Hungary - RECs and Medical Research

History

There are 3 tiers of ethical review in Hungary: national, regional and locally at healthcare institutions.

The national body, the Scientific and Research Ethics Council, was established in 1951. It now has 5 commissions - Scientific and Research Ethics Committee, Clinical Pharmacology Ethics Committee, Forensic Committee, Human Reproduction Committee and Research & Development commission. Their members are appointed by the Minister of Health for a fixed term that is subject to renewal. Each healthcare institution which carries out research also has to set up an REC and there are some institutions which also require a regional REC.

Summary of Hungarian REC

Type of REC	Scientific and Research Ethics Council	Regional REC	Local REC
Where situated?	Ministry for Health	Medical Universities	Healthcare Institutions
Who applies to them?	Researchers	Researchers	Researchers
Formal/Informal	Formal	Formal	Formal
National/Regional	National	Regional	Local
Laws Involved (see below)	23/2002 (V9) EuM decree on biomedical research on human beings 34/2003 (V1.7) ESZCSM Health Science Council (ETT)	23/2002 (V9) EuM decree on biomedical research on human beings 34/2003 (V1.7) ESZCSM Health Science Council (ETT)	23/2002 (V9) EuM decree on biomedical research on human beings 34/2003 (V1.7) ESZCSM Health Science Council (ETT)
Guidance Involved	-	-	-
Membership requirements	No formal requirements in the law, except for gender balance & represntation from various scientific fields Current TUKEB composition:Total: 25 members, including: Representative of the Catholic Church Representative of the Protestant Church A bioethicist A rabbi 2 lawyers A hospice expert A nurse 17 medical professors form various fields. Members and their professions have to be published in the officail gazette Additional ad hoc experts may be appointed	No formal requirements	At least 5 members with scientific & legal knowledge
Responsible/accountable to whom?	Ministry of Health	Scientific & Research Ethics Council	Regional RECs
Approval or Advisory powers	2/3 majority is necessary for scientific & ethical opinion,it may reject or approve the research project	Scientific & Ethical opinion	Monitoring condition of research & data protectionand the protection of subjects not having full competence

Laws and Regulations

Parliamentary Act No. CLIV. of 1997 on Public Health (Chapter VIII. on research on human beings). Amongst the rights of patients introduced in this Act is the right to gain access to medical records
Parliamentary Act No. VI. of 2002 on the ratification of the Oviedo Convention
23/ 2002. (V.9.) EüM decree on the biomedical research on human beings.
24/2002. (V. 9.) EüM decree on the clinical trials of the product for human use and the application of good clinical practice
34/2003. (VI.7.) ESZCSM on Health Science Council (with the Hungarian acronym: ETT)
Parliamentary Act No. IV. of 1978 [Criminal Code] "Crimes Against the Order of Medical Interventions and Medical Research, and Against Self-determination Related to Health Issues," [§.173./A -§173./H]
Constitution of the Republic of Hungary
Hungarian Laws, accepted by Parliament since 1990 - Hungarian

Institutions

Scientific and Research Ethics Committee [TUKEB]
National Institute of Pharmacy -links to pharmaceutical laws and regulations (in Hungarian)
Health Science Council
Foundation for patients' rights (in English & Hungarian)
Hungarian Medical Chamber - in Hungarian

Ethical Code of the Hungarian Medical Chamber, Chapter III deals with medical research issues and outlines the provisions of Act CLIV of 1997 - in Hungarian

National Institute for Strategic Health Research - in English

Feasibility Study Enumerating Legal Conditions of Creating a Computer System by which Patient's Data can be Collected from Different Institutions - in Hungarian

Hungarian Ministry of Health - in English
National Health Insurance Company - in Hungarian
State Public Health Authority - in Hungarian

Guidance

Collection of guidance from the Hungarian Medical Research Council

Bibliography

IME (Informatics and Management in Healthcare) - in Hungarian
Béla Blasszauer and Eszter Kismodi (2000) "Ethics Committees in Hungary," in Josef Glasa (ed.) Ethics Committees in Central and Eastern Europe (Bratislava: Charis-IMEB Foundation), pp. 190-193.
Judit Sandor (2003) Hungary, Medical Law. In International Encyclopedia of Laws, Medical Law, Supplement 31 (April 2003) (The Hague: Kluwer law International).
Imre Szebik (2003) "Masked Ball: Ethics, Laws and Financial Contradictions in Hungarian Health Care," in Science and Engineering Ethics 9: 109-124.

See the REC bibliography section for more links and papers