Twenty years of human research ethics committees in the baltic states

Developing World Bioethics

Volumn 11, Issue 1, 2011, Pages 48-54

  Dranseika, Vilius ^a   Gefenas, Eugenijus ^a   Cekanauskaite, Asta ^a   Hug, Kristina ^b   Mezinska, Signe ^c   Peicius, Eimantas ^d   Silis, Vents ^c   Soosaar, Andres ^e   Strosberg, Martin ^f  

^a VILNIUS UNIVERSITY   (Lithuania)

^b LUND UNIVERSITY   (Sweden)

^c RIGA STRADINS UNIVERSITY   (Latvia)

^d KAUNAS UNIVERSITY OF MEDICINE   (Lithuania)

^e UNIVERSITY OF TARTU   (Estonia)

^f MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Baltic States; ethical review; Research ethics committees; Transparency

Indexed keywords

ARTICLE; BALTIC STATES; CLINICAL TRIAL (TOPIC); CONFLICT OF INTEREST; ETHICS; HUMAN; HUMAN EXPERIMENT; INFORMATION DISSEMINATION; PROFESSIONAL STANDARD; RESEARCH ETHICS;

BALTIC STATES; CLINICAL TRIALS AS TOPIC; CONFLICT OF INTEREST; ETHICAL ANALYSIS; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INFORMATION DISSEMINATION;

EID: 79952763589     PISSN: 14718731     EISSN: 14718847     Source Type: Journal    
DOI: 10.1111/j.1471-8847.2010.00288.x     Document Type: Article

References (25)

