@article{476c2d82aab347c8970817075159d0bc,
title = "Use of altered informed consent in pragmatic clinical research",
abstract = "There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients rights and interests.",
keywords = "Common Rule, Informed consent, bioethics, clinical trial, cluster-randomized trial, institutional review board, practical clinical trial, pragmatic clinical research",
author = "McKinney, {Ross E.} and Beskow, {Laura M.} and Ford, {Daniel E.} and Lantos, {John D.} and Jonathan McCall and Bray Patrick-Lake and Pletcher, {Mark J.} and Brian Rath and Hollie Schmidt and Kevin Weinfurt",
note = "Funding Information: Dr McKinney reports receiving consulting payments or honoraria from Janssen Pharmaceuticals and the National Football League Players{\textquoteright} Association. Dr. Lantos reports receiving funding from a Clinical and Translational Science Award grant from the National Center for Advancing Translational Sciences awarded to the University of Kansas Medical Center for Frontiers: The Heartland Institute for Clinical and Translational Research (#UL1TR000001) and support from the Greater Plains Collaborative (a Clinical Data Research Network of the National Patient-Centered Clinical Research Network). Dr. Pletcher reports receiving funding support from Patient-Centered Outcomes Research Institute (PCORI) contract PPRN-1306-04709). None of the other authors have any conflicting interests to disclose. Funding Information: This work was supported by the National Institutes of Health (NIH) Common Fund, through a cooperative agreement (U54 AT007748) from the Office of Strategic Coordination within the Office of the NIH Director. A portion of Dr McKinney{\textquoteright}s efforts were also supported by a Clinical and Translational Science Award (UL1TR001117) to Duke University. Additional support was provided by the Patient-Centered Outcomes Research Institute (PCORI) Award for development of the National Patient-Centered Clinical Research Network (PCORnet). The views presented here are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health or of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee, or other participants in PCORnet. Publisher Copyright: {\textcopyright} 2015 The Society for Clinical Trials.",
year = "2015",
month = oct,
day = "1",
doi = "10.1177/1740774515597688",
language = "English (US)",
volume = "12",
pages = "494--502",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
number = "5",
}