Latvia - RECs and Medical Research
History
There is a Central Medical Ethics Committee in Latvia that was established by the Cabinet of Ministers in 1998. It is an independent committee which in addition to reviewing research projects, publishes opinions, recommendations and informs the public on bioethical issues.
There are also 3 independent ethics committees that consider clinical trials. Approval from both an ethics committee and the State Agency of Medicine is required for trials to go ahead.
Summary of Latvian RECs
| Type of REC | Central Medical Ethics Committee | Ethics committee for clinical trials of drugs | Ethics committee for clinical trials of drugs by Latvian Institute of Cardiology | Independent Ethics committee for investigation of drugs & pharmaceutical products |
| Where situated? | Ministry of Health | Latvian Institute of Organic Synthesis Clinical Research Unit | Latvian Institute of Cardiology | Centre for Infectious Diseases |
| Who applies to them? | Researchers | Clinical trial researchers | Clinical trial researchers | Clinical trial researchers |
| Formal/Informal | Formal | Formal | Formal | Formal |
| National/Regional | National | Regional | Regional | Regional |
| Laws Involved (see below) |
Law on Medical Treatment 1997 Statute
of the Ethics Committees 1998 |
Statute
of the Ethics Committees 1998 Regulation on clinical trials of medicines No. 312, 12 September 2000 |
Statute
of the Ethics Committees 1998 |
Statutes
of the Ethics Committees 1998 |
| Guidance Involved | WHO guidelines for ethics committees 2000 |
WHO guidelines for ethics committees 2000 |
WHO guidelines for ethics committees 2000 |
|
| Membership requirements | 14
members, including: Doctors, Nurses, Scientists, Lawyers, Pharamcists, Religious Rep., Rep. for Disabled People and a Rep. for the Retired |
14 members, including: Physicians, Pharmacist, Journalist, Lawyer, Computer Expert | 9
members: 6 physicians, Biologist, Biochemist, Laboratory Assistant |
12
members,including: Physicians, Economists, Pharmacologists, Lawyers, Psychologist, Laypersons |
| Responsible/accountable to whom? | Minister of Welfare (independent) | Minister of Welfare (independent) | Minister of Welfare | Minister of Welfare (independent) |
| Approval or Advisory powers | Advisory | Approval | Approval | Approval |
Not submitting research or failing to follow review
There are no consequences, except in the case of medical trials.
Which body, if not the REC itself takes this action, and how do they proceed?
The State Agency of Medicines assesses compliance with the standard of Good Clinical Practice and has the power to stop clinical trials.
Impact of Directive 2001/20 EC
The Directive was implemented through Amendments to the Cabinet Regulation on Clinical Trials of Medicines 2000.
Legal action that can be taken against RECs
There are no specific regulations regarding legal action. However, the Pharmacy Law establishes liability of persons who violate that law.
Links section
Laws and Guidance
- Pharmacy Law -last amendment 16 April 2003 (English translation, consolidated version)
- Regulation on clinical trials of medicines No. 312, 12 September 2000. Amendments on 9 September 2003 (No. 506) and on 15 June 2004 (No. 542)
- State Agency of Medicines - includes relevant legislation regarding clinical trials & ethical review (in Latvian & English)
Institutions
- Latvian Council of Science (in Latvian & English)
- Ministry of Welfare (in Latvian & English)
- Saeima - the Latvian parliament (in Latvian & English)
- Cabinet of Ministers (in Latvian & English)
Articles
- Rudze, Laima 'Ethics Committees in Latvia' In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).
- EGE Newsletter "Ethically Speaking": Issue nr. 2 - December 2003, page 23
See the REC bibliography section for more links and papers, or the Latvian data protection page for more information on data protection in Latvia.