Literature DB >> 12356961

New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interest.

E Cave1, S Holm.   

Abstract

This paper examines the UK's response to a recent European Clinical Trials Directive, namely the Department of Health, Central Office for Research Ethics Committee guidance, Governance Arrangements for NHS Research Ethics Committees. The revisions have been long awaited by researchers and research ethics committee members alike. They substantially reform the ethical review system in the UK. We examine the new arrangements and argue that though they go a long way toward addressing the uncertainty surrounding ethics committee function, the system favours the facilitation of research over the protection of the dignity and welfare of research participants.

Entities:  

Keywords:  Biomedical and Behavioral Research; Legal Approach

Mesh:

Year:  2002        PMID: 12356961      PMCID: PMC1733658          DOI: 10.1136/jme.28.5.318

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


  12 in total

1.  Ethical ethics committees?

Authors:  S G Barber
Journal:  J Med Ethics       Date:  2000-04       Impact factor: 2.903

2.  Multicentre research ethics committees: has the cure been worse than the disease? No, but idiosyncracies and obstructions to good research must be removed.

Authors:  K G Alberti
Journal:  BMJ       Date:  2000-04-29

3.  The new system of review by multicentre research ethics committees: prospective study.

Authors:  J Tully; N Ninis; R Booy; R Viner
Journal:  BMJ       Date:  2000-04-29

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Authors:  P Garfield
Journal:  BMJ       Date:  1995-09-09

5.  Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability.

Authors:  J Savulescu; I Chalmers; J Blunt
Journal:  BMJ       Date:  1996-11-30

6.  Diversity in the practice of district ethics committees.

Authors:  C Gilbert; K W Fulford; C Parker
Journal:  BMJ       Date:  1989-12-09

7.  The annual reports of Local Research Ethics Committees.

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

8.  Local research ethics committees: hindrance or help?

Authors:  Z J Penn; P J Steer
Journal:  Br J Obstet Gynaecol       Date:  1995-01

9.  The trouble with ethics committees.

Authors:  T W Meade
Journal:  J R Coll Physicians Lond       Date:  1994 Mar-Apr

10.  Why do research ethics committees disagree with each other?

Authors:  C Foster
Journal:  J R Coll Physicians Lond       Date:  1995 Jul-Aug
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  8 in total

Review 1.  US and UK policies governing research with humans.

Authors:  Karen J Maschke
Journal:  Psychopharmacology (Berl)       Date:  2003-11-13       Impact factor: 4.530

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

Authors:  R Dal-Ré; R Ortega; E Morejón
Journal:  J Med Ethics       Date:  2005-06       Impact factor: 2.903

3.  Recommendations in relation to the EU clinical trials directive and medical research involving incapacitated adults.

Authors:  Kathleen Liddell; Erwin J O Kompanje; François Lemaire; Bozidar Vrhovac; David K Menon; Julian Bion; Douglas Chamberlain; Christian J Wiedermann; Christiane Druml
Journal:  Wien Klin Wochenschr       Date:  2006-04       Impact factor: 1.704

4.  Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial.

Authors:  C M Seiler; P Kellmeyer; P Kienle; M W Büchler; H-P Knaebel
Journal:  J Med Ethics       Date:  2007-02       Impact factor: 2.903

5.  Efficiency and the proposed reforms to the NHS research ethics system.

Authors:  David Hunter
Journal:  J Med Ethics       Date:  2007-11       Impact factor: 2.903

Review 6.  Fostering IRB collaboration for review of international research.

Authors:  Francis Barchi; Megan Kasimatis Singleton; Jon F Merz
Journal:  Am J Bioeth       Date:  2014       Impact factor: 11.229

Review 7.  Research ethics committees in the UK--the pressure is now on research and development departments.

Authors:  Rustam Al-Shahi
Journal:  J R Soc Med       Date:  2005-10       Impact factor: 18.000

8.  In the lion's den? Experiences of interaction with research ethics committees.

Authors:  Elizabeth Fistein; Sally Quilligan
Journal:  J Med Ethics       Date:  2011-11-02       Impact factor: 2.903

  8 in total

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