Malta - RECs and Medical Research
History
Until recently there was only 1 committee that dealt with ethical review of research in Malta, based in the Medical School of St Luke's Hospital. Another committee has now been established at the Institute of Health Care to review research of their students and a further REC at university level. Approval of research projects by these committees is not compulsory, although there is an increasing awareness of the need for ethical review. The University Guidelines state what research involving humans is required by them to have ethical approval to proceed and also the sanctions it would apply if this was not followed.
There is also a Bioethics Consultative Committee appointed by the Ministry of Health. They produce opinions on ethical issues, publish articles, provide seminars and inform the public.
The Data Protection Commissioner has recently asked the University of Malta to see that all research in Malta is undertaken in accordance with the data protection laws. As a result the University has set up yet another REC, which is still in its infancy, to start doing this work.
Summary of Maltese RECs
| of REC | University of Malta Research Ethics Committee | Ethics Research Committee | Ethics Research Committee |
| Where situated? | University of Malta | Medical School St Luke's Hospital | Institute of Health Care |
| Who applies to them? | Anyone carrying out research involving humans at the University | Researchers | Researchers |
| Formal/Informal | Informal | Informal | Informal |
| National/Regional | Regional | National | Local |
| Laws Involved | - | ||
| Guidance Involved | - | ||
| Membership requirements | Not
defined, but generally: medical specialist,science representatives, ethicist and lay representation |
||
| Responsible/accountable to whom? | Dean of the University | Faculty of Medicine,Medical School,St Luke's hospital | |
| Approval or Advisory powers | Approval | Advisory | Advisory |
Not submitting research or failing to follow review
There are no consequences
as it is a voluntary system, however the REC at the University of Malta
has to monitor all research it has approved and can, according to its
guidelines (Section VI), stop the research in cases of non-compliance.
Which body, if not the REC itself takes this action, and how do they proceed?
In the case of the University REC, the Dean and Senate of the University decide on sanctions to be taken.
Legal action that can be taken against RECs
As there is no legal basis for ethical approval, this is not applicable.
Links section
- Bioethics Consultative Committee
- The Medical Association of Malta
- Government of Malta (in Maltese & English)
- Ministry of Health
- University
of Malta: Research
Ethics Committee Guidelines (in English)
See the REC bibliography section for more links and papers