Genotyping results were given for specific individuals. Some individuals are described as still alive, some deceased. We felt that the paper fell under the journal’s privacy policy and that we would need to know before going further that all living individuals described have seen a copy of the paper and consented to publication. The journal has a consent form for this purpose but we do not ask to see the patient’s signatures (instead just requiring the authors to obtain consent, file the form in patient records and update the paper to state that consent to publication has been obtained).
编辑器被问及个人信息was essential to the study. If it were deleted, would the paper still have value? The editor confirmed that the information was crucial to the study and could not be deleted. All agreed that the editor needs to weigh up the need to publish against any harm that might be caused by publication. Most believed that the harm involved was probably quite severe and so outweighs the need to publish. One test that can be applied is to consider whetheran investigative journalist would be able to identify the patients from the study (in this case, most Forum members felt that they could, therefore the risk of identification is high). The Forum did not believe it was that impractical for the authors to obtain consent and so they thought it was reasonable to ask the authors again to obtain consent. Did the authors make it clear to the patients how much detail and history would be published? Also, some noted that with pedigree studies, it can be very easy to identify patients. As with all such cases, the editor needs to make a judgement concerning the harm that might be caused to the patients in publishing and the benefits of publishing. Most believed that the risk of identification was high and that the editor should not publish without consent. The advice was to go back to the authors and ask them to obtain consent. COPE was asked about whether it could produce a generic consent form for all journals (to avoid problems of having to use multiple forms if a manuscript is reject by one journal and submitted to another). COPE Council agreed to consider this suggestion.
We approached group Y to clarify if they thought they should be acknowledged on the paper, or even included as authors, but they did not answer, as they believe that group X should be asked to clarify their position.
We approached group X for their response to these allegations. Group X maintain that their collaboration with group Y was their idea, as an obvious extension to their previous clinical publications. Group Y are chemists and had not published on any clinical topic prior to the collaboration with group X. Group X state that the collaboration came to an end in 2006 when the senior collaborator in group Y demanded that either s/he should be named as the last author or one of the junior members of group Y named as first author on any manuscript resulting from the collaboration. Group X considered this to be unreasonable and continued their studies using commercial reagents.
The authors responded that they had attempted to remove all identifiers from the paper (although the editors felt that very substantial and identifying details remained), and that revealing the patient’s identity to the editorial office would violate their clinical protocol, and the principle of patient anonymity. The editors discussed this and felt that it was still very important that the patient have read the paper and agreed to its publication; secondly however, we were concerned about the journal having access to (and our ability to keep confidential) the patients’ names. We also wondered whether under HIPAA law it would even be legal for the authors to give us the patient’s identity.
Therefore, the editors proposed that we would ask the author to have the patient (or patient’s parents) sign our consent-to-publication form, and then include in the paper a statement that they had done so, but that we stop asking authors to send us copies of these forms and simply rely on the authors’ word instead. Is this acceptable?
Advice:
The Forum agreed that this was a curious case and raised issues relating to HIPAA law. Some argued that there is no need for a journal to know the identity of the patients reported in case reports. The authors could be asked for a statement that they have followed the correct procedures and obtained consent from the patient. But there is no need for the journal to see the consent form and hence no need to reveal the identity of the patient. If a problem arises in the future, the journal would have a reasonable defence as the onus would be on the authors to have obtained consent. The editor could request a signed assertion from the authors that they have obtained consent. Although the journal’s own consent form can be used, the Forum noted that it would be very useful to have a generic consent form so that patients need only sign a form once in the event that the paper is rejected by one journal and submitted to another journal. The Forum agreed that the editor’s proposed course of action is acceptable.
Is the blanket ethical approval sufficient for us to publish these short case histories, or do the authors need permission from the parents of the children who died?
Advice:
The Forum’s view was that it is for the editor to decide whether or not he considers that the ethics approval, as obtained in this case, was sufficient. The editor is not bound by the decision of the ethics committee. Many journals take the view that if there is any possibility that the case can be identified, then consent is necessary, and will not publish case reports if consent from the patients or parents is not obtained. If it is impossible to obtain consent, the editor may decide that it is in the public interest to publish the case, but he or she would have to be prepared to justifiy their decision. The Forum questioned the relevance of the case reports and whether the cases could be summarised, omitting all case details. The general consensus was the it was up to the editor to make the final decision and that he should consider the relevance of publishing all of the details of the cases rather than just a summary.
A group in a developed country performed an audit of pregnancy and its outcome in a group of 250 women with congenital heart disease. There were four maternal deaths of women in the series. It was decided to write up the audit. The paper reports aggregated statistics classified by diagnosis, but also contains a brief account of the factors associated with the four deaths (an account of one of these deaths has already been published in considerably more detail in the confidential enquiry into maternal deaths). Because of the unusual and complex nature of the lesions, these cases will probably be identifiable to medical staff involved in their care, and to close family members. Permission for publication cannot be obtained from the patients, for obvious reasons.
Do the committee consider that the local ethics committee should review the paper before it is submitted for publication? The policy of the local committee specifically excludes audits from its remit.
《华尔街日报》获得患者p的病例报告resenting with a particular syndrome in which patients give approximate answers to simple questions. This syndrome has been considered as a dissociative condition but others have argued that it reflects simulation of psychiatric symptoms. The case report was an individual who had crashed his car and, following that, developed complaints of memory impairment and at psychiatric review this syndrome was diagnosed. The patient was reviewed by the authors three years later and showed a number of inconsistencies on examination. Furthermore, it was discovered that, despite the fact that he was unable to recall the day of the week or his own birthday date, he had successfully trained as an official sports umpire. The case thus provided good evidence that this syndrome may be associated with malingering.
A journal provisionally accepted a case report. When requested, the authors could not identify patients to obtain their signed consent. The authors offered to anonymise the data, but the journal was inclined to decline. - What should the editor do?