How does the ethical review process work in Latvia and which are the designated ethics committees?
Ethics Committees
The following ethics committees review biomedical research in Latvia:
- Central Medical Ethics Committee of Latvia
- Independent Ethics Committees for Investigation of Drugs and Pharmaceutical Products
- Ethics Committee of the Latvian Institute of Cardiology for Clinical and Physiological Research, and Drug and Pharmaceutical Product Clinical Investigation
- Ethics Committee of Medical Academy of Latvia
- Ethics Committee on Laboratory Animal Use in Biomedical Research
Central Medical Ethics Committee of Latvia
The central ethics committee of Latvia was set-up by the Cabinet of Ministers of the Republic of Latvia on 25.03.1998. The legal basis of the committee is a Rule of the cabinet of ministers of Latvia. The committee consists of 14 members and is multi-disciplinary composed of medical and non-medical experts and representatives. Debates within the Committee are open to the public. The main topics on which the Committee has given its views are the following: evaluation of research projects, evaluation of medical devices, recommendation to refine experimental techniques. Each decision regarding a protocol is voted with a simple majority. The decisions of the committee shall be given within 4 weeks in writing.
The tasks of the committee are to ensure that:
- the risks connected with the implementation of a project have been properly assessed;
- patients or healthy volunteers, participating in the project will be informed in writing about its content, foreseeable risks and advantages, and that their free and explicit consent will be obtained and given in writing;
- where patients are not able to consent, information will be given to, and consent obtained from, the closest relatives, or guardian;
- the information leaflets should clearly mention that patients and healthy volunteers or relatives, guardian or donor can withdraw their consent at any time.
The committee follows up individual projects and requires the final scientific report or publication to be submitted to them.
Ethics Committee of the Latvian Institute of Cardiology for Clinical and Physiological Research, and Drug and Pharmaceutical Product Clinical Investigation consists of 9 members (6 physicians, biologist, biochemist and laboratory assistant).
The Independent Ethics Committees for Investigation of Drugs and Pharmaceutical Products consists of 12 members (physicians, economists, pharmacologists, lawyers, psychologist, expert from drug agency, laypersons).
A clinical trial of drugs and pharmaceutical products may start only after a written approval from the independent ethics committee for clinical trials and drugs and a written permission from the State Agency of Medicines have been obtained. Applications for approval can be submitted to the State Agency of Medicines and the independent ethics committee for clinical trials of drugs in parallel.