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Clin Trials. 2015 Oct;12(5):494-502. doi: 10.1177/1740774515597688. Epub 2015 Sep 15.

Use of altered informed consent in pragmatic clinical research.

Author information

1
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.
2
Duke Clinical Research Institute, Durham, NC, USA.
3
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
4
Children's Mercy Bioethics Center, Children's Mercy Hospital, Kansas City, MO, US.
5
Clinical Trials Transformation Initiative, Duke Translational Medicine Institute, Durham, NC, USA.
6
Departments of Epidemiology and Biostatistics and Medicine, University of California, San Francisco, San Francisco, CA, USA.
7
Buchanan Ingersoll & Rooney PC, Princeton, NJ, USA.
8
Accelerated Cure Project for Multiple Sclerosis, Waltham, MA, USA.
9
Duke Clinical Research Institute, Durham, NC, USA Department of Psychiatry, Duke University School of Medicine, Durham, NC, USA.

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

PMID:
26374677
PMCID:
PMC4688909
DOI:
10.1177/1740774515597688
[Indexed for MEDLINE]
Free PMC Article
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