Literature DB >> 18210229

Research without consent: exception from and waiver of informed consent in resuscitation research.

Michelle H Biros1.   

Abstract

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a delay while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled "The Ethics of Research in Emergency Medicine".

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Year:  2007        PMID: 18210229     DOI: 10.1007/s11948-007-9020-y

Source DB:  PubMed          Journal:  Sci Eng Ethics        ISSN: 1353-3452            Impact factor:   3.525


  8 in total

1.  An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements.

Authors:  Ernest D Prentice; Dean L Antonson; Lyal G Leibrock; Vikram C Prabhu; Timothy K Kelso; Thomas D Sears
Journal:  IRB       Date:  1994 Jan-Apr

2.  IRB review of a Phase II randomized clinical trial involving incompetent patients suffering from severe closed head injury.

Authors:  Ernest D Prentice; Dean L Antonson; Lyal G Leibrock; Timothy K Kelso; Thomas D Sears
Journal:  IRB       Date:  1993 Sep-Oct

3.  Development of the multiorganizational document regarding emergency research consent.

Authors:  M H Biros
Journal:  Acad Emerg Med       Date:  1996-02       Impact factor: 3.451

4.  Deferred consent. A new approach for resuscitation research on comatose patients.

Authors:  N S Abramson; A Meisel; P Safar
Journal:  JAMA       Date:  1986-05-09       Impact factor: 56.272

Review 5.  Implementing the Food and Drug Administration's final rule for waiver of informed consent in certain emergency research circumstances.

Authors:  M H Biros; S S Fish; R J Lewis
Journal:  Acad Emerg Med       Date:  1999-12       Impact factor: 3.451

6.  An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent.

Authors:  J M Baren; J P Anicetti; S Ledesma; M H Biros; M Mahabee-Gittens; R J Lewis
Journal:  Acad Emerg Med       Date:  1999-12       Impact factor: 3.451

Review 7.  Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers.

Authors:  M H Biros; R J Lewis; C M Olson; J W Runge; R O Cummins; N Fost
Journal:  JAMA       Date:  1995-04-26       Impact factor: 56.272

8.  The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.

Authors: 
Journal:  J Am Coll Dent       Date:  2014
  8 in total
  5 in total

1.  Community consultation and public disclosure: preliminary results from a new model.

Authors:  Cornelia A Ramsey; Bonnie Quearry; Elizabeth Ripley
Journal:  Acad Emerg Med       Date:  2011-07-05       Impact factor: 3.451

2.  Simultaneous ring voice-over-Internet phone system enables rapid physician elicitation of explicit informed consent in prehospital stroke treatment trials.

Authors:  Nerses Sanossian; Sidney Starkman; David S Liebeskind; Latisha K Ali; Lucas Restrepo; Scott Hamilton; Robin Conwit; Jeffrey L Saver
Journal:  Cerebrovasc Dis       Date:  2009-10-16       Impact factor: 2.762

3.  Blood substitutes--the polyheme trials.

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

Review 4.  Exceptions to the rule of informed consent for research with an intervention.

Authors:  Susanne Rebers; Neil K Aaronson; Flora E van Leeuwen; Marjanka K Schmidt
Journal:  BMC Med Ethics       Date:  2016-02-06       Impact factor: 2.652

5.  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

  5 in total

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