美国营养学会及其《美国临床营养杂志》与《中华临床营养杂志》合作纪要

应美国营养学会（American Society of Nutrition,ASN）首席执行官和《美国临床营养杂志》（American Journal of Clinical Nutrition,AJCN）总编邀请,《中华临床营养杂志》（Chinese Journal of Clinical Nutrition,CJCN）代表团于2012年4月2313在美国圣地亚哥参加中、美双方协作会议,通过讨论达成共识,签订了合作备忘录。     

慢性病观察性研究论文统计学应用评价

目的 评价中华医学会影响因子在0.5以上的核心期刊中慢性病观察性研究论文的统计学应用情况.方法 选择近5年影响因子在0 5以上的中华医学会系列杂志,采用自行设计的调杳表,对是否有研究设计类型、样本量估计、变量及赋值描述,以及统计描述、推断及解释等进行调查,分析慢性病观察性研究论文统计学应用情况.结果 共 有《中华流行病学杂志》、《中华预防医学杂志》、《中华心血管病杂志》、《中华内分泌代谢杂志》、《中华内科杂志》和《中华肿瘤杂志》6种期刊中的352篇慢性病观察性论著人选.明确说明研究目的、目标对象、抽样对象、对象入选标准和变量定义率的分别为99.43％、98.57％、95.43％、92.86％和96.87％;计量资料和分类变量描述正确率分别为90.94％、91.46％;计量资料、分类变量及模型推断正确表达率分别为100％、95.32％和87.19％;研究结论正确回应研究目的的占89.49％.没有明示研究设计类型的占69.60％,需要进一步说明人选对象排除标准而没有说明的占11.14％,仅有5.16％论著提及了样本量估计情况,变量赋值说明率为24.21％.介绍了数据库建立方法的为24.15％,18.75％论著统计推断方法介绍不全.进行率标准化的论著约有1/4使用不当,对统计检验前提条件进行验证和说明的仅占24.12％,有9.94％论著需要做推断分析而未做.结论 目前中华医学会系列杂志发表的慢性病观察性研究论文统计学应用总体良好,但设计类型表述、样本量估计、变量赋值说明不充分;统计方法介绍不够明确;应加强了解统计推断使用的前提条件.     

《环境卫生学杂志》投稿要求

正《环境卫生学杂志》采用电子版投稿,来稿要求:(1)论文内容真实、数据准确,无泄密,有创新或有实际意义;(2)论文无一稿两投,文责自负,并同意编辑部作必要的文字修改;(3)涉及人体研究的应说明程序合法、得到相关伦理委员会批准及受试者知情同意,涉及动物的研究也需注明喂养符合相关标准和程序、实验过程符合相关保护法;(4)原创性论文其科研设计及数据处理需经统计学专家认可,英文摘要及涉及英文的内容也需经过相关专家认定;(5)请在投稿时填写论文版权转让协议书,经所有作者签名后,连同单位推荐信,尽快邮寄给本刊编辑部。     

《中国计划生育学杂志》论文中医学伦理意识的调查与思考

目的:从科技论文角度探讨我国计划生育科研工作中存在的医学伦理学问题。方法:查阅2005～2009年《中国计划生育学杂志》发表的学术论文,统计作者自述"通过伦理委员会审查""研究对象知情同意"情况。结果:5年间共出版60期(月刊),发表了以人为研究对象、前瞻性研究论文681篇,其中论文说明研究"经过伦理委员会审查"仅4篇(0.59%),"研究对象知情同意"49篇(7.20%)。结论:本次调查论文有关医学伦理学阐述的比例很低,反映出计划生育科研论文作者和编辑者的伦理学意识相当薄弱,与国外生物医学期刊差距较大。提示科技管理部门应重视对科研人员伦理学知识的宣传教育,加强计划生育科研工作伦理学规范。通过完善期刊编审程序,加强科研伦理学审查提高论文质量,促进我国人口和计划生育科学研究健康持续发展。     

