Variations in the application of exception from informed consent in a multicenter clinical trial

Jestin N. Carlson, Dana Zive, Denise Griffiths, Karen N. Brown, Robert H. Schmicker, Heather Herren, George Sopko, Sara DiFiore, Dixie Climer, Caroline Herdeman, Ahamed Idris, Graham Nichol, Henry E. Wang

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1-5
Number of pages5
JournalResuscitation
Volume135
DOIs
StatePublished - Feb 1 2019

Fingerprint

Informed Consent
Multicenter Studies
Clinical Trials
Referral and Consultation
Disclosure
Social Media
Out-of-Hospital Cardiac Arrest
Research Ethics Committees
Heart Arrest
Resuscitation
Documentation
Cross-Over Studies
Demography
Equipment and Supplies
Research

Keywords

  • Clinical trials
  • Community consultation
  • Exception from informed consent
  • Public disclosure

ASJC Scopus subject areas

  • Emergency Medicine
  • Emergency
  • Cardiology and Cardiovascular Medicine

Cite this

Variations in the application of exception from informed consent in a multicenter clinical trial. / Carlson, Jestin N.; Zive, Dana; Griffiths, Denise; Brown, Karen N.; Schmicker, Robert H.; Herren, Heather; Sopko, George; DiFiore, Sara; Climer, Dixie; Herdeman, Caroline; Idris, Ahamed; Nichol, Graham; Wang, Henry E.

In: Resuscitation, Vol. 135, 01.02.2019, p. 1-5.

Research output: Contribution to journalArticle

Carlson, JN, Zive, D, Griffiths, D, Brown, KN, Schmicker, RH, Herren, H, Sopko, G, DiFiore, S, Climer, D, Herdeman, C, Idris, A, Nichol, G & Wang, HE 2019, 'Variations in the application of exception from informed consent in a multicenter clinical trial', Resuscitation, vol. 135, pp. 1-5. https://doi.org/10.1016/j.resuscitation.2018.12.006
Carlson, Jestin N. ; Zive, Dana ; Griffiths, Denise ; Brown, Karen N. ; Schmicker, Robert H. ; Herren, Heather ; Sopko, George ; DiFiore, Sara ; Climer, Dixie ; Herdeman, Caroline ; Idris, Ahamed ; Nichol, Graham ; Wang, Henry E. / Variations in the application of exception from informed consent in a multicenter clinical trial. In: Resuscitation. 2019 ; Vol. 135. pp. 1-5.
@article{2b14158bd18743708cc7aaef40bce3f8,
title = "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",
author = "Carlson, {Jestin N.} and Dana Zive and Denise Griffiths and Brown, {Karen N.} and Schmicker, {Robert H.} and Heather Herren and George Sopko and Sara DiFiore and Dixie Climer and Caroline Herdeman and Ahamed Idris and Graham Nichol and Wang, {Henry E.}",
year = "2019",
month = "2",
day = "1",
doi = "10.1016/j.resuscitation.2018.12.006",
language = "English (US)",
volume = "135",
pages = "1--5",
journal = "Resuscitation",
issn = "0300-9572",
publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - Variations in the application of exception from informed consent in a multicenter clinical trial

AU - Carlson, Jestin N.

AU - Zive, Dana

AU - Griffiths, Denise

AU - Brown, Karen N.

AU - Schmicker, Robert H.

AU - Herren, Heather

AU - Sopko, George

AU - DiFiore, Sara

AU - Climer, Dixie

AU - Herdeman, Caroline

AU - Idris, Ahamed

AU - Nichol, Graham

AU - Wang, Henry E.

PY - 2019/2/1

Y1 - 2019/2/1

N2 - 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.

AB - 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.

KW - Clinical trials

KW - Community consultation

KW - Exception from informed consent

KW - Public disclosure

UR - http://www.scopus.com/inward/record.url?scp=85059935159&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85059935159&partnerID=8YFLogxK

U2 - 10.1016/j.resuscitation.2018.12.006

DO - 10.1016/j.resuscitation.2018.12.006

M3 - Article

C2 - 30572072

AN - SCOPUS:85059935159

VL - 135

SP - 1

EP - 5

JO - Resuscitation

JF - Resuscitation

SN - 0300-9572

ER -