Our journal publishes case reports describing the 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.
A manuscript was submitted with written consent that was accepted for publication and assigned to an issue. Just before the issue was to be folioed, the parents contacted the authors and revoked consent. The journal was able to pull the article prior to publication. The editorial board is concerned about this happening again and what the course of action would be if consent is withdrawn from a case that has already been published.
Question(s) for the COPE Forum
• Once written consent is provided, can it be revoked?
• If the article was already published, what would be the reasonable course of action? Retraction?
The case provoked much discussion among the Forum and raised many interesting questions. Do people really understand the full implications of giving consent to publish? Do patients really understand what consent means? Do patients/carers understand that once a paper is published online, it is very difficult to remove it? A journal can take down the paper, but it may have already been downloaded and/or printed copies may be in circulation. Hence a paper can never be removed completely from the internet.
论坛强调，在患者提供同意书之前，应该让患者充分意识到这一点。任何人都可以阅读一篇论文这一事实应该明确地告诉病人。例如，在对谱系的遗传学研究中，一篇论文可能不仅识别患者，而且识别患者的家庭，因此在这种情况下获得同意可能既困难又复杂。因此，论坛建议，期刊应努力避免出现患者或护理人员想要撤销同意的情况，提供明确的指示，说明首先提供同意的含义。此外，《华尔街日报》可能希望有自己的同意书，可以提供明确和详细的同意信息。
The Forum agreed that consent can be revoked and that a journal should respect the wishes of a patient if they wish to revoke consent. The journal should then remove the paper from their website but leave a place marker, with a note saying that the paper has been removed and stating the reasons why. The journal should inform the patient that although the paper has been removed, there is little that can be done regarding copies already in circulation.
For consent in children and young adults, some journals use a "minor assent form" along with parental permission, which is tailored to the age of the child. The child can then give their "assent".
The issue of consent forms has been raised at COPE in the past and the suggestion of a universal consent form was put forward. However, it was felt that one consent form could not cover all situations and instead, COPE plans to publish various on the COPE website examples of best practice journal consent forms for others to see and perhaps use for their own journal.
The editor was satisfied with the guidance the Forum provided. Based on feedback from the Forum, the journal is creating a sample parental consent form for authors to use as a template. The journal hopes to clarify what it means to give consent to publish a child’s case in the journal so that the parent is fully aware. The editor would be interested in any formal guidance on consent issues from COPE. The editor considers the case closed.
评论
Just two points:
1. Young persons aged 16-18 should be able to give consent in normal circumstances
2. What do you do with a person <16yrs who does not give assent but whose parents have consented ? I would be inclined to respect the child's wishes but what do others think?
Consent is obviously important and should be respected. However, don't the authors also have some rights? If they have received consent, done a huge amount of work to do the study, and not acted deceptively, surely they also have interests that should be taken into account. One might also suggest that the benefits of publication to science or health should also be a factor.
我不会说这样的考虑应该允许一个人放弃同意的要求，但在最后一刻改变主意并不等同于最初拒绝同意，也许应该接受一些审查和评估，就像所有与人类主体有关的工作都需要权衡利益和成本一样。