Ethical Principles for Research Involving Human Participants

The editorial board of the Eastern Ukrainian Medical Journal adheres to the highest standards of publication ethics and takes all measures to prevent violations of ethical norms in scientific research, including those involving humans.

The journal's ethical policy regarding research involving human subjects is based on the recommendations of COPE (Committee on Publication Ethics) and WAME (World Association of Medical Editors), as well as current Ukrainian legislation. It is intended to protect the rights, dignity, and well-being of research subjects.

All studies planned or currently being conducted involving human subjects must follow the principles of the World Medical Association's Declaration of Helsinki.

The authors whose manuscripts are based on research involving human participants must ensure that the research complies with national legislation, ethical standards, and international conventions on bioethics. All procedures must be transparent, reasonable, and harmless for participants.

Only manuscripts that meet the requirements of the relevant ethical protocols will be accepted for consideration.

To review and publish the results of any research involving human participants (including surveys, interviews, and the use of personal data), the editorial office requires:

  1. Ethics Committee Approval

All studies involving human subjects must be approved by the appropriate institutional ethics committee or its equivalent. The article must include the name of the institution, the protocol number, and the date of the bioethics committee's conclusion (IRB — Institutional Review Board).

If a study does not require ethical approval under national law, the authors should clearly state this in the manuscript.

  1. Informed Consent

Authors must confirm that all participants have provided voluntary written informed consent to participate in the study and publish the results. In cases where participants cannot provide consent on their own (e.g., minors, persons with impaired decision-making capacity), the consent is obtained from their legal representatives. Manuscripts should include a description of the consent procedure.

Data Privacy 

Any information that makes it possible to identify a person (name, unedited photo, document data) cannot be published unless it is of critical scientific importance and a corresponding permission has been obtained. All personal data of participants must be anonymized and depersonalized. Authors take full responsibility for following the legislation on the protection of personal data and confidentiality. The editorial board may request raw data, provided that data privacy is maintained throughout the review.

Policy on Research Involving Vulnerable Groups

Research involving vulnerable groups (the minors, pregnant women, the elderly, people with disabilities, people with mental disorders, patients in critical or terminal conditions, refugees, internally displaced persons, war victims, people with impaired decision-making capabilities, those in difficult straits, etc.) must meet the standards of ethical control and safety.

For such research, the authors must provide, along with the manuscript:

  • The decision of the ethics committee (IRB/REC), which contains the protocol number (IRB Protocol Number), date of approval, conditions of approval (informed consent of participants, child assent (for the minors), protection of confidentiality, etc.).
  • Informed consent of parents/guardians.
  • Child assent (7–18 years).
  • Justification for the vulnerable group inclusion.
  • Description of risk minimization mechanisms.

Manuscripts without these documents will not be accepted for review.

Clinical Trials and Research Registration Policy

In accordance with ICMJE recommendations and criteria, clinical trials involving humans should be registered in a public clinical trial registry (e.g., ClinicalTrials.gov, ISRCTN, WHO ICTRP Primary Registries, EU Clinical Trials Register, UMIN, ANZCTR, ChiCTR) prior to the recruitment of the first participant and are accepted for consideration.

Authors whose research includes clinical trials must provide, along with the manuscript:

  • Clinical trial number and site;
  • SPIRIT (for study protocols (if available);
  • CONSORT Checklist (for RCTs);
  • Ethics committee approval.

An article presenting the results of clinical trials involving humans should contain information about:

  • Inclusion and exclusion criteria for trial participants;
  • Randomization method;
  • Degree of anonymization;
  • Data on termination of participation;
  • CONSORT or SPIRIT reports.

Risks and Safety

Authors should describe potential risks to participants and measures taken to minimize them. Studies that pose unjustified risks are not eligible for publication.

Violation of Ethical Norms

Lack of ethical approval, violation of the consent procedure, or failure to register a clinical trial may be grounds for rejecting the manuscript at the review stage or for taking editorial action after publication, including retraction, depending on the results of the investigation.

The editorial office reserves the right to:

  1. Request copies of documents, i.e., to ask for original informed consent forms or ethics committee approval during review.
  2. Reject the manuscript, if there are reasonable doubts about the humane aspects of the experiment or the authenticity of the participants' consent, even if there is formal committee approval.
  3. Investigate possible misconduct, if possible violations are identified after publication, in particular after a patient complaint. In this case, the editorial board conducts an investigation in accordance with COPE recommendations and may publish a correction, an expression of concern, or a retraction of an already published article.