我们审查并发布了一个随机对照试验，其中儿童接触父母二手烟（SHS）是持续（通常的实践控制）或父母被要求避免在孩子周围吸烟（干预组）。该研究包括超过400名儿童平均9岁。父母提供书面知情同意书。该研究得到了研究人员机构的伦理委员会的批准。通过自我报告的调查问卷和访谈收集在学校环境中的数据。儿童根据SHS暴露量进行分类，并收集了关于几种症状的基线数据。有兴趣症状和暴露于SHS的儿童随机分为两组。第1组中的家庭吸烟成员被要求在孩子的存在下，在6个月的时间内吸烟，而第2组的人被要求不改变吸烟习惯。在学习注册之前，父母被告知他们不需要作为参与的一部分戒烟，相反，他们将被要求减少儿童的SHS曝光。6个月后，数据再次收集数据，以评估仍在显示感兴趣症状的两组儿童的比例。 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.
在审查过程中，处理编辑和审阅者都没有提出关于该研究的道德的问题。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.
在讨论中,编辑认为之一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?
编辑告诉论坛，作者回答了审查过程中提出的问题。作者告知编辑，制度审查委员会（IRB）已获得批准，但他们没有提供IRB批准的证据。论坛建议编辑发布这封信，并给出原位的机会回复。编辑器也可能考虑发布IRB批准声明。另一个建议是委托评论或在这个问题上写一个社论。
正如论坛所建议的那样，编辑联系了该研究作者以澄清协议说明。此外，该期刊还获得了一个独立伦理机构的机密磋商，其中四名专家总结了相关的道德问题。该期刊还征求了研究作者的一封信，回应了致编辑信中提出的问题，并从一个主要机构的生物伦理部征求专家意见。
向编辑的信，作者和专家评论的答复将在即将到来的问题上公布，同时向编辑人员的简要介绍性声明。这一介绍邀请日志读者审查材料，以进一步思考研究二手烟雾效果的伦理影响以及研究企业的伦理。