Food and Drug Administration and Institutional Review Board Approval of a Novel Prehospital Informed Consent Process for Emergency Research

Jason McMullanDepartment of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio (JM); Department of Pharmacy, UC Health – University of Cincinnati Medical Center, Cincinnati, Ohio (CD); Department of Surgery, United States Air Force and University of Cincinnati, Cincinnati, Ohio (CRS); Department of Biostatistics, Vanderbilt University Medical Center, Cincinnati, Ohio (CL); University of Cincinnati, Cincinnati, Ohio (MJL). Revision received July 14, 2020; accepted for publication July 30, 2020.Correspondence[email protected]

, MD MS FAEMS,

Christopher DroegeDepartment of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio (JM); Department of Pharmacy, UC Health – University of Cincinnati Medical Center, Cincinnati, Ohio (CD); Department of Surgery, United States Air Force and University of Cincinnati, Cincinnati, Ohio (CRS); Department of Biostatistics, Vanderbilt University Medical Center, Cincinnati, Ohio (CL); University of Cincinnati, Cincinnati, Ohio (MJL). Revision received July 14, 2020; accepted for publication July 30, 2020.

, PharmD, BCCCP, FCCM, FASHP,

Col. Richard StrilkaDepartment of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio (JM); Department of Pharmacy, UC Health – University of Cincinnati Medical Center, Cincinnati, Ohio (CD); Department of Surgery, United States Air Force and University of Cincinnati, Cincinnati, Ohio (CRS); Department of Biostatistics, Vanderbilt University Medical Center, Cincinnati, Ohio (CL); University of Cincinnati, Cincinnati, Ohio (MJL). Revision received July 14, 2020; accepted for publication July 30, 2020.

, MD PhD,

Christopher LindsellDepartment of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio (JM); Department of Pharmacy, UC Health – University of Cincinnati Medical Center, Cincinnati, Ohio (CD); Department of Surgery, United States Air Force and University of Cincinnati, Cincinnati, Ohio (CRS); Department of Biostatistics, Vanderbilt University Medical Center, Cincinnati, Ohio (CL); University of Cincinnati, Cincinnati, Ohio (MJL). Revision received July 14, 2020; accepted for publication July 30, 2020.

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Michael J. LinkeDepartment of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio (JM); Department of Pharmacy, UC Health – University of Cincinnati Medical Center, Cincinnati, Ohio (CD); Department of Surgery, United States Air Force and University of Cincinnati, Cincinnati, Ohio (CRS); Department of Biostatistics, Vanderbilt University Medical Center, Cincinnati, Ohio (CL); University of Cincinnati, Cincinnati, Ohio (MJL). Revision received July 14, 2020; accepted for publication July 30, 2020.

, PhD

Food and Drug Administration and Institutional Review Board Approval of a Novel Prehospital Informed Consent Process for Emergency Research

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