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Ethical issues in innovative clinical research

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Hepatobiliary Surgery and Nutrition 2022年第5期11卷 721-723页

作者： Yudong Qiu Medical ethics committee the Affiliated Drum Tower Hospital of Medical School of Nanjing UniversityNanjingChina

In today’s world,medical science has entered an era of rapid *** new drugs,devices,technologies,and diagnosis and treatment methods continue to emerge,bringing great benefits to our human ***,there are potential risks in the above innovative research and development process,and some can even endanger the health or life of the test *** a result,medical ethics plays an increasingly important role during the rapid development of innovative clinical research,acting as a“brake”on this high-speed *** article will illustrate some medical problems and solutions that are common in today’s clinical research in the following aspects.

关键词： clinical diagnosis drugs

Guidelines for the ethical review of laboratory animal welfare People’s Republic of China National Standard GB/T 35892-2018 [Issued 6 February 2018 Effective from 1 September 2018]

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Animal Models and Experimental Medicine 2020年第1期3卷 103-113页

作者： Judy A.MacArthur Clark Deming Sun JMC Welfare International SandwichKentUK National Research Institute for Health&Welfare and ethics committee of Chinese Association for Laboratory Animal Science BeijingChina

These Chinese National Guidelines(GB/T 35892-20181)were issued February 06,2018 and became effective September 01,*** authors recognized the urgent need for an authentic English translation to inform the international community of the compliance requirements in *** was appreciated that the final translation must reflect the specialist understanding of those working under the Guideline whilst remaining faithful to the meaning of the original Chinese text.A three-step translation process was therefore *** 1:A professional interpretation service(KL Communications,UK)was commissioned to prepare a literal translation of the Chinese *** documents were provided which explained specialist *** translation was checked by two bilingual *** 2:A workshop was held in Nanjing in May 2019 to which were invited experts in laboratory animal welfare and ethical *** included international native English-speaking and Chinese-speaking *** delegates worked in multilingual teams to review sections of the literal translation ahead of the workshop,and to agree an authentic interpretation during the *** 3:Following the workshop,three bilingual experts(two native Chinese speakers and one native English speaker)reviewed the entire document to ensure consistency of terminology and general *** document is thus not a“literal translation”but an“accurate interpretation”of the original *** challenge of work being performed under these Guidelines should rely on the Chinese text in the first ***,this translation may be used as mitigating evidence,especially where those performing the work are non-Chinese speakers.

关键词： speakers authentic terminology

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不当激励机制与学术论文发表的不端行为

科学通报 2015年第25期60卷 2360-2361页

作者： Virginia Barbour 安瑞 committee on Publication ethics (COPE) Brisbane Australia 不详

在过去的一些年里,伴随着新期刊和新的期刊运作模式的产生、新的技术、同行评议模式、以及新的研究协作关系及新传播方式的出现,学术出版行业正在变得越来越复杂.与此同时,学者在论文发表方面所承受的压力也日趋强烈.学术论文被认为是... 详细信息

在过去的一些年里,伴随着新期刊和新的期刊运作模式的产生、新的技术、同行评议模式、以及新的研究协作关系及新传播方式的出现,学术出版行业正在变得越来越复杂.与此同时,学者在论文发表方面所承受的压力也日趋强烈.学术论文被认为是学术界的＂通行货币＂——因其一直是获评终身教授、得到持续的资金支持以及职位晋升的关键因素.而且,当今出版物的＂货币价值＂作用愈演愈烈，其价值直接体现在学者的工资、奖金以及就业等各方面．

关键词：学术论文不端行为学术出版终身教授货币价值同行评议审稿人职位晋升撤稿学术不端

Cohort Study on Prognosis of Patients with Metastatic Colorectal Cancer Treated with Integrated Chinese and Western Medicine

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Chinese Journal of Integrative Medicine 2018年第8期24卷 573-578页

作者： ZHANG Tong HE Wen-ting ZI Ming-jie SONG Gang YI Dan-hui YANG Yu-fei Department of Oncology Xiyuan Hospital of China Academy of Chinese Medical Sciences Second Department of Oncology Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University ethics committee Xiyuan Hospital of China Academy of Chinese Medical Sciences Department of Digestive Oncology Beijing Cancer Hospital School of Statistics Renmin University of China

