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

被引:15
作者
Gefenas, E. [1 ]
Dranseika, V. [1 ]
Cekanauskaite, A. [1 ]
Hug, K. [2 ]
Mezinska, S.
Peicius, E. [4 ]
Silis, V. [3 ]
Soosaar, A. [5 ]
Strosberg, M. [6 ]
机构
[1] Vilnius Univ, Dept Med Hist & Eth, LT-03101 Vilnius, Lithuania
[2] Lund Univ, Dept Med Eth, Lund, Sweden
[3] Riga Stradins Univ, Dept Humanities, Riga, Latvia
[4] Kaunas Univ Med, Dept Philosophy & Social Sci, Kaunas, Lithuania
[5] Univ Tartu, Dept Publ Hlth, EE-50090 Tartu, Estonia
[6] Mt Sinai Sch Med, Bioeth Program, Union Grad Coll, Schenectady, NY USA
关键词
D O I
10.1136/jme.2009.035030
中图分类号
B82 [伦理学(道德学)];
学科分类号
摘要
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.
引用
收藏
页码:435 / 439
页数:5
相关论文
共 15 条
[1]  
[Anonymous], 2002, INT ETH GUID BIOM RE
[2]  
[Anonymous], 1964, Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects
[3]  
[Anonymous], 1993, Official journal of the european communities, V169, P1
[4]  
[Anonymous], 1995, OJL, V281, P31
[5]   Commentary: Ethics committees and countries in transition: a figleaf for structural violence? [J].
Ashcroft, RE .
BRITISH MEDICAL JOURNAL, 2005, 331 (7510) :229-230
[6]   How do we know that research ethics committees are really working? the neglected role of outcomes assessment in research ethics review [J].
Coleman C.H. ;
Bouësseau M.-C. .
BMC Medical Ethics, 9 (1)
[7]  
*COUNC EUR, 2005, ADD PROT CONV HUM RI
[8]  
DRANSEIKA V, DEV WORLD B IN PRESS
[9]  
*FL STAT U, HUM SUBJ COMM
[10]   Proportional ethical review and the identification of ethical issues [J].
Hunter, D. .
JOURNAL OF MEDICAL ETHICS, 2007, 33 (04) :241-245