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 2019

    Fingerprint

Keywords

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

ASJC Scopus subject areas

  • Emergency Medicine
  • Emergency
  • Cardiology and Cardiovascular Medicine

Cite this

Carlson, J. N., Zive, D., Griffiths, D., Brown, K. N., Schmicker, R. H., Herren, H., Sopko, G., DiFiore, S., Climer, D., Herdeman, C., Idris, A., Nichol, G., & Wang, H. E. (2019). Variations in the application of exception from informed consent in a multicenter clinical trial. Resuscitation, 135, 1-5. https://doi.org/10.1016/j.resuscitation.2018.12.006