Cited by 64Ethics in Clinical ResearchPoisoning and overdose treatmentsOpioid Use Disorder Treatment

Reduction in Ephedra Poisonings after FDA Ban

Zell-Kanter, Michele, Quigley, Meghan A., Leikin, Jerrold B.·2015·New England Journal of Medicine

Abstract

The findings of Lagler et al. that current consent templates are written at an education level that exceeds that of the general population are consistent with the findings of others who have evaluated consent forms and templates. 1These data suggest that the institutions where research is conducted, the research teams that write consent forms, or the oversight committees that review them (or all of the above) are not sufficiently focused on the goal of facilitating understanding among potential research participants.This seems true, as consent forms continue to increase in length, complexity, and the incorporation of legal language, thus jeopardizing understanding despite recognition of the need to improve consent forms. 2 I agree that substantial efforts are needed to improve consentform readability and understandability, and those efforts should include attention to the research teams, review groups, and research institutions that shape the consent forms.

Integrity signals

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Crossref · 10.1056/nejmc1502505

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1 of 1 references verified0 citation errors · 0 not checkable

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  • There is a chasm between the theoretical ideals of informed consent and what it accomplishes in actual practice.

    “There is a chasm between the theoretical ideals of informed consent and what it accomplishes in actual practice (46, 53, 55).”

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Authors
Zell-Kanter, M., Quigley, M. A., & Leikin, J. B.
Venue
New England Journal of Medicine
Published
2015-05-28
Volume
372
Issue
22
Pages
2172-2174
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W839463629
Cited by
64
References
1
Citations by year
2026: 2 · 2025: 6 · 2024: 7 · 2023: 2 · 2022: 5 · 2021: 7 · 2020: 2 · 2019: 6 · 2018: 3 · 2017: 10 · 2016: 10 · 2015: 4
FWCI
9.63
Type
journal article
Language
en
Open access
closed
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Emergency Medicine › Poisoning and overdose treatments
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
Keywords
Ephedra, FDA ban, herbal supplement safety, informed consent forms, informed consent
MeSH terms
Humans, Poisoning, United States, United States Food and Drug Administration, Ephedra, Safety-Based Drug Withdrawals

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