| Members of research ethics committees accepted a modification of the randomized consent design. | |
| | |
MedLine Citation:
|
PMID: 15878472 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND AND OBJECTIVE: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what extent a randomized consent design and a modification of this design is accepted by research ethics committees, in terms of ethics, health law, and methodology. METHODS: A postal survey was conducted among members of research ethics committees in the United Kingdom, and in The Netherlands, with professional competence in ethics, (health) law, methodology, or clinical practice. RESULTS: In both the UK and in The Netherlands, the modified randomized consent design appears to be statistically significantly more acceptable than the randomized consent design, with respect to ethical and judicial aspects. The overall rejection rate of the randomized consent design was 66% in the UK and 59% in The Netherlands. However, the modified randomized consent design was rejected by 47 and 41% in the two countries, respectively. CONCLUSION: the modified randomized consent design appears to be more acceptable than the randomized consent design. To increase consistency in the way research ethics committees handle study protocols, a discussion about the use of randomized consent designs appears necessary. |
| | |
Authors:
|
Ron Schellings; Alfons G Kessels; Gerben Ter Riet; Jos Kleijnen; Pieter Leffers; J André Knottnerus; Ferd Sturmans |
Publication Detail:
|
Type: Journal Article; Multicenter Study |
Journal Detail:
|
Title: Journal of clinical epidemiology Volume: 58 ISSN: 0895-4356 ISO Abbreviation: J Clin Epidemiol Publication Date: 2005 Jun |
Date Detail:
|
Created Date: 2005-05-09 Completed Date: 2005-07-20 Revised Date: 2007-11-15 |
Medline Journal Info:
|
Nlm Unique ID: 8801383 Medline TA: J Clin Epidemiol Country: England |
Other Details:
|
Languages: eng Pagination: 589-94 Citation Subset: E; IM |
Affiliation:
|
Public Health Supervisory Service of the Netherlands, the Inspectorate of Health Care, The Hague. Ron.schellings@worldonline.nl |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Ethics Committees, Research* Ethics, Research* Great Britain Humans Informed Consent / ethics*, legislation & jurisprudence Legislation, Medical Netherlands Questionnaires Randomized Controlled Trials as Topic / ethics*, legislation & jurisprudence, methods Research Design |
| Comments/Corrections | |
Comment In:
|
J Clin Epidemiol. 2006 May;59(5):544; author reply 545-6
[PMID:
16632145
]
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Uncertainty method improved on best-worst case analysis in a binary meta-analysis.
Next Document: The development of a comorbidity index with physical function as the outcome.