Literature DB >> 8910776

Delays and diversity in the practice of local research ethics committees.

A H Ahmed1, K G Nicholson.   

Abstract

OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study.
DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees.
SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms.
RESULTS: We received replies from all 36 chairmen contacted: four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines.
CONCLUSION: Obtaining ethical approval for a multi-centre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees.

Entities:  

Keywords:  Biomedical and Behavioral Research; Empirical Approach; Royal College of Physicians

Mesh:

Year:  1996        PMID: 8910776      PMCID: PMC1377056          DOI: 10.1136/jme.22.5.263

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


  7 in total

1.  Scrutinising research ethics committees.

Authors:  Tim Marshall; Peter Moodie
Journal:  BMJ       Date:  1988-09-24

2.  Too many ethical committees.

Authors:  T J Berry; T E Ades; C S Peckham
Journal:  BMJ       Date:  1990-12-01

3.  Diversity in the practice of district ethics committees.

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

4.  Are ethical committees reliable?

Authors:  M Hotopf; S Wessely; N Noah
Journal:  J R Soc Med       Date:  1995-01       Impact factor: 5.344

5.  Compensation and drug trials.

Authors:  A L Diamond; D R Laurence
Journal:  Br Med J (Clin Res Ed)       Date:  1983-09-03

6.  Comparison of haemodynamic responses to dopamine and salbutamol in severe cardiogenic shock complicating acute myocardial infarction.

Authors:  A D Timmis; M B Fowler; D A Chamberlain
Journal:  Br Med J (Clin Res Ed)       Date:  1981-01-03

7.  Local research ethics committees. Report of the 2nd National Conference.

Authors:  J Moran
Journal:  J R Coll Physicians Lond       Date:  1992-10
  7 in total
  24 in total

1.  Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

Authors:  R Dal-Ré; J Espada; R Ortega
Journal:  J Med Ethics       Date:  1999-06       Impact factor: 2.903

2.  The case for a new system for oversight of research on human subjects.

Authors:  K Jamrozik
Journal:  J Med Ethics       Date:  2000-10       Impact factor: 2.903

3.  Centralized national ethical review of clinical trials in Croatia.

Authors:  Dinko Vitezić; Maja Lovrek; Sinisa Tomić
Journal:  Croat Med J       Date:  2009-04       Impact factor: 1.351

4.  Innovations in the Ethical Review of Health-Related Quality Improvement and Research: The Alberta Research Ethics Community Consensus Initiative (ARECCI).

Authors:  Brad Hagen; Maeve O'Beirne; Sunil Desai; Michael Stingl; Cathy Anne Pachnowski; Sarah Hayward
Journal:  Healthc Policy       Date:  2007-05

5.  An appraisal of the process of protocol review by an ethics review conmmittee in a tertiary institution in Ibadan.

Authors:  O R Eyelade; A J Ajuwon; C A Adebamowo
Journal:  Afr J Med Med Sci       Date:  2011-06

6.  Ethical approval for research involving geographically dispersed subjects: unsuitability of the UK MREC/LREC system and relevance to uncommon genetic disorders.

Authors:  J C Lewis; S Tomkins; J R Sampson
Journal:  J Med Ethics       Date:  2001-10       Impact factor: 2.903

Review 7.  Ethics review of pediatric multi-center drug trials.

Authors:  Allison C Needham; Mufiza Z Kapadia; Martin Offringa
Journal:  Paediatr Drugs       Date:  2015-02       Impact factor: 3.022

8.  Implementing National System of Health Research Ethics Regulations: The Nigerian Experience.

Authors:  Aminu Yakubu; Clement A Adebamowo
Journal:  BEOnline       Date:  2012

Review 9.  Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.

Authors:  Charles W Lidz; Ekaterina Pivovarova; Paul Appelbaum; Deborah F Stiles; Alexandra Murray; Robert L Klitzman
Journal:  AJOB Empir Bioeth       Date:  2018-10-04

10.  The Myth of Community Differences as the Cause of Variations Among IRBs.

Authors:  Robert Klitzman
Journal:  AJOB Prim Res       Date:  2011
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