Special Articles  |   January 2020
International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials
Author Notes
  • From the Departments of Medicine and Health (T.J.S.), and 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.); and the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S.).
  • This article is accompanied by an editorial on p. 1 and by an article on p. 82.
    This article is accompanied by an editorial on p. 1 and by an article on p. 82.×
  • Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are available in both the HTML and PDF versions of this article. Links to the digital files are provided in the HTML text of this article on the Journal’s Web site (www.anesthesiology.org).
    Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are available in both the HTML and PDF versions of this article. Links to the digital files are provided in the HTML text of this article on the Journal’s Web site (www.anesthesiology.org).×
  • Submitted for publication December 20, 2018. Accepted for publication September 18, 2019.
    Submitted for publication December 20, 2018. Accepted for publication September 18, 2019.×
  • Address correspondence to Dr. Sessler: Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, 9500 Euclid Ave — P77, Cleveland, Ohio, 44195. DS@OR.org. Information on purchasing reprints may be found at www.anesthesiology.org or on the masthead page at the beginning of this issue. Anesthesiology’s articles are made freely accessible to all readers, for personal use only, 6 months from the cover date of the issue.
Article Information
Special Articles / Ethics / Medicolegal Issues / Quality Improvement
Special Articles   |   January 2020
International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials
Anesthesiology 1 2020, Vol.132, 44-54. doi:https://doi.org/10.1097/ALN.0000000000003020
Anesthesiology 1 2020, Vol.132, 44-54. doi:https://doi.org/10.1097/ALN.0000000000003020
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.