Targeted Consent for Research on Standard of Care Interventions in the Emergency Setting

• Type of Material: Article
• Authors: David Wendler, NIH Clinical Center; Neal Dickert Jr, Emory University; Robert Silbergleit, University of Michigan; Scott YH Kim, NIH Clinical Center; Jeremy Brown, National Institutes of Health
• Language: English
• Date: 2017-01-01
• Publisher: Lippincott, Williams & Wilkins
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2016 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
• Final Published Version (URL): http://dx.doi.org/10.1097/CCM.0000000000002023
• Title of Journal or Parent Work: Critical Care Medicine
• ISSN: 0090-3493
• Volume: 45
• Issue: 1
• Start Page: e105
• End Page: e110
• Grant/Funding Information: Dr. Dickert received support for article research from the NIH, received funding from the NIH for travel to a meeting at which this topic was discussed (as disclosed in the article), and received funding from the NIH/National Heart, Lung, and Blood Institute-Data and Safety Monitoring Board service.; His institution received funding from Patient-Centered Outcomes Research Institute (research contract) and the NIH (research grant).; Supported, in part, by National Institutes of Health intramural funds.; Dr. Wendler received support for article research from the National Institutes of Health (NIH) and disclosed government work.; He receives salary support from the Greenwall Foundation.; Dr. Kim disclosed government work and received support for article research from the NIH.
• Keywords: Disclosure; Standard of Care; United States; Emergencies; Pragmatic Clinical Trials as Topic; Informed Consent; Emergency Medicine; Humans
• Research Categories: Health Sciences, Public Health; Sociology, Ethnic and Racial Studies

Abstract

Objectives: There has been significant debate over what consent process, if any, should be used for clinical trials that compare two or more interventions within the standard of care. Some claim that all clinical trials should obtain in-depth research consent because they use subjects to obtain data for the benefit of future patients. Others argue that clinical trials that are limited to interventions within the standard of care do not need to obtain research consent at all. Settling this debate is especially challenging in the emergency setting. The potential for significant morbidity and mortality provides a strong reason to obtain research consent for standard-of-care trials in the emergency setting. Yet, the emergency setting also introduces significant barriers to traditional in-depth research consent. The present article considers to what extent a targeted consent process can resolve these tensions. Data Synthesis: We first identified the ethical goals that are promoted by obtaining consent for standard-of-care research and the barriers to obtaining consent that arise in the emergency setting. We then evaluated whether, despite the barriers, it is possible to develop a targeted consent process that promotes the goals for consent in the context of standard-of-care trials. Conclusions: Targeted consent offers an ethically appropriate way to obtain consent for many standard-of-care trials in the emergency setting. For studies subject to U.S. regulations, and those subject to other regulations that include similar consent requirements, targeted consent's verbal disclosure and written form provide a way to satisfy research regulations without blocking valuable studies. For trials that qualify for a waiver of the consent requirements, targeted consent's verbal disclosure is preferable to waiving consent, provided a slight delay is consistent with appropriate care, and there is a capacitated patient or surrogate available.