Research Ethical Policy and Informed Consent

All submitted manuscripts involving human or animal subjects, or medical records must contain a Statement of Ethics and a Conflict of Interest Statement.

If the Editors of the journal consider a submitted article to be ethically unsound, they may seek further advice or recommend investigation or action. This may be in addition to rejection of the article. In this case the authors will be first asked to respond to editorial concerns. In addition, the Editors may contact the head of the department where the work was undertaken for further comments and suggest a possible investigation. In the cases of serious ethical misconducts the Editors may inform the medical registration body of the article guarantor, senior investigator or regulatory bodies.

If ethical concerns raise after publication, the manuscript may lead to a correction, retraction, or expression of concern in line with COPE guidelines.

 

Studies involving human subjects

Studies involving human subjects must have been performed with the approval of an appropriate ethics committee and with appropriate participants’ informed consent in compliance with the Helsinki Declaration.

Authors submitting papers for publication in the journal should ensure that the quality of the article complies with high ethical standards in line with ICJM recommendations. Such considerations should be part of the planning process prior to undertaking gathering any data about the patient or undertaking the study. Authors must ensure research involving human subjects complies with the Declaration of Helsinki.

Approval from a properly constituted ethical committee or ethical review board is obligatory. For research requiring ethics committee approval, please include a statement to this effect in the Methods section of the manuscript, providing the full name of the ethics committee, and the corresponding number of approval. Authors submitting papers should provide documentary evidence of compliance with this requirement on request. If ethics approval was not required, this should also be detailed in the manuscript (including the name of the ethics committee which made that decision).

An important area of ethical consideration is the obtaining of informed consent from subjects participating in medical research (or their parent/legal guardian where appropriate), and a statement detailing this should appear in the manuscript.

According to the ICMJE recommendations, authors must avoid providing identifying information (written descriptions, photographs and pedigrees) and participants’ identifiable attributes must be anonymised unless the information is essential for scientific purposes and the patient (or parent or guardian) has given written informed consent for publication.

Clinical trials, in particular those involving pharmaceuticals, devices, or aspects relating to nutrition, should be registered prospectively in publicly accessible databases (such as ClinicalTrials.gov and EU Clinical Trials Register), and the paper should include registration numbers and the name of the register. Manuscripts reporting clinical trials must adhere to the relevant reporting guidelines, such as CONSORT for randomized controlled trials, TREND for non-randomized trials.

Case reports must include a statement detailing that written informed consent for publication was obtained and from whom. If the patient described in the case report is a minor or vulnerable or the patient has died, then consent for publication must be obtained from the parent/legal guardian. The consent form should be made available to the journal Editor if specifically requested and will be treated confidentially.

 

Studies involving animals

All manuscript submitted for consideration must have been designed and conducted according to Directive 2010/63/EU, or a relevant institutional and national guidelines and regulations (preferentially following), and considering the welfare, care and use of animals. Approval of research must be obtained from the relevant institutional review board or ethics committee prior to commencing the study. Manuscripts reporting animal research must provide a statement in the Methods section identifying the full name of the ethics committee that approved the study, and the corresponding reference number of approval, and state relevant details of steps taken to ameliorate animal suffering. Authors submitting papers should provide documentary evidence of this requirement on request. To maximize reproducibility and potential for re-use of data, authors are encouraged to upload a completed ARRIVE Guidelines Checklist to be published as supporting information.

Humane endpoints:

All manuscripts describing studies where death is an endpoint (e.g. assessment of survival, toxicity, longevity, terminal disease, or high rates of incidental mortality) must comprehensively report details of study design, rationale for the approach, and methodology, including consideration of humane endpoints. Accordingly, in the Methods sections of the manuscript, authors should report: the specific criteria (i.e. humane endpoints) used to determine when animals should be euthanized, the duration of the experiment, the numbers of animals used, euthanized, and found dead (if any); the cause of death for all animals, how frequently animal health and behaviour were monitored, and all animal welfare considerations taken, including efforts to minimize suffering and distress, use of analgesics or anaesthetics, or special housing conditions.