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.
“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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“[49] also emphasize that trustful communication with a clinician is necessary, but not sufficient to fully convey information for informed decision making, which requires supplementary written information and decision aids for laypersons.”
BackgroundDiscerning quality: an analysis of informed consent documents for common cardiovascular procedures
Shahu, A., Schwartz, J., Perez, M. N., Bernheim, S. M., Krumholz, H. M., & Spatz, E. S. (2016) · BMJ Quality & Safety · doi:10.1136/bmjqs-2016-005663 · Cited by 15 · see citing works
Self-citationIs Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion
Sirignano, P., Ceruti, S., Aloisi, F., Sirignano, A., Picozzi, M., & Taurino, M. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11154460 · Cited by 15 · see citing works
“Consequently, to enable patients to make decisions that are fully consistent with their individual preferences, physicians should strive to properly inform about the different treatment options, and the risks and benefits associated with each alternative [77], not forgetting the patients’ perspective [74].”
BackgroundConcurrent and Overlapping Surgery
Bryant, J., Markes, A. R., Woolridge, T., Cerruti, D., Dzeng, E. W., Koenig, B. A., & Diab, M. (2018) · Spine · doi:10.1097/brs.0000000000002745 · Cited by 15 · see citing works
Zwangsmaßnahmen in der Psychiatrie: praktische Konsequenzen ethischer Aspekte
Helmchen, H. (2020) · Der Nervenarzt · doi:10.1007/s00115-020-00998-7 · Cited by 9 · see citing works
Twelve tips for teaching the informed consent conversation
Anandaiah, A. M., & Rock, L. K. (2018) · Medical Teacher · doi:10.1080/0142159x.2018.1426844 · Cited by 14 · see citing works
“…legal rights and autonomy, they are now additionally recognized as an opportunity for patients to learn about their disease, reflect on personal goals and values, and engage in meaningful shared decision making with their health care providers (Barry and Edgman-Levitan 2012; Spatz et al. 2016).”
BackgroundInfluentialPatients’ knowledge about the outcomes of thyroid biopsy: a patient survey
Ospina, N. S., Castañeda-Guarderas, A., Ward, R., Brito, J. P., Maraka, S., Zeballos-Palacios, C. L., Yost, K. J., Dean, D. S., & Montori, V. M. (2018) · Endocrine · doi:10.1007/s12020-018-1639-8 · Cited by 14 · see citing works
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Sepucha, K., Langford, A. T., Belkora, J. K., Chang, Y., Moy, B., Partridge, A. H., & Lee, C. N. (2019) · Medical Decision Making · doi:10.1177/0272989x19862545 · Cited by 14 · see citing works
Evidence‐Based Medicine in Otolaryngology Part XII: Assessing Patient Preferences
Naunheim, M. R., Randolph, G. W., & Shin, J. J. (2020) · Otolaryngology · doi:10.1177/0194599820950723 · Cited by 14 · see citing works
“While informed consent is fundamental to current provision of care in the United States, these standards may change in exchange for increased burden on the provider to engage in a dialog about what is significant to patients.(39) The landmark case of Montgomery v.”
BackgroundRiedl, M. A., Neville, D., Cloud, B., Desai, B., & Bernstein, J. A. (2022) · Allergy and Asthma Proceedings · doi:10.2500/aap.2022.43.220050 · Cited by 13 · see citing works
Ethics as ritual: smoothing over moments of dislocation in biomedicine
Åm, H. (2018) · Sociology of Health and Illness · doi:10.1111/1467-9566.12818 · Cited by 8 · see citing works
“The scientists did not foster or facilitate participatory medicine (Prainsack 2014) or shared decision-making (Spatz et al. 2016).”
BackgroundInfluentialAttitudes, Beliefs, and Practices of Aesthetic Plastic Surgeons Regarding Informed Consent
Hagopian, C. O. P., Ades, T. B., Hagopian, T. M., Wolfswinkel, E. M., & Stevens, W. G. (2019) · Aesthetic Surgery Journal · doi:10.1093/asj/sjz206 · Cited by 12 · see citing works
Direitos humanos da paciente criança
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Perioperative Management of the Facelift Patient
Santosa, K. B., Oliver, J. D., Thompson, G., & Beil, R. J. (2019) · Clinics in Plastic Surgery · doi:10.1016/j.cps.2019.06.008 · Cited by 12 · see citing works
Sakurada, T., Koitabashi, K., Murasawa, M., Kohatsu, K., Kojima, S., & Shibagaki, Y. (2022) · Therapeutic Apheresis and Dialysis · doi:10.1111/1744-9987.13941 · Cited by 12 · see citing works
“This process has become known as shared decisionmaking (SDM), and SDM is defined as the cooperation of the patient and the medical team to choose the best treatment for the patient based on sharing information with each other [8, 9].”
BackgroundGlobal considerations for informed consent with shared decision-making in the digital age
John, E. S., Moore, C., Pillarisetti, R. R., & Spatz, E. S. (2024) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2023-112740 · Cited by 11 · see citing works
Self-citationA Scoping Review of Informed Consent Practices in Human–Computer Interaction Research
Schwind, V., Tadesse, N. Z., da Cunha, E. S., Hamidi, Y., Sultani, S. S., & Sehrt, J. (2025) · ACM Transactions on Computer-Human Interaction · doi:10.1145/3721284 · Cited by 12 · see citing works
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Die Entwicklung des Konzepts der Einwilligung nach Aufklärung in der psychiatrischen Forschung
Helmchen, H. (2019) · Ethik in der Medizin · doi:10.1007/s00481-019-00532-7 · Cited by 6 · see citing works
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“answering peri-procedural questions may protect both patient and provider [34,36].”
BackgroundHsu, H. W., Lu, T., Hansraj, N. Z., Russeau, A. P., Kougias, P., & Barshes, N. R. (2021) · Annals of Vascular Surgery · doi:10.1016/j.avsg.2021.08.039 · Cited by 11 · see citing works
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“Communication between trusted clinicians/nurses and patients is irreplaceable in a discussion process without prejudice, transparency and comprehensiveness (48).”
BackgroundInformed consent in assisted reproduction: an Ethics Committee opinion
(2023) · Fertility and Sterility · doi:10.1016/j.fertnstert.2023.03.009 · Cited by 10 · see citing works
“Jurisdictions vary on what the relevant standard is, with some pegging the standard to what reasonable providers do and others pegging it to what reasonable patients would want to know (1).”
BackgroundDigital Versus Paper-Based Consent from the UK NHS Perspective: A Micro-costing Analysis
Houten, R., Hussain, M. I., Martin, A. P., Ainsworth, N., Lameirinhas, C., Coombs, A. W., Toh, S. K. C., Rao, C., & John, E. S. (2024) · PharmacoEconomics - Open · doi:10.1007/s41669-024-00536-0 · Cited by 10 · see citing works
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Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making
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Communicating cancer treatment with pictogram-based timeline visualizations
Jambor, H. K., Ketges, J., Otto, A. L., von Bonin, M., Trautmann‐Grill, K., Teipel, R., Middeke, J. M., Uhlig, M., Eichler, M., Pannasch, S., et al. (2024) · Journal of the American Medical Informatics Association · doi:10.1093/jamia/ocae319 · Cited by 9 · see citing works
- 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
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › 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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