Acting without asking: An ethical analysis of the food and drug administration waiver of informed consent for emergency research

J. G. Adams*, J. Wegener

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

51 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)218-223
Number of pages6
JournalAnnals of Emergency Medicine
Volume33
Issue number2
DOIs
StatePublished - 1999

ASJC Scopus subject areas

  • Emergency Medicine

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