The following aspects of bioethics policy compliance requirements are covered:
– Requirements for manuscripts related to the publication of research results involving animals and humans.
– Requirements for manuscripts related to the consent of the research participants.
– Requirements for manuscripts in terms of registration of a clinical trial.
– Requirements for manuscripts in terms of the principles of describing human biological samples.
– Requirements for manuscripts that report experiments involving human embryos, gametes and stem cells.
– Requirements for the presentation of experimental data in manuscripts.
– Requirements for supplements and supplementary materials for manuscripts.
Requirements for manuscripts related to the publication of research results involving animals and humans
A manuscript derived from research involving living vertebrates and/or higher invertebrates must include a statement identifying the institutional and / or licensing committee approving the experiments. At the same time, all possible details of the experimental part of the study should be reported, including housing conditions, sex of animals, other characteristics that could have a significant impact on the results obtained. The authors are advised to follow the principles of the EU Directive 2010/63/EU on the protection of animals used for scientific purposes in the course of such studies, conducting experiments in accordance with the recommendations of ARRIVE.
A manuscript prepared from research involving human subjects must contain a statement of consent from all research participants obtained after being fully informed about the research. Authors should determine a committee to approve the study by conducting the study in full compliance with the World Medical Association's Code of Ethics (Declaration of Helsinki), verifying personally that the requirements of the Code have been met and confirming it with their statement in the manuscript.
A manuscript based on research involving vulnerable groups should explain why the categorization was important, for example, based on disability, disease, race, ethnicity, etc. the editorial board considers insufficient, it will ask for additional documentary evidence. Such evidence may take the form of blank consent forms and other appropriate discussion papers from the ethics board. Such an additional check is considered by the editors as measures for additional assurance of compliance by the author with the requirements of the bioethics policy.
Requirements for manuscripts related to the consent of the research participants
In cases where research is conducted with human participation, authors must obtain appropriate permission from research participants. However, authors should be guided by the principle that the provision of any information about research participants must comply with all applicable laws and regulations regarding the privacy and / or security of personal information. For authors from Ukraine, the law of Ukraine "On the seizure of personal tributes" is regulating.
Below are the main points of responsibility of authors:
– the need to notify an individual, the guardian of this person or another person empowered to act on behalf of this person, about the intention to create a photo, video recording, any other image in an identifiable form, and about the purpose of these actions. Each such person must give the author explicit written consent for the author to perform such actions, which must remain with the author and, if necessary, if requested by the editors, provide a copy of such consent. When research involves children, special attention must be paid to obtaining consent. In a situation where the child's parents or guardians do not agree that the child's image will be used, consent is not considered obtained;
– the need to ensure that parts that allow identifying a person are not visible in the image, or that references are made to the person's name/surname or other personal data in the text. Image captions must be respectful;
– the need to ensure that the manuscript does not use hospital/social security numbers, as well as personal information such as dates of birth, names/initials of research subjects;
– the need to ensure that images of research subjects are not used in the manuscript, even if consent was obtained, but the image itself does not carry informational load in the context of obtaining scientific results. The deliberate changes in the identification parameters of research subjects allowed in order to protect anonymity imply obligatory guarantees of the authors regarding the invariability of the scientific meaning. For the purposes of anonymity, when no consent has been obtained, it is not enough to use blurring of the face or applying a black stripe over the eyes for photographs. Consensus at the level of formalization is not necessary if the images themselves are completely anonymous: X-rays, ultrasound images, pathology slides or laparoscopic images. Moreover, such images should not contain any identification marks and text that will allow the identification of the subject.
Requirements for manuscripts regarding registration of a clinical trial
If the manuscript reports on the conducted clinical trials, it is mandatory to indicate that these clinical trials were registered before the registration of patients, and information about this can be stored in a public storage, unless the main purpose of the trials was to study pharmacokinetics.
Requirements for manuscripts in terms of principles for describing human biological samples
If it is necessary to use a description of human biological samples in the manuscript, the editors recommend using the BRISQ reporting guidelines.
Requirements for manuscripts reporting experiments involving human embryos, gametes, and stem cells
If the results of experimental studies of human embryos and gametes, human embryonic stem cells and related materials are presented in the manuscript, as well as the results of the clinical use of stem cells, it is necessary to cite the corresponding ethical statements in the manuscript. Such statements should be based on guidelines from institutional and/or licensing committees endorsing such experiments. Such statements must contain the consent obtained from all recipients and/or donors of cells or tissues, and a description of the conditions for the donation of materials for research, in particular human embryos or gametes.
If necessary, due in part to doubts about compliance with the guidelines, the editors may request copies of approved and revised documents confirming compliance with the necessary conditions in relation to the consent received.
Requirements for the presentation of experimental data in manuscripts
The experimental part of the manuscript should contain the most detailed description of each set of data used, contain information regarding the repeatability of the experiments and the applied data processing methods. The significance of the estimated parameters representing the results should be checked for the selected level of significance (confidence level), the corresponding results should be reflected in the manuscript. Lack of such information is considered as insufficient evidence base in relation to the results obtained.
Requirements for attachments and additional materials for manuscripts
If desired, the authors can submit to the editorial office additional materials confirming the results obtained in the course of the study. These can be video or audio files, screenshots or printouts of the results of using (displaying) software products, Excel files, etc.