Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure
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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
Measuring the efficacy of community consultation in a pediatric exception from informed consent trial
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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