Literature DB >> 20606000

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

E Gefenas1, V Dranseika, A Cekanauskaite, K Hug, S Mezinska, E Peicius, V Silis, A Soosaar, M Strosberg.   

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.

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Year:  2010        PMID: 20606000      PMCID: PMC3072805          DOI: 10.1136/jme.2009.035030

Source DB:  PubMed          Journal:  J Med Ethics        ISSN: 0306-6800            Impact factor:   2.903


  7 in total

1.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

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Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

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Authors:  Richard E Ashcroft
Journal:  BMJ       Date:  2005-07-23

Review 3.  Proportional ethical review and the identification of ethical issues.

Authors:  D Hunter
Journal:  J Med Ethics       Date:  2007-04       Impact factor: 2.903

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Journal:  Int J Epidemiol       Date:  1995-04       Impact factor: 7.196

5.  Twenty years of human research ethics committees in the Baltic States.

Authors:  Vilius Dranseika; Eugenijus Gefenas; Asta Cekanauskaite; Kristina Hug; Signe Mezinska; Eimantas Peicius; Vents Silis; Andres Soosaar; Martin Strosberg
Journal:  Dev World Bioeth       Date:  2010-12-07       Impact factor: 2.294

6.  Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (adopted by the Committee of Ministers on 19 November 1996). Council of Europe Convention of Biomedicine.

Authors: 
Journal:  Hum Reprod       Date:  1997-09       Impact factor: 6.918

7.  How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review.

Authors:  Carl H Coleman; Marie-Charlotte Bouësseau
Journal:  BMC Med Ethics       Date:  2008-03-28       Impact factor: 2.652

  7 in total
  7 in total

1.  Can significant differences in regulating medical and non-medical research be justified?

Authors:  David Hunter
Journal:  Monash Bioeth Rev       Date:  2014 Sep-Dec

2.  Research ethics review: identifying public policy and program gaps.

Authors:  Martin A Strosberg; Eugenijus Gefenas; Andrei Famenka
Journal:  J Empir Res Hum Res Ethics       Date:  2014-04       Impact factor: 1.742

3.  Building research ethics capacity in post-communist countries: experience of two Fogarty training programs.

Authors:  Martin A Strosberg; Eugenijus Gefenas; Sana Loue; Sean Philpott
Journal:  J Empir Res Hum Res Ethics       Date:  2013-12       Impact factor: 1.742

4.  Research Ethics in the Context of Transition: Gaps in Policies and Programs on the Protection of Research Participants in the Selected Countries of Central and Eastern Europe.

Authors:  Andrei Famenka
Journal:  Sci Eng Ethics       Date:  2015-11-09       Impact factor: 3.525

5.  Failures in clinical trials in the European Union: lessons from the Polish experience.

Authors:  Marcin Waligora
Journal:  Sci Eng Ethics       Date:  2012-10-06       Impact factor: 3.525

6.  Optimization of a Deep Learning Algorithm for Security Protection of Big Data from Video Images.

Authors:  Qiang Geng; Huifeng Yan; Xingru Lu
Journal:  Comput Intell Neurosci       Date:  2022-03-08

7.  Publication ethics in biomedical journals from countries in Central and Eastern Europe.

Authors:  Mindaugas Broga; Goran Mijaljica; Marcin Waligora; Aime Keis; Ana Marusic
Journal:  Sci Eng Ethics       Date:  2013-03-01       Impact factor: 3.525

  7 in total

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