Policies Clinical Trial Registration


Clinical Trial Registration

All Applis Journals adheres to ICMJE’s Clinical Trials Registration Statement. All clinical trials published in Applis journals must be registered in a public trials registry at or before the onset of participant enrolment. Manuscripts should include the exact URL and unique identification number for the trial registration at the time of submission. This information will be published in the article and we ask that you include the URL and identification number on the title page of your manuscript. A list of recommended registries can be found on the ICMJE website. Results posted in the same clinical trials registry in which the primary registration resides will not be considered prior publication if they are presented in the form of a brief abstract.
Applis journals encourages authors to include a statement that indicates that the results have not yet been published in a peer-reviewed journal, and to update the registration with the full journal citation when the results are published.
Registration of Systematic Reviews
The prospective registration of systematic reviews is welcomed and we encourage all authors to register their systematic reviews in a suitable registry such as PROSPERO. Please include the registration number in the last line of the manuscript abstract.
Standards of Reporting
We recommend all authors to follow the correct standards of reporting regarding biomedical research. Please refer to EQUATOR for guidelines for health research and MIBBI for guidelines and tools for bioscience reporting. Authors are strongly encouraged to use these guidelines as a checklist when writing their manuscripts.
Authors of systematic reviews must provide a link in the Methods section that shows all details of the search strategy. Refer to Cochrane Reviewers’ Handbook for examples of the presentation of search strategies.
Authors must use standardized gene nomenclature. The HUGO Gene Nomenclature Committee details human gene symbols and names. Information on other species can be found at www.genenames.org/about/faq#otherspecies; the Human Genome Variation Society provides guidelines on mutation nomenclature.
Authors are expected to comply with current field-specific standards regarding the preparation and recording of data (www.biosharing.org/standards/), while also maintaining strict patient confidentiality. In addition, when using unpublished data, authors must make contact with the owners of the data before starting their own research.
Human Subjects Research
All research involving human participants must have been approved by the authors’ Institutional Review Board (IRB) or by equivalent ethics committee(s), and must have been conducted according to the principles expressed in the Declaration of Helsinki. Authors should be able to submit, upon request, a statement from the IRB or ethics committee indicating approval of the research. We reserve the right to reject work that we believe has not been conducted to a high ethical standard, even when formal approval has been obtained.
Subjects must have been properly instructed and have indicated that they consent to participate by signing the appropriate informed consent paperwork. Authors may be asked to submit a blank, sample copy of a subject consent form. If consent was verbal instead of written, or if consent could not be obtained, the authors must explain the reason in the manuscript, and the use of verbal consent or the lack of consent must have been approved by the IRB or ethics committee.
All efforts should be made to protect patient privacy and anonymity. Identifying information, including photos, should not be included in the manuscript unless the information is crucial and the individual has provided written consent by completing the Consent Form for Publication in a PLOS Journal (PDF). Download additional translations of the form from the Downloads and Translations page. More information about patient privacy, anonymity, and informed consent can be found in the International Committee of Medical Journal Editors (ICMJE) Privacy and Confidentiality guidelines.
Manuscripts should conform to the following reporting guidelines:
• Studies of diagnostic accuracy: STARD
• Observational studies: STROBE
• Microarray experiments: MIAME
• Other types of health-related research: Consult the EQUATOR web site for appropriate reporting guidelines
• Methods sections of papers on research using human subjects or samples must include ethics statements that specify:
• The name of the approving institutional review board or equivalent committee(s). If approval was not obtained, the authors must provide a detailed statement explaining why it was not needed.
• Whether informed consent was written or oral. If informed consent was oral, it must be stated in the manuscript:
• Why written consent could not be obtained
• That the Institutional Review Board (IRB) approved use of oral consent
• How oral consent was documented
• For studies involving humans categorized by race/ethnicity, age, disease/disabilities, religion, sex/gender, sexual orientation, or other socially constructed groupings, authors should:
• Explicitly describe their methods of categorizing human populations
• Define categories in as much detail as the study protocol allows
• Justify their choices of definitions and categories, including for example whether any rules of human categorization were required by their funding agency
• Explain whether (and if so, how) they controlled for confounding variables such as socioeconomic status, nutrition, environmental exposures, or similar factors in their analysis.
Author Requirments:
Researchers submitting studies involving human participants must meet the following requirements:
Obtain prior approval for human subject’s research by an institutional review board (IRB) or equivalent ethics committee(s)
Declare compliance with ethical practices upon submission of a manuscript
Report details on how informed consent for the research was obtained (or explain why consent was not obtained)
Submit, upon request from the journal, documentation from the review board or ethics committee confirming approval of the research.
For clinical trials, provide trial registration details, the study protocol, and CONSORT documentation (more information below)
Confirm that an identified individual has provided written consent for the use of that information.
Animal Research
All research involving vertebrates or cephalopods must have approval from the authors’ Institutional Animal Care and Use Committee (IACUC) or equivalent ethics committee(s), and must have been conducted according to applicable national and international guidelines. Approval must be received prior to beginning research.
Author Requirements
• Studies involving animals must be conducted according to internationally-accepted standards.

• Authors must obtain prior approval from their Institutional Animal Care and Use Committee (IACUC) or equivalent ethics committee(s).
• The name of the IACUC or equivalent ethics committee, as well as relevant permit numbers, must be provided at submission.
This information should be reported in the manuscript. For further information read the submission guidelines. Applis Publishers requires additional information for studies in which death of a regulated animal (vertebrate, cephalopod) is a likely outcome or a planned experimental endpoint.
Non-Human Primates
Non-human primate studies must be performed in accordance with the recommendations of the Weather all report, The use of non-human primates in research. Manuscripts describing research involving non-human primates must include details of animal welfare, including information about housing, feeding, and environmental enrichment, and steps taken to minimize suffering, including use of anesthesia and method of sacrifice if appropriate.