Journal A is dedicated to communication about practical treatments related directly to patient and personal experiences. These ongoing discussions have been part of this specific medical profession for the past 50 years and journal A is a platform for these discussions.
Regarding new treatments and new developments, permission from the local medical ethical commission is mandatory as well as patient written permission for publication. For all other cases concerning standard practise reports about practical treatment issues, only written informed consent from the patient is needed before publication. As expected, only successful practical treatment cases are submitted for publication to journal A.
The society related to the journal organizes a biannual complication meeting which is attended by a small audience of around 120 doctors at which participants present their complication cases. At this meeting, many basic complications are discussed, which can be related to lack of education, lack of knowledge of materials, lack of knowledge about patient disease, or insufficient training, some of which have devastating outcomes. Many of these complications are avoidable.
As an editor and a doctor, I would like to publish some of these cases to improve patient safety and healthcare in general. However, the authors are often afraid of legal repercussions and patients are often not willing to provide consent after bad experiences. My solution would be to publish a series of these case reports as one publication with all authors in alphabetic order. I would leave out specific patient demographics, such as age and gender, and I would do so without written patient informed consent.
Question(s) for the COPE Forum
Would this publication violate COPE guidelines? If yes, how could this be resolved?
Is there any other way to resolve these issues?
The Forum agreed that the idea of presenting cases which do not result in improved patient safety or actual patient harm for learning opportunities is an interesting one and worthy of exploration. If any of the cases in this series have pending legal issues within an institution, this would be a significant consideration to protect the legal process. The editor must consider the legal environment in the country of origin, including regulations on informed consent.
As there are 120 cases, are there also 120 authors? If there are many authors, it may be easy to anonymise the cases, especially if the authors could be added in alphabetical order to help disguise identities. Otherwise, it is difficult to anonymise the data and retain essential elements for learning purposes. A suggestion was to publish one case per issue, deidentifying the data and to make all 120 presenters (or however many there are) the author(s). Another suggestion was to have a recurring column in a journal that has an ethics committee, who would review the cases and make necessary changes for protecting subjects’ identities. The journal could also seek institutional review of the cases to ensure that blinding was sufficient.
The Forum noted that changing the data is not acceptable unless that is clearly indicated in the text; if the case is a composite, this must also be stated. The reason being that researchers might be interested in doing composites of these cases, which would be based on false data unless the original cases are clearly labelled as composite or fictional scenarios.
The journal should consider that an investigative journalist may be able to uncover the actual identities, which might harm the journal, the authors and possibly the patients. If the authors are not able to anonymise the data, patient or family permission should be obtained, as well as legal advice. The editor may wish to consult the COPE guidelines “Journals’ Best Practices for ensuring consent for publishing medical case reports” https://publicationethics.org/resources/guidelines/journals%E2%80%99-bes...
If the editor wants to develop this project, he needs to have a strategic plan to publish these cases that considers the larger picture, and involves a sound, rational approach, which might be very valuable to readers. The Forum encouraged a careful review of the potential legal and privacy issues that must be addressed.
Authors Virginia Barbour, Muhammad Irfan, Deborah Poff and Michael Wise on behalf of COPE Council Version 1 December 2016 How to cite this COPE Council. Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports. Version 1. December 2016 https://doi.org/10.24318/cope.2019.1.6
Our COPE materials are available to use under the Creative Commons Attribution-NonCommercial-NoDerivs license https://creativecommons.org/licenses/by-nc-nd/3.0/ Attribution — You must attribute the work in the manner specified by the author or licensor (but not in any way that suggests that they endorse you or your use of the work). Non-commercial — You may not use this work for commercial purposes. No Derivative Works — You may not alter, transform, or build upon this work. We ask that you give full accreditation to COPE with a link to our website: publicationethics.org
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 paper was submitted to our journal. The managing editor was concerned about patient information in the paper and queried the authors. The authors responded that the data were collected from routine samples and so consent was never obtained. The patients were lost to follow-up, and there was no ethics committee approval as it involved the study of existing data, but they did discuss with the institutional review board who said it was exempt.
The cohort was 2500 patients, all with one syndrome, in one hospital. The paper contains two tables that display data from 12 patients: sex, age, presenting symptom, as well as laboratory parameters and outcome.
