Literature DB >> 19156538

Polish Research Ethics Committees in the European Union system of assessing medical experiments.

Marek Czarkowski1, Krzysztof Rózanowski.   

Abstract

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 +/- 31.7 (range: 0-131) projects of clinical trials and 71.1 +/- 139.8 (range: 0-638) projects of other types of medical research. During one BC meeting an average of 10.3 +/- 14.7 (range: 0-71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary.

Mesh:

Year:  2009        PMID: 19156538     DOI: 10.1007/s11948-009-9113-x

Source DB:  PubMed          Journal:  Sci Eng Ethics        ISSN: 1353-3452            Impact factor:   3.525


  9 in total

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3.  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

4.  Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?

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Journal:  J Med Ethics       Date:  2005-06       Impact factor: 2.903

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Authors:  Marek Czarkowski
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Journal:  J Med Ethics       Date:  2008-05       Impact factor: 2.903

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Authors:  C G Foster; T Marshall; P Moodie
Journal:  J Med Ethics       Date:  1995-08       Impact factor: 2.903

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Authors:  Evelyne Decullier; Véronique Lhéritier; François Chapuis
Journal:  BMC Med Ethics       Date:  2005-10-17       Impact factor: 2.652

  9 in total
  4 in total

1.  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

2.  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

3.  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

4.  Performance of IRBs in China: a survey on IRB employees and researchers' experiences and perceptions.

Authors:  Xing Liu; Ying Wu; Min Yang; Yang Li; Kaveh Khoshnood; Esther Luo; Lun Li; Xiaomin Wang
Journal:  BMC Med Ethics       Date:  2022-08-29       Impact factor: 2.834

  4 in total

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