The Doctrine of Informed Consent: Beyond a Signature on a Form

A Review Article for Postgraduate Training in Internal Medicine

Moving from a ritualistic practice to a robust process that respects patient autonomy and meets legal standards

Dr Neeraj Manikath , claude.ai

Abstract

Informed consent represents the ethical and legal cornerstone of modern medical practice, yet it remains one of the most misunderstood and poorly executed aspects of patient care. This review examines the evolution of consent from a mere formality to a fundamental right, exploring the legal framework established by landmark Indian Supreme Court judgments, the spectrum of consent types encountered in clinical practice, and the nuanced scenarios that challenge even experienced clinicians. By understanding the doctrine comprehensively, internists can transform consent from a defensive ritual into a meaningful therapeutic partnership.

Keywords: Informed consent, patient autonomy, medical ethics, legal standards, real consent

Introduction

Picture a typical morning ward round: a hastily signed form thrust before a bewildered patient, perhaps in pain or anxious, with barely comprehensible medical jargon about a procedure they don't fully understand. A signature is obtained, filed away, and the clinical team moves on, satisfied that the legal requirement has been met. This scenario, unfortunately common in busy medical wards and intensive care units, represents a profound failure to honor the doctrine of informed consent.

Informed consent is not merely about obtaining a signature on a preprinted form. It is a process of communication, education, and shared decision-making that respects the patient's right to self-determination. The transformation from paternalistic medicine ("Doctor knows best") to patient-centered care has placed informed consent at the heart of the physician-patient relationship. For the internist managing complex, multisystem diseases with potentially hazardous interventions, understanding the full depth of this doctrine is essential not only for legal protection but for ethical practice.

This review aims to equip postgraduate trainees and practicing internists with a comprehensive understanding of informed consent, moving beyond checkbox compliance to genuine respect for patient autonomy.

Implied, Expressed, and Valid Consent: Understanding the Spectrum

Implied Consent

Implied consent occurs when a patient's actions, rather than explicit words, indicate agreement to a medical intervention. This form of consent is commonplace in routine clinical practice and relies on the principle that reasonable patients understand and accept certain standard procedures.

Clinical Examples from the Medical Ward:

Venipuncture for blood sampling: When a patient extends their arm after being told "I need to take a blood sample," they are providing implied consent. The action of rolling up a sleeve and offering the arm constitutes non-verbal agreement.
Physical examination: A patient who lies down on the examination couch and unbuttons their shirt for auscultation is implicitly consenting to the examination. The clinician's statement "I need to examine your chest" followed by patient cooperation implies consent.
Vital signs monitoring: In the ICU, when a patient allows the nursing staff to attach monitoring equipment without protest, implied consent is operating.

The Pearl: Implied consent is valid only for routine, non-invasive, and commonly understood procedures where the risks are minimal and the benefits are obvious. Never assume implied consent for any procedure that carries significant risk or requires disclosure of alternatives.

Expressed Consent

Expressed consent is explicit agreement, given either verbally or in writing. This is the standard for most medical interventions beyond simple examinations.

Verbal Expressed Consent:

In many clinical situations, verbal consent suffices and may be more meaningful than a hastily signed form. Examples include:

Medication administration in the ICU: "Mr. Sharma, your blood pressure is quite high. I'm going to give you a medication through your IV line to bring it down. It may make you feel a bit lightheaded initially. Is that alright?" The patient's verbal "Yes" constitutes expressed consent.
Nasogastric tube insertion: "We need to pass a tube through your nose into your stomach to drain the fluid and relieve your distension. It will be uncomfortable for a few moments. Are you willing to proceed?"

Written Expressed Consent:

Written consent provides documentation and is mandatory for procedures carrying significant risk. However, the form itself is merely evidence of the consent process, not the consent itself.

Clinical Example - Central Venous Catheter in ICU: A 58-year-old woman with septic shock requiring vasopressor support needs a central line. The intensivist explains: the purpose (medication delivery and monitoring), the procedure (insertion site, technique), risks (infection, bleeding, pneumothorax, arterial puncture), alternatives (peripheral access with limitations), and prognosis without the procedure (difficulty managing shock). The patient or family member signs the form only after understanding this information.

Valid Consent: The Gold Standard

For consent to be legally and ethically valid, four essential elements must be present:

Capacity: The patient must have the mental ability to understand the information and appreciate the consequences of their decision.
Information: Adequate disclosure must occur (discussed in detail below under "Real Consent Standard").
Voluntariness: The consent must be given freely, without coercion, undue influence, or manipulation.
Specificity: The consent must relate to the specific intervention proposed.

