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   Articles with "exception informed" as a keyword



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Public Approval of Exception From Informed Consent in Emergency Clinical Trials

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recommendations! Published in 2019 at "JAMA Network Open"

DOI: 10.1001/jamanetworkopen.2019.7591

Abstract: Key Points Question How does the public view emergency research conducted with an exception from informed consent (EFIC)? Findings In this systematic review of survey data from 27 emergency clinical trials with responses from 42 448… read more here.

Keywords: emergency clinical; emergency; exception informed; clinical trials ... See more keywords

Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure

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recommendations! Published in 2020 at "AJOB Empirical Bioethics"

DOI: 10.1080/23294515.2020.1818878

Abstract: Abstract Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment. To better understand how IRB… read more here.

Keywords: community; exception informed; community consultation; irb members ... See more keywords

Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial

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recommendations! Published in 2024 at "Academic Emergency Medicine"

DOI: 10.1111/acem.14884

Abstract: Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose Optimization… read more here.

Keywords: consent; exception informed; trial; consent efic ... See more keywords

Measuring the efficacy of community consultation in a pediatric exception from informed consent trial

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recommendations! Published in 2024 at "Academic Emergency Medicine"

DOI: 10.1111/acem.15073

Abstract: Community consultation activities are required by the Food and Drug Administration prior to conducting research using exception from informed consent (EFIC) for emergency research and aim to provide additional participant protections. However, it is difficult… read more here.

Keywords: exception informed; informed consent; efficacy; consultation ... See more keywords