Are studies using exception under informed consent viable in emergency medicine and trauma response research to increase enrollment?

Author(s):  
Jacinda Bunch
2019 ◽  
Vol 34 (02) ◽  
pp. 111-113
Author(s):  
Jeffrey D. Ho ◽  
Jon B. Cole ◽  
Lauren R. Klein ◽  
Travis D. Olives ◽  
Brian E. Driver ◽  
...  

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


2004 ◽  
Vol 11 (10) ◽  
pp. 1082-1089 ◽  
Author(s):  
◽  
Terri A. Schmidt ◽  
David Salo ◽  
Jason A. Hughes ◽  
Jean T. Abbott ◽  
...  

1996 ◽  
Vol 14 (1) ◽  
pp. 245-254 ◽  
Author(s):  
Jeffrey Thewes ◽  
Denis FitzGerald ◽  
Daniel P. Sulmasy

2017 ◽  
Vol 1 (3) ◽  
pp. 221-224
Author(s):  
Emily S. Binstadt ◽  
Nathaniel D. Curl ◽  
Jessie G. Nelson ◽  
Gail L. Johnson ◽  
Cullen B. Hegarty ◽  
...  

2019 ◽  
Vol 58 (14) ◽  
pp. 1509-1514
Author(s):  
B. Lorrie Edwards ◽  
Heidi Werner ◽  
Yorghos Tripodis ◽  
David Dorfman ◽  
Tehnaz Boyle ◽  
...  

Although informed consent is a cornerstone of medical ethics, it is unclear if the practice for obtaining informed consent is consistent among pediatric emergency departments. This study’s goal is to describe the current practice for written informed consent in academic pediatric emergency departments for non-emergent procedures. A questionnaire distributed to pediatric emergency medicine fellowship directors queried whether written informed consent was standard of care for 15 procedures and assessed departmental consent policies and use of “blanket” consent-to-treat forms. Response rate was 80% (n = 64). Institutions obtained written consent for a mean of 4.4 procedures. Written informed consent was most commonly obtained for procedural sedation (82.5%), blood transfusion (72.9%), and lumbar puncture (66.5%). Twenty-one institutions (32.8%) had policies specifying procedures requiring written consent. Thirty-five institutions (54.7%) used “blanket” consent-to-treat forms. Our results suggest that there is variability in the use of written informed consent for non-emergent procedures among academic pediatric emergency departments.


2008 ◽  
Vol 15 (6) ◽  
pp. 573-576 ◽  
Author(s):  
Edward Monico ◽  
Gregory Luke Larkin ◽  
Linda Degutis

2013 ◽  
Vol 20 (4) ◽  
pp. 403-407 ◽  
Author(s):  
Steven R. Offerman ◽  
Daniel K. Nishijima ◽  
Dustin W. Ballard ◽  
Uli K. Chetipally ◽  
David R. Vinson ◽  
...  

2009 ◽  
Vol 53 (3) ◽  
pp. 341-350.e2 ◽  
Author(s):  
Eileen M. Bulger ◽  
Terri A. Schmidt ◽  
Andrea J. Cook ◽  
Karen J. Brasel ◽  
Denise E. Griffiths ◽  
...  

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