Informed consent in cluster randomised trials: a guide for the perplexed
In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster r...
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| Veröffentlicht in: | BMJ open Jg. 11; H. 9; S. e054213 |
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British Medical Journal Publishing Group
27.09.2021
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| Abstract | In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention—not the unit of randomisation—that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT. |
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| AbstractList | In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention-not the unit of randomisation-that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT. In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention-not the unit of randomisation-that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention-not the unit of randomisation-that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT. |
| Author | Nix, Hayden P Goldstein, Cory E Brehaut, Jamie C Forster, David Taljaard, Monica Weijer, Charles |
| AuthorAffiliation | 6 School of Epidemiology and Public Health , University of Ottawa , Ottawa , Ontario , Canada 2 Department of Philosophy , Western University , London , Ontario , Canada 3 Department of Epidemiology & Biostatistics , Western University , London , Ontario , Canada 4 Department of Medicine , Western University , London , Ontario , Canada 7 Institutional Review Board , WIRB-Copernicus Group Inc , Puyallup , Washington , USA 1 Schulich School of Medicine and Dentistry , Western University , London , Ontario , Canada 5 Clinical Epidemiology Program , Ottawa Hospital Research Institute , Ottawa , Ontario , Canada |
| AuthorAffiliation_xml | – name: 4 Department of Medicine , Western University , London , Ontario , Canada – name: 2 Department of Philosophy , Western University , London , Ontario , Canada – name: 3 Department of Epidemiology & Biostatistics , Western University , London , Ontario , Canada – name: 1 Schulich School of Medicine and Dentistry , Western University , London , Ontario , Canada – name: 7 Institutional Review Board , WIRB-Copernicus Group Inc , Puyallup , Washington , USA – name: 5 Clinical Epidemiology Program , Ottawa Hospital Research Institute , Ottawa , Ontario , Canada – name: 6 School of Epidemiology and Public Health , University of Ottawa , Ottawa , Ontario , Canada |
| Author_xml | – sequence: 1 givenname: Hayden P orcidid: 0000-0002-4205-5857 surname: Nix fullname: Nix, Hayden P email: hnix@uwo.ca organization: Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada – sequence: 2 givenname: Charles surname: Weijer fullname: Weijer, Charles organization: Department of Medicine, Western University, London, Ontario, Canada – sequence: 3 givenname: Jamie C surname: Brehaut fullname: Brehaut, Jamie C organization: School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada – sequence: 4 givenname: David surname: Forster fullname: Forster, David organization: Institutional Review Board, WIRB-Copernicus Group Inc, Puyallup, Washington, USA – sequence: 5 givenname: Cory E surname: Goldstein fullname: Goldstein, Cory E organization: Department of Philosophy, Western University, London, Ontario, Canada – sequence: 6 givenname: Monica orcidid: 0000-0002-3978-8961 surname: Taljaard fullname: Taljaard, Monica organization: School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34580104$$D View this record in MEDLINE/PubMed |
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| Snippet | In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The... In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The... |
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| SubjectTerms | Committees Data collection education & training (see medical education & training) Ethics ethics (see medical ethics) Ethics Committees, Research Ethics, Research Humans Informed Consent Intervention Medical ethics Professional ethics Randomized Controlled Trials as Topic Research Design Research Personnel statistics & research methods Waivers |
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| Title | Informed consent in cluster randomised trials: a guide for the perplexed |
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