Literature DB >> 17222939

Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure.

Joshua G Salzman1, Ralph J Frascone, Bobette K Godding, Terry A Provo, Elie Gertner.   

Abstract

Conducting emergency research in the out-of-hospital and emergency department setting is a challenge because of the inability of patients to provide informed consent in many situations. Federal guidelines allowing research under an exception from informed consent for emergency research have been established (21 CRF 50.24). Community consultation and public disclosure, 2 required components of obtaining this exception, are seen by many as a barrier to resuscitation research. This article will provide a brief overview of the history of the exception from informed consent for emergency research and summarize our methods recently used to successfully complete community consultation and public disclosure for a trial evaluating 2 devices used during cardiopulmonary resuscitation in a large metropolitan area.

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Year:  2007        PMID: 17222939     DOI: 10.1016/j.annemergmed.2006.10.013

Source DB:  PubMed          Journal:  Ann Emerg Med        ISSN: 0196-0644            Impact factor:   5.721


  9 in total

1.  Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial.

Authors:  Maija Holsti; Roger Zemek; Jill Baren; Rachel M Stanley; Prashant Mahajan; Cheryl Vance; Kathleen M Brown; Victor Gonzalez; Denise King; Kammy Jacobsen; Kate Shreve; Katrina van de Bruinhorst; Anne Marie Jones; James M Chamberlain
Journal:  Clin Trials       Date:  2014-11-04       Impact factor: 2.486

2.  A community consultation survey to evaluate support for and success of the IMMEDIATE trial.

Authors:  Joni R Beshansky; Patricia R Sheehan; Kenneth J Klima; Nira Hadar; Ellen M Vickery; Harry P Selker
Journal:  Clin Trials       Date:  2014-04       Impact factor: 2.486

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

Authors:  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
Journal:  Resuscitation       Date:  2018-12-17       Impact factor: 5.262

4.  Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups.

Authors:  James M Chamberlain; Kathleen Lillis; Cheryl Vance; Kathleen M Brown; Olubunmi Fawumi; Shari Nichols; Colleen O Davis; Tasmeen Singh; Jill M Baren
Journal:  Acad Emerg Med       Date:  2009-08       Impact factor: 3.451

5.  Informed consent: the rate-limiting step in acute stroke trials.

Authors:  David Z Rose; Scott E Kasner
Journal:  Front Neurol       Date:  2011-10-17       Impact factor: 4.003

Review 6.  Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.

Authors:  Neal W Dickert; Kathleen Metz; Michael D Fetters; Adrianne N Haggins; Deneil K Harney; Candace D Speight; Robert Silbergleit
Journal:  Acad Emerg Med       Date:  2021-05-26       Impact factor: 5.221

7.  Blood substitutes--the polyheme trials.

Authors:  Sameer S Apte
Journal:  Mcgill J Med       Date:  2008-01

8.  Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study.

Authors:  Jeremy Furyk; Kristin McBain-Rigg; Kerrianne Watt; Theophilus I Emeto; Richard C Franklin; Donna Franklin; Andreas Schibler; Stuart R Dalziel; Franz E Babl; Catherine Wilson; Natalie Phillips; Robin Ray
Journal:  BMJ Open       Date:  2017-11-15       Impact factor: 2.692

9.  Improving community understanding of medical research: audience response technology for community consultation for exception to informed consent.

Authors:  Taher Vohra; Raphe Bou Chebl; Joseph Miller; Andrew Russman; Anna Baker; Christopher Lewandowski
Journal:  West J Emerg Med       Date:  2014-07
  9 in total

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