HUNGARY

Research Ethics Committees

Short description of RECs system

Ethics committees of the Medical Research Council of Hungary (ETT) could be grouped as following:

• National Ethics Committee for clinical Pharmacology (KFEB): the only ethics committee in Hungary which evaluates single- and multi-site clinical trial protocols with medicinal investigational products, with the exception of non-interventional trials. KFEB based in Budapest.

• National Ethics Committee for Human Reproduction (HRB): evaluates single- and multi-site clinical trials dealing with interventions for human reproduction, with human genetics and advanced medicinal products (cell and gene therapy).

• National Scientific and Ethical Committee (TUKEB): evaluates multi-site clinical trials outside the concern of the other two committees. In the case of trials with medical devices and non-interventional trials also the single-site trials fall in the nationwide competence of TUKEB.

• Regional Scientific and Ethical Committees (RKEBs): there are 10 such committees covering the territory of Hungary. They evaluate biomedical research of local or regional coverage, e.g. unicentral research projects or clinical trials (not involving investigational medicinal products), projects of graduate and postgraduate students. RKEBs do not review projects on human reproduction, human genetics, advanced medicinal products, trials or research with medical devices where the principle of single opinion for the country prevails. The RKEBs are supervised by the Presidency of ETT. The list and territorial competence of RKEBs are included in attachment 1 of the Decree Nr. 23/2002 of the minister of Health.

• Institutional Research Ethics Committees (IKEBs): in every institution executing clinical trials an IKEB has to operate, otherwise each investigation site has to register in an IKEB within its region. IKEBs are not authorized to evaluate research protocols but to control whether the conditions for the studies running in the institution or registered sites cope with GCP and are sufficient to fulfil the research plan, whether local human and technical resources are adequate for a particular trial. IKEBs are registered with the RKEB of their region. They are in contact with the leader of the institution and with the respective RKEB, and may advice the central ethics committees concerning the eligibility of an investigation site.

All these kinds of ethics committees are defined in the Health Care Act as independent committees. KFEB, TUKEB and HRB members are appointed by the Minister of Health. RKEBs and IKEBs are set up by the respective university or hospital administrator (Decree Nr. 23/2002 of the Minister of Health , § 12, section (2)) taking into account the rules laid down in the Health Act, § 159, and the tasks of the committee.

Networking between RECs

Every research (including clinical trials) conducted on human subjects need to be authorized by a competent authority; the condition for authorization is a supportive opinion of the competent ethics committee.

All ethics committees competent to give such a decisive ethical opinion are designated in the Act on Health to belong to the the Medical Research Council (Egészségügyi Tudományos Tanács, ETT). The disciplinal repartition of the authority of the individual ETT committees is also defined in the Act on Health and in a governmental decree. The authority of the ethics committee defined this way is univocal for the whole country: eo ipso for the three national committees, and by the regional competence of the RKEBs according to the residence of the investigation site in unicentral research projects.

By definition, the ETT is the advisory body of the minister responsible for health consisting of the members of its independent committees as well as a board (presidency) headed by the president of ETT. The working facilities of all these bodies (committees and presidency) are assured by the secretariat supported by the Ministry of Human Resources.

ETT runs a website keeping up-to-date the information on each of its constituents, the relevant rules of law, the timetables of the meetings of the national ethics committees, of the guidelines and recommendations of the presidency and of the ethics committees.

The regional ethics committees (RKEBs) cover the territory of Hungary, are co-ordinated and supervised by the Presidency, and from now are supplied with successive information bulletins. They are convocated yearly for a conference.

The control of the realization of the authorized research and clinical trials is performed by institutional ethics committees (IKEBs) under the auspices of the RKEBs.