我国医学期刊论文的伦理学评价

目的 促进我国医学期刊的正确导向,引导医学临床试验,切实加强对试验对象的伦理学保护。方法 收集2004-2013年发表在134种医学期刊310篇肿瘤随机对照临床试验论文,对其伦理学评价,比较核心与非核心期刊、中华与非中华医学系列期刊论文的伦理学差异。结果 发现我国医学期刊论文的伦理学水平整体较低;存在临床试验注册不足;知情同意、伦理委员会批准和不伤害方面有待改善等问题。结论 我国医学期刊论文的伦理学评价不乐观,需要进一步完善伦理委员会的审查、监督体系,提高作者和编辑的伦理学意识等等。     

医学期刊对涉及人的研究论文进行伦理审查的原则及实践路径

【目的】提高国内医学期刊的伦理规范意识,促进医学期刊发挥正确的伦理学导向作用。【方法】采用文献分析法,通过分析医学期刊对涉及人的研究论文进行伦理审查的意义,探讨其伦理审查的原则及实践路径。【结果】医学期刊作为坚守科研道德阵地的最后防线,对涉及人的研究论文进行伦理审查具有重要的时代意义,应坚持维护受试者利益、科学性、知情同意等原则,并通过完善投稿须知或稿约、把好审稿关等相关路径予以实现。【结论】医学期刊对涉及人的研究论文进行伦理审查具有重要意义,应坚持有关原则进行审查,并通过相关实践路径实现规范有序的伦理审查。     

《中华性传播感染杂志》英文版征文启事

Chinese Journal of Sexually Transmitted Infections(中华性传播感染杂志英文版)是中华临床医药学会、中华性传播感染研究学会和深圳市慢性病防治院皮肤性病防治研究所主办,香港医药科技出版社出版,面向全世界发行的有关性传播感染科学的英文版专业学术期刊(国际刊号:ISSN 1608-6260/ CN 98-0022/HK)。本刊为季刊,以预防部门广大性病艾滋病防治人员,临床相关部门如皮肤科、泌尿外科、妇产科、性学科、检验科及传染科等专业技术人员为主要读者对象。本着"让世界了解中国、让中国走向世界"的宗旨,反映我国包括大陆、台湾、香港、澳门及邻近国家地区的有关性传播感染、HIV/ AIDS及性医学的基础、临床、流行病学、防治等研究工作的进展,促进性传播感染科学的学术交流。征文栏目:论著(基础、临床及流行病学及防治研究)、短篇论著、述评、综述、病例报告、读者来信、消息等。欢迎踊跃投稿。     

基于Citespace软件的医院感染文献可视化分析

目的探讨CiteSpace软件对医院感染近3年发表文献的可视化应用。方法用CiteSpace 5.3.R4软件,对2016-2018年CNKI和Web of Sciences数据库收录的医院感染文献进行归纳分析,检索中文期刊《中华医院感染学杂志》,英文期刊《Infection Control and Hospital Epidemiology》,《American Journal of Infection Control》,《The Journal of Hospital Infection》发表的所有文献,进行国家、研究机构、作者、关键词的可视化分析。结果共纳入4 770篇中文文献,1 569篇英文文献。从国家和研究机构来看,美国、加拿大、中国位列前3名,美国疾病预防控制中心发表文献最多,我国发表最多的为解放军总医院感染管理与疾病控制科。Donskey CJ、Safdar N等在国际领域具有较大影响力,我国刘运喜、胡必杰、高晓东、索继江等学者在国内有较大影响力。英文高频关键词为risk factor、epidemiology、surveillance、prevention,中文高频关键词为病原菌、危险因素、耐药性。值得注意的是,血流感染、病原学、炎症因子、老年等为我国最近新兴的研究热点。结论 CiteSpace软件能直观展示国内外医院感染研究领域的热点和趋势。     

转化医学中利益冲突及其影响

医学、法律和伦理是相互伴生的科学.近年来,转化医学的提出及其开展,促进基础研究成果的快速的临床转化和应用,促使研究成果尽快形成市场化的产品,提高医疗诊断水平和促进健康.同时面临一些新的挑战,产生新的伦理问题,并使一些现有伦理问题更为凸显.开展转化医学具有潜在的风险和问题,利益冲突,及其对受试者权益保护和知情同意的潜在影响还没有受到应有的重视,需要伦理委员会加强审核.     

