Linked Life Data

19638233

Source:http://linkedlifedata.com/resource/pubmed/id/19638233

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2009-8-12
pubmed:abstractText
BACKGROUND: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities--rather than individual themselves--are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1) identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2) understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK); (3) elicit the views and experiences of trial participants and cluster representatives; (4) develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5) disseminate the guidelines to researchers, research ethics boards (REBs), journal editors, and research funders. METHODS: We will use a mixed-methods (qualitative and quantitative) approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An Expert Panel of researchers, ethicists, health lawyers, consumer advocates, REB members, and representatives from low-middle income countries will be appointed. A consensus conference will be convened and draft guidelines will be generated by the Panel; an e-consultation phase will then be launched to invite comments from the broader community of researchers, policy-makers, and the public before a final set of guidelines is generated by the Panel and widely disseminated by the research team.
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-10037634, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-10334756, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-10970227, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-11180314, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-11477039, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-11782029, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-14998805, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-15170195, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-15663713, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-16279130, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-1749015, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-18279507, http://linkedlifedata.com/resource/pubmed/commentcorrection/19638233-9703533
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
1745-6215
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
10
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
61
pubmed:dateRevised
2009-11-18
pubmed:meshHeading
pubmed:year
2009
pubmed:articleTitle
Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study.
pubmed:affiliation
Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa Hospital, 1053 Carling Avenue, Civic Campus, C409, Ottawa, ON K1Y4E9, Canada. mtaljaard@ohri.ca
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't