Randomizing Patients without Consent: Waiver vs Exception from Informed Consent
نویسندگان
چکیده
منابع مشابه
Informed consent without autonomy.
This Essay explains why and how the Roman Catholic basis for informed consent is different from the secular basis. It argues that the Catholic basis, which is rooted in “natural law,” is the better model for society to adopt. The author explains that the secular view is rooted in the belief that patient autonomy must never be violated but the Catholic view is based on human dignity, which simpl...
متن کاملWithout Informed Consent
The requirement of always obtaining participants’ informed consent in research with human subjects cannot always be met, for a variety of reasons. This paper describes and categorises research situations where informed consent is unobtainable. Some of these kinds of situations, common in biomedicine and psychology, have been previously discussed, whereas others, for example, those more prevalen...
متن کاملCommunity 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 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 and Disaster Medicine
سال: 2016
ISSN: 1049-023X,1945-1938
DOI: 10.1017/s1049023x16000479