A census of clinical trials conducted under the U.S. exception from informed consent rule
Author:
Affiliation:
1. Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania USA
2. Department of Medical Ethics & Health Policy Perelman School of Medicine at the University of Pennsylvania Philadelphia Pennsylvania USA
Publisher
Wiley
Subject
Emergency Medicine,General Medicine
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1111/acem.14645
Reference48 articles.
1. Drug Amendments of 1962 § 103(b) Public Law 87‐781.1962.
2. Procedural and interpretative regulations; investigational use;Fed Regist,1963
3. Research without consent: current status, 2003;Biros MH;Acad Emerg Med,2003
4. The History and Policy Evolution of Waivers of Informed Consent in Research
5. Code of Federal Regulations title 45 Part 46 Subpart A.2021.
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1. Willingness to participate in an active exception from informed consent trial in the pediatric intensive care unit;Academic Emergency Medicine;2024-07-23
2. Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial;Academic Emergency Medicine;2024-03-07
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