Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
E. Gefenas, V. Dranseika, A. Cekanauskaite, K. Hug, S. Mezinska, E. Peicius, V. Silis, A. Soosaar & M. Strosberg
Journal of Medical Ethics 36 (7):435-439 (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.
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
Marcin Waligora (2013). Failures in Clinical Trials in the European Union: Lessons From the Polish Experience. Science and Engineering Ethics 19 (3):1087-1098.
Marcin Waligora (2013). A European Consistency for Functioning of RECs? We Just Lost Our Chance. Journal of Medical Ethics 39 (6):408-409.
Similar books and articles
Vilius Dranseika, Eugenijus Gefenas, Asta Cekanauskaite, H. U. G. Kristina, Signe Mezinska, Eimantas Peicius, Vents Silis, Andres Soosaar & Martin Strosberg (2011). Twenty Years of Human Research Ethics Committees in the Baltic States. Developing World Bioethics 11 (1):48-54.
Dannie Di Tillio-Gonzalez Ruth L. Fischbach (2008). Harmonizing Regulations for Biomedical Research: A Critical Analysis of the Us and Venezuelan Systems. Developing World Bioethics 8 (3):167-177.
Lisa Eckenwiler (2001). Moral Reasoning and the Review of Research Involving Human Subjects. Kennedy Institute of Ethics Journal 11 (1):37-69.
Andrzej Górski (2006). The Responsible Conduct of Basic and Clinical Research. Science and Engineering Ethics 12 (1):3-4.
Sara Svensson & Sven Ove Hansson (2007). Protecting People in Research: A Comparison Between Biomedical and Traffic Research. [REVIEW] Science and Engineering Ethics 13 (1):99-115.
Dennis John Mazur (2007). Evaluating the Science and Ethics of Research on Humans: A Guide for Irb Members. Johns Hopkins University Press.
E. Cave & C. Nichols (2007). Clinical Audit and Reform of the UK Research Ethics Review System. Theoretical Medicine and Bioethics 28 (3):181-203.
Baruch A. Brody (1998). The Ethics of Biomedical Research: An International Perspective. Oxford University Press.
Adil E. Shamoo (2009). Responsible Conduct of Research. Oxford University Press.
Frederick T. L. Leong & Brent Lyons (2011). Ethical Challenges for Cross-Cultural Research Conducted by Psychologists From the United States. Ethics and Behavior 20 (3):250-264.
Mindaugas Broga, Goran Mijaljica, Marcin Waligora, Aime Keis & Ana Marusic (2013). Publication Ethics in Biomedical Journals From Countries in Central and Eastern Europe. Science and Engineering Ethics (1):1-11.
Paul M. McNeill (1993). The Ethics and Politics of Human Experimentation. Cambridge University Press.
Added to index2010-09-13
Total downloads7 ( #204,517 of 1,410,227 )
Recent downloads (6 months)1 ( #155,456 of 1,410,227 )
How can I increase my downloads?