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An Ethical Analysis of Exception from Informed Consent Regulations

Year: 2005
Type: article
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: Marilyn C. Morris
Language: English
Field: Medicine
Open Access status: bronze
OpenAlex ID: W2108317562
FWCI: 3.232
Cites: 43
Cited by: 27
Related to: 10