Slovenia - RECs and Medical Research
History
There has been a long history of ethical review in Slovenia and the National Medical Ethics Committee (NMEC) was established in 1977. Recently local ethics committees have been set up at university and regional hospitals. Most biomedical research is reviewed by the National committee and this is required for all state funded research, all research for DSc and MSc thesis and all multi-centre trials. Approval of the Agency for Medicinal Products is also required in the case of clinical drug trials. The local/regional ethics committees are authorised to review local studies that do not present any serious risk to the participants.
Research involving gene technology or medicaly assisted procreation must also be passed by relevant special advisory committees before going to the NMEC for approval.
The NMEC also gives opinions on bioethical issues, advises parliament and assists in formulating relevant laws. It has also produced guidelines for researchers carrying out research involving humans.
Summary of Slovenian RECs
| Type of REC | National Medical Ethics Committee (NMEC) | Local / Regional Ethics Committee |
| Where situated? | - | University/ Regional Hospitals |
| Who applies to them? | Researchers Parliament Ministry of Health |
Researchers not requiring NMEC approval |
| Formal/Informal | Formal | Formal |
| National/Regional | National | Regional |
| Laws Involved | Directive on Clinical Drug Trials | Directive on Clinical Drug Trials |
| Guidance Involved | Oviedo
Convention Declaration of Helsinki |
Oviedo
Convention Declaration of Helsinki |
| Membership requirements | 13 members - multidisciplinary | - |
| Responsible/accountable to whom? | Independent body | NMEC |
| Approval or Advisory powers | Approval & Advisory | Approval |
Not submitting research or failing to follow review
No cases have so far been recorded but it has been suggested that disciplinary action would be taken. Additionally researchers would not have their work published without appropriate ethical approval.
Impact of Directive 2001/20 EC
The Slovenian Directive on Clinical Drug Testing is based on this Directive.
Legal action that can be taken against RECs
No legal action can be taken, although decisions taken by local/regional ethics committees can be appealed against to the NMEC. The NMEC must reconsider its decisions if they vary from those made by the World Health Organisation or the CDBI of the Council of Europe.
Links section
- Republic of Slovenia portal (in Slovene & English)
- Government of Slovenia (in Slovene & English)
- Ministry of Health (in Slovene)
- Oviedo Convention
See the REC bibliography section for more links and papers