Non-equivalent stringency of ethical review in the Baltic States: A sign of a systematic problem in Europe?

Journal of Medical Ethics

Volumn 36, Issue 7, 2010, Pages 435-439

  Gefenas, E ^a   Dranseika, V ^a   Cekanauskaite, A ^a   Hug, K ^b   Mezinska, S ^c   Peicius, E ^d   Silis, V ^c   Soosaar, A ^e   Strosberg, M ^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

[No Author keywords available]

Indexed keywords

ARTICLE; BALTIC STATES; ETHICS; EUROPE; HUMAN; HUMAN EXPERIMENT; LEGAL ASPECT; MEDICAL RESEARCH; RISK; STANDARD;

BALTIC STATES; BIOMEDICAL RESEARCH; ETHICAL REVIEW; EUROPE; HUMAN EXPERIMENTATION; HUMANS; RISK;

EID: 77958107560     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2009.035030     Document Type: Article

References (21)

1. Coleman C, Bouësseau MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics 2008;9:6.
2. Ashcroft RE. Commentary: Ethics Committees and Countries in Transition: a figleaf for structural violence? Br Med J 2005;331:229-30.
3. Dranseika V, Gefenas E, Cekanauskaite A, et al. 20 years of Human Research Ethics Committees in the Baltic States. Developing World Bioethics (Forthcoming).
4. Hunter D. Proportional Ethical Review and the Identification of Ethical Issues. J Med Ethics 2007;33:241-5.
5. University of Ottawa. Minimal risk review and expedited review. http://www.rges.uottawa.ca/ethics/minimal_risk.asp (accessed Apr 2010).
6. Florida State University. Human Subjects Committee. http://www.research.fsu.edu/humansubjects (accessed Apr 2010).
7. Anon. 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. Official Journal of the European Union 2001;121:34.
8. Anon. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Union 1993;169:1e43.
9. Saeima of the Republic of Latvia. 2002. Republic of Latvia Law on Human Genome Research, 2002. http://www.ttc.lv/export/sites/default/docs/LRTA/Likumi/Human_Genome_Research_Law.doc (accessed Apr 2010).
10. Council of Europe. 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, 1997. http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm (accessed 5 Apr 2010).
11. Seimas of the Republic of Lithuania. Republic of Lithuania Law on Ethics of Biomedical Research, 2000. http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_e?p_id=148740 (accessed 5 Apr 2010).
12. The Parliament of Estonia. Estonian human genes research act, 2000. http://www.geenivaramu.ee/index.php?id=98 (accessed 5 Apr 2010).
13. The Parliament of Estonia. Estonian Health Services Organisation Act (Tervishoiuteenuste korraldamise seadus), 2001. http://www.riigiteataja.ee/ert/act.jsp?id=13202311 (accessed 5 Apr 2010).
14. Anon. Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data. OJL 1995;281:31e50.
15. Department of Health and Human Services. Code of Federal Regulations. Title 46 Public Welfare. Part 46 Protection of Human Subjects, 2005. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm (accessed 5 Apr 2010).
16. Swedish Ministry of Education and Cultural Affairs, 2003. The Act concerning the Ethical Review of Research Involving Humans (Lag om etikprövning av forskning som avser människor). http://www.riksdagen.se/webbnav/index.aspx? nid=3911&bet=2003:460 (accessed 5 Apr 2010).
17. Council of Europe. Additional protocol to the convention on human rights and biomedicine, concerning biomedical research, 2005. http://conventions.coe.int/treaty/en/Treaties/Html/195.htm (accessed 5 Apr 2010).
18. Council of Europe Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin, 2006. http://www.coe.int/t/e/legal_affairs/legal_co-peration/bioethics/texts_and_documents/ Rec_2006_4.pdf (accessed 5 Apr 2010).
19. 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). 2008. http://www.wma.net/en/30publications/10policies/b3/index.html (accessed Apr 2010).
20. Council for International Organizations of Medical Sciences (CIOMS). International Ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: CIOMS, 2002. http://www.cioms.ch/frame_guidelines_nov_2002.htm (accessed Apr 2010).
21. European Commission. Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC, 2009. Public Consultation Paper. http://ec.europa.eu/enterprise/pharmaceuticals/clinicaltrials/docs/2009_10_09_public-consultationpaper.pdf (accessed 5 Apr 2010).