我们对生产制作纸张批准的机构审查委员会（IRB）进行了查询。
The paper reports on a 2 year follow-up and cost-effectiveness evaluation for a treatment programme. A previously published paper reports on the original evaluation of the treatment programme. The authors have not obtained IRB approval for either body of research.
The initial research was described as a report of outcomes from 5 years of clinical experience with the programme, rather than as a clinical trial, and as such IRB approval was not sought. For the paper currently under consideration, the authors’ original statement in the paper was that “Institutional review board approval was not required as patients were treated with approved diagnostic and therapeutic procedures according to generally accepted standards of care”. We were unable to verify this as a valid reason for exemption from the requirement for IRB approval.
在提供的基础上发现没有明确的理由，我们要求提交人提供有关此基础的参考或进一步的信息。如果这些来源公开可用，或者如果记录了这些来源，则答复了以下美国联邦监管的研究豁免：“涉及收集或研究现有数据，文件，记录，病理标本或诊断标本的研究，或者录制信息调查员以这种方式不能直接或通过与受试者联系起来的标识符来识别受试者“。
我们对此理由的担忧是数据不公开，数据包括后续电话访谈，这似乎与要求数据应该被证明的要求相冲突，并且确实是后续访谈信息是新数据，而不是现有数据或记录。
Question(s) for the COPE Forum
- Is this research publishable in the absence of IRB approval?
The majority of the Forum noted that they would err on the side of caution—if the editor is unable to verify that the study received IRB approval, then they suggest that he should not publish. The Forum advised contacting the authors and informing them of the journal’s decision. The Forum noted that this is a good opportunity to look at the journal’s instructions to authors. The instructions to authors should be very clear about the journal’s policy on IRB approval, and what type of ethical review is required by the journal.
If however, the editor did decide to publish, the Forum would advise publishing an explicit statement within the paper, outlining the ethics approval process and detailing the facts of the case and what the actions of the editor were.
当选问一个私人机构审查委员会（IRB）作者审查研究，私人IRB证实，这项研究是豁免（追溯，去识别的数据）。我们获得了IRB的决定副本，并发表了豁免的解释。
注释
I would agree with the authors that IRB review of this project would not be required--not for the reason that the authors gave ("patients were treated with approved diagnostic and therapeutic procedures according to generally accepted standards of care”) but because a "cost effectiveness evaluation of a treatment program" does not meet the definition of RESEARCH as indicated by the federal regulations (45 CFR 46.102[d]), and, if it is not research, it is also not research that involves human subjects, and, if it is not research that involves human subjects, then IRB review is not required. THAT should have been the position taken by the authors: "this is not a research project that involves human subjects; as such, IRB review was not required."
作为北欧杂志的编辑Acta accketricica et Gynecologica Scandinavica（AOG）我经常遇到丹麦，荷兰和英国等国家的禁止问题，其中医院审计型调查或在机构或国家电子寄存器中使用数据看似豁免监管/法律。有时，这通过后续或访谈数据补充，如在所示的情况下。这里的一个基本问题是研究人员不应该自行决定可以研究和如何研究。外部和独立的机构应批准进行特定研究项目的道德规范以及如何完成。这就是道德委员会（IRB）是什么。在这些国家，不可能使用没有道德批准的生物标本，而是可以访问允许记录（通常是非常个人信息）和寄存器中的信息的信息。这有明显的差异。至于寄存器，它们的使用甚至可以以加密或匿名形式的形式受到数据保护机构的批准，但这是一种误解，使得具有道德批准。
I agree with the advice to be on the cautionary side in this case. Here journal editors could give a lead and governments or similar authorities should ensure that ethical approval is essential to using all human data, whether in a biobank, a case record system or in an electronic file that is or is not anonymized, not to speak of contacting people by telephone. In a clinical setting one can contact directly one´s own patients by telephone or similar means, but that situation should not be translated into a reserach setting.