Hungary

For an overview of human subject protections in Hungary, see the EFGCP Report

Governing Agencies and Ethics Review Structure

Useful Documents

 

Points to Consider – Investigators

  • Generally, biomedical research can only be carried out with authorization and with the research purpose of developing diagnostic, therapeutic, preventive and rehabilitation procedures, for elaborating new biomedical procedures and for a better understanding of the etiology and pathogenesis of illnesses
  • Concern for the interests of the subjects must always prevail over the interests of science and society
  • Each research protocol intending to involve human beings has usually to be reviewed by two ethics committees
  • The Clinical Pharmacology Ethics Commission (KFEB) reviews all clinical trials involving medicinal products
  • The Scientific and Research Ethics Commission (TUKEB) reviews the following research protocols:
  • protocols that apply not yet accepted treatment or diagnostic procedures, if invasive intervention is carried out in connection with the procedure;
  • clinical testing of medical devices;
  • research on the development and characteristics of genetically determined illnesses through population genetics, somatic genetics; genetic epidemiology;
  • if more than one regional research ethics board would be responsible for the review of the protocol;
  • in any case where the regional research ethics board refers the case to the TUKEB
  • The Human Reproduction Commission (HRB) reviews all research protocols, which are aimed at the modification of the human genome; are related to human reproduction; are related to prenatal examinations
  • The regional research ethics board reviews all remaining research protocols (epidemiological studies, research based on biological materials taken from deceased persons etc.)
  • Consent of the research subject or his/her legal representative is essential for the biomedical research
  • NFP is the national agency of the European drug information network, it collects and processes data and information of other institutions and provides national and international organizations with them to help decision making on the exploration, treatment and solution of the drug problem

Local Research Institutions