Variations in the application of exception from informed consent in a multicenter clinical trial
- PMID: 30572072
- PMCID: PMC6939445
- DOI: 10.1016/j.resuscitation.2018.12.006
Variations in the application of exception from informed consent in a multicenter clinical trial
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.
Keywords: Clinical trials; Community consultation; Exception from informed consent; Public disclosure.
Copyright © 2018 Elsevier B.V. All rights reserved.
References
-
- 21 cfr 50.24 exception from informed consent requirements for emergency research. 1996;5024 - PubMed
-
- U.S. Department of Health and Human Services FaDA. Guidance for institutional review boards, clinical investigators, and sponsors: Exception from informed consent requirements for emergency research 2013
-
- Wang HE, Prince DK, Stephens SW, Herren H, Daya M, Richmond N, Carlson J, Warden C, Colella MR, Brienza A, Aufderheide TP, Idris AH, Schmicker R, May S, Nichol G. Design and implementation of the resuscitation outcomes consortium pragmatic airway resuscitation trial (part). Resuscitation. 2016;101:57–64 - PMC - PubMed
-
- Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a strategy of initial laryngeal tube insertion vs endotracheal intubation on 72-hour survival in adults with out-of-hospital cardiac arrest: A randomized clinical trial. JAMA. 2018;320:769–778 - PMC - PubMed
-
- Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G, Resuscitation Outcomes Consortium I. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med. 2011;365:798–806 - PMC - PubMed
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