title: Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?
abstract: 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.
authors.affiliation: Department of Medical History and Ethics, Vilnius University, MK Ciurlionio St 21/27, Vilnius LT-03101, Lithuania. eugenijus.gefenas@mf.vu.lt
authors.forename: E
authors.initials: E
authors.lastname: Gefenas
authors.forename: V
authors.initials: V
authors.lastname: Dranseika
authors.forename: A
authors.initials: A
authors.lastname: Cekanauskaite
authors.forename: K
authors.initials: K
authors.lastname: Hug
authors.forename: S
authors.initials: S
authors.lastname: Mezinska
authors.forename: E
authors.initials: E
authors.lastname: Peicius
authors.forename: V
authors.initials: V
authors.lastname: Silis
authors.forename: A
authors.initials: A
authors.lastname: Soosaar
authors.forename: M
authors.initials: M
authors.lastname: Strosberg
mesh_terms: D001454:Baltic States; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D026724:Ethical Review / Q000592:standards*; D005060:Europe; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D012306:Risk