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Bioethics policy

Research with Human Participation and Consent

If research participants are human, authors must indicate the committee that approved the research and confirm compliance with the Code of Ethics (Declaration of Helsinki), include a statement in their manuscript confirming that informed consent has been obtained from all participants. Authors should be aware that the provision of any information about research participants must comply with laws regarding the confidentiality and security of personal information. It is recommended, in particular, to comply with the principles of the regulator GDPR (EU) 2016/679. The editorial board of the journal reserves the right to request documentary evidence from the author regarding confirmation of consent. Such evidence includes blank consent forms and documents from the ethics board. In the event that the study involves vulnerable groups, divided / identified according to some principle, such as: by race, ethnicity, gender, disability, disease, etc., an additional check is possible, including with a request for appropriate confirmation. In this case, the manuscript must necessarily contain justifications for the need for appropriate categorization.

If in the manuscript it is planned to use any images related to the visual display of individuals, the author should follow the following principles:

– each individual must be informed about the fact of using the image in the manuscript and the purpose of such use, and from such person must be given a written consent to the use of images. In the capacity of such a person, if it is personally impossible for him to give consent, and there are legal grounds, a legal guardian or other person authorized to legally represent this individual may act;

– if we are talking about a child, then the consent of his parents or guardians is required. If such consent is not given from them, the images cannot be used;

– if all consent is obtained and the image is used in the manuscript, then the captions of the images and the text associated with them should not contain elements (statements, hints, etc.) that demean the dignity of the person being portrayed, and represent him in an unworthy form, and be completely respectful;

– images of research subjects and their identification data should not be used in the event that this information is not important for the scientific purposes of the research and explicit permission has not been given within the framework of the consent;

– if the characteristics of the subject contain data that allow him to be identified, but have been changed to protect anonymity, the authors must provide guarantees that such changes do not distort the scientific meaning in the context of the full manuscript or a separate part of it;

– any personal or identifying information such as: patient names, initials, dates of birth, hospital or social security numbers, etc. is not recommended;

– if the manuscript contains identifiable images of research participants, it must include a statement from the author that they received informed consent to publish the images;

– to protect the anonymity of research participants, the authors must take all necessary measures, and, if necessary, the editorial board reserves the right to obtain evidence regarding the authors' informed consent. In the absence of the latter, the manuscript is not considered.

– if no consent was obtained from the research participants, then to maintain anonymity it is not enough to use a black strip in front of the eyes or blur the face of the person concerned in the photograph (image).

Formal consent is not required only if completely anonymous images are used, by which it is impossible to identify a person. The latter include: X-rays, ultrasound images, pathology or laparoscopic image slides, provided that they do not contain any markings and / or text that could identify the person concerned.

Research involving human embryos, gametes and stem cells

For such studies, the manuscripts must contain confirmation that all experiments were performed in accordance with the relevant guidelines and rules. Ethics statements must be included that state:

– the institutional / licensing committees that have approved the relevant experiments,

– the informed consent obtained from all recipients and / or donors of cells or tissues, describing the conditions for donating research materials. The editors reserve the right to request copies of the relevant documents.

 

Human biological samples

For the description of human biological samples, the Editorial Board recommends that authors refer to the BRISQ reporting guidelines to ensure that at least a Level 1 characterization is provided.

Clinical Trials Registration Prospective clinical trials must be registered prior to patient registration or an equivalent public repository. This requirement is limited to trials in which the primary purpose is to determine pharmacokinetics.

 

Animal Research

All animal experiments must comply with ARRIVE's guidelines and be carried out in accordance with the guidelines of EU Directive 2010/63 / EU on the protection of animals used for scientific purposes. Manuscripts reporting animal studies must contain statements including:

– the institutional/licensing committee that approved the experiments

– the characteristics of the animals and their living conditions that may affect the results obtained.

Experiments with plants or microorganisms

Botanical identity

For commercially available cultivars, the name and details of the supplier must be indicated by the authors. Where breeding, collection, distribution and rearing is carried out in a specific region, the line must be described by specifying the local name and source of origin of the seed, plant or germ material. For cultivated medicinal plants, its botanical identity must be established and documented. It includes: scientific name, cultivar, species, subspecies/variety, author and family, and the common name in local and English. The latter is necessary if available.

Selection of medicinal plants

 The species or botanical varieties selected for the cultivation of such plants must comply with those specified in the national pharmacopoeia or recommended by other authoritative national documents of the country of the final consumer. In the absence of relevant national documents, the selection of species or botanical varieties is recommended to be carried out on the basis of the pharmacopoeia or other authoritative documents of other countries. If medicinal plants are considered for the first time, the specimens or botanical varieties selected for cultivation must be identified and documented as raw materials used or described in the traditional medicine of the country of origin. In the event that plants or microorganisms are imported from abroad, experiments with them should be carried out with special permits.

 

Experimental data presentation

The experimental data, a description of the procedure for their processing, the results of such processing and their presentation must be correct from the point of view of the use of statistical methods and software. When studying the structure of substances, authors should provide experimental information that is exhaustive as arguments. Manuscripts should contain an accurate description of each dataset used. Manuscripts submitted without evidence of reproducibility of results will not be considered.