Literature DB >> 16877630

Research ethics committees in Europe: implementing the directive, respecting diversity.

A Hedgecoe1, F Carvalho, P Lobmayer, F Raka.   

Abstract

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees (RECs) across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union (EU). How four different member states-Hungary, Portugal, Sweden and the UK-have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees.

Mesh:

Year:  2006        PMID: 16877630      PMCID: PMC2563384          DOI: 10.1136/jme.2005.013888

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


  9 in total

1.  Impact of EU clinical trial directive.

Authors:  S Christey
Journal:  Eur J Cancer       Date:  2001-10       Impact factor: 9.162

2.  Another threat to research in the United Kingdom.

Authors:  Richard Nicholson
Journal:  BMJ       Date:  2004-05-22

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.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

4.  Reforming research ethics committees.

Authors:  Richard E Ashcroft; Ainsley J Newson; Piers M W Benn
Journal:  BMJ       Date:  2005-09-17

5.  The Ad Hoc Advisory Group's proposals for research ethics committees: a mixture of the timid, the revolutionary, and the bizarre.

Authors:  A J Dawson
Journal:  J Med Ethics       Date:  2005-08       Impact factor: 2.903

6.  The reform of UK research ethics committees: throwing the baby out with the bath water?

Authors:  S Kerrison; A M Pollock
Journal:  J Med Ethics       Date:  2005-08       Impact factor: 2.903

7.  Local research ethics committees.

Authors:  K G Alberti
Journal:  BMJ       Date:  1995-09-09

8.  Medical ethics in the European Community.

Authors:  P Riis
Journal:  J Med Ethics       Date:  1993-03       Impact factor: 2.903

9.  Research ethics committees: differences and moral judgement.

Authors:  Sarah J L Edwards; Richard Ashcroft; Simon Kirchin
Journal:  Bioethics       Date:  2004-09       Impact factor: 1.898

  9 in total
  10 in total

1.  Frontline ethical issues in pediatric clinical research: ethical and regulatory aspects of seven current bottlenecks in pediatric clinical research.

Authors:  Wim Pinxten; Herman Nys; Kris Dierickx
Journal:  Eur J Pediatr       Date:  2010-07-29       Impact factor: 3.183

2.  Clinical Ethics Consultation in the Transition Countries of Central and Eastern Europe.

Authors:  Marcin Orzechowski; Maximilian Schochow; Florian Steger
Journal:  Sci Eng Ethics       Date:  2019-10-05       Impact factor: 3.525

3.  ETHICAL REVIEW OF BIOMEDICAL RESEARCH IN BELARUS: CURRENT STATUS, PROBLEMS AND PERSPECTIVES.

Authors:  Andrei Famenka
Journal:  Rev Rom Bioet       Date:  2011-04

4.  Increasing value and reducing waste in biomedical research regulation and management.

Authors:  Rustam Al-Shahi Salman; Elaine Beller; Jonathan Kagan; Elina Hemminki; Robert S Phillips; Julian Savulescu; Malcolm Macleod; Janet Wisely; Iain Chalmers
Journal:  Lancet       Date:  2014-01-08       Impact factor: 79.321

5.  From anonymity to "open doors": IRB responses to tensions with researchers.

Authors:  Robert Klitzman
Journal:  BMC Res Notes       Date:  2012-07-03

6.  How local IRBs view central IRBs in the US.

Authors:  Robert Klitzman
Journal:  BMC Med Ethics       Date:  2011-06-23       Impact factor: 2.652

7.  National Human Research Ethics: A Preliminary Comparative Case Study of Germany, Great Britain, Romania, and Sweden.

Authors:  Bernard Gallagher; Anne H Berman; Justyna Bieganski; Adele D Jones; Liliana Foca; Ben Raikes; Johanna Schiratzki; Mirjam Urban; Sara Ullman
Journal:  Ethics Behav       Date:  2015-11-03

8.  Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States.

Authors:  Elina Hemminki
Journal:  Health Res Policy Syst       Date:  2016-01-19

9.  Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

Authors:  Go Yoshizawa; Teguh H Sasongko; Chih-Hsing Ho; Kazuto Kato
Journal:  Front Genet       Date:  2017-07-20       Impact factor: 4.599

10.  How ethics committees and requirements are structuring health research in the Philippines: a qualitative study.

Authors:  Gideon Lasco; Vincen Gregory Yu; Lia Palileo-Villanueva
Journal:  BMC Med Ethics       Date:  2021-07-01       Impact factor: 2.652

  10 in total

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