Literature DB >> 18210228

Informed consent in emergency research: a contradiction in terms.

Malcolm G Booth1.   

Abstract

Improving the treatment of life threatening emergency illness or disease requires that new or novel therapies be assessed in clinical trials. As most subjects for these trials will be incapacitated there is some controversy about they might best protected whilst still allowing research to continue. Recent European and UK clinical trials legislation, which has effectively stopped research into emergency conditions, is discussed. Possible changes to these regulations are proposed.

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Year:  2007        PMID: 18210228     DOI: 10.1007/s11948-007-9028-3

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


  13 in total

1.  Update on progress in the international, multicenter, randomized, controlled trial of corticosteroids after significant head injury (Medical Research Council CRASH Trial).

Authors: 
Journal:  Curr Opin Crit Care       Date:  2003-04       Impact factor: 3.687

2.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

3.  The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient.

Authors:  F Lemaire; J Bion; J Blanco; P Damas; C Druml; K Falke; J Kesecioglu; A Larsson; J Mancebo; D Matamis; A Pesenti; J Pimentel; M Ranieri
Journal:  Intensive Care Med       Date:  2005-02-15       Impact factor: 17.440

4.  Compliance with antiseptic hand rub use in intensive care units: the Hawthorne effect.

Authors:  Tim Eckmanns; Jan Bessert; Michael Behnke; Petra Gastmeier; Henning Ruden
Journal:  Infect Control Hosp Epidemiol       Date:  2006-08-22       Impact factor: 3.254

5.  Brief report on the experience of using proxy consent for incapacitated adults.

Authors:  S Mason; H Barrow; A Phillips; G Eddison; A Nelson; N Cullum; J Nixon
Journal:  J Med Ethics       Date:  2006-01       Impact factor: 2.903

6.  The European Clinical Trials Directive revisited: the VISEAR recommendations.

Authors:  Kathleen Liddell; Douglas Chamberlain; David K Menon; Julian Bion; Erwin J O Kompanje; François Lemaire; Christiane Druml; Bozidar Vrhovac; Christian J Wiedermann; Fritz Sterz
Journal:  Resuscitation       Date:  2006-03-02       Impact factor: 5.262

7.  From the Food and Drug Administration.

Authors:  S L Nightingale
Journal:  JAMA       Date:  1996-11-27       Impact factor: 56.272

8.  Waiver of informed consent: a survey of emergency medicine patients.

Authors:  H A Smithline; M L Gerstle
Journal:  Am J Emerg Med       Date:  1998-01       Impact factor: 2.469

9.  Public perception of emergency research: a questionnaire.

Authors:  M G Booth; A Lind; E Read; J Kinsella
Journal:  Eur J Anaesthesiol       Date:  2005-12       Impact factor: 4.330

Review 10.  The accuracy of surrogate decision makers: a systematic review.

Authors:  David I Shalowitz; Elizabeth Garrett-Mayer; David Wendler
Journal:  Arch Intern Med       Date:  2006-03-13
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  4 in total

1.  What's new in ethics of cardio-pulmonary resuscitation research: too little time and too many rules?

Authors:  Antoniu O Petriş; Diana C Cimpoeşu; Didona Ungureanu
Journal:  Intensive Care Med       Date:  2014-11-22       Impact factor: 17.440

Review 2.  Ethical challenges in resuscitation.

Authors:  Spyros D Mentzelopoulos; Anne-Marie Slowther; Zoe Fritz; Claudio Sandroni; Theodoros Xanthos; Clifton Callaway; Gavin D Perkins; Craig Newgard; Eleni Ischaki; Robert Greif; Erwin Kompanje; Leo Bossaert
Journal:  Intensive Care Med       Date:  2018-05-10       Impact factor: 17.440

3.  Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.

Authors:  Victoria Shepherd
Journal:  Contemp Clin Trials       Date:  2020-06-08       Impact factor: 2.226

Review 4.  [Ethics of resuscitation and end of life decisions].

Authors:  Spyros D Mentzelopoulos; Keith Couper; Patrick Van de Voorde; Patrick Druwé; Marieke Blom; Gavin D Perkins; Ileana Lulic; Jana Djakow; Violetta Raffay; Gisela Lilja; Leo Bossaert
Journal:  Notf Rett Med       Date:  2021-06-02       Impact factor: 0.826

  4 in total

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