膳食纤维降乳腺癌风险

<正>中美两国学者2月16日在线发表于《欧洲营养学杂志》(European Journal of Nutrition)的一项研究表明,绝经前女性摄入可溶性膳食纤维与雌激素受体(ER)阴性乳腺癌风险显著降低相关。该研究结果尚需更大样本量研究的证实。     

'Informed consent' in public health activities: based on the universal declaration on bioethics and human rights, UNESCO

OBJECTIVES: The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. METHODS: The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. RESULTS: It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. CONCLUSIONS: Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.     

医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

【目的】 探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】 通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】 共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】 编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。     

《中华流行病学杂志》1999-2005年学术质量评估及影响力分析

目的分析《中华流行病学杂志》近7年各项期刊被引用计量指标及学术质量和影响力。方法检索该刊1999—2005年载文中述评、原著论文、论文摘要、综述等，并对作者来源地区、载文及引文信息进行统计分析，对标志杂志学术质量及影响力的总被引频次、影响因子、即年指标、他引总引比、基金项目等指标进行综合比对。结果该刊1999—2005年载文中作者来自全国26～31个省（直辖市）；大部分作者来自国内医学相关高等院校、省及省级以上科研和疾病预防控制机构，论文比为0．60～0．77；年度载文量由206篇增加到367篇；信息充分度由2．0增加到2．8，信息量略有下降；年度参考文献量由575条增加到2992条，外文引文能力由46．1％增加到77．4％；7年内学术质量及影响力略有波动，但各指标一直维持在国内较高水平。结论该刊作者群覆盖地区较广；年度载文量和信息充分度增加；引文能力呈自然状态，基本稳定，外文引文能力逐年增加；目前该刊学术质量在国内同类期刊中处于较高水平。     

2007年首都医学发展科研基金申请书伦理自评及管理状况调查

目的评价2007年首都医学发展科研基金伦理管理现状。方法采用现况调查方法对基金申请标书做描述性分析,评价基金申请人对临床研究伦理问题的认知和基金伦理管理现状。结果652份申请书覆盖北京地区14区2县128家医院。申请者对伦理问题有一定认识的占88．7％;标书中考虑了受试者知情同意的占72．5％;考虑研究工作可能对受试者造成伤害的潜在风险的占62．0％;说明研究工作将保护受试者个人隐私的占49．4％;但进行受益／风险评估的仅有28．7％。三级医院申请者对伦理问题有一定认识的比例（90．2％）高于二级医院和一级医院（84．6％）。教学系统附属医院申请者对伦理问题有一定认识的比例（93．9％）高于军队系统医院（80．2％）。55岁及以上申请者对伦理问题有一定认识的比例（70．0％）低于其他年龄段申请者（89．2％）。描述性研究和病因学研究申请者对伦理问题的认识低于其它类型的研究者。578份申请书填写了医院伦理委员会或科研管理部门伦理审查意见,其中62．6％的填写基本规范。结论2007年北京地区临床研究基金申请者中多数对l临床研究涉及的伦理问题已有初步认识,但认识水平亟需提高。医院伦理委员会或科研管理部门已开始对临床研究基金申请进行伦理审查管理。在临床研究基余中开展伦弹管理的外部条件已初步具备。     

Epidemiology between ethics and politics

Over the last two decades ethics in epidemiology has been the subject of a substantial number of conferences, books, articles, guidelines as well as training courses. The relevance of ethics for epidemiology does not make the ethical approach sufficient to exhaust the analysis of the relationship between epidemiology and society: on one side the ethical assessment of an epidemiological investigation is not self-sufficient but depends on the evaluation of the scientific worth of the study (a planned study involving humans is automatically unethical if scientifically unsound) and, on the other side, to be of practical value it needs expanding as to its policy implications. A few remarks on two issues, ethics committees and human reproductive cloning, support the general contention that translating knowledge into effective public health actions may be grounded in ethical considerations but necessitates a substantial development at political level.     

