From Protocol to Publication: Why Ethical Approval is a Mandatory Step in Research

This editorial analyses the role and regulatory requirements for ethical statements in modern biomedical research involving humans and animals. With the growing number of studies in health, nutrition, and biotechnology, adherence to ethical standards is no longer a formality and is becoming the foundation of scientific integrity, data reliability, and public trust. The article substantiates the mandatory approval of an independent ethics committee as an essential condition for publication in peer-reviewed scientific journals. Based on an analysis of international guidelines (the Declaration of Helsinki, GCP principles, the 3Rs, and ARRIVE), the information regarding ethical approval required of authors in the "Materials and Methods" section is detailed. Standard disclaimer formulations for various types of studies are presented, along with practical recommendations for their implementation. The focus is on a systematic approach to ethical statements, which should encompass not only an assessment of the study design but also animal welfare conditions, personnel qualifications, and compliance with the principles of Good Laboratory Practice for preclinical trials. This article is intended for researchers, project managers, and members of ethics committees to scientific ethics standards when preparing publications.

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