Objective： To investigate the efficacy of integrated Chinese and Western medicine（IM） in the treatment of metastatic colorectal cancer（m CRC） in a cohort ***： The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine *** study design was adopted with ＂continuous administration of Chinese medicine for 3 months＂ as the exposure *** who met this exposure factor were assigned to the IM cohort（Group A,110 patients）.Patients who did not meet this exposure factor were assigned to the Western medicine cohort（Group B,225 patients）.The overall survival（OS）,progression-free survival（PFS）,and 1 st year,2 nd year,and 3 rd year survival in the two cohorts were ***： The median OS in Group A and B were 18 months [95% confidence interval（CI） 15-21] and 16 months（95% CI 14-18）,respectively,and the median PFS in Group A and B were 6 months（95% CI 4-7） and 5 months（95% CI 4-6）,*** statistically significant differences were observed between the groups（P=0.186,P=0.223）.Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups： female patients,patients with lesions in the right half of the colon,and those who received first-line treatment（P〈0.05）.In the subgroup of elderly patients（age〉65 years）,the OS in Group A was longer than that in Group B（P〈0.05）.Conclusion： IM could prolong the survival of patients with m CRC.（Registry *** CTR-IOR-17010497）

关键词： cohort study metastatic colorectal cancer integrative medicine

Medical ethics Review in China

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Medical Ethics Review in China

The concepts of assent and parental permission in pediatrics

科研伦理培训与伦理审查能力建设专题研讨会

作者： Minsheng Fan Shanghai University of Traditional Chinese Medicine National Medical ethics Expertise committee of NHFPC

＜正＞～～

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World Journal of Pediatrics 2014年第1期10卷 89-90页

作者： Urh Groselj Hassib Narchi Department of Pediatric Endocrinology Diabetes and Metabolic DiseasesUniversity Children's Hospital Ljubljanaand National Medical Ethics Committee of Slovenia LjubljanaSlovenia Department of Pediatrics College of Medicine&Health Sciences United Arab Emirates University Al Ain United Arab Emirates

The recently published article by Narchi et al[1]brings an important empirical insight into a very complex issue of parental consent for lumbar puncture(LP)in children;quite worrisome observation from authors'clinical practice that almost half of the parents refused to give consent for the LP is confirmed.[1]However,the concept of(parental)consent,used by Narchi et al,[1]would need to be further elaborated with introduction of two other important concepts in pediatrics-child's assent and parental *** concepts were endorsed by the policy statement of the American Academy of Pediatrics(published in 1995;reaffirmed in 2011).[2]Accordingly,only the patients with appropriate decisional capacity could give their informed *** all other situations,parents provide informed permission for an intervention on their child,with assent of the child if appropriate.[2]Most of children from age seven are thought to understand basic information if adequately presented,[3]The need for assent was also supported by the Confederation of European Specialists in Pediatrics,stating that all children have a right to give their assent(or dissent)and may refuse interventions that are not necessary to save their lives or prevent serious harm.[4]Furthermore,the responsibility to make decision in children is shared between physicians and *** later should provide informed permission before interventions(except in emergency situations),which includes all the elements of informed consent,reflecting the child's best interests.

关键词： parental statement consent

The 2nd International Conference on ethics and Laws of Communication ＆ Journalism Call for Speakers and Conference Theme

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The 2nd International Conference on Ethics and Laws of Commu...

Revaluation of Drug with Abnormal Behavior,and Medical statistical-ethics,etc.

作者： Organizing committee of the 2~(nd) International Conference on ethics and Laws of Communication & Journalism Department of Journalism and Communication of China Youth University for Political Sciences The Global Alliance of Media ethics and Law The Global Rhetoric Society Organizing committee of the 2 International Conference on ethics and Laws of Communication ＆ Journalism Department of Journalism and Communication of China Youth University for Political Sciences The Global Alliance of Media ethics and Law The Global Rhetoric Society

＜正＞Dear colleagues,The Global Alliance of Media ethics and Law（GAMEL）plans to convene the2nd International Conference on ethics and Laws of Communication＆Journalism in Beijing in the spring（April or May）of *** conference program consists of presentations selected from submitted paper abstracts,student papers,and proposals

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Revaluation of Drug with Abnormal Behavior,and Medical stati...

