Bioethics policy
Studies involving animals and humans
For research manuscripts reporting experiments on living vertebrates and / or higher invertebrates, the correspondent author must confirm that all experiments were performed in accordance with the relevant guidelines and rules. The manuscript should include a statement indicating the institutional and / or licensing committee approving the experiments, including any relevant details. Gender and other characteristics of animals that may affect results should be described. Details of housing and livestock should be included if they can affect experimental results. All animal experiments must comply with ARRIVE guidelines and be conducted in accordance with the EU Directive 2010/63/EU on the protection of animals used for scientific purposes.
For a study in which people are participants, authors must identify a committee approving the study, ensure that the work has been carried out in accordance with the Code of Ethics of the World Medical Association (Helsinki Declaration) and include in your manuscript a statement confirming that informed consent was obtained from all participants (recommendations for obtaining informed consent).
If the study reports a study involving vulnerable groups, additional verification may be done. The submitted manuscript will be scrutinized by the editors and documentary evidence (blank consent forms and any relevant ethics council discussion papers) must be provided upon request. In addition, when studies describe groups by race, ethnicity, gender, disability, disease, etc., the article should clearly explain why this categorization was necessary.
Consent of study participants
Appropriate consents, permits and permissions must be obtained if authors wish to include research details related to human participation, including social surveys, images of patients and any other person, images of patients/research participants, or other personal information in the publication. 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, including but not limited to the General Data Protection Regulation (GDPR) (EU) 2016/679, the Law of Ukraine on the Protection of Personal Tributes.
The author is responsible for:
- Each individual, or the individual's legal guardian or other person with legal authority to act on the individual's behalf who appears in any video, recording,photograph, image, illustration or case report (or in any other identifiable form) is made aware in advance of the fact that such photographs are being taken or such video, recording, photograph, image, illustration or report is being made, and of all the purposes for which they might be used, including disclosure to Elsevier and use by Elsevier or its licensees in any work or product. That individual, legal guardian or person with legal authority must give his/her explicit written consent. Written consents must be retained by the author and copies of the consents or evidence that such consents have been obtained must be provided to editorial on request
- The form of written consent complies with each requirement of all applicable Data Protection and Privacy Laws. Particular care should be taken with obtaining consent where children are concerned (in particular where a child has special needs or learning disabilities), where an individual's head or face appears, or where reference is made to an individual's name or other personal details.
- In the case of a child, if parents or guardians disagree on the use of the images of that child, then consent should be deemed not to have been given and those images should not be used. It is also important to ensure that only images of children in suitable dress are used to reduce the risk of images being used inappropriately.
- Even if consent has been obtained, care must be taken to ensure that the portrayal and captioning of the individual concerned are respectful and could not be seen as denigrating that individual.
Special considerations
- Patients' and research subjects' names, initials, hospital or social security numbers, dates of birth or other personal or identifying information should not be used.
- Images of patients or research subjects should not be used unless the information is essential for scientific purposes and explicit permission has been given as part of the consent. Even where consent has been given, identifying details should be omitted if they are not essential.
- If identifying characteristics are altered to protect anonymity, authors should provide assurances that such alterations do not distort scientific meaning.
Non-identifiable images
- Formal consents are not required for the use of entirely anonymised images from which the individual cannot be identified- for example, xrays, ultrasound images, pathology slides or laparoscopic images, provided that these do not contain any identifying marks and are not accompanied by text that might identify the individual concerned.
- If consent has not been obtained, it is generally not sufficient to anonymise a photograph simply by using eye bars or blurring the face of the individual concerned.
Clinical trial registration
Prospective clinical trials should be registered prior to the registration of patients or in a similar public store (trials in which the main purpose is to determine pharmacokinetics are excluded.)
Human biological samples
To describe human biological samples, we recommend that you refer to the BRISQ reporting guidelines (reporting on biological samples to improve the quality of the study) and ensure that at least level 1 characteristics are provided (link).
Publication of images of participants in human subject research
When publishing identifiable images of study participants, authors should include a statement in the published article confirming that they have received informed consent to publish the images. All reasonable measures should be taken to protect the anonymity of the patient. Black stripes above the eyes are not an acceptable means of anonymization. In some cases, we may insist on obtaining evidence of the informed consent of the authors. Images without appropriate consent will be removed from the publication.
Studies involving human embryos, gametes, and stem cells
Manuscripts reporting experiments involving the use of human embryos and gametes, human embryonic stem cells and related materials, as well as the clinical use of stem cells, should include confirmation that all experiments have been performed in accordance with relevant guidelines and the rules.
The manuscript should include an ethical statement that identifies the institutional and / or licensing committees that approve the experiments and describe any relevant details. A statement of ethics should also confirm that informed consent has been obtained from all recipients and / or donors of cells or tissues, where necessary, and describe the conditions of donation of research materials, such as human embryos or gametes. The editors may request copies of approved and edited consent documents.
Experiments involving plants or microorganisms
Experiments with plants or microorganisms taken from outside the country of the authors should have been carried out with special permission.
Botanical identity. For each cultivated medicinal plant, its botanical identity must be established and documented - scientific name (variety, species, subspecies / variety, author and family). The common name (if any) must also be indicated in the local and English languages. If necessary, other relevant information should also be indicated, including the name of the cultivar, its ecotype, chemotype and phenotype.
For cultivated plant varieties available for sale, you must specify its name, as well as the supplier. In the case of collection, breeding, distribution and cultivation of landrace in a particular region, the line should be described with its local name, indicating the sources of origin of the seed, plant or sprout material.
Selection of medicinal plants. Where appropriate, the species or botanical species that are selected for cultivation should correspond to those indicated in the national pharmacopoeia or recommended by other authoritative national documents of the country of the final consumer. In the absence of such national documents, the selection of species or botanical varieties should be based on the pharmacopoeia or other authoritative documents of other countries. In the case when medicinal plants are considered for the first time, samples or botanical varieties selected for cultivation should be defined and documented as raw materials used or described in traditional medicine of the country of origin.
Experimental data
Analytical data should be statistically processed using appropriate programs.
When establishing the structure of substances, the authors must provide sufficient experimental information, in particular, the available 1H and 13C NMR spectra, and X-ray crystalline structural determinations are necessary for metal complexes.
The author is responsible for presenting the correct chemical nomenclature and terminology.
An accurate description of each data set should be provided, which is shown and should include the number of biological repeats, the number of experiments performed, and a description and use of appropriate statistical methods. To verify the significance of differences in results, appropriate statistical methods should be used. The term “significant” should not be used unless a statistical analysis has been performed and the probability value used to determine significance (usually p-value) should be indicated. Manuscripts submitted without evidence of reproducibility will be rejected without formal review.
Applications and additional materials
Authors who wish to publish electronic supplementary materials to their article (Excel files, images, audio and video files) can send these files along with the manuscript.
