We had provisionally accepted a randomised controlled trial of an exclusion diet given to young children with a particular condition. The trial design was that one group started the exclusion diet a month before the second group. In other words, both were given the “treatment.” One part of the trial was that children who were thought to have an allergy to a particular food were rechallenged with that food. We discovered rather late in the day that the study had been done without ethics committee approval, despite the fact that the trial had been carried out in a major British hospital. The reason the authors gave for not submitting the study for ethics committee approval was: “because all children received advice on dietary exclusion. The only difference between the control and the trial group was that the dietary advice was delayed for a month. Thus all the children were given a trial of an exclusion diet as part of routine management. No drugs were involved. In view of this, ethics committee approval did not seem necessary. I discussed this informally with a member of the ethics committee who felt that this was a reasonable decision.” We rejected the paper on the grounds that ethics committee approval had not been sought, but should have been. But should we do more? Is this an example of research misconduct?
Advice:
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Agreement that this was a blatant experiment on children.
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The parents had given permission for the administration of the diet but had been informed that this was a trial, which was felt to be sloppy conduct rather than intentional avoidance of ethical approval.
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Agreement that this was an example of research misconduct.
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Editor advised to write to the authors’ institution drawing attention to the matter, copying the letter to the authors and their head of department.
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The editor should ask for feedback from the institution.
Follow up:
A complaint was made to the chief executive of the trust, and he held an investigation. As a result, requirements to obtain ethics committee approval have been tightened.
我们收到了一份文件，其中作者将一群婴儿暴露在生理上不自然的情况。然而，在一些人民的生命中，这些情况发生了很大。没有一个婴儿对他们有任何问题，但其中一些是曾经死过的婴儿兄弟姐妹。一些婴儿表现出在不自然的情况下的生理变化，这提出了如果暴露于普通生命中的那些情况，他们可能会遭受严重后果的可能性。这项研究的确切含义很难解释，但它确实表明这些生理上不自然的情况可能对婴儿产生严重的后果。医院道德委员会批准了该研究，所有儿童的父母都提供了知情同意。然而，我们的编辑委员会担心这是非治疗性的研究，兄弟姐妹死亡的儿童的父母可能会发现拒绝同意这项研究很难。因此，我们委托了一个道德评论，其中提交人认为这项研究是不道德的，部分原因是我们所确定的同意问题，部分原因是，研究人员没有明确的先发病人，并且没有进行电力计算。因此，它们产生的研究非常难以解释。（1）研究是否足以不道德，我们不应该发布它？ (2) Can we publish the research with a commentary arguing that it is unethical? If we so, should the authors be given the right of reply? (3) Or should we, as the authors argue, write the commentary ourselves rather than commission an outsider? In our commentary we could voice our ethical doubts, but say that we thought the paper was nevertheless publishable.
Advice:
(1) The ethics committee have approved this study, but there is dissonance among the committee, editor and commentator. The paper has been accepted and the authors told that a commentary and editorial would be commissioned which they will see before publication. (2) This is a case of having one’s cake and eating it. (3) Ideally the chairman of the ethics committee should write the commentary.
Follow up:
The paper was published with a commentary on the ethical aspects.