Current status of research on the federal guidelines for performing research using an exception from informed consent

Terri A. Schmidt, Roger J. Lewis, Lynne D. Richardson

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

In order to set the stage for the later discussion of future directions, this Consensus Conference began by reviewing some of the existing research on conducting resuscitation studies using an exception from informed consent. That research is described in this article. The authors conclude that, based on the experiences reported by researchers and institutional review boards, resuscitation research may be ethically and legally conducted under the current regulations, but such research requires substantial effort, financial resources, and personnel. Federal regulations have set the bar appropriately high, and this may pose significant difficulties for small sponsors and individual investigators. However, further study of the experiences of subjects, researchers, and the regulatory process is warranted.

Original languageEnglish (US)
Pages (from-to)1022-1026
Number of pages5
JournalAcademic Emergency Medicine
Volume12
Issue number11
DOIs
StatePublished - Nov 1 2005

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Keywords

  • Informed consent
  • Research ethics
  • Resuscitation

ASJC Scopus subject areas

  • Emergency Medicine

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