Jestin N Carlson1, Dana Zive2, Denise Griffiths2, Karen N Brown3, Robert H Schmicker4, Heather Herren4, George Sopko5, Sara DiFiore6, Dixie Climer7, Caroline Herdeman8, Ahamed Idris7, Graham Nichol9, Henry E Wang10. 1. Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA; Department of Emergency Medicine, Allegheny Health Network, Pittsburgh, PA. Electronic address: jcarlson@svhs.org. 2. Department of Emergency Medicine, Oregon Health and Science University, Portland, OR. 3. Department of Emergency Medicine University of Alabama at Birmingham, Birmingham, AL. 4. Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA. 5. National Heart, Lung and Blood Institute, Bethesda, MD. 6. Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA. 7. Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, TX. 8. Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI. 9. Harborview Center for Prehospital Emergency Care, University of Washington, Seattle, WA. 10. Department of Emergency Medicine University of Alabama at Birmingham, Birmingham, AL; Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, TX.
Abstract
BACKGROUND: Exception from infor med consent (EFIC) is allowed using federal regulations 21 CFR 50.24 and facilitates research on patients with critical conditions such as cardiac arrest. Little is known regarding the differences in the application of EFIC requirements such as community consultation (CC), public disclosure (PD) and patient notification. We sought to characterize variations in the fulfillment of EFIC requirements in a national multicenter clinical trial in the United States. METHODS: We determined the strategies for fulfillment of EFIC requirements at five regional coordinating centers of the Pragmatic Airway Resuscitation Trial (PART), a cluster-crossover randomized trial comparing airway devices in out-of-hospital cardiac arrest. We collected information from the including site demographics, how CC and PD were implemented, methods undertaken by the site investigative team to meet the local IRB's interpretation, and patient notification timing (post-enrollment). We analyzed the data using descriptive statistics. RESULTS: Sites had multiple approaches to CC, including social media advertising, random digit dialing surveys, working with city officials, and websites with embedded surveys. All sites used more than one approach for conducting CC. Public Disclosure activities included press releases through various means, website documentation, and letters to community members and local officials. Time from CC to study approval ranged from 42 days to 253 days. CONCLUSION: EFIC implementation varies across sites and highlight community and regional variation. Different EFIC approaches may be needed to effectively accomplish the goals of community consultation, public disclosure, and patient notification.
RCT Entities:
BACKGROUND: Exception from infor med consent (EFIC) is allowed using federal regulations 21 CFR 50.24 and facilitates research on patients with critical conditions such as cardiac arrest. Little is known regarding the differences in the application of EFIC requirements such as community consultation (CC), public disclosure (PD) and patient notification. We sought to characterize variations in the fulfillment of EFIC requirements in a national multicenter clinical trial in the United States. METHODS: We determined the strategies for fulfillment of EFIC requirements at five regional coordinating centers of the Pragmatic Airway Resuscitation Trial (PART), a cluster-crossover randomized trial comparing airway devices in out-of-hospital cardiac arrest. We collected information from the including site demographics, how CC and PD were implemented, methods undertaken by the site investigative team to meet the local IRB's interpretation, and patient notification timing (post-enrollment). We analyzed the data using descriptive statistics. RESULTS: Sites had multiple approaches to CC, including social media advertising, random digit dialing surveys, working with city officials, and websites with embedded surveys. All sites used more than one approach for conducting CC. Public Disclosure activities included press releases through various means, website documentation, and letters to community members and local officials. Time from CC to study approval ranged from 42 days to 253 days. CONCLUSION: EFIC implementation varies across sites and highlight community and regional variation. Different EFIC approaches may be needed to effectively accomplish the goals of community consultation, public disclosure, and patient notification.
Authors: Graham Nichol; Brian Leroux; Henry Wang; Clifton W Callaway; George Sopko; Myron Weisfeldt; Ian Stiell; Laurie J Morrison; Tom P Aufderheide; Sheldon Cheskes; Jim Christenson; Peter Kudenchuk; Christian Vaillancourt; Thomas D Rea; Ahamed H Idris; Riccardo Colella; Marshal Isaacs; Ron Straight; Shannon Stephens; Joe Richardson; Joe Condle; Robert H Schmicker; Debra Egan; Susanne May; Joseph P Ornato Journal: N Engl J Med Date: 2015-11-09 Impact factor: 91.245
Authors: Joshua G Salzman; Ralph J Frascone; Bobette K Godding; Terry A Provo; Elie Gertner Journal: Ann Emerg Med Date: 2007-01-12 Impact factor: 5.721
Authors: Maria Nelson; Terri A Schmidt; Nicole M DeIorio; K John McConnell; Denise E Griffiths; Katie B McClure Journal: Prehosp Emerg Care Date: 2008 Oct-Dec Impact factor: 3.077
Authors: Henry E Wang; David K Prince; Shannon W Stephens; Heather Herren; Mohamud Daya; Neal Richmond; Jestin Carlson; Craig Warden; M Riccardo Colella; Ashley Brienza; Tom P Aufderheide; Ahamed H Idris; Robert Schmicker; Susanne May; Graham Nichol Journal: Resuscitation Date: 2016-02-02 Impact factor: 5.262
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