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Informed Consent, Comparative Effectiveness, and Learning Health Care
Abstract
The authors argue that in a learning health care system with ethically robust oversight policies, a streamlined consent process could replace formal written informed-consent procedures for many studies, and patient consent would not be required at all for some trials.
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“The recent INDEPENDENT trial replicated these findings in a low-resource setting (India). 615”
From Time for united action on depression: a Lancet–World Psychiatric Association Commission (2022) · cites this paper as [615]
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Metadata
- Authors
- Faden, R. R., Beauchamp, T. L., & Kass, N. E.
- Affiliations
- Johns Hopkins University (US)
- Georgetown University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-02-20
- Volume
- 370
- Issue
- 8
- Pages
- 766-768
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2022826022
- Cited by
- 214
- References
- 5
- Citations by year
- 2026: 8 · 2025: 9 · 2024: 12 · 2023: 5 · 2022: 15 · 2021: 11 · 2020: 15 · 2019: 20 · 2018: 17 · 2017: 20 · 2016: 20 · 2015: 39 · 2014: 21
- FWCI
- 33.02
- 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 › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Keywords
- informed consent, comparative effectiveness research, clinical trials, ethical oversight, patient consent, research ethics
- MeSH terms
- Delivery of Health Care, Humans, Informed Consent, Patient Participation, Randomized Controlled Trials as Topic, Ethics, Research, Comparative Effectiveness Research
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