The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
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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In the citing paper
“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]
Citations
Cites
Faden, R. R., Kass, N. E., Goodman, S. N., Pronovost, P., Tunis, S., & Beauchamp, T. L. (2013) · Hastings Center Report · doi:10.1002/hast.134 · Cited by 498
Self-citationKass, N. E., Faden, R. R., Goodman, S. N., Pronovost, P., Tunis, S., & Beauchamp, T. L. (2013) · Hastings Center Report · doi:10.1002/hast.133 · Cited by 235
Self-citationIs Informed Consent Always Necessary for Randomized, Controlled Trials?
Truog, R. D., Robinson, W. M., Randolph, A. G., & Morris, A. H. (1999) · New England Journal of Medicine · doi:10.1056/nejm199903113401013 · Cited by 192
Faden, R., KASS, N. E., Whicher, D. M., Stewart, W., & Tunis, S. (2013) · Medical Care · doi:10.1097/mlr.0b013e31829b1e4b · Cited by 75
Self-citationRandomized, controlled trials as minimal risk: An ethical analysis*
Morris, M. C., & Nelson, R. M. (2007) · Critical Care Medicine · doi:10.1097/01.ccm.0000257333.95528.b8 · Cited by 28
Cited by
Sorted by citations
Items 201–214 of 214
Special Considerations for Clinical Research
Nicolini, M., Grady, C., & Inui, T. S. (2025) · doi:10.1093/med/9780197640814.003.0027
Roke, R., Lillie, E., Daneman, N., Mason, S. A., TOMLINSON, G. A., Jiang, Y., Shiroky, J. S., Puran, S., Smith, D. E., Khalil, J. A., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-104375
Morain, S. R., Brickler, A., Semler, M. W., & Casey, J. D. (2025) · Clinical Trials · doi:10.1177/17407745251377730
Niyibizi, N. K., Speight, C. D., Najarro, G. R., Mitchell, A. R., Sadan, O., Ko, Y.-A., & Dickert, N. W. (2022) · Figshare · doi:10.6084/m9.figshare.19445819
Niyibizi, N. K., Speight, C. D., Najarro, G. R., Mitchell, A. R., Sadan, O., Ko, Y.-A., & Dickert, N. W. (2022) · Figshare · doi:10.6084/m9.figshare.19445816
Niyibizi, N. K., Speight, C. D., Najarro, G. R., Mitchell, A. R., Sadan, O., Ko, Y.-A., & Dickert, N. W. (2022) · Figshare · doi:10.6084/m9.figshare.19445822
Niyibizi, N. K., Speight, C. D., Najarro, G. R., Mitchell, A. R., Sadan, O., Ko, Y.-A., & Dickert, N. W. (2022) · Figshare · doi:10.6084/m9.figshare.19445813
Niyibizi, N. K., Speight, C. D., Najarro, G. R., Mitchell, A. R., Sadan, O., Ko, Y.-A., & Dickert, N. W. (2022) · Figshare · doi:10.6084/m9.figshare.19445810
Beyond Consent Waivers: A Governance-First Model for Learning Health Systems
Yang, Y. T. (2026) · The American Journal of Bioethics · doi:10.1080/15265161.2026.2623848
Asking Patients on Principle: Public Deliberation About Waiver or Modification of Consent
Schwartz, P. H. (2026) · The American Journal of Bioethics · doi:10.1080/15265161.2026.2623863
Consent and consents in contemporary healthcare
Toomey, J. (2026) · Journal of Medical Ethics · doi:10.1136/jme-2026-111892
Ethical Considerations in Photocarcinoma
Singh, K., Singh, A., Miatmoko, A., & Kumar, R. N. (2026) · Springer eBooks · doi:10.1007/978-981-95-7358-5_18
Guidelines for adapting and obtaining informed consent
Bouche, J. E. V. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-34264-6.00006-x
Relational consent: Redesigning the solution space for consent and disclosure
Kempeneers, A. R., & Simonse, L. W. L. (2026) · The Information Society · doi:10.1080/01972243.2026.2713455
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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