.
We have considered adding a statement in the journal for patients who might read it, and recognise or believe that they recognise themselves, or their story. One of our founder members addressed this very idea in the preface of a book, asking patients to accept that no-one but themselves would be able to recognise them and to understand that, although each is unique, there are many like them who share similar problems; they are not alone.
We would appreciate your advice on the following points:
1) Is there any justification for continuing the current practice of ensuring anonymity by altering elements of the case history—for example, name, occupation, family details, appearance, geographical location, etc—and continuing to avoid an absolute requirement to obtain consent from patients? As a training body can we claim ‘special case status’ in view of the need to use case material to further training aims for future generations of doctors?
2) It has been suggested by a lawyer who is however not a medicolegal expert that we might interpret the GMC guidance and the NHS Code of Practice on Confidentiality to mean that consent is not needed where the doctor is satisfied that he or she can anonymise the data to be used (bearing in mind that the symptoms might be an identifier).
3) If you feel that we do need to change our practice and require authors to obtain consent from patients whose case histories they wish to present; it would be very helpful to have your advice on how this might be implemented.
All acknowledged that this is a difficult situation. This issue has come before the Forum many times, particularly in the case of child protection procedures. Such cases have proved almost impossible to publish in the UK and the public interest defence (that public health interests in knowing the information are greater than the requirement for confidentiality) does not seem to hold up.
The Forum warned that if enough information is available in the published report that a good investigative journalist can identify the patient, then the editor is in breach of the Data Protection Act. The Forum also warned that the editor, if on the UK medical register, could be in breach of the General Medical Council (GMC) regulations and was advised to consult the GMC’s documents Good Medical Practice and Patient Confidentiality and Consent.
The Forum also advised contacting the GMC for advice and approaching the Information Commissioner for the DPA. The Forum noted that even producing educational and training leaflets can be contentious and consent should be sought and a disclaimer added to the effect that patients should accept that no-one but themselves would be able to recognise them and that patients need to understand that, although each is unique, there are many like them who share similar problems. PLoS and the BMJ have policies on these issues and it was suggested that the editor might be able to adapt these.
While some advised seeking consent or publishing vignettes of anonymised cases, it is almost impossible to fully anonymise case studies and often such heavily anonymised cases can be educationally useless.
As recommended, we have spoken to the Information Commissioner for the DPA. He advised us that anonymised information could be published, and said that if the patient is not 100% sure that he/she is being described, then this is anonymised information. He said that it would nevertheless be best to ask for consent to publish a case history in its anonymised form.
We filled out the questionnaire from the GMC consultation on their new draft guidance on confidentiality. We have noted that the GMC proposes to change the recommendation that consent is obtained whether or not you think the patient can be identified, to recommending that consent is obtained if the information cannot be anonymised. The glossary now adds the word “reasonably” when discussing identification of information.
Pending the outcome of the GMC Consultation, it is likely that we will change our Guidelines to contributors to recommend that consent is obtained prior to publication of case reports in our journal, even when these have been anonymised. In situations where it is not possible to obtain consent, authors would be asked to confirm that, in their opinion, there is adequate anonymisation of the patient’s details; we have also produced a form for this purpose.
We raised these issues with the members of our organisation at a meeting in November 2008. We explained the background and provided a sample consent form for their use, together with our plans to provide sample patient letters to request consent, clinic information leaflets and suggestions on how to ensure anonymisation. We found that most were in agreement with our suggestions.
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.