TY - JOUR
T1 - Acting without asking
T2 - An ethical analysis of the food and drug administration waiver of informed consent for emergency research
AU - Adams, J. G.
AU - Wegener, J.
PY - 1999
Y1 - 1999
N2 - 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.
AB - 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.
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U2 - 10.1016/S0196-0644(99)70398-7
DO - 10.1016/S0196-0644(99)70398-7
M3 - Article
C2 - 9922420
AN - SCOPUS:0032902987
SN - 0196-0644
VL - 33
SP - 218
EP - 223
JO - Journal of the American College of Emergency Physicians
JF - Journal of the American College of Emergency Physicians
IS - 2
ER -