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1、,第四军医大学唐都医院神经外科,Privacy and Confidentiality,Patients have a right to privacy that should not be violated without informed consent.Identifying information,including names,initials,or hospital numbers,should not be published in written descriptions,photographs,or pedigrees unless the information is es
2、sential for scientific purposes and the patient(or parent or guardian)gives written informed consent for publication.Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published.Authors should disclose to these patients whether any potential identif
3、iable material might be available via the Internet as well as in print after publication.Patient consent should be written and archived with the journal,the authors,or both,as dictated by local regulations or laws.,Protection of Human Subjects and Animals in Research,When reporting experiments on hu
4、man subjects,authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation(institutional and national)and with the Helsinki Declaration of 1975,as revised in 2008(5).If doubt exists whether the research was
5、 conducted in accordance with the Helsinki Declaration,the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study.,Obligation to Register Clinical Trials,The ICMJE believes that it is important to
6、 foster a comprehensive,publicly available database of clinical trials.The ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical interven
7、tion and a health outcome.Medical interventions include drugs,surgical procedures,devices,behavioral treatments,process-of-care changes,and the like.,It is important to note that the ICMJE requires registration of trial methodology but does not require registration of trial results;it recognizes the
8、 potential problems that could arise from the posting of research results that have not been subjected to an independent peer-review process,The ICMJE will not consider results to be previous publication if they are posted in the same primary clinical trial registry as the initial registration and i
9、f the results are posted in the tabular form dictated by the FDAAA.,The ICMJE recommends that journals publish the trial registration number at the end of the abstract.The ICMJE also recommends that,whenever a registration number is available,authors list this number the first time they use a trial
10、acronym to refer to either the trial they are reporting or to other trials that they mention in the manuscript.,The ICMJE does not advocate one particular registry,but its member journals will require authors to register their trial in a registry that meets several criteria.The registry must be acce
11、ssible to the public at no charge.It must be open to all prospective registrants and managed by a not-for-profit organization.There must be a mechanism to ensure the validity of the registration data,and the registry should be electronically searchable.An acceptable registry must include at minimum
12、the following information:a unique identifying number,a statement of the intervention(or interventions)and comparison(or comparisons)studied,a statement of the study hypothesis,definitions of the primary and secondary outcome measures,eligibility criteria,key trial dates(registration date,anticipate
13、d or actual start date,anticipated or actual date of last follow-up,planned or actual date of closure to data entry,and date trial data considered complete),target number of subjects,funding source,and contact information for the principal investigator.To our knowledge,at present,only www.clinicaltrials.gov,sponsored by the US National Library of Medicine,meets these requirements;there may be other registries,now or in the future,that meet all these requirements,敬请各位老师、同学批评指正 谢 谢,
