EMS Providers and Exception from Informed Consent Research: Benefits, Ethics, and Community Consultation
نویسندگان
چکیده
منابع مشابه
Community attitudes towards emergency research and exception from informed consent.
OBJECTIVE To determine public attitudes towards emergency research, exception from informed consent (EFIC) and a specific proposed clinical trial using EFIC. METHODS As part of a planned community consultation activity, a survey was conducted at a popular public venue. Participants answered demographic questions and then were asked their opinions on specifically described consent circumstance...
متن کاملResearch Ethics and Informed Consent : Not Applicable
Copyright and reuse: The Warwick Research Archive Portal (WRAP) makes this work of researchers of the University of Warwick available open access under the following conditions. Copyright © and all moral rights to the version of the paper presented here belong to the individual author(s) and/or other copyright owners. To the extent reasonable and practicable the material made available in WRAP ...
متن کاملImproving Community Understanding of Medical Research: Audience Response Technology for Community Consultation for Exception to Informed Consent
INTRODUCTION The Department of Health and Human Services and Food and Drug Administration described guidelines for exception from informed consent (EFIC) research. These guidelines require community consultation (CC) events, which allow members of the community to understand the study, provide feedback and give advice. A real-time gauge of audience understanding would allow the speaker to modif...
متن کاملResearch conditions that qualify for emergency exception from informed consent.
Medical research involving critically ill and injured subjects unable to provide informed consent can only be conducted under federal regulations that attempt to balance the need to develop lifesaving treatments with protection of research subjects' rights. Regulators, researchers, and medical ethicists have all struggled to define the conditions under which an emergency exception from informed...
متن کاملException from informed consent requirements for emergency research.
Researchers who plan to conduct research protocols in an emergency setting when they know that it will not be possible to obtain consent from the patient or legally authorized and the research involves an FDA regulated product are required to conduct the research in accordance with the FDA regulations 50.24 and DHHS regulations 45.CFR 46.101(i). The HHS and FDA regulations have been harmonized ...
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ژورنال
عنوان ژورنال: Prehospital Emergency Care
سال: 2012
ISSN: 1090-3127,1545-0066
DOI: 10.3109/10903127.2012.702189