Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?
- E Gefenas1,
- V Dranseika1,
- A Cekanauskaite1,
- K Hug2,
- S Mezinska3,
- E Peicius4,
- V Silis5,
- A Soosaar6,
- M Strosberg7
- 1Department of Medical History and Ethics, Vilnius University, Vilnius, Lithuania
- 2Department of Medical Ethics, Lund University, Lund, Sweden
- 3Riga Stradins University, Riga, Latvia
- 4Department of Philosophy and Social Sciences, Kaunas University of Medicine, Kaunas, Lithuania
- 5Department of Humanities, Riga Stradins University, Riga, Latvia
- 6Department of Public Health, University of Tartu, Tartu, Estonia
- 7Bioethics Program, Union Graduate College - Mount Sinai School of Medicine, Schenectady, New York, USA
- Correspondence to Eugenijus Gefenas, Department of Medical History and Ethics, Vilnius University, M.K.Ciurlionio St. 21/27, Vilnius LT-03101, Lithuania;
- Received 14 December 2009
- Revised 8 April 2010
- Accepted 12 April 2010
We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems.
- Biomedical research
- drug evaluation
- human research
- equivalent stringency of ethical review
- research ethics committees
- Baltic States
- research ethics
- legal aspects
- policy guidelines/inst. review boards/review cttes.
- social control of human experimentation
Funding Other Funders: NIH.
Competing interests Andres Soosaar is at the University of Tartu Human Research Ethics Committee. Eugenijus Gefenas and Asta Cekanauskaite are at the Lithuanian Bioethics Committee. Eimantas Peicius is at Kaunas Regional Biomedical Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.