General principle of ethical approval of articles

1. CLINICAL STUDIES (research involving patients, including medical record data)

Permission to conduct a clinical study must be obtained prior to its initiation, at the planning stage. Additionally, during the organization stage of the clinical study, the local ethics committee approves the Informed Consent forms, which are intended to explain the patient's participation in a specific study. Responsibility for obtaining consent lies entirely with the authors, while the editorial office verifies the presence of the relevant statement before peer review begins.

The author must indicate the protocol number and date (Protocol No. XX dated DD.MM.YYYY) of the LOCAL ethics committee of the healthcare institution where the patient was treated.

DATA ANONYMIZATION

Before submitting an article describing: patients, clinical cases, questionnaires, medical data, human biomaterial, interaction with humans, animals or their data — anonymization must be performed. Anonymization means that identification of the individual is impossible.

The author must remove all direct identifiers: full name, initials, medical record number, exact date of birth, address, contact details. For images: remove faces or mask eyes, delete any markers (names, numbers, metadata), including CT/MRI/US, etc.

FORMULATION IN THE ARTICLE

Ethics Approval Statement (EN):

The study was approved by the Local Ethics Committee of the medical institution (Protocol No. XX, dated DD.MM.YYYY). Written informed consent was obtained from the patient(s) for publication of this case report and accompanying images. All data were anonymized prior to analysis, and no identifiable personal information was included.

2. EXPERIMENTAL STUDIES (animals, interventions, laboratory models)

OPTION 1 — study conducted as part of a research project (R&D)

The author must indicate the title and state registration number of the R&D project and ethics approval data (Protocol No. XX dated DD.MM.YYYY).

OPTION 2 — pilot study conducted outside R&D

The author must apply to the institutional bioethics committee, obtain an expert conclusion and provide protocol details (Protocol No. XX dated DD.MM.YYYY).

FORMULATION IN THE ARTICLE

Ethics Approval Statement (EN):

The experimental protocol was approved by the Institutional Ethics Committee (Protocol No. XX, dated DD.MM.YYYY). All procedures involving animals were conducted in accordance with international guidelines for humane treatment.

3. STUDIES WITHOUT HUMAN OR ANIMAL BIOLOGICAL MATERIAL

Ethics Approval Statement (EN):

The study did not involve human participants or personal data; therefore, ethical approval was not required.

4. SURVEY-BASED STUDIES

Ось повний точний переклад цього фрагмента англійською, без скорочення і зі збереженням структури:

OPTION 1 – a widely known, specialist-developed, validated instrument, agreed for use in similar studies, was used (for example, the Hospital Anxiety and Depression Scale (HADS), SF-36 Health Survey).

The author must indicate the developer, the country, and the bibliographic reference to the source that validated this instrument (i.e., used it in a similar cohort and demonstrated that the instrument provides reliable, scientifically grounded results rather than random or distorted data).

OPTION 2 – the instrument was developed by the author for the FIRST time for a specific study. Please note that before using the instrument, it must обязательно be reviewed at an authoritative meeting/body (department, methodological committee, expert group, professional association, etc.) and recommended for use.

The author must indicate the reference details of the meeting/body (Protocol No. XX dated DD.MM.YYYY).

Formulation in the article

Ethics Approval Statement (EN):

The questionnaire was validated before the study began at the department/methodological committee level (Protocol No. XX, dated DD.MM.YYYY). The survey was voluntary and anonymous.

5. REVIEWS / META-ANALYSES

Ethics Approval Statement (EN):

The study is based on data taken from open sources, so ethical approval was not required.

Ось повний переклад із збереженням структури, CAPS і маркерів:

Risk to humans, animals or the environment

If the study involves the use of chemical substances, biological agents, or technological procedures that pose a potential risk to humans, animals, or the environment, the authors must clearly state this in the manuscript and describe the safety measures that were implemented.

PRIVACY AND DATA PROTECTION POLICY

USMYJ complies with the requirements of the General Data Protection Regulation (GDPR, Regulation (EU) 2016/679) regarding the processing of personal data.

  • Any personal identifiers may not be published without the written consent of the respective individual.
  • Data obtained during manuscript submission (names, email addresses, ORCID, affiliations, etc.) are used exclusively for the editorial process and are not shared with third parties.
  • Authors, reviewers, and editors are obliged to handle personal data in accordance with GDPR requirements and ethical principles of confidentiality.

Compliance with the above provisions ensures that all publications in USMYJ meet the requirements of:

  • Declaration of Helsinki (2013) — for research involving human participants;
  • EU Directive 2010/63/EU — for research involving animals;
  • GDPR (Regulation (EU) 2016/679) — for the protection of personal data;
  • and the principles of COPE / ICMJE / WHO regarding research ethics.

ATTENTION!

The editorial office may request the author to provide scanned copies of the above-mentioned documents.

The absence of such documents is considered a sign of misconduct and constitutes grounds for rejection of the manuscript.