Slovakia - RECs and Medical Research

History

The first ethics committees were established in 1990 after the ‘velvet revolution’ of 1989. These were based in research institutes and major teaching hospitals. The Ministry of Health also set up a Central Ethics Committee (CEC) in 1990 which provides support and guidance to the Local Ethics Committees (LECs). The Central Committee produced guidelines for LECs in 1992.

The development of these committees was driven by scientists, bioethicists and the good clinical practice requirements of pharmaceutical companies. Initially there were problems in the working and funding of ethical review but this is improving now with greater education regarding ethical issues.

For clinical trials, the approval of the State Institute for Drug Control is required in addition to LEC approval. The final decision regarding research is taken by the director of the institute using LEC recommendations as guidance.

The CEC also considers and drafts legislation in the fields of health care, medicine and biomedical research. New Health Laws were passed by parliament in late 2004 and will be implemented soon; these will give more detailed provisions regarding local ethics committees and also allow for the establishment of regional ethics committes that will deal with multi-centre trials (see links section below for new health law).

Summary of Slovakian RECs

Type of REC	Central Ethics Committee	Local Ethics Committees
Where situated?	Ministry of Health	Research Institutes Major teaching hospitals
Who applies to them?	Ministry of Health State Institutions LECs	Researchers
Formal/Informal	Formal	Formal
National/Regional	National	Regional
Laws Involved	Law 140/1998 on Drugs & Health Equipment Law 277/1994 on Health Care Laws 13,14,27/1992	Act on Healthcare and Healthcare-related Services No. 576/2004 Coll. of 22 Sept 2004 Law 140/1998 on Drugs & Health Equipment Law 277/1994 on Health Care Laws 13,14,27/1992
Guidance Involved	Deontological code of Slovak Medical Chamber CEC guidelines (1992) Declaration of Helsinki ICH-GCP	Deontological code of Slovak Medical Chamber CEC guidelines (1992) Declaration of Helsinki ICH-GCP
Membership requirements	19 members Interdisciplinary	Interdisciplinary Odd number of members Chair must be a physician
Responsible/accountable to whom?	Ministry of Health	Ministry of Health
Approval or Advisory powers	Advisory	Advisory - Director of Institute makes final decision

Not submitting research or failing to follow review

The State Institute for Drug Control monitors all clinical trials.

Which body, if not the REC itself takes this action, and how do they proceed?

Impact of Directive 2001/20 EC

Law 140/1998 on Drugs & Health Equipment was amended in December 2003 to implement this Directive.

Legal action that can be taken against RECs

As there is no legal basis for LECs, it would appear that no legal action can be taken against their decisions.

Links section

Act No. 576/2004 Coll. of 22 Sept 2004 On Healthcare and Healthcare-related Services (in English)
Slovakia Institute for Drug Control (in Slovak)
Slovak government (in English & Slovak)
Ministry of Health (in Slovak)
The Constitution of the Slovak Republic (in English & Slovak)
New Health Laws 2004 (in Slovak)
Central Ethics Commission (in English & Slovak)

See the REC bibliography section for more links and papers