The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
The New Era of Informed Consent: Getting to a Reasonable-Patient Standard Through Shared Decision Making
Open accessAbstract
The rights of patients tobeinformedaboutcaredecisions in clinical practice is yet again under scrutiny, both in the United States and around the world.The well-ingrained ethical-legal process of informed consent, so fundamental to patient autonomy-or the patient's right to selfdetermination-was the subject of a 2015 UK Supreme Court case (Montgomery v Lanarkshire Health Board). 1 In that case, a woman with insulin-dependent diabetes, claimedthatherobstetricianfailedtocommunicatetherisk of shoulder dystocia during vaginal delivery (a complication associated with fetal macrosomia) that ultimately resultedinseverefetalbrainanoxia.Sheclaimedthathadshe received full information about the risks, she would have opted for a cesarean delivery.Yet the treating obstetrician (andotherexpertphysicianscalledtotrial)claimedthatthe ensuing risk was very small and thus appropriately not communicated because a cesarean delivery is not in the maternal interest.The obstetrician reported that "…had I raised it [the risks of shoulder dystocia] with her then yes, she would have no doubt requested a caesarean section, as would any diabetic today." 1 In its final decision, the UK Supreme Court ruled that the standard for what physicians should inform patients about the risks, benefits, and alternatives of treatment will no longer be determined by what a responsible body of physicians deems important but rather by what a reasonable patient deems important.In rendering this decision, the court swept away decades of medical paternalism in the United Kingdom to embrace a new patient-centered standard.Perhaps more compelling, the head of the Royal College of Surgeons urged that the only way to operationalize such a substantial and needed change is through shared decision making, a collaborative communication processbetweencliniciansandpatientsthatintegratesthe best evidence available with the patients' values and preferences, to promote high-quality health care decisions.The UK law is not unprecedented.In the United States, approximately half of the states have adopted the reasonable-patient standard.The reasonable-patient standard views the informed consent communication process from the patient's perspective.It requires physicians and other health care practitioners to disclose all relevant information about the risks, benefits, and alternatives of a proposed treatment that an objective patient would find material in making an intelligent decision as to whether to agree to the proposed procedure.2 Even in those states that apply the reasonable-patient standard, however, the informed consent process is often ill-configured to meet patients' informational needs.
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“Informed consent represents an important development in medical ethics and patient rights, representing a departure from the historically paternalistic nature of medical practice [42].”
From Proposing a Principle-Based Approach for Teaching AI Ethics in Medical Education (2024) · cites this paper as [42]
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Cites
Decision aids for people facing health treatment or screening decisions
Stacey, D., Légaré, F., Lewis, K., Barry, M. J., Bennett, C. L., Eden, K. B., Holmes-Rovner, M., Llewellyn-Thomas, H., Lyddiatt, A., Thomson, R., et al. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001431.pub5 · Cited by 6,685
Decision aids for people facing health treatment or screening decisions
Stacey, D., Légaré, F., Col, N. F., Bennett, C. L., Barry, M. J., Eden, K., Holmes-Rovner, M. M., Llewellyn‐Thomas, H. A., Lyddiatt, A., Thomson, R., et al. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001431.pub4 · Cited by 1,540
Elwyn, G. J., Scholl, I., Tietbohl, C. K., Mann, M. K., Edwards, A., Clay, C. F., Légaré, F., van der Weijden, T., Lewis, C. L., Wexler, R., et al. (2013) · BMC Medical Informatics and Decision Making · doi:10.1186/1472-6947-13-s2-s14 · Cited by 515
Informed Consent to Promote Patient-Centered Care
Krumholz, H. M. (2010) · JAMA · doi:10.1001/jama.2010.309 · Cited by 124
Self-citationThe readability of currently used surgical/procedure consent forms in the United States
Hopper, K. D., TenHave, T. R., Tully, D. A., & Hall, T. E. L. (1998) · Surgery · doi:10.1067/msy.1998.87236 · Cited by 82
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Research works printed but not linked: 1
- [4]Washington State Legislature. Consent form — Contents — Prima facie evidence — Shared decision making — Patient decision aid — Failure to use. Title 7 Chapter 770 Section 770060.
