Human and Animal rights
Human and Animal rights policy
The following aspects of human and animal rights policy (bioethics) compliance requirements are covered in this section:
– 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 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 ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments).
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.
Medical case reports concents should be collected and presented in accordance to the COPE guidance.
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.
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 containing a description of experiments involving plants or microorganisms
Manuscripts containing descriptions of experiments involving plants or microorganisms should take into account the fulfillment of the following requirements:
– availability of special permissions;
– availability of information on botanical identity;
– availability of information on the selection of medicinal plants;
– optional presence of attachments and additional materials for manuscripts.
Availability of special permissions
Special permission is required if the experiments described in the manuscript were carried out with plants or microorganisms taken from outside the country with which the authors are affiliated and in which the authors are located.
Availability of information on botanical identity
Botanical identity must be properly documented for cultivated medicinal plants. In particular, the scientific name (cultivar, species, subspecies/variety, author and family), common name in English and local language (if available) must be indicated. It is advisable to provide other information that allows additional identification and seems important in the context of the description, for example, the name of the cultivar, its ecotype, chemotype and phenotype.
In the case of collection, breeding, distribution and cultivation of landraces in a specific region, when indicating this, it is necessary to indicate the local name, citing the source of origin of the seed, plant or germ material.
Availability of information on the breeding of medicinal plants
The species or botanical varieties selected for cultivation must correspond to those species or botanical varieties that are indicated in the national pharmacopoeia, or those recommended by other authoritative national documents of the country of the final consumer. This requirement is realizable if it is acceptable for some conditioned and justified factors of national characteristics.
If medicinal plants are considered for the first time, the samples taken or the botanical varieties selected for cultivation must be identified and documented as the raw material used, or have corresponding descriptions in the traditional medicine of their country of origin.
Optional presence of 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 of software products.
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.
Clinical Trials
We follow the ICMJE recommendations concerning clinical trials.
- Registration
We require registration of clinical trials in a public registry at or before the time of first patient enrollment as a condition of consideration for publication.
We use the date trial registration materials were first submitted to a registry as the date of registration. When there is a substantial delay between the submission of registration materials and their posting at the trial registry, editors may inquire about the circumstances that led to the delay.
In accordance with ICMJE, we define a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. The ICMJE does not define the timing of first participant enrollment, but best practice dictates registration by the time of first participant consent.
The ICMJE accepts publicly accessible registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) that includes the minimum acceptable 24-item trial registration data set or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP. The ICMJE endorses these registries because they meet several criteria. They are accessible to the public at no charge, open to all prospective registrants, managed by a not-for-profit organization, have a mechanism to ensure the validity of the registration data, and are electronically searchable. An acceptable registry must include the minimum 24-item trial registration data set (http://prsinfo.clinicaltrials.gov/trainTrainer/WHO-ICMJE-ClinTrialsgov-Cross-Ref.pdf or www.who.int/clinical-trials-registry-platform) at the time of registration and before enrollment of the first participant. We consider inadequate trial registrations missing any of the 24 data fields, those that have fields that contain uninformative information, or registrations that are not made publicly accessible such as phase I trials submitted to the CTIS (Clinical Trials Information System) and trials of devices for which the information is placed in a “lock box.” In order to comply with ICMJE policy, investigators registering trials of devices at ClinicalTrials.gov must “opt out” of the lock box by electing public posting prior to device approval. Approval to conduct a study from an independent local, regional, or national review body (e.g., ethics committee, institutional review board) does not fulfill the ICMJE requirement for prospective clinical trial registration.
The purpose of clinical trial registration is to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of research effort, to help patients and the public know what trials are planned or ongoing into which they might want to enroll, and to help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering. Retrospective registration, for example at the time of manuscript submission, meets none of these purposes. Those purposes apply also to research with alternative designs, for example observational studies.
Secondary data analyses of primary (parent) clinical trials should not be registered as separate clinical trials, but instead should reference the trial registration number of the primary trial.
We expect authors to ensure that they have met the requirements of their funding and regulatory agencies regarding aggregate clinical trial results reporting in clinical trial registries. It is the authors’, and not the journal editors’, responsibility to explain any discrepancies between results reported in registries and journal publications. We will not consider as prior publication the posting of trial results in any registry that meets the above criteria if results are limited to a brief structured abstract or tables (to include trial participants enrolled, baseline characteristics, primary and secondary outcomes, and adverse events).
We recommend that, whenever a registration number is available, authors list this number the first time they use a trial acronym to refer either to the trial they are reporting or to other trials that they mention in the manuscript.
- Data Sharing
Clinical trials must include a data sharing plan in the trial's registration. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
Data sharing statements must indicate the following: whether individual deidentified participant data (including data dictionaries) will be shared (“undecided” is not an acceptable answer); what data in particular will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism).
Authors of secondary analyses using shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. They must also reference the source of the data using its unique, persistent identifier to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Authors of secondary analyses must explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their efforts. Those using data collected by others should seek collaboration with those who collected the data. As collaboration will not always be possible, practical, or desired, the efforts of those who generated the data must be recognized.
Updated September 26, 2024
