Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries-Reference-Cited by-同舟云学术

Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries

Published:2021-08-06 Issue:12 Volume:28 Page:1421-1429
ISSN:1069-6563
Container-title:Academic Emergency Medicine
language:en
Short-container-title:Academic Emergency Medicine

Author:

Linakis Seth W.¹²^ORCID,Kuppermann Nathan³,Stanley Rachel M.¹²,Hewes Hilary⁴,Myers Sage⁵,VanBuren John M.⁴,Casper T. Charles⁴,Bobinski Matthew³,Ghetti Simona⁶,Schalick Walton O.⁷,Nishijima Daniel K.²^ORCID,Barnhard Sarah E,Holmes James F,Tran Nam K,Tzimenatos Leah S,Zwienenberg Marike,Galante Joseph,Fenton Stephen,Brockmeyer Doug,Pysher Theodore,Nance Michael L,Lang Chen Shih‐Shan,Sesok‐Pizzini Deborah,Thakkar Raj,Sribnik Eric,Nicol Kathleen,Adelson P. David,Roberts Ian,

Affiliation:

1. Division of Pediatric Emergency Medicine Nationwide Children’s Hospital Columbus Ohio USA

2. Department of Pediatrics The Ohio State University Columbus Ohio USA

3. Department of Emergency Medicine University of California at Davis School of Medicine Sacramento California USA

4. Department of Pediatrics University of Utah School of Medicine Salt Lake City Utah USA

5. Division of Emergency Medicine Department of Pediatrics Children’s Hospital of Philadelphia Philadelphia Pennsylvania USA

6. Department of Psychology University of California at Davis Davis California USA

7. Department of Orthopedics and Rehabilitation University of Wisconsin Madison Wisconsin USA

Funder

Health Resources and Services Administration

National Heart, Lung, and Blood Institute

National Center for Advancing Translational Sciences

Publisher

Wiley

Subject

Emergency Medicine,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/acem.14343

Reference16 articles.

1. Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards Clinical Investigators and Sponsors.Food and Drug Administration website. 2013. Accessed February 25 2021.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/exception‐informed‐consent‐requirements‐emergency‐research

2. Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) trial

3. Enrollment in research under exception from informed consent: The Patients’ Experiences in Emergency Research (PEER) study

4. Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations

5. Exception from informed consent for emergency research

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1. Traumatic injury clinical trial evaluating tranexamic acid in children ( TIC‐TOC ): A pilot randomized trial;Academic Emergency Medicine;2022-04-08