Human Subjects Research

Ethics approval

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.

Misconduct

CTOR PRESS takes seriously all allegations of potential misconduct. As an aspiring member of Committee on Publication Ethics (COPE), CTOR PRESS and INNOVATION will follow the Committee on Publication Ethics (COPE) for handling cases of suspected research or publication misconduct.

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.