Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research.

Abstract:

:This article summarizes the current requirements for a waiver of informed consent for emergency research and analyzes ethical issues that are involved. Researchers who intend to apply for a waiver of informed consent for emergency research must understand that they are asking for the major protector of human subjects, the informed consent process, to be removed. In its absence, other protections are required. These include communication with the community, family members, and others close to the patient. It is unlikely that even these additional protections can equal that afforded by an adequate consent process. With this understanding, investigators' actions must be in accordance with the highest ethical standards. It is therefore necessary for investigators to know the ethical implications of conducting controlled research without the subjects' consent.

journal_name

Ann Emerg Med

authors

Adams JG,Wegener J

doi

10.1016/s0196-0644(99)70398-7

subject

Has Abstract

pub_date

1999-02-01 00:00:00

pages

218-23

issue

2

eissn

0196-0644

issn

1097-6760

pii

S0196064499000475

journal_volume

33

pub_type

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