Advanced

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

Gefenas, E.; Dranseika, V.; Cekanauskaite, A.; Hug, Kristina LU ; Mezinska, S.; Peicius, E.; Silis, V.; Soosaar, A. and Strosberg, M. (2010) In Journal of Medical Ethics 36(7). p.435-439
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... (More)
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. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Medical Ethics
volume
36
issue
7
pages
435 - 439
publisher
BMJ Publishing Group
external identifiers
  • wos:000279529900014
  • scopus:77958107560
ISSN
1473-4257
DOI
10.1136/jme.2009.035030
language
English
LU publication?
yes
id
c5656030-44dc-4e0a-9660-885fcd135861 (old id 1657835)
date added to LUP
2010-08-20 09:25:06
date last changed
2018-05-29 10:08:56
@article{c5656030-44dc-4e0a-9660-885fcd135861,
  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.},
  author       = {Gefenas, E. and Dranseika, V. and Cekanauskaite, A. and Hug, Kristina and Mezinska, S. and Peicius, E. and Silis, V. and Soosaar, A. and Strosberg, M.},
  issn         = {1473-4257},
  language     = {eng},
  number       = {7},
  pages        = {435--439},
  publisher    = {BMJ Publishing Group},
  series       = {Journal of Medical Ethics},
  title        = {Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?},
  url          = {http://dx.doi.org/10.1136/jme.2009.035030},
  volume       = {36},
  year         = {2010},
}