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

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

Research output: Contribution to journalArticle

9 Citations (Scopus)

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 2005

Fingerprint

Informed Consent
Guidelines
Research Personnel
Research
Resuscitation
Research Ethics Committees

Keywords

  • Informed consent
  • Research ethics
  • Resuscitation

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

Current status of research on the federal guidelines for performing research using an exception from informed consent. / Schmidt, Terri; Lewis, Roger J.; Richardson, Lynne D.

In: Academic Emergency Medicine, Vol. 12, No. 11, 11.2005, p. 1022-1026.

Research output: Contribution to journalArticle

Schmidt, Terri ; Lewis, Roger J. ; Richardson, Lynne D. / Current status of research on the federal guidelines for performing research using an exception from informed consent. In: Academic Emergency Medicine. 2005 ; Vol. 12, No. 11. pp. 1022-1026.
@article{da70629fe4794439a9a3fce05cf6750e,
title = "Current status of research on the federal guidelines for performing research using an exception from informed consent",
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.",
keywords = "Informed consent, Research ethics, Resuscitation",
author = "Terri Schmidt and Lewis, {Roger J.} and Richardson, {Lynne D.}",
year = "2005",
month = "11",
doi = "10.1197/j.aem.2005.06.012",
language = "English (US)",
volume = "12",
pages = "1022--1026",
journal = "Academic Emergency Medicine",
issn = "1069-6563",
publisher = "Wiley-Blackwell",
number = "11",

}

TY - JOUR

T1 - Current status of research on the federal guidelines for performing research using an exception from informed consent

AU - Schmidt, Terri

AU - Lewis, Roger J.

AU - Richardson, Lynne D.

PY - 2005/11

Y1 - 2005/11

N2 - 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.

AB - 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.

KW - Informed consent

KW - Research ethics

KW - Resuscitation

UR - http://www.scopus.com/inward/record.url?scp=27144434024&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=27144434024&partnerID=8YFLogxK

U2 - 10.1197/j.aem.2005.06.012

DO - 10.1197/j.aem.2005.06.012

M3 - Article

VL - 12

SP - 1022

EP - 1026

JO - Academic Emergency Medicine

JF - Academic Emergency Medicine

SN - 1069-6563

IS - 11

ER -