An ethical analysis of exception from informed consent regulations.

Full Abstract

Federal regulations enacted in 1996 allow clinical research with an exception from informed consent in select emergency circumstances. Such research is only permitted when the therapy may directly benefit the research participant and it is not possible to conduct the research with informed consent. Among others, protective mechanisms include a process of community consultation and public disclosure and the establishment of a mandatory data safety monitoring board. Although the regulations do not preserve the right of self-determination of the research participant, the author argues that they do provide an ethical means to advance the science of resuscitation.

Author information

Author/s: Morris, Marilyn C (MC);

Affiliation: The Morgan Stanley Children's Hospital of New York-Presbyterian, New York, NY, USA. mcm2113(-atsign-)columbia.edu

Journal and publication information

Publication Type: Historical Article; Journal Article

Journal: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine (Acad Emerg Med), published in United States. (Language: eng)

Reference: 2005-Nov; vol 12 (issue 11) : pp 1113-9

Dates: Created 2005/11/02; Completed 2006/03/15; Revised 2007/11/15;

PMID: 16264082, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )

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