Literature DB >> 12670849

Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification.

Katie B McClure1, Nicole M DeIorio, Mary D Gunnels, Maria J Ochsner, Michelle H Biros, Terri A Schmidt.   

Abstract

OBJECTIVE: To assess public views on emergency exception to informed consent in resuscitation research, public awareness of such studies, and effective methods of community consultation and public notification.
METHODS: A face-to-face survey was conducted in two academic Level I trauma center emergency departments (EDs) in Oregon and Minnesota from June through August 2001.
RESULTS: Five hundred thirty people completed the survey, with an 82% response rate. The mean age of the respondents was 41 years (range 18-95) with a standard deviation of 14.5; 46% were female and 64% white. Most (88%) believed that research subjects should be informed prior to being enrolled, while 49% believed enrolling patients without prior consent in an emergency situation would be acceptable and 70% (369) would not object to be entered into such a study without providing prospective informed consent. Informing and consulting the community as a substitute for patient consent in emergency research was thought to be reasonable by 45% of the respondents. Most respondents would prefer to be informed about a study using emergency exception from informed consent by radio and television media (42%). Two hundred fifty-eight respondents (49%) stated they would attend a community meeting; the less educated were more likely to attend than those with college degrees (OR = 0.53; 95% CI = 0.33 to 0.85, p = 0.008). However, only 5% knew of ongoing studies in their community using emergency exception from informed consent.
CONCLUSIONS: Most respondents disagreed with foregoing prospective informed consent for research participation even in emergency situations; however, many would be willing to participate in studies using emergency exception from informed consent. Most respondents would not attend community meetings, and would prefer to rely upon the media for information. Very few were aware of emergency exception from informed consent studies in their community. This suggests that current methods of community notification may not be effective.

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Mesh:

Year:  2003        PMID: 12670849     DOI: 10.1111/j.1553-2712.2003.tb01348.x

Source DB:  PubMed          Journal:  Acad Emerg Med        ISSN: 1069-6563            Impact factor:   3.451


  34 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.  'Treat first, ask later?' Emergency research in acute neurology and neurotraumatology in the European Union.

Authors:  Erwin J O Kompanje; Andrew I R Maas
Journal:  Intensive Care Med       Date:  2003-11-21       Impact factor: 17.440

3.  A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent.

Authors:  Katie B McClure; Nicole M Delorio; Terri A Schmidt; Gary Chiodo; Paul Gorman
Journal:  J Med Ethics       Date:  2007-05       Impact factor: 2.903

4.  What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent?

Authors:  P-A Abboud; K Heard; A A Al-Marshad; S R Lowenstein
Journal:  J Med Ethics       Date:  2006-08       Impact factor: 2.903

5.  Informed consent in clinical trials in critical care: experience from the PAC-Man Study.

Authors:  Sheila E Harvey; Diana Elbourne; Joanne Ashcroft; Carys M Jones; Kathryn Rowan
Journal:  Intensive Care Med       Date:  2006-09-21       Impact factor: 17.440

6.  Ischemic stroke survivors' opinion regarding research utilizing exception from informed consent.

Authors:  Dawn Kleindorfer; Christopher J Lindsell; Kathleen Alwell; Daniel Woo; Matthew L Flaherty; Jane Eilerman; Pooja Khatri; Opeolu Adeoye; Simona Ferioli; Brett M Kissela
Journal:  Cerebrovasc Dis       Date:  2011-09-15       Impact factor: 2.762

7.  Exception from informed consent for emergency research: consulting the trauma community.

Authors:  Carrie A Sims; Joshua A Isserman; Daniel Holena; Latha Mary Sundaram; Nikolai Tolstoy; Sarah Greer; Seema Sonnad; Jose Pascual; Patrick Reilly
Journal:  J Trauma Acute Care Surg       Date:  2013-01       Impact factor: 3.313

8.  Emergency medical service providers' attitudes and experiences regarding enrolling patients in clinical research trials.

Authors:  Terri A Schmidt; Maria Nelson; Mohamud Daya; Nicole M DeIorio; Denise Griffiths; Pontine Rosteck
Journal:  Prehosp Emerg Care       Date:  2009 Apr-Jun       Impact factor: 3.077

9.  The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent.

Authors:  Eileen M Bulger; Terri A Schmidt; Andrea J Cook; Karen J Brasel; Denise E Griffiths; Peter J Kudenchuk; Daniel Davis; Berit Bardarson; Ahamed H Idris; Tom P Aufderheide
Journal:  Ann Emerg Med       Date:  2008-09-27       Impact factor: 5.721

10.  Enrollment in research under exception from informed consent: the Patients' Experiences in Emergency Research (PEER) study.

Authors:  Neal W Dickert; Victoria A Mah; Jill M Baren; Michelle H Biros; Prasanthi Govindarajan; Arthur Pancioli; Robert Silbergleit; David W Wright; Rebecca D Pentz
Journal:  Resuscitation       Date:  2013-04-16       Impact factor: 5.262

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