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Accepted (AM)Open Access (License Unspecified), Open
Journal article
Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients
Annals of emergency medicine, v 67(4), pp 538-545
01 Apr 2016
PMID: 26707358
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Barriers to informed consent are ubiquitous in the conduct of emergency care research across a wide range of conditions and clinical contexts. They are largely unavoidable; can be related to time constraints, physical symptoms, emotional stress, and cognitive impairment; and affect patients and surrogates. US regulations permit an exception from informed consent for certain clinical trials in emergency settings, but these regulations have generally been used to facilitate trials in which patients are unconscious and no surrogate is available. Most emergency care research, however, involves conscious patients, and surrogates are often available. Unfortunately, there is neither clear regulatory guidance nor established ethical standards in regard to consent in these settings. In this report-the result of a workshop convened by the National Institutes of Health Office of Emergency Care Research and Department of Bioethics to address ethical challenges in emergency care research-we clarify potential gaps in ethical understanding and federal regulations about research in emergency care in which limited involvement of patients or surrogates in enrollment decisions is possible. We propose a spectrum of approaches directed toward realistic ethical goals and a research and policy agenda for addressing these issues to facilitate clinical research necessary to improve emergency care.
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Details
- Title
- Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients
- Creators
- Neal W Dickert - Emory UniversityJeremy Brown - National Institute of General Medical SciencesCharles B Cairns - University of ArizonaAaliyah Eaves-Leanos - Center for Devices and Radiological HealthSara F Goldkind - United States Food and Drug AdministrationScott Y H Kim - National Institutes of HealthGraham Nichol - Harborview Medical CenterKatie J O'Conor - Johns Hopkins University School of MedicineJane D Scott - National Heart Lung and Blood InstituteRichard Sinert - SUNY Downstate Health Sciences UniversityDavid Wendler - National Institutes of HealthDavid W Wright - Emory UniversityRobert Silbergleit - University of Michigan
- Publication Details
- Annals of emergency medicine, v 67(4), pp 538-545
- Publisher
- Elsevier
- Grant note
- U10 NS059032 / NINDS NIH HHS U01 NS062778 / NINDS NIH HHS
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Medicine
- Web of Science ID
- WOS:000373241800022
- Scopus ID
- 2-s2.0-84950273125
- Other Identifier
- 991021448033004721
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InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Emergency Medicine