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Items 201–234 of 234
Fan, R., & Zhang, X. (2019) · JOURNAL OF ENGINEERING STUDIES · doi:10.3724/sp.j.1224.2019.00542
Ethics of Informed Consent: Coercive and Preventive Medication
Helmchen, H. (2022) · Springer eBooks · doi:10.1007/978-3-030-62059-2_404
Development and validation of informed consent for blood transfusion questionnaire
Senin, M. H., Sopian, M. M., Shaharuddin, B., & Nasir, M. J. M. (2022) · Asian Journal of Transfusion Science · doi:10.4103/ajts.ajts_176_21
Medicolegal Issues in Skull Base Reconstruction
Choi, J. S., & Doherty, J. K. (2023) · Springer eBooks · doi:10.1007/978-3-031-27937-9_33
Lapham, Z. K., Gardner, M., Sheinker, S., Suorsa, K. I., Kogan, B. A., Lee, P. A., & Sandberg, D. E. (2023) · Frontiers in Urology · doi:10.3389/fruro.2023.1188822
“In contrast, current literature suggests that written informed consent documents tend to be generic and emphasize preventing litigation, rather than providing procedure-speci fi c information (33).”
Schears, R. M., & Bellolio, F. (2023) · Springer eBooks · doi:10.1007/978-3-031-26510-5_12
Engaging Women in Decisions About Their Heart Health
Lewis, K. B., Ahmed, F., Lauck, S., Carroll, S. L., & Stacey, D. (2023) · Advances in biochemistry in health and disease · doi:10.1007/978-3-031-39928-2_22
Priešoperacinis pacientų informuotumas apie anesteziją
Bujauskienė, L., & Gedrimė, L. (2024) · Slauga Mokslas ir praktika · doi:10.47458/slauga.2024.5.2
Narita, A., Shimada, I., Suzuki, N., & Toyama, A. (2023) · Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) · doi:10.5649/jjphcs.49.39
Švab, I., Klemenc–Ketiš, Z., & Homar, V. (2024) · doi:10.18690/um.mf.1.2024
Rolfes, V., Hinz, U., Fangerau, H., Voßberg, D., & Haupt, M. (2024) · Fortschritte der Neurologie · Psychiatrie · doi:10.1055/a-2236-9338
Arima, Y., Watanabe, T., Shitou, Y., Sumitomo, K., & Okada, K. (2024) · An Official Journal of the Japan Primary Care Association · doi:10.14442/generalist.47.34
Determining patient-provider suitability and informed consent
Martin, W. F. (2024) · Elsevier eBooks · doi:10.1016/b978-0-323-87041-2.00017-8
(2024) · V&R unipress eBooks · doi:10.14220/9783737017497.153
Rolfes, V., Hinz, U., Fangerau, H., Voßberg, D., & Haupt, M. (2025) · Nervenheilkunde · doi:10.1055/a-2453-1280
Societal Framework of Psychiatry
Helmchen, H., & Sartorius, N. (2025) · The International Library of Bioethics · doi:10.1007/978-94-024-2274-0_7
Mancini, B., Siar, J., Valentine, K. D., Simmons, L. H., Leavitt, L., & Sepucha, K. (2025) · Medical Decision Making · doi:10.1177/0272989x251340704
Ayten, A. (2025) · World Journal of Urology · doi:10.1007/s00345-025-05737-8
Bioethics of Kidney Transplantation in the Older Adult Population
Long, J. J., Diwan, T. S., Donnelly, C. B., Liyanage, L. N., Long, M. J., & Kimberly, L. L. (2025) · Current Transplantation Reports · doi:10.1007/s40472-025-00497-1
Taghriri, M., Modaber, M., Parsapoor, A., Nasiri, S., Ahmadi, A., & Gooshki, E. S. (2025) · Asian Bioethics Review · doi:10.1007/s41649-025-00372-2
“This comprehensive approach allows patients to thoughtfully consider the reasons, methods, risks, benefits, and choices involved in making informed decisions (Spatz et al. 2016).”
Momiyama, S., Katayanagi, H., Nakabayashi, M., Fujino, T., Sakoda, N., Sato, Y., Noguchi, T., Susaka, H., Hishinuma, H., Tozawa, T., et al. (2026) · International Emergency Nursing · doi:10.1016/j.ienj.2026.101749
Kauro, a graph-based chatbot for high-fidelity information transmission conversationsPreprint
King, C. H. S., Barrick, R., Almalvez, M., Blanco, K., Dios, I. D., Fusaro, V. A., Délot, E. C., Donohue, C., Berger, S. I., Xiao, C., et al. (2026) · medRxiv · doi:10.64898/2026.01.30.25342358
“The first, and perhaps most important conversation is the informed consent conversation, where a person agrees to become a participant in a study, or to receive care 4 .”
