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Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial.
Andrews, Joseph E; Moore, J Brian; Weinberg, Richard B; Sissine, Mysha; Gesell, Sabina; Halladay, Jacquie; Rosamond, Wayne; Bushnell, Cheryl; Jones, Sara; Means, Paula; King, Nancy M P; Omoyeni, Diana; Duncan, Pamela W.
Afiliação
  • Andrews JE; Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Moore JB; Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Weinberg RB; Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Sissine M; Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Gesell S; Public Health Sciences Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Halladay J; Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
  • Rosamond W; Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.
  • Bushnell C; Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Jones S; Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.
  • Means P; Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • King NMP; Center for Bioethics, Health, and Society; Public Health Sciences Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
  • Omoyeni D; Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Duncan PW; Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
J Med Ethics ; 44(8): 560-566, 2018 08.
Article em En | MEDLINE | ID: mdl-29720489
Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. TRIAL REGISTRATION NUMBER: NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Acidente Vascular Cerebral / Ética em Pesquisa / Consentimento Livre e Esclarecido Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Adult / Aged / Humans / Middle aged Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Acidente Vascular Cerebral / Ética em Pesquisa / Consentimento Livre e Esclarecido Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Adult / Aged / Humans / Middle aged Idioma: En Ano de publicação: 2018 Tipo de documento: Article