STrengthening the Reporting of OBservational studies in Epidemiology: Molecular Epidemiology STROBE-ME. An extension of the STROBE statement

Advances in laboratory techniques have led to a rapidly increasing use of biomarkers in epidemiological studies. Biomarkers of internal dose, early biological change, susceptibility, and clinical outcomes are used as proxies for investigating the interactions between external and/or endogenous agents and the body components or processes. The need for improved reporting of scientific research led to influential statements of recommendations such as STrengthening Reporting of Observational studies in Epidemiology (STROBE) statement. The STROBE initiative established in 2004 aimed to provide guidance on how to report observational research. Its guidelines provide a user-friendly checklist of 22 items to be reported in epidemiological studies, with items specific to the three main study designs: cohort studies, case-control studies and cross-sectional studies. The present STrengthening the Reporting of OBservational studies in Epidemiology - Molecular Epidemiology (STROBE-ME) initiative builds on the STROBE Statement implementing 9 existing items of STROBE and providing 17 additional items to the 22 items of STROBE checklist. The additions relate to the use of biomarkers in epidemiological studies, concerning collection, handling and storage of biological samples; laboratory methods, validity and reliability of biomarkers; specificities of study design; and ethical considerations. The STROBE-ME recommendations are intended to complement the STROBE recommendations.     

Scientific research on human subjects and ethics procedures at the Istituto Superiore di Sanità: a survey of the articles issued in 2001

Principles promoting the protection of subjects involved in biomedical research are interpreted differently within the scientific community. The purpose of this paper is to describe the attitudes of researchers working at the Istituto Superiore di Sanità (ISS) regarding the ethical implications of studies involving human beings, with particular emphasis on aspects concerning informed consent (IC) and ethics committee (EC) review. In 2001, ISS researchers published a total of 733 articles, 93 (12.7%) of which were studies involving human beings. Nearly 2/3 (60/93) were epidemiological, while the remaining 35.5% were based on laboratory data. Half (47/93) reported physical or psychological interventions or treatments on study subjects. 40.9% of articles mentioned that informed consent had been obtained and only 12.9% that approval had been given by an ethics committee. The low proportion of articles on which a protocol had been submitted the EC was due in part to the type of studies, but also to the absence of an institutional EC prior to 2001. Ethical procedures were more present in laboratory than in epidemiologic studies (IC: 69.7% vs 25.0%, p < 0.001) (EC: 27.3% vs 5.0% p = 0.004). Those differences were more likely due to the less interventionist nature of the epidemiologic studies rather than in poor ethical awareness on the part of epidemiologists. Further efforts are needed to develop and enforce clear institutional policies regarding ethical procedures.     

Informed consent in China: quality of information provided to participants in a research project

AIMS: A study was carried out of informed consent strategies in an epidemiological project approved by the regional research ethics committees in Sweden and China and conducted in three areas south-west of Shanghai. METHODS: All participants in the epidemiological project (EP) were included in the research ethical study (RES), which was conducted as a questionnaire-based interview survey in the three areas. Answers were collected by five field interviewers. RESULTS: All participants included answered the questionnaire. Almost all perceived the information provided as rather good or quite good. However, a majority (on average 76%) had the impression that the EP was part of routine healthcare measures, and not a research project. Almost all participants felt free to abstain from participation although 38% in area II stated that they had not been informed about freedom to abstain from participation. A large proportion of participants did not fully understand the nature of the EP. However, almost all participants stated that they would agree to participate in a similar study in the future. CONCLUSION: Although informed consent procedures are supposed to be internationally applicable our study illustrates that it is not always easy to convey information and obtain consent in the present study setting.     

Ethics,big data and computing in epidemiology and public health

PurposeThis article reflects on the activities of the Ethics Committee of the American College of Epidemiology (ACE). Members of the Ethics Committee identified an opportunity to elaborate on knowledge gained since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000.MethodsThe ACE Ethics Committee presented a symposium session at the 2016 Epidemiology Congress of the Americas in Miami on the evolving complexities of ethics and epidemiology as it pertains to “big data.” This article presents a summary and further discussion of that symposium session.ResultsThree topic areas were presented: the policy implications of big data and computing, the fallacy of “secondary” data sources, and the duty of citizens to contribute to big data. A balanced perspective is needed that provides safeguards for individuals but also furthers research to improve population health. Our in-depth review offers next steps for teaching of ethics and epidemiology, as well as for epidemiological research, public health practice, and health policy.ConclusionsTo address contemporary topics in the area of ethics and epidemiology, the Ethics Committee hosted a symposium session on the timely topic of big data. Technological advancements in clinical medicine and genetic epidemiology research coupled with rapid advancements in data networks, storage, and computation at a lower cost are resulting in the growth of huge data repositories. Big data increases concerns about data integrity; informed consent; protection of individual privacy, confidentiality, and harm; data reidentification; and the reporting of faulty inferences.