International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials
There 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 u...
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| Published in | Anesthesiology (Philadelphia) Vol. 132; no. 1; pp. 44 - 54 |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
the American Society of Anesthesiologists, Inc. Wolters Kluwer Health, Inc
01.01.2020
Copyright by , the American Society of Anesthesiologists, Inc. Wolters Kluwer Health, Inc |
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| Abstract | There 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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| AbstractList | There 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. There 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.There 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. There 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. |
| Author | Myles, Paul S. Symons, Tanya J. Zeps, Nikolajs Sessler, Daniel I. Morris, Jonathan M. |
| AuthorAffiliation | 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.) |
| AuthorAffiliation_xml | – name: 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.) |
| Author_xml | – sequence: 1 givenname: Tanya surname: Symons middlename: J. fullname: Symons, Tanya J. organization: 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.) – sequence: 2 givenname: Nikolajs surname: Zeps fullname: Zeps, Nikolajs – sequence: 3 givenname: Paul surname: Myles middlename: S. fullname: Myles, Paul S. – sequence: 4 givenname: Jonathan surname: Morris middlename: M. fullname: Morris, Jonathan M. – sequence: 5 givenname: Daniel surname: Sessler middlename: I. fullname: Sessler, Daniel I. |
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| Cites_doi | 10.1111/hex.12821 10.1093/ofid/ofx162.088 10.1002/hast.548 10.1186/s12874-017-0420-7 10.1056/NEJMms1603756 10.1016/j.jclinepi.2017.03.019 10.1177/1740774511398368 10.1056/NEJMra1510057 10.1056/NEJMhle1312508 10.1111/bioe.12325 10.1111/bioe.12315 10.1016/j.jclinepi.2016.12.023 10.1016/j.bja.2017.11.003 10.1080/23294515.2016.1156188 10.1056/NEJMp1707991 10.1161/CIRCULATIONAHA.115.019902 10.1080/23294515.2015.1117536 10.1002/lrh2.10045 10.1001/jama.2014.2144 10.1177/1740774515597687 10.5694/j.1326-5377.2007.tb00808.x 10.1007/s11606-014-3169-2 10.1111/inm.12499 10.1097/ALN.0b013e318295262a 10.1177/1740774515597688 10.1016/0197-2456(87)90157-7 10.7326/M15-0166 10.1258/147775007783560193 10.1213/ANE.0000000000000950 10.1002/lrh2.10047 10.1159/000360650 10.1046/j.1365-3156.2000.00581.x 10.1097/01.coc.0000135925.83221.b3 10.1016/j.jval.2017.04.005 10.2105/AJPH.2013.301706 10.1371/journal.pmed.1001346 10.7326/M15-0817 10.1186/s12910-018-0253-x 10.1001/jama.2014.4164 10.1056/NEJMsa071456 10.1177/1740774516648907 10.1056/NEJMoa1308789 10.1093/eurheartj/ehy235 10.1016/j.ahj.2018.06.008 |
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| SubjectTerms | Australia Biomedical Research - ethics Biomedical Research - legislation & jurisprudence England Health Policy - legislation & jurisprudence Humans Informed Consent - ethics Informed Consent - legislation & jurisprudence Internationality Research Subjects - legislation & jurisprudence Risk United States |
| Title | International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials |
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