Bulgaria - RECs and Medical Research
History
There
are 2 central commissions dealing with medical research in Bulgaria, one
at the Ministry of Health dealing with ethics in drug trials, and the
other at the Ministry of Education and Science, dealing with research
ethics. In addition there are local REC's at regional hospitals, universities
and research institutions.
Summary of Bulgarian RECs
| Type of REC | Central commission on ethics in drugs trials | Central commission on research ethics | Local commission on ethics in drug trials | Local commission |
| Where situated? | Ministry of health | Ministry of education & science | Regional hospitals | Universities & research institutions |
| Who applies to them? | Clinical trial proposals | researchers | Clinical trial proposals | researchers |
| Formal/Informal | Formal | Formal | Formal | Formal |
| National/Regional | National | National | Local | Local |
| Laws Involved (see below) |
|
Regulations of respective ministries |
|
Regulations of respective ministries |
| Guidance Involved |
|
Declaration of Helsinki |
|
Declaration of Helsinki |
| Membership requirements | At least 9 members, both medical & non-medical and of both sexes | At least 9 members, both medical & non-medical and of both sexes | At least 7 members, of whom no less than 1 is non-medical & 1 who is independent of applying hospital | At least 7 members, of whom no less than 1 is non-medical & 1 who is independent of applying hospital |
| Responsible/accountable to whom? | To the Ministry of Health | To the Ministry of Education & Science | To the Central commission on ethics in drugs trials | To the Central commission on research ethics |
| Approval or Advisory powers | Approval | Approval | Approval | Approval |
Not submitting research or failing to follow review
There are no consequences, but review is necessary for further consideration by the decision-making body
Which body, if not the REC itself takes this action, and how do they proceed?
Impact of Directive 2001/20 EC
Legal action that can be taken against RECs
There is no legal action which can be taken against RECs.
Links section
Relevant Papers
- Ethical approval for health research in central & eastern Europe: an international survey
- Clinical trials in Bulgaria
See the REC bibliography section for more links and papers