Research involving human subjects, human tissues, or human data, must have been performed in accordance with the Declaration of Helsinki and must have been approved by an appropriate ethics committee. Authors must explicitly state their adherence to these ethical standards and include the name of the ethics committee and the reference number (where appropriate) in all manuscripts reporting research involving humans.
Ethics exemption
Authors must state clearly if their study was granted an exemption from the required ethics approval, including the name of the ethics committee that granted the exemption. The INNOVATION Editor may request additional information and documentation of the exemption. Failure to comply with the request or with INNOVATION Human Subjects Research Guidelines will result in the manuscript being rejected. If deemed appropriate, the Editor may directly contact the appropriate ethics committee for further information.
Retroactive ethics approval
No manuscript will be accepted for peer review if the appropriate ethics committee approval was granted after the study started.
Non-conventional clinical use of devices or procedures
Authors reporting the non-conventional clinical use of a device or procedure must explicitly state in the manuscript why this approach, rather than use of a conventional device or procedure, was used to treat the study subjects. This justification is not required if the non-conventional device or procedure is already approved for clinical use at the authors’ institution. Authors must obtain ethics committee approval and informed consent from each study subject for any experimental use of the non-conventional use of a device or procedure if no advantage based on clinical need has been established prior to treatment.
Informed Consent to Participate
Informed Consent to Participate in the study must be obtained from each study subject (or the parent or legal guardian of subjects aged 16 years or younger). Authors must explicitly state that such Informed Consent to Participate was obtained in the Methods Section of the manuscript.
Informed Consent for Publication
For all manuscripts that include any identifying data related to individual study subjects (including, but not limited to, age, gender, address, race, ethnicity, image(s), video, audio), written Informed Consent for Publication of these data must be obtained from each subject (or the parent or legal guardian for subjects aged 16 years or younger). If the study subject has died, then Informed Consent for Publication must be sought from the subject’s next of kin. Authors must explicitly state that such Informed Consent for Publication was obtained in the Methods Section of the manuscript. Documentation showing Informed Consent for Publication must be made available to the INNOVATION Editor upon request. All such requests and documentation will be treated confidentially. In cases where images are entirely unidentifiable and there are no details on individuals reported within the manuscript, Informed Consent for Publication of images may not be required. The final decision on whether Informed Consent for Publication is required will be made by the INNOVATION Editor.
Trial registration
Per the World Health Organization (WHO), a clinical trial (Phases I-IV) is
“any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”.
Following ICMJE Guidelines, CTOR PRESS requires all clinical trials published in INNOVATION to be registered in a publicly available database. Authors who are uncertain if their study qualifies as a clinical trial are referred to the ICMJE FAQs for clarification. Publicly available clinical trial registries can be found on the ICMJE website, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov. The trial registration number (TRN) and registration date must be included in the Methods Section and in the last line of the Abstract. Authors who have not obtained a TRN prior to the start of the study should apply for a TRN retrospectively.
Animal Research
All scientific research on vertebrates or any regulated invertebrates must comply with institutional, national, or international guidelines, and must be approved by an appropriate ethics committee. Researchers must adhere to the Animal Welfare Act from the US Department of Agriculture (USDA) and the National Institute of Health (NIH) Guide for the Care and Use of Laboratory Animals.
A statement indicating that approval was granted by the appropriate ethic committee (including the name of the ethics committee and the protocol reference number) must be included in the Methods Section of the manuscript.
If the study was granted an exemption from ethics approval, this must be detailed in the manuscript (including the name of the ethics committee that granted the exemption and the reasons for the exemption).
The INNOVATION Editor has the right to reject a manuscript if the research involves protocols that do not adhere to the Animal Welfare Act (USDA) and the Guide for the Care and Use of Laboratory Animals (NIH), even if an exemption from the ethics committee was granted. In rare cases, the INNOVATION Editor may contact the appropriate ethics committee for further information about protocols used in a submitted manuscript.
Statistical methods
Authors should include full information on the statistical methods and measures used in their research, including justification of the appropriateness of the statistical test used (see SAMPL guidelines for more information). Reviewers will be asked to check the statistical methods, and the manuscript may be sent for specialist statistical review if considered necessary.
Resource Identification
To enable effective tracking of the key resources used to produce the scientific findings reported in the biomedical literature, authors are expected to include a full description of all resources with enough information to allow them to be uniquely identified. In support of the Resource Identification Initiative (RII), we encourage authors to use unique Resource Identifiers (RRIDs) in the manuscript to identify all animals and materials used.
If human cell lines are used, authors must include the following information in their manuscript:
The source of the cell line, including when it was obtained
Whether the cell line has recently been authenticated and by what method
Whether the cell line has recently been tested for mycoplasma contamination
Further information is available from the International Cell Line Authentication Committee (ICLAC) International Cell Line Authentication Committee (ICLAC). We recommend that authors check the NCBI Database NCBI database for misidentification and contamination of human cell lines.
All research involving humans (including data and tissues) and animals must have been conducted within an appropriate ethical framework (see our Research Policies). If the research in a submitted manuscript is suspected of not having been conducted within an ethical framework set by an appropriate ethics committee, the INNOVATION Editor may reject a manuscript and may inform third parties, for example, author(s)’ institution(s) and ethics committee(s) of the suspected misconduct.
In cases of proven research misconduct involving published articles, or where the scientific integrity of the article is significantly undermined, articles may be retracted. See our Retraction Policy for further information.
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