Austria - RECs and Medical Research
History
The system for ethical review was initiated in the early 1980's by 3 medical faculties - Vienna, Graz and Innsbruck - and was originally voluntary. These committees began to be formalised in 1988, and further laws amended and extended their roles until 1997 when an amendment to the Act on University Organization provided regulations for RECs
The Federal Act on University Organization stipulates that RECs have to be established to review 'applied medical research on humans'. Ethical review of medical research on humans that does not involve drugs, medical devices, or the application of a new medical method is mandatory only in university settings.
A Federal order of June, 2001, established a bioethics commission to advise on all social, natural scientific and legal issues arising from the scientific developments in human medicine and human biology from an ethical standpoint.
Summary of Austrian RECs
| Type of REC | University | Hospital | For studies outside hospital |
| Where situated? | Medical Faculty | Hospital | |
| Who applies to them? | researchers | researchers | researchers |
| Formal/Informal | Formal - regulated by law | Formal
- regulated by law Voluntary where research doesn't involve drugs, medical devices or the application of a new medical method |
Formal
- regulated by law Voluntary where research doesn't involve drugs, medical devices or the application of a new medical method |
| National/Regional | Regional | Regional | National |
| Laws Involved (see below) | Federal
state law Federal Act on Hospitals |
Federal state law | |
| Guidance Involved |
Declaration
of Helsinki |
Declaration
of Helsinki |
Declaration
of Helsinki EC-GCP Guidelines ICH-GCP Guidelines |
| Membership requirements |
A
medical doctor (not investigator) In
the case of research on medical devices: |
A
medical doctor (not investigator or director of hospital) In
the case of research on medical devices: |
A
medical doctor (not investigator) In
the case of research on medical devices: |
| Responsible/accountable to whom? | To the medical faculty | To the body responsible for the hospital | To the government of the respective federal state |
| Approval or Advisory powers | Advisory | Advisory & medical director can overrule | Advisory |
Not submitting research or failing to follow review
Primary discipline action by hospital or university.
Which body, if not the REC itself takes this action, and how do they proceed?
As above, and if failures are brought to the public's attention, the medical association, Federal government and /or the Courts may also take action
Impact of Directive 2001/20 EC
The Directive will impact only for studies on medicinal products: a favourable opinion of the REC will be necessary for the start of a trial, a unique opinion will have to be provided for multicentre trials, only a single request for additional information will be possible & the paperwork will be enhanced. There will also be a reduction in the time limit for the evaluation of amendments.
Legal action that can be taken against RECs
The REC may be liable in case of an
injury of a trial subject when it has approved patient information.
At present no action can be taken against a negative decision
Links section
- All Austrian Federal and State Laws (in German)
- Declaration of Helsinki
- Austrian bioethics commission (in German & English)
- EU laws involved in research
See the REC bibliography section for more links and papers, and the Data Protection Page