title: Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients.
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.
authors.affiliation: Department of Medicine, Emory University School of Medicine, Atlanta, GA; Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA. Electronic address: njr@emory.edu.
authors.forename: Neal W
authors.initials: NW
authors.lastname: Dickert
authors.affiliation: Office of Emergency Care Research, National Institute of General Medical Sciences, Bethesda, MD.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Brown
authors.affiliation: University of Arizona College of Medicine, Tucson, AZ.
authors.forename: Charles B
authors.initials: CB
authors.lastname: Cairns
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD; Albert Gnaegi Center for Health Care Ethics, Saint Louis University, St. Louis, MO.
authors.forename: Aaliyah
authors.initials: A
authors.lastname: Eaves-Leanos
authors.affiliation: Office of the Commissioner, Food and Drug Administration, Silver Spring, MD; Research and Clinical Bioethics Consultant.
authors.forename: Sara F
authors.initials: SF
authors.lastname: Goldkind
authors.affiliation: Department of Bioethics, National Institutes of Health, Bethesda, MD.
authors.forename: Scott Y H
authors.initials: SY
authors.lastname: Kim
authors.affiliation: University of Washington-Harborview Center for Prehospital Emergency Care, University of Washington, Seattle, WA.
authors.forename: Graham
authors.initials: G
authors.lastname: Nichol
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD.
authors.forename: Katie J
authors.initials: KJ
authors.lastname: O'Conor
authors.affiliation: National Heart, Lung, and Blood Institute, Bethesda, MD.
authors.forename: Jane D
authors.initials: JD
authors.lastname: Scott
authors.affiliation: Department of Emergency Medicine, State University of New York Downstate Medical Center, New York, NY.
authors.forename: Richard
authors.initials: R
authors.lastname: Sinert
authors.affiliation: Department of Bioethics, National Institutes of Health, Bethesda, MD.
authors.forename: David
authors.initials: D
authors.lastname: Wendler
authors.affiliation: Department of Emergency Medicine, Emory University School of Medicine, Atlanta, GA.
authors.forename: David W
authors.initials: DW
authors.lastname: Wright
authors.affiliation: Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI.
authors.forename: Robert
authors.initials: R
authors.lastname: Silbergleit
mesh_terms: D003243:Consciousness; D004635:Emergency Medicine; D032984:Ethics, Research; D006805:Human Experimentation / Q000941:ethics* / Q000592:standards*; D006801:Humans; D007258:Informed Consent; D014481:United States