Research Ethics policy

Research ethics policy (Sep 2023 revised version)
• Human and Animal Rights
  

  When reporting experiments on human 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). If doubt exists whether the research was conducted in accordance with the ethical standards, the authors must explain the rationale for their approach, and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should be asked to indicate whether the institutional and national guide for the care and use of laboratory animals was followed.

  Research involving human subjects
  

  When reporting experiments on human 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). If doubt exists whether the research was conducted in accordance with the ethical standards, the authors must explain the rationale for their approach, and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. 

  
  

  All studies that involve human subjects must abide by the rules of the appropriate institutional review board (or equivalent organization) of the institution in which the research was conducted and by the tenets of the World Medical Association’s most recently revised Declaration of Helsinki. A statement regarding ethical approval and Helsinki compliance must be included in the Methods section of the paper.

  Published studies that involve human subjects should not provide subjects’ identifying information (e.g., names, true initials, recognizable images) unless the information is essential for scientific purposes and the patient (or the patient’s parent/guardian) gives written informed consent for publication. If your study requires the appropriate written consent, please send a statement to zgazzz@china-oncology.com affirming that you possess the patient’s informed consent. See the Uniform Requirements for Manuscripts Submitted to Biomedical Journals for further information.

  
  

  Research involving animal subjects

  When reporting experiments on animals, authors should be asked to indicate whether the institutional and national guide for the care and use of laboratory animals was followed.

  
  

  All studies referring animals should follow the ARRIVE guidelines for reporting in vivo experiments in animal research. A statement regarding institutional animal care and use committee approval (or equivalent) must be included in the Methods section of the article.

  
  

  
  

  Clinical trial reporting and registry

  China Oncology welcomes submission of manuscripts reporting on clinical trials whether phase 1, 2, 3 or 4. Reports should include a full description of the study design, patient population, methodology and conduct, and statistical plan. All articles will undergo peer review and will be evaluated for technical merit, novelty, clinical and scientific impact, and other measures to determine suitability for publication.

  As defined by the International Committee of Medical Journal Editors (ICMJE), a clinical trial is ‘any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome’.

  China Oncology follows the trial registration policy of the ICMJE and considers only trials that have been registered before submission, and before the onset of patient enrollment. Acceptable registries must be ICMJE-approved (see more information in the section below).

  For authors reporting phase II and phase III randomized controlled trials, it is recommended to consult the CONSORT Statement and CONSORT Checklist on Equator Network to facilitate the complete and transparent reporting of trial findings. In addition, including a Patient Flow Diagram in the manuscript is recommended for randomized studies.

  Registration number and name of the trial registry must be provided at the end of the article abstract.

  In accordance with the guidelines published by the International Committee of Medical Journal Editors (ICMJE), China Oncology requires, as a condition of consideration for publication, that all clinical trials be registered in any of the primary registers that participate in the WHO International Clinical Trial Registry Platform (ICTRP) or in ClinicalTrials.gov. (See full list here). Trials must be registered at or before the onset of patient enrollment.

  In addition to accepting registration in any of the above five registries, China Oncology will accept registration of clinical trials in any of the primary registers that participate in the WHO International Clinical Trial Registry Platform (ICTRP) or in European Union Drug Regulating Authorities Clinical Trials Database(EudraCT). Registration in a partner register only is insufficient.

  Following ICMJE, China Oncology will not consider results posted in the same clinical trials registry in which the primary registration resides to be previous publication if the results are presented in the form of a brief (< 500 words), structured abstract or table.

  For more information, see the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals.

  
  

  
  

  Informed Consent Policies
  Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent is required for Case report, original/research articles and visualized surgery. The statement should be included in the footnote.

  
  

  
  It may be possible to publish without explicit consent if the report is important to public health (or is in some other way important); consent would be unusually burdensome to obtain; and a reasonable individual would be unlikely to object to publication (all three conditions must be met).

  
  

  
  

  Ethical issues
  Authorship
  The manuscript must have been read and approved by all authors and that all authors agree to the submission of the manuscript to China Oncology. All authors should have made substantial contributions to all of the following: 
   ● conception and design of the study, acquisition of the data, or analysis and interpretation of the data; 
  
   ● drafting of the article or critical revision of the article for important intellectual content; 
  
   ● final approval of the version to be submitted. When authorship is attributed to a group, all authors must meet the listed criteria and must be responsible for the quality, accuracy, and ethics of the work. All authors must participate in determining the order of authorship.
  
  Conflict of interest and source of funding
  China Oncology requires that all sources of institutional, private, and corporate financial support for the work within the manuscript must be fully acknowledged, and any potential conflicts of interest noted. Grant or contribution numbers may be acknowledged, and principal grant holders should be listed.
   
  Submissions will be considered for publication in China Oncology only if they are submitted solely to China Oncology and do not overlap substantially with a published article. Any manuscript that has similar or near similar hypothesis, sample characteristics, methodology, results, and conclusions to a published article is a duplicate article and is prohibited. 

  
  

  Data sharing policy 

  China Oncology follows the data sharing statement policy released by ICMJE:

   The ICMJE’s data sharing statement policy is detailed in an editorial (see Updates and Editorials).

  1.      As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below.

  1. Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial's registration. The ICMJE's policy regarding trial registration is explained above. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.

          2.  Data sharing statements must indicate the following: whether individual deidentified participant data (including data dictionaries) will be shared (“undecided” is not an acceptable answer); what data in particular will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism).

   

  Authors of secondary analyses using shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. They must also reference the source of the data using its unique, persistent identifier to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Authors of secondary analyses must explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their efforts. Those using data collected by others should seek collaboration with those who collected the data. As collaboration will not always be possible, practical, or desired, the efforts of those who generated the data must be recognized.

  (More information should be seen on ICMJE | Recommendations | About the Recommendations)

  
  
  

2023-09-01 Visited: 118141