• Tanya J Symons, Nikolajs Zeps, Paul S Myles, Jonathan M Morris, and Daniel I Sessler.
• From the Departments of Medicine and Health (T.J.S.) Clinical and Population Perinatal Health (J.M.M.), Northern Clinical School, The University of Sydney, Sydney, Australia Academic and Medical Services, Epworth HealthCare, Eastern Clinical School of Monash University, Melbourne, Australia (N.Z.) the Department of Anesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia (P.S.M.) the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S.).
• Anesthesiology. 2020 Jan 1; 132 (1): 44-54.

AbstractThere is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.This article examines whether international ethical guidelines and the policy frameworks in three countries-the United States, England, and Australia-permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.

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