Czech Republic - RECs and Medical Research
History
The Ministry of Health established a Central Ethics Committee in 1990 as an advisory body. The Committee gives opinions and recommendations on ethical issues to the Ministry. At the same time the Ministry recommended the establishment of Local Ethics Committees in major healthcare facilities, and by 2001 there were 25-30 permanent Ethics Committees.
The Central Committee also organizes educational events and conferences on ethical issues. There is also a Bioethics Commission of the Research and Development Council which acts as an advisory board to the Government.
Summary of Czech Republic's RECs
| Type of REC | Bioethics Commission of the Research and Development Council | Central Ethics Committee | Local Ethics Committees |
| Where situated? | Research and Development Council | Ministry of Health | Large
hospitals Research Institutes Healthcare Institutions |
| Who applies to them? |
Research and Development Council They can also set their own agenda |
- | Clinical researchers |
| Formal/Informal | Formal | Formal | Formal |
| National/Regional | National | National | Regional |
| Laws Involved |
Drug Act No.79 1997 Ministerial decree on GCP in drug trials 472/2000 Act 123/2000 on Medical Devices |
Drug Act No.79 1997 Ministerial decree on GCP in drug trials 472/2000 Act 123/2000 on Medical Devices |
|
| Guidance Involved | - | - | |
| Membership requirements | 15 members representing different areas of expertise - medicine, biology, ethics/philosophy, law & theology | 23 members | >5 members including health care workers; at least 1 member without medical or scientific training; at least 1 member not employed by a research institute |
| Responsible/accountable to whom? | Research and Development Council | No direct responsibility but the Ministry of Health appoints and can recall members | No direct responsibility but the head of the health care facility appoints and can recall members |
| Approval or Advisory powers | Advisory | Advisory | Approval |
Not submitting research or failing to follow review
Fines can be imposed on the researchers involved and in certain situations legal sanctions may be used.
Which body, if not the REC itself takes this action, and how do they proceed?
The employers of the researchers or a self-governing body such as the Czech Medical Chamber may take action.
Impact of Directive 2001/20 EC
European Directive 2001/20/EC was implemented by an amendment to the Drug Act No. 79 1997 through Act No. 129 of 5th June 2003.
Legal action that can be taken against RECs
There is no form of appeal against an REC decision. The only possible form of sanction against an REC would be the recalling of members.
Links section
- Czech Medical Association of J.E.Purkyne (in English & Czech)
- Ministry of Health (in Czech)
- Czech Republic Government (in English & Czech)
- Academy of Sciences of the Czech Republic (in English & Czech)
- Grant Agency of the Czech Republic (in English & Czech)
- State Agency for Drug control – includes legislation covering ethical review (in English & Czech)
- Research & Development Council - Bioethics Commission (in English & Czech)
Papers
- Simek, J, Silhanova, J, Vrbatova,I : ‘Ethics committees in the Czech Republic’ In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).
- Perlik,F; ‘Ethical considerations in clinical trials’ EMEA workshop (2001)
See the REC bibliography section for more links and papers, and the Data Protection Page