Food and Drug Administration and Institutional Review Board Approval of a Novel Prehospital Informed Consent Process for Emergency Research
| Autor: | Michael J. Linke, Jason T. McMullan, Christopher A. Droege, Christopher J. Lindsell, Col. Richard Strilka |
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| Rok vydání: | 2020 |
| Předmět: |
Emergency Medical Services
Process (engineering) 030204 cardiovascular system & hematology Emergency Nursing Food and drug administration 03 medical and health sciences 0302 clinical medicine Emergency research Informed consent Humans Medicine Acute pain Informed Consent United States Food and Drug Administration business.industry 030208 emergency & critical care medicine Pain management medicine.disease Institutional review board United States Clinical trial Emergency Medicine Medical emergency Emergencies business Ethics Committees Research |
| Zdroj: | Prehospital Emergency Care. :1-7 |
| ISSN: | 1545-0066 1090-3127 |
| Popis: | Research on the management of acute pain in the prehospital setting is fraught with challenges. The prehospital setting is complex due to constrained time, resources, and training. Research activities must not interfere with the underlying clinical priorities of immediate patient stabilization and rapid transport to an appropriate hospital. The patient’s pain, fear, and anxiety immediately after a traumatic event may interfere with undertaking an adequate informed consent process. Pain management trials do not satisfy the criteria for application of the U.S. Food and Drug Administration (FDA) 21 CFR 50.24 exception from informed consent. While nonstandard informed consent processes exist, waiver or alteration of informed consent may be limited if Institutional Review Boards or the FDA consider these studies to involve more than minimal risk related to the setting of the study, even if the interventions themselves might involve no more than minimal risk in other settings. In addition, any study requiring an Investigational New Drug application requires fully documented standard informed consent. Emergency Medical Services agencies and fire departments become research institutions, and paramedics become study staff, but both the institutions and the staff often lack experience conducting human subjects research and are rarely formally affiliated with the academic institution overseeing the research. As such, additional administrative burdens must be overcome in interventional prehospital studies, including additional training in the study protocol, research operations, and human subjects protections. Institutions conducting federally funded studies commit to regulations covering human subjects protections in the form of a Federalwide Assurance (FWA); prehospital organizations participating in research must either obtain an FWA or have coverage extended to them from an academic partner. We describe how these challenges were addressed during Institutional Review Board review and approval of an FDA-regulated randomized placebo-controlled trial of intranasal ketamine (vs. placebo) in acutely injured patients receiving standard of care fentanyl for prehospital pain management (NCT02866071). To our knowledge, this trial is the first instance in the United States of paramedics screening, consenting, enrolling, and administering study medications to patients without direct, real-time support from a dedicated clinical research team. |
| Databáze: | OpenAIRE |
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