Question(s) for the COPE Forum • Are these patients identifiable? • If we remove, say, age and sex, would that be sufficient to render the data anonymous? Would we lose clinical significance by removing age and gender for those patients, although the paper does mention that of the 12 patients most were female and gives the median age group? • Should we publish this without patient consent? • The study also mentions controls who underwent biopsy, but what is not clear is whether those controls were also from the same cohort and perhaps underwent biopsy as part of routine screening. Would they need ethics approval for biopsy?
The Forum agreed that the case was concerning. With the sophisticated knowledge and information that can be trawled from the internet, the concept of anonymity is becoming more and more difficult. However, editors have to do their best to protect patients’ identities, and it is has to be an editorial decision on the risk–benefit of publishing.
Journals have different policies on publishing papers without consent or approval, although many of the Forum participants said that they would reject a paper if there was no patient consent and/or no ethics approval.
The advice from the Forum was to contact the authors and ask for the Institutional Review Board (IRB) documentation. The editor should ask the authors to clarify why the study was exempt from ethics approval. If the authors insist the study did not require ethics approval, then the editor should ask for proof—for example, a written statement from the IRB. The editor could also contact the IRB directly with their concerns.
The Forum also advised that the issue of consent should be raised with the authors—both consent to participate in the study and consent to have the data published. Was consent received from the whole cohort? Did the authors receive consent to publish from the patients whose data were published?
Following the discussion at the Forum, the journal asked the authors to provide any information that they had about informed consent at the time of treatment. The authors sent their translated form, which specifically mentioned they had consent for treatment and not for publication explicitly. Hence on these grounds, the editor decided to reject the paper. The editor informed the authors, who did understand and said that they could not find the patients to seek consent as they were lost of follow-up. The journal considers the case closed.
The author was the subject of his study. He depleted himself of a vital nutrient until he had overt clinical and biochemical signs of the deficiency. He monitored various biochemical parameters as he became more deficient and submitted two manuscripts presenting his results: one detailing the biochemical changes and one detailing the differences in results obtained from different commercially available assays for the nutrient.
Reviewers of the first manuscript raised some concerns about the experimental model used and also concerns about the ethics of the study, particularly the lack of any oversight from an institutional research board. The second manuscript was not reviewed and both were rejected on the basis of the ethical concerns raised by the reviewer and concerns about the scientific validity of the results obtained from one individual.
The author feels very strongly that his experiment was not unethical and argues for the autonomy of researchers. He provided the following arguments for his study: — The author is both experimenter and single subject, so the requirement for informed consent does not apply. — There is no institutional involvement, so there is no possibility of coercion. — The subject was assessed by a psychiatrist and found to be competent to evaluate the risks and benefits and to accept full responsibility for the conduct of the experiment. — The Declaration of Helsinki does not comment on self-experimentation; it is concerned with research in patients and healthy volunteers. The requirement for ethics approval therefore does not apply. The Declaration of Helsinki cannot be cited as a reason for rejecting reports of independent self-experimentation. The Declaration was not intended to prevent autonomous independent humans from performing and reporting self-experimentation — The subject was monitored by a qualified psychiatrist who continually assessed the condition of the subject. It was agreed in advance that the psychiatrist would intervene if, but only if, there was an immediate life-threatening condition. — The motivation for performing the experiment was ethical in that the subject wanted to investigate the gross differences between the immunoassays he found in an earlier experiment because he was aware of the potential severe consequences of such errors in measurement of this nutrient. There was no conflict of interest. — The need for IRB or ethics committee approval would totally exclude from publication any self-experimentation research performed by an independent researcher because they will not have access to any ethics committee or institutional review board. This would have prevented the publication of reports of highly useful reports (http://careers.bmj.com/careers/advice/view-article.html?id=20002566 and http://www.bmj.com/content/341/bmj.c7103.long)
The author appealed the decision to reject his manuscripts. Although the appeal was not upheld, we agreed to bring the author's arguments for self-experimentation to the COPE Forum for wider discussion. It is worth noting that the author’s two papers were eventually published in another peer reviewed journal without any negative response over the ethical issues.
