Reduction in Ephedra Poisonings after FDA Ban
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.
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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).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [46]
Cites
Shekelle, P. G., Hardy, M. L., Morton, S. C., Maglione, M., Mojica, W. A., Suttorp, M. J., Rhodes, S. L., Jungvig, L., & Gagné, J. (2003) · JAMA · doi:10.1001/jama.289.12.1537 · Cited by 511 · see citing works
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Lessons from HeLa Cells: The Ethics and Policy of Biospecimens
Beskow, L. M. (2016) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-083115-022536 · Cited by 146 · see citing works
Spanakis, M., Bakaros, E., Papadopoulou, S.-N., Fournaraki, A., & Symvoulakis, E. K. (2025) · Pharmacoepidemiology · doi:10.3390/pharma4040022 · Cited by 6 · see citing works
- Authors
- Zell-Kanter, M., Quigley, M. A., & Leikin, J. B.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- 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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