Understanding the Role: Promoting Agency and Informed Decision-Making in Family Caregiving
Mercado, N. R., & Applebaum, A. J. (2026) · Journal of Aging & Social Policy · doi:10.1080/08959420.2026.2630880
Personalized Video Education in Surgical Consent: Lessons from a Diverse Safety-Net Population
Monasterio, D., Hanson, N. C., Diaz, G., Yao, J., Romero, J., & Steen, S. T. (2026) · The Joint Commission Journal on Quality and Patient Safety · doi:10.1016/j.jcjq.2026.02.002
Iida, M., Nabeshima, S., Kaneko, S., Kamijo, Y., Kobayashi, T., & Ando, Y. (2026) · Nursing Reports · doi:10.3390/nursrep16040142
“…participation in SDM. SDM is a process in which healthcare professionals share their specialized knowledge with patients and their families while patients contribute their values, preferences, and life circumstances, enabling the collaborative determination of an optimal treatment plan [24,25].”
Bayraktar, Z. (2026) · Journal of Sex & Marital Therapy · doi:10.1080/0092623x.2026.2678257
Risk-calibrated sharing of human brain data
Hendriks, S., Beckel-Mitchener, A. C., Eberwine, J. H., Farahany, N. A., Hsu, N. S., Ngai, J., & Grady, C. (2026) · Brain · doi:10.1093/brain/awag205
Birney, K. (2026) · Journal of Perioperative Care · doi:10.12968/jpoc.2026.0008
Ethics and AI in Healthcare: Balancing Innovation with Patient Rights and Organizational Culture
Vashistha, R., Bhushan, P., & Jewandah, S. (2026) · BENTHAM SCIENCE PUBLISHERS eBooks · doi:10.2174/9798898816452126010012
Tănase, A. D., Dinu, Ş., Cosoroabă, R.-M., Pădure, A., & Talpoș-Niculescu, C. I. (2026) · Healthcare · doi:10.3390/healthcare14172680
“…in positive law has continued into the early twenty-first century, with several European and common-law jurisdictions moving from physician-centered disclosure standards toward patient-centered standards and increasingly treating consent as a documented dialogue rather than a signature [1,5,6].”
Özgüncü, C. (2026) · Healthcare · doi:10.3390/healthcare14182956
“A key theoretical contribution of this study is advancing document assessment into a practical HTA framework by synthesizing LLM comprehension with established medical law—specifically the Montgomery v Lanarkshire ruling on the “disclosure of material risks” [50,51].”
Teaching Informed Consent in Surgical Training: A Scoping Review
Sobol, C. G., Moore, G., Kopecky, K. E., Christensen, L., Blackie, M., & Maggio, L. A. (2026) · Journal of surgical education · doi:10.1016/j.jsurg.2026.104207
Metadata
- Authors
- Spatz, E. S., Krumholz, H. M., & Moulton, B. W.
- Affiliations
- Yale New Haven Hospital (US)
- Healthwise (US)
- Corresponding author
- Spatz, Erica S.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2016-05-17
- Volume
- 315
- Issue
- 19
- Pages
- 2063
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC5459384
- OpenAlex
- W2338227561
- Cited by
- 236
- References
- 5
- Citations by year
- 2026: 18 · 2025: 16 · 2024: 25 · 2023: 19 · 2022: 35 · 2021: 17 · 2020: 23 · 2019: 27 · 2018: 20 · 2017: 23 · 2016: 13
- FWCI
- 27.28
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Yale University (K12HS023000)
- Patient-Centered Outcomes Research Institute (K12HS023000)
- Agency for Healthcare Research and Quality (K12HS023000)
- National Heart, Lung, and Blood Institute (U01HL105270)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
- Social Sciences › Law › Medical and Health Sciences Research
- Keywords
- informed consent, shared decision-making, patient autonomy, medical paternalism, Montgomery v Lanarkshire Health Board, patient-centered care, patient-provider communication, medical law
- MeSH terms
- Decision Making, Humans, Informed Consent, Patient Education as Topic, Patient Participation, United Nations, United States, Patient-Centered Care, Disclosure, Consent Forms
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