Ethical and Methodological Standards for Laboratory and Medical Biological Rhythm Research
Ethical and Methodological Standards for Laboratory and Medical Biological Rhythm Research
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DOI：
10.1080/07420520802544530
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发表时间：
2008-01-01
影响因子：
2.8
通讯作者：
Smolensky, Michael H.
中科院分区：
文献类型：
--
作者：
Portaluppi, Francesco;Touitou, Yvan;Smolensky, Michael H.
本文的主要目标是更新人类和动物生物节律研究的道德标准，并推荐高质量的时间生物学研究信息的基本要素，这对生命节律的新研究者特别有用。第二个目的是为那些对时间生物学研究结果感兴趣，但可能不熟悉该领域的人提供生物节律研究和时间序列数据分析的基本方法和标准的介绍。该杂志及其编辑认可所有研究者遵守世界医学协会赫尔辛基宣言的原则，该宣言涉及对人类进行伦理研究，以及国家研究理事会实验动物研究所的实验动物护理和使用指南，该指南涉及对实验室和其他动物进行伦理研究。该杂志的编辑和读者希望投稿作者在进行调查时遵守当地，国家和国际法律法规规定的道德标准，并在报告从未发表过的研究结果时保持公正和准确。科学论文的作者必须披露所有潜在的利益冲突，特别是当研究部分或全部由医疗和制药行业资助时，当作者是生产或销售所研究产品的公司的股东时，或者当作者是所涉公司最近或目前的付费顾问时。提交稿件的作者有责任清楚地提供有关研究主题同步时间表的足够详细信息（即，睡眠-觉醒时间表、环境光-暗周期、环境光暴露的强度和光谱、进行研究的季节、涉及轮班工作的研究中的轮班时间表以及涉及年轻女性的研究中的月经周期阶段）。时间序列数据的节律分析应该从不同时期的节律可能叠加在所观察到的感兴趣的时间模式上的角度进行。各种不同的和互补的统计过程可以用于节律检测。与简单的数据检查和叙述性描述相比，将数学模型拟合到时间序列数据提供了对时间序列数据的更好和更客观的分析，并且如果通过客观方法记录节律性，则其表征需要通过相关参数，例如节律的周期（τ）、MESOR（时间序列平均值）、振幅（时间变化范围）、峰值相位（峰值的时间）和深相（谷值的时间）。然而，时间序列建模的基本假设必须在每种情况下都得到满足和适用，特别是余弦分析中的正弦性假设，然后才能被适当地接受。对提交给国际时间生物学的手稿进行同行评审的一个重要方面是判断研究方案和方法是否符合本文所述的标准。
The main objectives of this article are to update the ethical standards for the conduct of human and animal biological rhythm research and recommend essential elements for quality chronobiological research information, which should be especially useful for new investigators of the rhythms of life. A secondary objective is to provide for those with an interest in the results of chronobiology investigations, but who might be unfamiliar with the field, an introduction to the basic methods and standards of biological rhythm research and time series data analysis. The journal and its editors endorse compliance of all investigators to the principles of the Declaration of Helsinki of the World Medical Association, which relate to the conduct of ethical research on human beings, and the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, which relate to the conduct of ethical research on laboratory and other animals. The editors and the readers of the journal expect the authors of submitted manuscripts to have adhered to the ethical standards dictated by local, national, and international laws and regulations in the conduct of investigations and to be unbiased and accurate in reporting never-before-published research findings. Authors of scientific papers are required to disclose all potential conflicts of interest, particularly when the research is funded in part or in full by the medical and pharmaceutical industry, when the authors are stock-holders of the company that manufactures or markets the products under study, or when the authors are a recent or current paid consultant to the involved company. It is the responsibility of the authors of submitted manuscripts to clearly present sufficient detail about the synchronizer schedule of the studied subjects (i.e., the sleep-wake schedule, ambient light-dark cycle, intensity and spectrum of ambient light exposure, seasons when the research was conducted, shift schedule in studies involving shift work, and menstrual cycle stage in studies involving young women). Rhythm analysis of time series data should be performed with the perspective that rhythms of different periods might be superimposed upon the observed temporal pattern of interest. A variety of different and complementary statistical procedures can be used for rhythm detection. Fitting a mathematical model to the time series data provides a better and more objective analysis of time series data than simple data inspection and narrative description, and if rhythmicity is documented by objective methods, its characterization is required by relevant parameters such as the rhythm's period (tau), MESOR (time series average), amplitude (range of temporal variation), acrophase (time of peak value), and bathyphase (time of trough value). However, the assumptions underlying the time series modeling must be satisfied and applicable in each case, especially the assumption of sinusoidality in the case of cosinor analaysis, before it can be accepted as appropriate. An important aspect of the peer review of manuscripts submitted to Chronobiology International entails judgment of the conformity of research protocols and methods to the standards described in this article.