Willingness to participate in an active exception from informed consent trial in the pediatric intensive care unit-Reference-Cited by-同舟云学术

Willingness to participate in an active exception from informed consent trial in the pediatric intensive care unit

Published:2024-07-23 Issue: Volume: Page:
ISSN:1069-6563
Container-title:Academic Emergency Medicine
language:en
Short-container-title:Academic Emergency Medicine

Author:

Ross Catherine E.¹²^ORCID,Asad Muhammad¹²,Kundun Harshannie¹²,Gathers Cody‐Aaron L.³,Berg Robert A.³,Kleinman Monica E.⁴

Affiliation:

1. Division of Medical Critical Care, Department of Pediatrics Boston Children's Hospital, Harvard Medical School Boston Massachusetts USA

2. Center for Resuscitation Science, Department of Emergency Medicine Beth Israel Deaconess Medical Center, Harvard Medical School Boston Massachusetts USA

3. Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine Children's Hospital of Philadelphia, University of Pennsylvania Philadelphia Pennsylvania USA

4. Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine Boston Children's Hospital, Harvard Medical School Boston Massachusetts USA

Funder

National Heart, Lung, and Blood Institute

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/acem.14978

Reference11 articles.

1. 21 CFR 50.24. Exception from informed consent requirements for emergency research;U.S. Food and Drug Administration and Department of Health and Human Services;Fed Regist,1996

2. U.S. Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health.Guidance for Institutional Review Boards Clinical Investigators and Sponsors: Exception from Informed Consent Requirements for Emergency Research.2013. Accessed 19 February 2024.https://www.fda.gov/downloads/Regulatoryinformation/Guidances/UCM249673.pdf

3. Public Approval of Exception From Informed Consent in Emergency Clinical Trials

4. A census of clinical trials conducted under the U.S. exception from informed consent rule

5. Community consultation in the pediatric intensive care unit for an exception from informed consent Trial: A survey of patient caregivers