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Text
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URL Address
<a href="http://doi.org/10.1016/j.burns.2012.02.009" target="_blank" rel="noreferrer noopener">http://doi.org/10.1016/j.burns.2012.02.009</a>
Pages
807–812
Issue
6
Volume
38
Dublin Core
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Title
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A burn center paradigm to fulfill deferred consent public disclosure and community consultation requirements for emergency care research.
Publisher
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Burns (03054179)
Date
A point or period of time associated with an event in the lifecycle of the resource
2012
2012-09
Subject
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United States; Health Services Research; Human; Truth Disclosure; Consent; Community-Institutional Relations; Government Regulations; Burn Units – Legislation and Jurisprudence; Burns – Therapy
Creator
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Blackford MG; Falletta L; Andrews DA; Reed MD
Description
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INTRODUCTION: To fulfill Food and Drug Administration and Department of Health and Human Services emergency care research informed consent requirements, our burn center planned and executed a deferred consent strategy gaining Institutional Review Board (IRB) approval to proceed with the clinical study. These federal regulations dictate public disclosure and community consultation unique to acute care research. OBJECTIVE: Our regional burn center developed and implemented a deferred consent public notification and community consultation paradigm appropriate for a burn study. METHODS: Published accounts of deferred consent strategies focus on acute care resuscitation practices. We adapted those strategies to design and conduct a comprehensive public notification/community consultation plan to satisfy deferred consent requirements for burn center research. RESULTS: To implement a robust media campaign we engaged the hospital's public relations department, distributed media materials, recruited hospital staff for speaking engagements, enlisted community volunteers, and developed initiatives to inform 'hard-to-reach' populations. The hospital's IRB determined we fulfilled our obligation to notify the defined community. CONCLUSION: Our communication strategy should provide a paradigm other burn centers may appropriate and adapt when planning and executing a deferred consent initiative.
Identifier
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<a href="http://doi.org/10.1016/j.burns.2012.02.009" target="_blank" rel="noreferrer noopener">10.1016/j.burns.2012.02.009</a>
Rights
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2012
Andrews DA
Blackford MG
Burn Units – Legislation and Jurisprudence
Burns – Therapy
Burns (03054179)
Community-Institutional Relations
Consent
Falletta L
Government Regulations
Health Services Research
Human
Reed MD
Truth Disclosure
United States