Research Ethics Policy
When reporting the results of experiments on human subjects, the authors should inform the Editors whether the procedures followed have respected the ethical standards of the competent committee on human experimentation (both institutional and national) and the Declaration of Helsinki. In Polish reality, projects that have to be submitted to the Bioethics Committee include, among others:
- invasive tests conducted on patients or volunteers; medical trials (including therapeutic and research trials), commercial and non-commercial clinical trials
- research works including so-called non-interventional trials performed under multi- or single-centre grants
- survey research conducted based on proprietary surveys in the following specialisations: paediatrics and psychiatry, as well as surveys concerning the sexual life sphere (the Committee verifies whether the questions and the way in which they are formulated meet the generally accepted ethical principles)
The projects that usually do not have to be submitted to the Committee include:
- retrospective research, including e.g. the analysis of medical documentation, case studies, if the results of such research does not affect the routine treatment of the patient (e.g. it will not cause a change in treating the patient during observation, as a result of the conclusions of the conducted analysis)
- surveys conducted with use of standardised surveys, used in compliance with their intended purpose, if the aim of the research is the statistical processing of selected elements of the survey
In these cases, the Bioethics Committee may state, on a writ submitted by the interested party, that the research is not a medical trial, does not require an opinion of the Committee and that it is not necessary to issue a resolution.
The statement confirming that the research project was submitted to the Bioethics Committee must be included in the manuscript, along with the name of the Committee and the reference numbers of the permit, if available. The authors must be prepared to provide the editorial team of the journal with further information on request.
In order for a paper to be considered for publication in the journals of Medical Communications Sp. z o.o., the clinical trial has to be registered prospectively (i.e. before the recruitment of participants) in a public trial register. For clinical trials that have not been registered prospectively, a retrospective registration may be required, i.e. authors of such research have to be prepared to provide the editorial team of the journal with additional information on demand (see also: ICMJE – Clinical Trials).
A clinical case study is a detailed clinical report concerning an individual patient. Due to the high level of detail such case studies present a real risk of identifying the person presented. Thus, before every such submission the authors should obtain a voluntary informed consent of the patients (or their legal guardians, if the patient is a minor or is incapable of expressing informed consent, or the closest relatives if the patients died) for publication. The anonymization of the image, i.e. removing personal data and retouching the photograph in order to prevent identification is insufficient. The authors should use their own template of consent and archive the document obtained from the patient, remembering that the editorial team may demand presenting a copy thereof. The manuscript should contain a statement confirming obtaining the consent for publication. More on this subject: see Informed Consent Policy.
When providing detailed information about the patient’s race, ethnic origin, age, religion, sex, sexual orientation, etc., a tactful, non-discriminating and non-stigmatising language should be used.
As for reporting the results of experiments on animals, the authors must indicate whether the applicable institutional and national guidelines for the care and use of laboratory animals have been respected. With respect to the above, the Publisher deems valid the Interdisciplinary Principles and Guidelines for the Use of Animals in Research, Testing, and Education published by the New York Academy of Sciences – Ad Hoc Committee on Animal Research (see also ICMJE – Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals and Author Guidelines on Animal Ethics and Welfare)