In modern medicine, consent is more than a signature on a form. The doctrine of informed consent protects a patient’s right to make decisions about her or his own body after receiving adequate information about diagnosis, prognosis, options, and material risks. This blog explains the doctrine in plain language, contrasts the Indian and international approaches, and discusses the leading case law that shaped the rules doctors and hospitals must follow.
What is informed consent?
Informed consent is a legal and ethical requirement that a patient agree to a medical intervention after being given information sufficient to understand:
- the nature and purpose of the proposed intervention;
- the material risks and likely benefits;
- reasonable alternatives (including the option of no treatment);
- the likely consequences of refusing treatment.
Four core elements are usually emphasized: capacity, voluntariness, adequate disclosure, and understanding. Each element builds a foundation for autonomy and protects patients from unnecessary or unwanted medical intervention.
International Landmark: Canterbury v. Spence (1972)
In the United States, Canterbury v. Spence (1972) is a watershed judgment that transformed medical disclosure standards.
Cause of Action in Canterbury v. Spence
The case arose when 18-year-old Jerry Canterbury underwent a laminectomy (spinal surgery) performed by Dr. Spence. Crucially, the doctor did not disclose the material risk of paralysis, a known risk associated with the procedure. After the surgery, Canterbury fell from his hospital bed, suffered paralysis, and underwent additional operations. The paralysis was linked to the fall post‑surgery, not the surgical act itself. This distinction highlights that the legal issue was nondisclosure of risk, not negligent performance of the operation.
He sued the doctor alleging medical negligence based on failure to obtain informed consent. His cause of action was that:
- had the risk been disclosed, he might have refused or postponed surgery, and
- the doctor’s nondisclosure denied him his right to make an informed choice.
Thus, the case centered on inadequate disclosure and breach of the duty to inform, rather than negligent performance of the surgery itself.
Legal Impact of Canterbury
The court rejected the older physician-centric model and held that the standard is what a reasonable patient would want to know. This “materiality test” emphasized that risks must be disclosed if they would influence the patient’s decision — even if doctors traditionally did not disclose them. The judgment explicitly rejected reliance on professional custom alone, marking a departure from the Bolam‑style physician‑centric approach.
The Indian Context and the Samira Kohli Doctrine
India’s approach evolved from a paternalistic, doctor-centric tradition influenced by Bolam toward a more patient-centered model rooted in autonomy and dignity.
The defining Indian precedent is Samira Kohli v. Dr. Prabha Manchanda (2008).
Cause of Action in Samira Kohli
Ms. Samira Kohli consulted a gynecologist for menstrual irregularities. She consented only to a diagnostic laparoscopy. However, while she was under general anesthesia, the surgeon performed a total hysterectomy and bilateral salpingo-oophorectomy — complete removal of the uterus and ovaries — without her specific consent and without any emergency that required immediate action. The defense of implied consent for ‘beneficial’ procedures was expressly rejected, reinforcing that autonomy cannot be overridden by medical judgment absent emergency.
Samira sued for:
- violation of her bodily autonomy,
- unauthorized surgery,
- lack of informed, specific consent,
- mental, physical, and reproductive harm.
Thus, the cause of action centered on performing a major surgical procedure beyond the scope of consent, amounting to medical negligence and infringement of patient autonomy.
Legal Impact of Samira Kohli
The Supreme Court held that:
- consent must be real, valid, and specific, not blanket or implied for other procedures;
- doctors must disclose the nature, risks, benefits, and alternatives in language the patient understands;
- additional surgery without consent is permissible only if a life-saving emergency exists, which was absent here.
The Court underscored that blanket or broad consent cannot justify unrelated major interventions, thereby strengthening patient rights against unauthorized procedures. The Court formulated a practical, India-specific standard emphasizing a balance between professional judgment and patient rights — clearly departing from blind reliance on Bolam.
How is the standard of disclosure determined?
Globally, two broad approaches exist:
1. Professional Standard (Bolam Test)
This asks what a reasonable and responsible body of medical professionals would disclose. Historically dominant, it often favored medical discretion.
Important note: Bolam was originally a general negligence standard concerning medical practice, not disclosure specifically. Its influence on consent cases was indirect until Canterbury and Montgomery shifted the focus to patient autonomy.
2. Patient-Centered or Materiality Standard (Canterbury/Montgomery)
Disclosure is judged by what a reasonable patient would want to know. This approach prioritizes autonomy and informed decision-making.
India’s Position
Post-Samira Kohli, Indian law increasingly adopts a patient-oriented perspective, especially in disclosure-based negligence claims. While the Bolam test may still apply in technical matters of diagnosis and treatment, informed consent now requires active disclosure of all material risks.
Practical Medicolegal Implications for Doctors and Hospitals
- Documentation: A signed consent form is not enough — doctors must document the conversation and ensure understanding.
- Specific consent: Consent for one procedure does not authorize another unrelated or major surgery.
- Language and comprehension: Disclosure must be in simple language the patient understands.
- Risk communication: Material risks and alternatives must be explained.
- Emergencies: Only genuine, immediate threats to life justify proceeding without consent.
- Refusal of treatment: If a patient refuses, it must be properly recorded.
Common medico-legal mistakes
- Treating consent as a mere formality.
- Overly technical explanations without confirming understanding.
- Performing additional procedures without consent.
- Failing to record discussions or alternatives.
Balancing autonomy with clinical judgment
Informed consent is not an obstacle to medical practice but a safeguard that improves outcomes and trust. It respects human dignity and protects both patients and doctors. Shared decision-making aligns treatment with patient values and protects doctors from litigation based on nondisclosure.
Conclusion
The doctrine of informed consent stands at the intersection of ethics, constitutional rights, and medical practice. Canterbury v. Spence brought a global shift toward the “reasonable patient” standard, while India’s Samira Kohli judgment solidified the requirement of specific, informed, voluntary consent. Together, they highlight that meaningful disclosure and patient autonomy are essential pillars of modern medical law. The comparative trajectory shows a global convergence: from Bolam’s professional deference to Canterbury’s materiality and Montgomery’s autonomy, with Samira Kohli adapting these principles to India’s constitutional and cultural context.
References
- Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).
- Samira Kohli v. Dr. Prabha Manchanda, Supreme Court of India (2008).
- Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582.
- Montgomery v. Lanarkshire Health Board [2015] UKSC 11.
- Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations.
#InformedConsent #MedicalLaw #SamiraKohli #CanterburyVSpence #MedicalNegligence #PatientRights #HealthLaw #Bolam #Montgomery #MedicoLegal #DrGaneshVisavale #Jurisprudence
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Dr. Ganesh Visavale 