The Oyster (Hidden Problem): A signature on a form does not automatically mean valid consent. A confused, delirious patient who signs a consent form lacks capacity. A patient who signs under pressure from anxious relatives has not given voluntary consent. A general hospital admission consent does not cover high-risk procedures.

The Hack: Document the consent conversation in the clinical notes: "Discussed with patient the indication for lumbar puncture, explained the procedure, mentioned risks including headache, bleeding, infection, and rare serious complications. Patient verbalized understanding, asked questions about post-procedure headache which were addressed. Written consent obtained." This narrative documentation proves that genuine communication occurred, not just signature collection.

The "Real Consent" Standard: What Would a Reasonable Person Want to Know?

The landmark Indian Supreme Court judgment in Samira Kohli v. Dr. Prabha Manchanda (2008) fundamentally changed the landscape of medical consent in India. The Court rejected the older "professional standard" (what a responsible body of medical professionals would disclose) in favor of the "real consent" or "reasonable person" standard.

The Legal Framework

The Supreme Court held that informed consent requires disclosure of material risks that a reasonable person in the patient's position would consider significant in making their decision. The Court emphasized that consent involves understanding:

The nature of the procedure: What will actually be done?
The purpose and expected benefits: Why is this being recommended?
Material risks and complications: What could go wrong?
Alternative treatment options: Are there other ways to address this problem?
Consequences of refusing treatment: What happens if I say no?

What Constitutes a "Material Risk"?

A risk is material if:

It occurs frequently, even if the severity is low (e.g., post-lumbar puncture headache occurs in 10-30% of patients)
It is rare but severe (e.g., spinal hematoma from lumbar puncture is rare but catastrophic)
A reasonable person in the patient's circumstances would likely attach significance to it (e.g., the risk of impotence after certain surgeries would be highly material to a young man)

Clinical Application - Bone Marrow Biopsy:

Consider a 45-year-old teacher with pancytopenia requiring bone marrow aspiration and biopsy. The "real consent" conversation should include:

"Mr. Kumar, we need to take a sample from your bone marrow to understand why your blood counts are low. I'll insert a needle through your hip bone after numbing the area. You'll feel pressure and a sharp, brief pain when I aspirate the marrow. Common issues include pain at the site for a few days, bruising, and rarely, bleeding or infection. Very rarely, the needle could break or we might need to repeat it if the sample is inadequate. This test is essential because it's the only way to definitively diagnose conditions like leukemia, aplastic anemia, or infections. Without it, we'd be treating you blindly. Are there any questions?"

This disclosure addresses the reasonable person standard by covering nature, purpose, common and serious risks, and consequences of refusal.

The Pearl: Tailor your disclosure to the individual patient. A young athlete needs to know that a procedure might affect their sports participation. An elderly person living alone needs to understand post-procedure mobility restrictions. The "reasonable person" standard is contextualized to "this reasonable person."

The Hack: Use the "teach-back" method. After explaining, ask: "Just so I'm sure I've explained clearly, can you tell me in your own words what we're planning to do and why?" This ensures genuine understanding and provides evidence of valid consent.

Special Scenarios: The Unconscious Patient, Mentally Ill, and Minors

The Unconscious Patient

Medical emergencies present a unique challenge: the patient requiring immediate intervention cannot provide consent. The doctrine of necessity and implied consent by law permits treatment in these circumstances.

Legal Principle: When a patient is unconscious and unable to consent, treatment may proceed under the doctrine of necessity if it is immediately necessary to save life or prevent serious deterioration.

Clinical Example - ICU Scenario:

A 62-year-old man is brought to the emergency department unconscious following a road traffic accident, with a Glasgow Coma Scale score of 6. He requires endotracheal intubation, central venous access, and emergency CT imaging. There are no relatives immediately available.

Action: Proceed with life-saving interventions under the doctrine of necessity. Document clearly: "Patient brought unconscious, GCS 6, requiring immediate airway protection and resuscitation. No relatives available. Treatment initiated under doctrine of necessity. Will obtain consent from family for further procedures once they arrive."

The Pearl: The doctrine of necessity covers only immediately necessary, life-saving interventions. Once the patient is stabilized and relatives arrive, or if the patient regains capacity, proper informed consent must be obtained for further non-emergency procedures.

The Oyster: What if relatives arrive and refuse life-saving treatment? In India, if the patient is an adult, the physician's duty is to save life. Relatives cannot refuse essential emergency treatment on behalf of an unconscious adult patient. However, once the patient is stable and conscious, they can refuse further treatment. Document such conflicts meticulously and consider seeking legal counsel or hospital ethics committee guidance.

The Mentally Ill Patient

Mental illness does not automatically negate capacity. Capacity is decision-specific and must be assessed for each particular treatment decision.