第十二次全国医学遗传学学术会议

作者： LIU Li ZENG Fandian YANG Xiaoyan Institute of Clinical Pharmacology Department of PharmacologyTongji Medical CollegeHuazhong University of Science and Technology The Clinical Trial ethics committee of Huazhong University of Science and Technology Wuhan

Objectives Under the condition of great asymmetry in medical information,we predicted there were serious problems with famous antiplatelet clopidogrel’s core data from the analysis of its abnormal behaviors after its *** hoped to find direct evidence that core data of phaseⅢCAPRIE trial of clopidogrel must be wrong according to the forecast and deduction on the basis of behavioral economics,and that it was noise trading and effect of herd behavior, instead of practical therapeutic effect that made anti-platelet clopidogrel the global’s second-largest selling lemon drug,and we hope that our findings will be helpful for families and the society to reduce high expenditure on medical treatment,revising medical statistical theory from the impeccable negative example,and building new disciplines such as medical statistical-ethics,medical-behavioral economics,*** Based on methodology of phaseⅢCAPRIE trial,we studied the core data of CAPRIE trial’s results by philosophy,logistics and *** In the table 6 of CAPRIE study,all of the data of fatal events between the fourth and fifth subgroup(Clopidogrel,No.4 subgroup:No.5 subgroup=490:560;Aspirin,No.4:No.5 =487:571),between the second and third subgroup(Clopidogrel,No.2:No.3 =302:350;Aspirin, No.2:No.3 subgroup =314:378),between the first and second subgroup(Clopidogrel,No.1: No.2 =308:302;Aspirin,No.l:No.2 =321:314) were unbalanced or *** The statistical data and analysis of the CAPRIE study were wrong and *** results of CAPRIE were distorted or false and couldn’t demonstrate that clopidogrel was superior to aspirin. Statisticaly significant(p=0043) relative-risk reduction of 8-7%in favour of clopidogrel(95%CI 0-3-16-5) came from the virtual *** of clopidogrel would reduce the unnecessary burden on family and society and maybe save several billion dollars every *** suggested modifying guidelines for clopidogrel administration,revising medical statistical the

关键词： clopidogrel aspirin anti-platelet therapy randomized blinded trial sample size ischemic stroke myocardial infarction medical statistical-ethics pharmaco-behavioral economics healthy-behavioral economics.

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科研道德委员会面临的挑战:一些实际建议

英国医学杂志中文版 1998年第1期1卷 45-47页

作者： Jennifer Blunt Julian Savulescu Alastair J M Watson 陶涛 Manchester M45 7PR former chairman salford Research ethics committee Oxford Radcliffe Hospitals Oxford OX3 9RP clinical ethicist Department of Medicine University of Manchester Hope Hospital Salford M6 8HD senior lecturer

本文要点地方性科研道德委员会面临几个挑战:研究的规模、类型和复杂性不断增加;建立一个多中心科研道德委员会系统;缺乏对研究结果的汇总;发现科研失误和欺骗。面对这些挑战,地方性委员会必须有受过良好训练、具备多种技能的会员,充足... 详细信息

本文要点地方性科研道德委员会面临几个挑战:研究的规模、类型和复杂性不断增加;建立一个多中心科研道德委员会系统;缺乏对研究结果的汇总;发现科研失误和欺骗。面对这些挑战,地方性委员会必须有受过良好训练、具备多种技能的会员,充足的人力及财力资源,以及一个监督已批准的研究项目进程的体系。在多中心研究中,道德评估由多中心委员会和地方性委员会共同承担,后者只保留本地承认的决定权。假如地方性和多中心科研道德委员会采用共同的道德审查标准,其效果和效率将得到提高。

关键词：科研道德审查标准项目进程财力资源监督质量科研结果科研人员科研项目研究项目欺骗行为