Question(s) for the COPE Forum • Do other editors at the COPE Forum consider manuscripts on self-experimentation without formal IRB approval? • What criteria do editors use to determine whether such studies are acceptable?
The Forum suggested there are two issues here: the ethical issue of self-experimentation and whether the study warrants publication with an n of 1.
The Forum agreed that the author has the right to perform the experiments on himself, but he does not the right to have his findings published. There have been some highly publicised cases of self-experimentation, which in one case led to a Nobel prize for Barry Marshall after he infected himself with Helicobacter pylori (the causative organism of peptic ulcers). There was also the case of Spurlock’s documentary, Super Size Me, a social experiment in fast food gastronomy.
Regarding the second issue, the Forum agreed that this has to be a judgement call for any editor. Does the study warrant scientific publication? The author has the option of blogging about his experiments if he wants to disseminate his results.
The editor told the Forum that they were interested in learning if any journals had a specific policy on this issue, but among the Forum audience, no journal had such a policy. The discussion ended in agreement that this is a topic that needs further debate.
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 questionnaire was distributed to knowledge workers in an organisation to investigate the following hypotheses:
— H1.There is a positive and significant relationship between ethics and organizational performance. — H2. There is a positive and significant relationship between ethics and intellectual capital. — H3. There is a positive and significant relationship between intellectual capital and organizational performance.
Partly due to the very high rate of response (148/160), consecutive queries were made to the authors about the procedures for subject consent.
Our most recent (and direct) query was: "What we need to know more about is what was done to protect the interests of the individuals who were surveyed. Was there any inducement for them to take part (for example, a reward, or a punishment for not doing so)? Did you collect any consent forms from those individuals? What did they say (please supply a translation as an additional document)? Were any reassurances made to them, or is there a possibility that giving an answer that managers, the government or religious authorities don't like could result in harm for the individual? If there are possibilities of harm were the 160 individuals surveyed warned about them? How? Were they told what the data would be used for? What were they told? When you have amended the paper to give some indication and can supply a (translated) consent form, please visit the instructions to authors to complete your submission".
In response to these queries the following reply was received. "We have set a cover letter in the first part of questionnaire which included the following items: the questionnaire was developed without any name and individual information. As discussed before during the learning programs within the organization, strong attention and commitment to ethical issues are important to reach organizational objectives. Considering the importance of both ethics and IC, the ultimate goal of this study is to explore the relationship between them, and finally their impact on organizational performance. The result of this research will be published by considering privacy issues. It is important to note that the organization’s management has a strong commitment to the above noted subjects. Besides a non-valuable reward, the most important incentive for employees’ participation is that they are in this believed that their organization should be pioneer in comparison with their competitors. Due to being knowledge-based organization, employees have actively participated in such studies, and also they have perceived their positive outcome well, accordingly involving in such studies was accepted as a common subject in that organization".
It thus appears that no consent forms were collected and nothing was said about possible harm to participants. There is no assurance that they were able to answer freely. Given the wider context of the research, do human research ethics constitute a barrier to publication of this paper?
The Forum confirmed that consent forms are not necessary if the questionnaires are anonymous. Ideally, the authors should produce an “ethical reviewer waiver” so that the editor knows that an expert has looked over the protocol and deemed that ethics approval is not required. If the study was conducted at a university, then there should be a university ethics committee. If the editor decides to publish the paper, he could write a note saying that this paper does not have any ethical oversight. But if the editor still has some concerns, he could consider contacting the authors again for more information, and writing out in a very clear way the questions that he requires answers to.
The editor followed the advice of the COPE Forum. However, when peer-reviewed, the reviewers’ decision was 'reject', so the paper was rejected.
A manuscript underwent peer review and the resulting reviewer comments raised grave concerns about the ethical legitimacy of the study. The reviewer:
questioned the authors’ impartiality, suggesting that there was an undeclared conflict of interest;
raised serious concerns about the extent to which participants gave informed consent;
strongly doubted that the study would have gained ethics committee approval; and
suggested that the study violates the World Medical Association’s 1964 Helsinki Declaration on Scientific Research with Humans, which states that the welfare of the research subject takes precedence over the interests of science and society.
