Exception from informed consent for emergency research
نویسندگان
چکیده
منابع مشابه
Research 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 ...
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 کاملEnrollment in research under exception from informed consent: the Patients' Experiences in Emergency Research (PEER) study.
BACKGROUND Resuscitation research requires an exception from informed consent (EFIC). Despite concerns that patients may find EFIC unacceptable, the views and experiences of patients enrolled in an EFIC study are largely unknown. METHODS The Patients' Experience in Emergency Research (PEER) study was nested within the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) for pre-ho...
متن کاملException from informed consent for emergency research: consulting the trauma community.
BACKGROUND Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation" as a means of protecting patient autonomy. We hypothe...
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ژورنال
عنوان ژورنال: Journal of Trauma and Acute Care Surgery
سال: 2013
ISSN: 2163-0755
DOI: 10.1097/ta.0b013e318278908a