Assessing Capacity (The Four-Part Test):

Understanding: Can the patient comprehend the information about the treatment?
Retention: Can they retain this information long enough to make a decision?
Weighing: Can they weigh the risks and benefits?
Communication: Can they communicate their decision?

Clinical Example - Medical Ward:

A 40-year-old woman with known schizophrenia, admitted with diabetic ketoacidosis, refuses insulin infusion, stating "I don't need insulin, the voices told me I'm cured."

Assessment: She demonstrates lack of capacity for this specific decision—she cannot rationally weigh information due to active psychotic symptoms affecting her judgment about this particular treatment.

Action: Treatment can proceed under the Mental Healthcare Act, 2017, which permits treatment without consent when the person lacks capacity and the treatment is in their best interest. A relative or legal guardian should be involved, and the decision should be documented thoroughly, ideally with a second opinion from a psychiatrist.

The Hack: In ambiguous cases, use the "sliding scale" approach: the more serious the consequences of the decision (e.g., refusing life-saving treatment vs. refusing physiotherapy), the higher the level of capacity required. Always seek psychiatric consultation when in doubt.

Minors

The general principle is that parents or legal guardians provide consent for minors (persons under 18 years). However, this area is nuanced.

Parental Consent:

Parents have the legal authority to consent for their children, but this is not absolute—it must be exercised in the child's best interest.

Clinical Example - Adolescent in Medical Ward:

A 16-year-old boy with newly diagnosed type 1 diabetes requires insulin therapy. His parents, influenced by unscientific beliefs, refuse insulin, preferring "natural healing."

Action: The physician's duty is to the child, not the parents. If parental refusal of treatment would result in serious harm or death to the child, the physician must seek intervention through hospital authorities, child protection services, or court orders to provide necessary treatment in the child's best interest.

Mature Minor Doctrine:

An adolescent who demonstrates sufficient maturity and understanding may have their wishes considered, even if they differ from parental wishes, particularly regarding their own healthcare.

The Pearl: Always involve minors in the consent discussion at an age-appropriate level. Even if their consent is not legally binding, their assent (agreement) is ethically important. A 14-year-old refusing a procedure requires exploration of their concerns and attempts at persuasion, not coercion.

The Oyster: Cultural sensitivity is crucial. In many Indian families, extended family members or community elders may influence decisions. While legally only parents/guardians can consent, practically, ignoring family dynamics may undermine trust and compliance. Balance legal requirements with cultural humility.

High-Risk Procedures and Specific Consents: Beyond the General Admission Form

The general hospital admission consent typically covers routine care: examinations, routine blood tests, standard medications, and basic nursing care. It does NOT cover high-risk or invasive procedures.

When is Specific Consent Mandatory?

Specific written consent is essential for procedures that:

Carry significant risk of morbidity or mortality
Involve invasion of body cavities beyond simple venipuncture
Require sedation or anesthesia
Have potential for serious complications
Have reasonable alternatives that should be discussed

Lumbar Puncture (LP)

Why Specific Consent is Needed:

LP involves inserting a needle into the spinal canal, with risks including headache (10-30%), infection, bleeding, nerve damage, herniation in cases of raised intracranial pressure, and rarely, permanent neurological complications.

The Comprehensive LP Consent Discussion:

"Mrs. Patel, you have a fever and stiff neck, and we're concerned about meningitis—an infection around the brain. To diagnose this, we need to analyze the fluid surrounding your spinal cord. I'll insert a needle between your lower back bones, after numbing the area. You'll need to lie curled on your side and stay very still. Most people experience a headache afterward, sometimes lasting days, which we can treat. Rare but serious risks include infection, bleeding, or if there's pressure in your brain, pushing of brain tissue, which is why we're doing a CT scan first. Without this test, we cannot definitively diagnose or treat your infection appropriately, and meningitis can be life-threatening if untreated. Do you have questions?"

The Hack: Address the most feared complication explicitly, even if rare. Patients often hear about "paralysis from spinal procedures" from neighbors. Stating clearly "paralysis from LP is extraordinarily rare when performed correctly, far less than 1 in 10,000 procedures" prevents post-procedure accusation of non-disclosure.

Central Venous Catheter (Central Line)

Why Specific Consent is Needed:

Central line insertion carries risks of pneumothorax, hemothorax, arterial puncture, air embolism, catheter-related bloodstream infection, and thrombosis.

