作者维吉尼亚·巴伯、穆罕默德·伊尔凡、黛博拉·波夫和迈克尔·怀斯代表议会 Version 1December 2016 如何引用 COPE Council. Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports. Version 1. December 2016https://doi.org/10.24318/cope.2019.1.6
The International Rhuematology Editors' Group would like to receive comments from wider specialty communities on their framework below. Please send any comments to谢纳兹·艾哈迈德.
Planned further steps by the journal for future cases:
•此类辩论必须考虑到患者的兴趣。 •在同意书中加入一句话，告知患者发表后辩论的可能性。 •可能包括关于此类辩论的免责声明，告知此类辩论的限制？ • Possibly include a reminder about the patient's perspective in the author guidelines for debate?
COPE论坛的问题
•让读者猜测患者的诊断、治疗选择等是否合乎道德？ •论坛成员是否在各自的期刊上进行过类似的讨论？ •采取/计划的步骤是否合理？ • Does the Forum have additional advice on how we can avoid such problems in the future?
Letters to the editor commenting on case reports could include disclaimers, and it is important to remind people to think about the patient and their family.
The most intriguing case reports often have an aura of ‘mystery’, treading a fine line between the ‘obvious’ versus the ‘suspense’ of whether the patient did get the right treatment but this should not compromise accurate reporting or condoning poor practice. Authors need to be upfront about the details of the case, including the diagnosis. Authors should not disclose additional information after publication. Post-publication speculation must be handled carefully as it can be distressing for the patient and the patient’s family.
In the paper, the authors note that “parental consent was not required” because “all of the participants were older than 15 at the time of the interview, which is the legal age in the country where the study was performed”.
Because they identified the source of a number of quotations from the interviews that they conducted as being from 15 year olds, I contacted the first author for clarification. I also asked where the statute is listed that states 15 years as the age of consent in your country and also asked if the study was reviewed by an ethical review board.
The Forum suggested there are two issues here: the age of legal consent without parental approval and the ethical issue.
While the study has institutional backing, some of the Forum were of the opinion that the study should have been reviewed by an institutional review board. Only an institutional review board or an ethical board can judge whether or not consent should have been obtained.
One view was that parents should have been informed for the younger aged participants (15 and 16 year olds). However, another view was that the benefits outweigh the risks, and that if the parents had been informed, that may have prevented the participants taking part in the study. The age of consent varies widely in different countries. If participants are over the age of consent for that particular country and the study was done according to national standards, then the authors should be allowed to publish. A suggestion was that if the paper is accepted for publication, the editor could put a statement or note on the paper around the issue of consent, in the cultural context. It may also be useful for the editor to write an editorial comment as readers may also have similar questions.
这篇文章的评论和返回article was rejected based on the merit of the paper. The matter regarding this specific submission is closed. The authors followed the letter of the law in their country, but the editor still wonders if there should be a universal age for consent of minors, without parental approval. There are many sides to the issue.
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.
COPE论坛的问题 • Are these patients identifiable? •如果我们去掉年龄和性别，这是否足以使数据匿名？如果剔除这些患者的年龄和性别，我们是否会失去临床意义，尽管论文确实提到12名患者中大多数是女性，并给出了中位年龄组？ • Should we publish this without patient consent? •该研究还提到了接受活检的对照组，但不清楚的是，这些对照组是否也来自同一队列，可能作为常规筛查的一部分接受了活检。活检是否需要伦理批准？
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?
我们的杂志出版病例报告描述evaluation, diagnosis and treatment of unusual cases. Parents must provide written informed consent prior to manuscript submission. No cases are presented with unique identifiers and each is anonymised as much as possible.
The Forum discussed having a universal consent form, which has been discussed by COPE in the past. Hence if a patient consented to publication for one journal, if the article was then rejected and submitted to another journal, another consent form would not have to completed. From a poll of the Forum, there was some support for a universal consent form. About a third of the audience currently use a specific consent form for publication that requires the authors to have gained written consent from the patient before any identifying material can be published.
Child abuse is a common but underdiagnosed problem in our country. The abuse ranges from minor injury to severe head trauma. The true incidence of intentional head injury in children remains uncertain.
Some members of the Forum questioned whether it was necessary to print the photograph of the child. Could the case have been described adequately without the photo? Although the photograph is already published, some suggested removing the picture from the online version of the journal. Others argued that as the editor believed overwhelmingly in the importance of this case and had published it in good faith, he should stand by his original decision. The father of the child had agreed to the photograph being published and the child had since died, so there was no issue of consent. Another suggestion was to write an editorial on the subject highlighting the issues involved.
The authors wish to publish a case report that aims to characterise complex chromosomal abnormalities in a rare congenital syndrome. It describes, in detail, the clinical features of two newborn infants. When asked about consent to publish, the authors said they did not obtain it because the data were reported from existing clinical diagnostic test results and therefore did not constitute a systematic investigation and that no identifiable information was included in the manuscript.
The authors were told that consent was still needed and that they should attempt to obtain it from the children’s parents or next of kin. The authors said that it would not be possible to obtain consent from the parents since the mother of one child was now deceased and the other was lost to follow-up, but that they would attempt to obtain a waiver from their IRB. They provided a copy of an IRB approval letter with no specific mention of waiver of consent, but they did provide a copy of the application form which included a section where they provided a justification for not obtaining consent. The justification was that they were unable to obtain consent from the mothers and that the data they analysed was pre-existing clinical information and that no photographs or identifiable information would be published.
The Forum pointed out that consent to a treatment or intervention should not be confused with consent to publish. It is up to the journal to ensure that appropriate consent has been obtained and this is separate from IRB approval. If the balance of judgement is in favour of public interest, then the editor could consider publishing the cases, but only if the cases are completely anonymised with no identifying features. The Forum noted that this is a particular problem in paediatrics, which has often been discussed at the Forum. The Forum questioned whether it would be possible to write a comment on the general condition, without publishing the actual cases. Can a useful message be conveyed without giving specific details on the cases? In the end, it is a judgement call for the editor. He should try and obtain consent from anyone who is eligible or seek a balance of opinion from experts in the field and then decide whether or not to publish.