TY - JOUR
T1 - Current status of research on the federal guidelines for performing research using an exception from informed consent
AU - Schmidt, Terri A.
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
C2 - 16264068
AN - SCOPUS:27144434024
SN - 1069-6563
VL - 12
SP - 1022
EP - 1026
JO - Academic Emergency Medicine
JF - Academic Emergency Medicine
IS - 11
ER -