Premium
Current Status of Research on the Federal Guidelines for Performing Research Using an Exception from Informed Consent
Author(s) -
Schmidt Terri A.,
Lewis Roger J.,
Richardson Lynne D.
Publication year - 2005
Publication title -
academic emergency medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.221
H-Index - 124
eISSN - 1553-2712
pISSN - 1069-6563
DOI - 10.1197/j.aem.2005.06.012
Subject(s) - medicine , informed consent , set (abstract data type) , resuscitation , order (exchange) , medical education , engineering ethics , alternative medicine , emergency medicine , pathology , programming language , engineering , finance , computer science , economics
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.