Lithuania - RECs and Medical Research
History
The Law on Ethics of Biomedical Research came into force in 2000 and established a two level system of review in Lithuania. There is a national review body, the Lithuanian Bioethics Committee, and Regional Biomedical Research Ethics Committees. These are situated in counties where there is a University.
The Regional RECs may only consider research to be carried out solely in their region and are under the authority of the National Committee. In the case of multi-centre clinical research, approval from the National Committee is required. All approvals by the Regional RECs must be notified to the National Committee. Approval by the State Drug Control Agency is necessary for clinical research of medicinal products. In the case of clinical research on medical instruments or substances, approval from the State Health Care Accreditation Agency is required.
The Lithuanian Bioethics Committee was established in 1995 and is appointed by the MInistry of Health. In addition to approving biomedical research in certain cases, it provides advise on ethical issues to the Ministry of Health and other government bodies, informs and educates the public and gives support and education to the regional RECs.
Summary of Lithuanian RECs
| of REC | Lithuanian Bioethics Committee | Regional Biomedical Research Ethics Committees |
| Where situated? | Vilnius | Regional Universities |
| Who applies to them? |
Researchers/sponsors of research Researchers carrying out multi-centre trials |
Researchers/sponsors of research |
| Formal/Informal | Formal | Formal |
| National/Regional | National | Regional |
| Laws Involved |
Law
on Ethics of Biomedical Research 2001 Ministry of Health Decrees on:
|
Law on Ethics of Biomedical Research 2001 Ministry of Health Decrees on:
|
| Guidance Involved | Model Operating Procedures for Regional Biomedical Research Ethics Committees |
|
| Membership requirements | At least 9 members | Not defined but must include representatives of the degree-holding academic community, health-care specialists and the general public |
| Responsible/accountable to whom? | Ministry of Health | The
University where they are situated. Lithuanian Bioethics committee. |
| Approval or Advisory powers | Approval | Approval |
Not submitting research or failing to follow review
Article 18 of the Law on Ethics of Biomedical Research states that 'Carrying out of biomedical research without an approval or not in the conformity with the requirements of this Law and other legal acts provided the research has not damaged the research subject's health shall be treated as an act of malpractice.'
Which body, if not the REC itself takes this action, and how do they proceed?
It is a legal matter if the research
has damaged the subject’s health, otherwise it is regarded as malpractice.
Article 29 of the Law on Legal Protection of Personal Data states that
the extent of damage sustained through unlawful processing of personal
data shall be determined by the court.
Impact of Directive 2001/20 EC
This was implemented through a Ministry of Health Decree of May 11 2004. The most significant change in the system was that approval from the State Drug Control Agency is required for clinical trials on medicinal products in addition to a positive opinion from an REC.
Legal action that can be taken against RECs
Researchers can appeal against an REC decision to the National Committee and can appeal to the courts if they disagree with a National Committee decision.
Links section
Laws and guidance
- Relevant Laws (in English) from the Lithuanian Bioethics Committee
- Law on Ethics of Biomedical Research 2001 (in English)
- Law on Legal Protection of Personal Data 2003 (in English)
- Law on the Health System 1998 (in English)
Institutions
- Ministry of Health
- Seimas (Parliament)
- Lithuanian Bioethics Committee (in English & Lithuanian)
See the REC bibliography section for more links and papers, and the PRIVIREAL Lithuania data protection page