How does the ethical review process work in Hungary and which are the designated ethics committees?

Each research protocol is usually reviewed by two ethics committees. There are three different levels of ethics committees: national, regional and local level.

National Ethics Commissions.
Within the Health Science Council, there are three different National Research Ethics Commissions:

  • The Scientific and Research Ethics Commission (TUKEB),
  • the Clinical Pharmacology Ethics Commission (KFEB),
  • and Human Reproduction Commission.

Regional Research Ethics Boards.
The 23/2002 Health Ministry Decree on biomedical research involving human beings resulted in the establishment of 12 regional research ethics boards (RKEB) throughout the country.

Institutional Research Ethics Boards.
Each health care institution where research involving human beings is carried out has to set up an institutional research ethics board.

Every research project is to be reviewed by the institutional research ethics board of the health care institution where the research is intended to be carried out.  If the research is carried out at more than one health care institution, each institution’s ethics board has to review the protocol.

The review performed by the institutional research ethics board is limited as to whether the given health care institution is able to carry out the research (existence of trained personnel, adequate medical equipment etc.). The role of the institutional research ethics board is the supervision of the research including ongoing inspection of documentation, study protocol compliance, etc. The board has the power to suspend the research in case of non-compliance with the requirements.

Dependent on the nature of the research, the program is to be reviewed on a national or on a regional level.

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:

1. Protocols that apply not yet accepted treatment or diagnostic procedures, if invasive intervention is carried out in connection with the procedure;
2. Clinical testing of medical devices;
3. Research on the development and characteristics of genetically determined illnesses through population genetics, somatic genetics; genetic epidemiology;
4. If more than one regional research ethics board would be responsible for the review of the protocol;
5. 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

1. Are aimed at the modification of the human genome;
2. Are related to human reproduction;
3. 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.).