Policy on Mandatory Ethical Approval for Research Involving Humans, Animals, Their Biological Materials, or Personal and Confidential Data
This policy establishes the requirements for obtaining mandatory ethical approval for research involving humans, animals, their biological materials, as well as the processing of personal or confidential data.
The Journal considers manuscripts for publication only if they comply with publication ethics standards and the applicable legislation of Ukraine.
Scope of the Policy
This policy applies to research that:
– involves human participants (patients, healthy volunteers, survey respondents) and/or the use of human biological materials;
– involves animals and/or the use of animal biological materials;
– includes the processing of personal data or confidential information.
Mandatory Requirements for Publication
Authors must ensure that, prior to the commencement of the study:
– approval has been obtained from an ethics committee (institutional or local), or another appropriate authorization document where required;
– informed consent has been obtained from research participants (or their legal representatives), where applicable;
– confidentiality, anonymization, and lawful data processing have been ensured;
– in studies involving animals, principles of humane treatment and minimization of suffering have been followed.
Requirements for the “Ethical Considerations” Section
Manuscripts falling under this policy must include a dedicated subsection containing the following information:
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Research involving humans or human biological materials:
– name of the ethics committee (institution), protocol/approval number and date;
– information on informed consent or a justified waiver with reference to the ethics committee decision;
– confirmation of compliance with confidentiality and anonymity requirements (especially for medical data). -
Clinical trials of medicinal products:
– confirmation that the study was conducted in accordance with the regulations of the Ministry of Health of Ukraine (including ethics committee approval, with relevant details);
– confirmation of the efficacy and safety of the investigated medicinal products. -
Research involving animals or animal biological materials:
– name of the ethics committee or authority, approval number and date;
– description of measures to minimize pain and suffering, adherence to the 3R principles (Replacement, Reduction, Refinement), and humane endpoints where applicable. -
Personal data and confidential information:
– data status (personal, pseudonymized, or anonymized), legal basis for processing, and basic data protection measures;
– confirmation of compliance with the Law of Ukraine “On Personal Data Protection” and requirements for confidential information.
Documents That May Be Requested by the Editorial Board
The Editorial Board may request:
– a copy of the ethics committee approval or protocol;
– a sample of the informed consent form or participant information sheet;
– documentary evidence of lawful access to data or biological materials (agreements, permits, decisions, etc.).
Editorial Decisions in Case of Non-Compliance
In cases of non-compliance with ethical requirements:
– the absence of proper ethical or legal approval constitutes grounds for returning the manuscript for revision or rejecting it;
– if violations are identified after publication, the Journal applies correction or retraction procedures in accordance with its academic integrity policy.
