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.
authors.affiliation: Trent Center for Bioethics, Humanities, & History of Medicine and Division of Infectious Diseases, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA ross.mckinney@dm.duke.edu.
authors.forename: Ross E
authors.initials: RE
authors.lastname: McKinney
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Beskow
authors.affiliation: Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Ford
authors.affiliation: Children's Mercy Bioethics Center, Children's Mercy Hospital, Kansas City, MO, US.
authors.forename: John D
authors.initials: JD
authors.lastname: Lantos
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: McCall
authors.affiliation: Clinical Trials Transformation Initiative, Duke Translational Medicine Institute, Durham, NC, USA.
authors.forename: Bray
authors.initials: B
authors.lastname: Patrick-Lake
authors.affiliation: Departments of Epidemiology and Biostatistics and Medicine, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Pletcher
authors.affiliation: Buchanan Ingersoll & Rooney PC, Princeton, NJ, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Rath
authors.affiliation: Accelerated Cure Project for Multiple Sclerosis, Waltham, MA, USA.
authors.forename: Hollie
authors.initials: H
authors.lastname: Schmidt
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA Department of Psychiatry, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Weinfurt
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000592:standards; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence*; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States
keywords: Common Rule; Informed consent; bioethics; clinical trial; cluster-randomized trial; institutional review board; practical clinical trial; pragmatic clinical research