The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials
[...]of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated. * The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical d...
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| Veröffentlicht in: | PLoS medicine Jg. 9; H. 11; S. e1001346 |
|---|---|
| Hauptverfasser: | , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
United States
Public Library of Science
01.11.2012
Public Library of Science (PLoS) |
| Schlagworte: | |
| ISSN: | 1549-1676, 1549-1277, 1549-1676 |
| Online-Zugang: | Volltext |
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| Abstract | [...]of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated. * The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs. * A five-year mixed methods research project explored the ethical challenges of CRTs. [...]researchers and research ethics committees (RECs) currently lack specific guidelines to help them design, conduct, and review CRTs according to internationally accepted ethical standards. |
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| AbstractList | [...]of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated. * The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs. * A five-year mixed methods research project explored the ethical challenges of CRTs. [...]researchers and research ethics committees (RECs) currently lack specific guidelines to help them design, conduct, and review CRTs according to internationally accepted ethical standards. [...]of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated. * The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs. * A five-year mixed methods research project explored the ethical challenges of CRTs. [...]researchers and research ethics committees (RECs) currently lack specific guidelines to help them design, conduct, and review CRTs according to internationally accepted ethical standards. The Ottawa Ethics of Cluster Trials Consensus Group sets out 15 recommendations for the ethical design and conduct of cluster randomized trials. |
| Audience | Academic |
| Author | McRae, Andrew D. Brehaut, Jamie C. Taljaard, Monica White, Angela Eccles, Martin P. Weijer, Charles Grimshaw, Jeremy M. |
| AuthorAffiliation | 5 Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada 8 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada 2 Department of Medicine, Western University, London, Ontario, Canada 1 Rotman Institute of Philosophy, Department of Philosophy, Western University, London, Ontario, Canada 3 Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada 6 Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom 7 Division of Emergency Medicine, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada 4 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada |
| AuthorAffiliation_xml | – name: 5 Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada – name: 3 Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada – name: 4 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada – name: 8 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada – name: 6 Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom – name: 7 Division of Emergency Medicine, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada – name: 2 Department of Medicine, Western University, London, Ontario, Canada – name: 1 Rotman Institute of Philosophy, Department of Philosophy, Western University, London, Ontario, Canada |
| Author_xml | – sequence: 1 givenname: Charles surname: Weijer fullname: Weijer, Charles – sequence: 2 givenname: Jeremy M. surname: Grimshaw fullname: Grimshaw, Jeremy M. – sequence: 3 givenname: Martin P. surname: Eccles fullname: Eccles, Martin P. – sequence: 4 givenname: Andrew D. surname: McRae fullname: McRae, Andrew D. – sequence: 5 givenname: Angela surname: White fullname: White, Angela – sequence: 6 givenname: Jamie C. surname: Brehaut fullname: Brehaut, Jamie C. – sequence: 7 givenname: Monica surname: Taljaard fullname: Taljaard, Monica |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23185138$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Naughton, Eileen S Spence, Julie Brehaut, Jamie C Donner, Allan Taljaard, Monica Lohr, Kathleen Elbourne, Diana White, Gerald McRae, Andrew D Brown, Judith Belle Weijer, Charles Eldridge, Sandra Gallo, Antonio Eccles, Martin P Saxena, Abha Chaudhry, Shazia Kiefe, Catarina Althabe, Fernando Polson, Rex J Binik, Ariella Edwards, Sarah Kimmelman, Jonathan Saginur, Raphael Boruch, Robert Grimshaw, Jeremy M Loder, Elizabeth Dubois-Flynn, Geneviéve White, Angela Forster, David Zwarenstein, Merrick Lin, Melody |
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| Copyright | COPYRIGHT 2012 Public Library of Science 2012 Weijer et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, et al. (2012) The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med 9(11): e1001346. doi:10.1371/journal.pmed.1001346 2012 Weijer et al 2012 Weijer et al |
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| Issue | 11 |
| Keywords | Epidemiologic Research Design Humans Cluster Analysis Randomized Controlled Trials as Topic |
| Language | English |
| License | This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. Creative Commons Attribution License |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Instructional Material/Guideline-3 ObjectType-Article-2 ObjectType-Instructional Material/Guideline-1 ObjectType-Feature-3 content type line 23 Provenance: Not commissioned; externally peer reviewed. The Guidelines and Guidance section contains advice on conducting and reporting medical research. Wrote the first draft of the manuscript: CW JMG MPE ADM AW JCB MT. Contributed to the writing of the manuscript: CW JMG MPE ADM AW JCB MT. ICMJE criteria for authorship read and met: CW JMG MPE ADM AW JCB MT. Agree with manuscript results and conclusions: CW JMG MPE ADM AW JCB MT. Contributed to the conception and design of the study and secured funding: CW JMG MPE ADM JCB MT. Conducted the ethical analysis: CW JMG MPE ADM AW JCB MT. Membership of the Ottawa Ethics of Cluster Randomized Trials Consensus Group is provided in the Acknowledgments. The authors have declared that no competing interests exist. |
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An overview of recent trials publication-title: Br J Gen Pract doi: 10.3399/bjgp10X514819 – volume: 318 start-page: 1407 year: 1999 ident: ref8 article-title: Ethical issues in the design and conduct of cluster randomised controlled trials publication-title: BMJ doi: 10.1136/bmj.318.7195.1407 – ident: ref2 doi: 10.1201/9781584888178 – volume: 17 start-page: S11 year: 2000 ident: ref35 article-title: Experimental and quasi-experimental designs for evaluating guideline implementation strategies publication-title: Fam Pract doi: 10.1093/fampra/17.suppl_1.S11 – volume: 15 start-page: 80 year: 1998 ident: ref23 article-title: Trials which randomize practices I: how should they be analysed? publication-title: Fam Pract doi: 10.1093/fampra/15.1.80 – volume: 180 start-page: 998 year: 2009 ident: ref38 article-title: What kind of randomized trials do we need? publication-title: CMAJ doi: 10.1503/cmaj.082007 – volume: 339 start-page: b4006 year: 2009 ident: ref29 article-title: Bias in identifying and recruiting participants in cluster randomised trials: what can be done? publication-title: BMJ doi: 10.1136/bmj.b4006 – volume: 2 start-page: 91 year: 2005 ident: ref10 article-title: Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care publication-title: Clin Trials doi: 10.1191/1740774505cn070oa – volume: 345 start-page: e5661 year: 2012 ident: ref6 article-title: CONSORT 2010 statement: extension to cluster randomised trials publication-title: BMJ doi: 10.1136/bmj.e5661 – volume: 26 start-page: 543 year: 2009 ident: ref36 article-title: Do family doctors have an obligation to facilitate research? publication-title: Fam Pract doi: 10.1093/fampra/cmp045 – reference: 31449856 - J Clin Epidemiol. 2019 Dec;116:146-149 |
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| SubjectTerms | Cluster Analysis Community Epidemiologic Research Design Ethical aspects Guidelines and Guidance Hospitals Humans Informed consent Intervention Medical ethics Medical research Medical tests Medicine Philosophy Practice Randomized Controlled Trials as Topic - ethics Randomized Controlled Trials as Topic - methods Science Policy Studies |
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| Title | The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials |
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