Randomizing Patients without Consent: Waiver vs Exception from Informed Consent

Cole, Jon B.; Ho, Jeffrey D.; Biros, Michelle H.

doi:10.1017/s1049023x16000479

Prehosp. Disaster med.

2016

DOI: 10.1017/s1049023x16000479

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Randomizing Patients without Consent: Waiver vs Exception from Informed Consent

Jon B. Cole

Jeffrey D. Ho

Michelle H. Biros

Abstract: ColeJB, HoJD, BirosMH. Randomizing patients without consent: waiver vs exception from informed consent. Prehosp Disaster Med.2016;31(4):457–458.

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“…In fact, Prehospital and Disaster Medicine published a randomized trial comparing haloperidol and midazolam for prehospital agitation in 2015 approved under WIC. 25,26 Due to the undeserved negative media coverage, we elected to cease study data collection. The study was not suspended by the institution in a disciplinary manner; rather, the investigators voluntarily paused data collection in a good-faith effort to maintain the public trust for the benefit of our institution, community, and patients.…”

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The Hennepin Ketamine Study Investigators’ Reply

Cole

Klein

et al. 2019

Prehosp. Disaster med.

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We read with interest the recent editorial, “The Hennepin Ketamine Study,” by Dr. Samuel Stratton commenting on the research ethics, methodology, and the current public controversy surrounding this study.1 As researchers and investigators of this study, we strongly agree that prospective clinical research in the prehospital environment is necessary to advance the science of Emergency Medical Services (EMS) and emergency medicine. We also agree that accomplishing this is challenging as the prehospital environment often encounters patient populations who cannot provide meaningful informed consent due to their emergent conditions. To ensure that fellow emergency medicine researchers understand the facts of our work so they may plan future studies, and to address some of the questions and concerns in Dr. Stratton’s editorial, the lay press, and in social media,2 we would like to call attention to some inaccuracies in Dr. Stratton’s editorial, and to the lay media stories on which it appears to be based.Ho JD, Cole JB, Klein LR, Olives TD, Driver BE, Moore JC, Nystrom PC, Arens AM, Simpson NS, Hick JL, Chavez RA, Lynch WL, Miner JR. The Hennepin Ketamine Study investigators’ reply. Prehosp Disaster Med. 2019;34(2):111–113

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The Hennepin Ketamine Study Investigators’ Reply

Cole

Klein

et al. 2019

Prehosp. Disaster med.

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Intramuscular Midazolam, Olanzapine, Ziprasidone, or Haloperidol for Treating Acute Agitation in the Emergency Department

Klein

Driver

Miner

et al. 2018

Annals of Emergency Medicine

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