The manuscript described a randomised controlled trial conducted on patients undergoing brain surgery. Participants were recruited between January 2010 and February 2012 in a single hospital.
The stated aim of the study was to establish the effect of varying the time for which blood flow to the brain is substantially reduced during surgery on postoperative function and disability. It is already well established that reducing the blood flow in this manner for a prolonged period of time is likely to lead to poorer postoperative outcomes due to reduced oxygen supply to the brain.
In order to avoid negative outcomes and improve patient safety, there already exists a warning criterion used in surgery of this type, which alerts the surgeon to the extent of oxygen starvation and indicates when blood supply should be restored.
In the manuscript, the authors outline their knowledge of the risks involved with the procedure itself and report that many surgeons feel that this procedure should only be used as a last resort due to the increased risks outlined above. However, if the procedure is deemed necessary, the risks can be reduced by employing the pre-established warning criterion.
The authors outline perceived flaws of the pre-existing criterion and go on to describe a novel warning mechanism —conceived by them—that they intend to test during the study. Testing this new criterion entailed increasing the time that blood supply in the brain is reduced—to the extent that, in some cases, the current recommended threshold was significantly exceeded. Additionally, while the procedure was underway, the authors ensured that the surgeon was blinded to the patient’s status with respect to the established risk threshold, making is impossible for them to gauge the level of danger the patient was being exposed to. This, as is noted within the manuscript itself, poses serious risk to the patients.
Participants were divided into three groups. In the control group risk was assessed using the normal criterion and blood supply was reinstated once this threshold was crossed. In the second group, blood supply was reduced for a longer period of time. In the third group, blood supply was reduced or completely cut-off for significantly longer.
In the results section, the authors state that in the control group one patient became severely disabled, and that all patients in the third group experienced negative outcomes. Of the patients in the third group, three were severely disabled as a result of the procedure and all of the others suffered some neurological deficit. As the reviewer points out, the pattern of outcomes raises serious ethical concerns about the study. The reviewer questions whether this was (and even should have been) tested on animals first, as this would have provided an upper limit and ‘red flag’ for testing.
The reviewer believes that this study violates the Helsinki Declaration on Scientific Research with Humans in that it appears that subjects randomly included in the third experimental group were subjected to an experimental condition that caused three of them to be severely disabled, and nine of them to be moderately disabled by the experimental manipulation. Because patients were assigned to intervention and control groups randomly and the outcomes between the groups differed significantly, it is highly unlikely that the negative outcomes among group 3 patients are attributable to technical surgical problems in one group only.
It appears that the negative outcomes found in group 3 patients were due to the blood supply being reduced or occluded for long periods of time. The reviewer also suggests that for the control group, there was an omission of a standard of care practiced by most modern medical centres that perform this procedure. The reviewer suggests these findings cannot be generalised to other procedures of this type and he wonders why the original warning criterion was not utilised in this study to further protect these patients.
Furthermore, the study raises serious concerns about the extent to which patient consent (for which consent forms were obtained from the patients) was properly informed. There is no indication that the risks to the participants inherent in an experiment such as this were properly conveyed to the individuals before participation was agreed.
Finally, the Declaration of Helsinki also states that “Physicians must immediately stop a study when the risks are found to outweigh the potential benefits…”; the authors did not stop this study for over a year. And, an unproven intervention should only ever be carried out if “it offers hope of saving life, re-establishing health or alleviating suffering” and that in the nature of research it is “designed to evaluate its safety and efficacy” not to establish a benchmark
The Forum were in agreement that this was very dangerous and very unethical research and that the editor should act quickly. The advice was for the editor to contact the authors informing them that there are substantial concerns with the content of the paper. The editor should copy in all of the authors, giving them a specific and short deadline in which to respond. The editor should tell the authors that he will contact the authors’ institution if no response or an unsatisfactory response is received.
The editor can ask to see proof of the ethics approval of the study, as well as the patient consent forms. Was the trial registered? If no response is received, the editor should contact the institution, copying in all of the authors. If there is no response from the institution, the editor should contact the general medical council or equivalent, or the funding body. For this form of potential misconduct, it is the editor’s responsibility to bring it to the attention of the institution or authority body that can investigate the case.
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.
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.