1. One of the first descriptions of RECs in Baltic States can be found in J. Glasa, ed. 2000. Ethics Committees in Central and Eastern Europe. Strasbourg: Council of Europe. However, recently there have been some Europe-wide initiatives to collect information on ethical review of human research that also covered the Baltic States. One important source is the PRIVIREAL project, started in 2002. However, the information provided by the project's website (Privireal. 2005. Research Ethics Committees - Countries. Sheffield, UK: Privireal. Available at: [Accessed 31 Mar 2010].) is in some respects already outdated. Results were published as D. Beyleveld, D. Townend & J. Wright, eds. 2005. Research Ethics Committees, Data Protection and Medical Research in European Countries. Hants: Ashgate. Another initiative is the European Forum for Good Clinical Practice (EFGCP) ongoing survey of ethical review procedures and practices related to clinical drug trials. Even though information provided by this survey is very recent (report was published in 2007 (EFGCP Ethics Working Party on the Structure and Function of Research Ethics Committees in the European Union. The Procedure for the Ethical Review of Protocols for Clinical Research Projects in the European Union. Int J Pharm Med 2007; 21: 1-113.); updates on the website are correct as of 2009 (EFGCP. 2009. Update of the Report, as of 2009. Brussels: EFGCP. Available at: [Accessed 31 Mar 2010].)) and comprehensive, it covers only a limited area of human research because drug-unrelated clinical trials as well as other types of biomedical research are not covered by the EU Clinical Trials Directive (European Commission, Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ L 121, 1.05.2001, that the EFGCP activities are based on.200134
2. As is indicated by Lithuanian bioethicists, '[t]he process of development of ethical review in Lithuania (and probably many other Central and Eastern European countries) was strongly facilitated by foreign pharmaceutical companies.' A. Cekanauskaite, E. Gefenas. Research Ethics Committees in Lithuania. In Beyleveld et al. eds. op. cit. note 1: 140-147, p. 141. Similar views were expressed by Estonian and Latvian experts as well. In the questionnaire received from one of the Estonian RECs, it was indicated that the motive for the establishment was to embrace 'new possibilities to take part in international medical research. The international requirements demanded independent body for the overview of research projects.' One of the Latvian RECs also reported that the main motive was 'the necessity to review the research involving human participants, as well as rapid development of drugs clinical research'. 2005
3. T. Veidebaum2005Research Ethics in Estonia. In Beyleveld et al. eds., op. cit. note 141-43
4. Seimas of the Republic of Lithuania. 1995. Republic of Lithuania Law on the Health System. Parliamentary Record, 12.01.1995, No. 12. Available at: [Accessed 31 Mar2010
5. Seimas of the Republic of Lithuania. 2000. Republic of Lithuania Law on Ethics of Biomedical Research. Available at: [Accessed 31 Mar2010
6. Latvijas Republikas Saeima (Saeima of the Republic of Latvia). 1998. Arstniecibas likums (Medical Treatment Law). Latvijas vestnesis, 01.07.1997, Nr. 167. Available at: [Accessed 31 Mar2010
7. Latvijas Republikas Ministru kabinets (Cabinet of Ministers of the Republic of Latvia). 1998. Centralas medicinas etikas komitejas nolikums (Statutes of Central Medical Ethics Committee). Latvijas vestnesis, 15.01.1998, Nr. 10. Available at: [Accessed 31 Mar2010
8. Eg. Privireal. 2005. Latvia - RECs and Medical Research. Sheffield, UK: Privireal. Available at: [Accessed 31 Mar2010
9. European Commission, op. cit. note 1
10. An exception is the website of the Lithuanian Bioethics Committee (Available at: [Accessed 31 Mar 2010]). This institution also has an official template for information requests and is obliged to answer inquiries. However, even here information sometimes is not regularly updated. For example, at the time of this research, statistics on the number of reviewed protocols had not been updated since mid2005
11. An example of one such database is ClinicalTrials.gov, a service of the US National Institutes of Health (Available at: [Accessed 31 Mar 2010]).?Also, Article 19 of Helsinki Declaration (World Medical Association. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (Helsinki: 1964; amended Tokyo: 1975; Venice: 1983; Hong Kong: 1989; Republic of South Africa: 1996; Edinburgh: 2000; Washington: 2002; Tokyo 2004; Seoul 2008). Available at: [Accessed 31 Mar 2010].) states that: 'Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.' This idea was also supported by the International Committee of Editors of Medical Journals which stipulates that member journals require authors to register their trials (including methodology) in a registry that is accessible to the public free of charge (International Committee of Medical Journal Editors. 2009. Obligation to Register Clinical Trials. Available at: [Accessed 31 Mar 2010].). The European Commission also issued guidelines on the list of fields contained in the EudraCT clinical trials database that should be made publicly available (European Commission. 2009. List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02. Available at: [Accessed 31 Mar2010
12. The Ethics Review Committee on Human Research of the University of Tartu has published an annual list of all approvals since 2008; see Tartu Ülikooli inimuuringute eetika komitee (Ethics Review Committee on Human Research of the University of Tartu). 2009. Tartu Ülikooli inimuuringute eetika komitee menetlus 2008 (Approvals given by the Ethics Review Committee on Human Research of the University of Tartu in 2008). Available at: [Accessed 31 Mar2010
13. For example, the Statutes of Tallinn MREC [provided by the REC] simply state that members who are not 'independent from the performers of the research' may not vote
14. In Latvia, it is true only of those RECs that review clinical drug trials
15. Lietuvos Respublikos Sveikatos apsaugos ministerija (Ministry of Health of the Republic of Lithuania). 2008. Lietuvos Respublikos sveikatos apsaugos ministro isakymas del regioniniu biomedicininiu tyrimu etikos komitetu nariu skyrimo tvarkos apraso patvirtinimo (Decree of the Minister of Health of the Republic of Lithuania on the Procedure of Nomination of the Members of Regional Biomedical Research Ethics Committees). Valstybes zinios, 2008-06-17, Nr. 69-2635. Available at: [Accessed 31 Mar2010
16. Lietuvos bioetikos komitetas (Lithuanian Bioethics Committee). 2007. Lietuvos bioetikos komiteto pirmininko isakymas V-8 Del Lietuvos bioetikos komiteto biomedicininiu tyrimu ekspertu grupes darbo reglamento patvirtinimo (Decree of the Lithuanian Bioethics Committee no. V-8 on the Working Procedures of the Biomedical Research Experts' Group). Valstybes zinios, 2008-02-28, Nr. 24-893. Available at: [Accessed 31 Mar2010
17. Latvijas Republikas Ministru kabinets (Cabinet of Ministers of the Republic of Latvia), op. cit. note 7. Art. 3
18. University of Tartu. 2007. Statute of the Ethics Review Committee on Human Research of the University of Tartu. Available at: [Accessed 31 Mar2010
19. For a general argument that REC members should be adequately remunerated, see Ch. Druml et al. Research Ethics Committees in Europe: Trials and Tribulations. Intensive Care Med2009351636-1640
20. This also leads to the issue of rotation of REC members. Lack of potential candidates may be dealt with by having no formal term limits for an REC member. For example, in Estonia, term limits were introduced only in2007
21. European Commission, op. cit. note 1
22. Seimas of the Republic of Lithuania, op. cit. note 5, Art 2.1.
23. For Estonia, some guidance can be found in the Oviedo Convention (Council of Europe. 1997. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Available at: [Accessed 31 Mar 2010].). This treaty has been ratified by Estonia and Lithuania but not Latvia. The Convention states that human scientific research in the field of biology and biomedicine cannot be conducted without 'multidisciplinary review of its ethical acceptability' (Art 16.3).
24. Human research conducted by students in educational setting may also involve significant risks to research subjects and therefore should receive ethical scrutiny. However, it may be impracticable to apply stringent procedures to student research. There is no definition of student research in Lithuanian, Latvian or Estonian legislation. Most medical schools in the Baltic States have internal regulations concerning the need for ethical review of student research. These internal regulations are based on local initiative not on overarching national policies.
25. Information on the Baltic research ethics network activities can be found on the website of Lithuanian Bioethics Committee. Available at: [Accessed 31 Mar2010