The Research Ethics Committee at the Medical University “Prof. Dr. Paraskev Stoyanov" – Varna is an expert and advisory authority established by the Rector's order. Its primary role is to conduct initial ethical reviews, provide ongoing oversight, and issue opinions on the ethical aspects of scientific research conducted within the institution.
The Committee is responsible for safeguarding the rights, safety, well-being, and human dignity of all research participants. It ensures that all researchers and research teams adhere to established ethical standards throughout all stages of the research process, including the publication of results.
The Research Ethics Committee conducts expert evaluations of both clinical and non-clinical biomedical and medico-social research involving human subjects, as well as research using personal biomedical data, human tissues, and, in particular, genetically modified animals and microorganisms.
Additionally, the Committee addresses ethical concerns related to the protection of public interests, ensuring that researchers follow ethical practices in the production, reporting, presentation, and publication of scientific findings.
The REC does not assess clinical trials involving medicinal products in humans as defined in Articles 87 and 88 of the Medicinal Products in Human Medicine Act (promulgated in State Gazette No. 31, April 13, 2007).
The Committee develops standard operating procedures, guidelines, and forms for the ethical evaluation of scientific research under Bulgarian legislation, international regulations, the principles of the Declaration of Helsinki by the World Medical Association, and Good Clinical Practice.
Furthermore, the REC supports research teams in navigating ethical challenges through consultations and training, thereby enhancing their ability to address ethical dilemmas in research practice.
The activities of the Research Ethics Committee (REC) at the Medical University – Varna are carried out under:
Universal Declaration of Human Rights
WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
Convention for the Protection of Human Rights and Dignity of the Human Being regarding the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 1997)
Bulgarian Health Act
Ordinance No. 31 of the Ministry of Health (2007) on the Rules of Good Clinical Practice, including the requirements of other national and international documents in research ethics and scientific publications, amended by Ordinance published in SG No. 77 of October 4, 2016.