Key Points to Discuss:

Indication: "Your peripheral veins cannot tolerate the strong medications needed for your blood pressure" or "We need reliable access for frequent blood sampling and medication in the ICU."
Procedure: Site selection (internal jugular, subclavian, femoral—each with different risk profiles), use of ultrasound guidance, sterile technique.
Risks:
- Common: Bruising, discomfort, minor bleeding
- Significant: Infection (greatest risk with femoral lines), blood clots
- Serious: Pneumothorax (air in chest cavity, especially with subclavian approach, may require chest tube), arterial injury, rhythm disturbances
Alternatives: Peripheral IV lines (limited duration and medication types), peripherally inserted central catheters (PICC lines, which have lower pneumothorax risk but higher thrombosis risk).

The Pearl: The site of insertion affects the risk profile. For a patient with severe lung disease, avoiding the subclavian approach (higher pneumothorax risk) and preferring internal jugular or femoral with clear documentation shows individualized risk consideration.

Bone Marrow Aspiration and Biopsy

Why Specific Consent is Needed:

This procedure is painful despite local anesthesia, carries risks of bleeding (especially in thrombocytopenic patients), infection, and rarely, injury to underlying structures.

Specific Considerations:

Pain: Be honest that despite local anesthesia, the aspiration causes sharp pain. Patients appreciate honesty more than false reassurance.
Bleeding risk: In patients with coagulopathy or severe thrombocytopenia, discuss the increased bleeding risk and measures taken (platelet transfusion, pressure dressing).
Adequacy: Mention that occasionally the sample is inadequate and the procedure must be repeated.
Alternatives: Discuss whether peripheral blood examination, imaging, or lymph node biopsy could provide diagnostic information, or explain why bone marrow specifically is needed.

The Hack for High-Risk Procedures: Create a two-stage consent process for critically ill patients. Stage 1: General discussion with family about the treatment plan and likely procedures. Stage 2: Detailed, procedure-specific consent immediately before the intervention when urgency permits. This avoids overwhelming families while ensuring informed decisions.

Practical Pearls and Clinical Hacks

Pearl 1: The "What Would I Want to Know?" Test

If you or your family member were the patient, what would you want explained? This simple question guides disclosure better than any checklist.

Pearl 2: Document Refusals Meticulously

When a patient refuses a recommended procedure, document:

What was offered and why
What risks of refusal were explained
That the patient demonstrated understanding
That the patient's decision was voluntary
Ideally, have the patient sign a "refusal of treatment" form

Example: "Recommended diagnostic lumbar puncture for suspected meningitis. Explained that without this test, diagnosis is presumptive and treatment may be inadequate, with risk of mortality or permanent neurological damage. Patient verbalized understanding but declined, stating fear of procedure. Offered sedation and further discussion; patient continues to decline. Refusal documented and accepted. Will continue empiric antibiotics and observe closely."

Pearl 3: Use Visual Aids

For complex procedures, simple diagrams or models dramatically improve understanding. A sketch showing where the central line goes helps more than lengthy verbal explanations.

Pearl 4: The "Cooling-Off" Period

For non-urgent procedures, give patients time to consider. "You don't need to decide right now. Think about it, discuss with your family, and we can talk again tomorrow" respects autonomy and often leads to better decisions.

Pearl 5: Address Language and Literacy Barriers

Use trained interpreters, not family members, for consent discussions. Family interpreters may filter information based on their own wishes. For illiterate patients, have a literate witness co-sign the consent form after confirming the patient understood through verbal discussion in their language.

Oyster 1: The "Double Effect" of Consent Forms

Consent forms protect institutions more than physicians. The detailed conversation is what protects you legally and ethically. Never hide behind a form instead of having a real discussion.

Oyster 2: Consent is Not Static

Patients can withdraw consent at any time before or even during a procedure (if safe to stop). Conversely, consent for a procedure should be reaffirmed if circumstances change significantly. A consent obtained three days ago for an elective procedure may need refreshing if the patient's condition has evolved.

Oyster 3: The Relative Who Demands Non-Disclosure

Sometimes families request "Don't tell father he has cancer; he can't handle it." This violates the patient's right to autonomy. Respectfully explain: "I understand your concern, but Mr. Singh has the right to know his diagnosis and make decisions about his care. I can discuss the best way to share this information sensitively, but I cannot withhold it from him."

Hack 1: The Pre-Procedure Checklist

Before any high-risk procedure, use a modified "timeout" that includes:

✓ Correct patient, correct procedure, correct site
✓ Informed consent obtained and documented
✓ Patient or family had opportunity to ask questions
✓ Potential complications discussed
✓ Post-procedure care plan explained

Hack 2: Consent in the Teach-Back Format

"Mrs. D'Souza, I've explained a lot of information. To make sure I've been clear, could you tell me what you understand about why we're recommending this procedure and what the main risks are?" This reveals gaps in understanding before the signature.

Hack 3: Shared Decision-Making Tools

For decisions where reasonable alternatives exist (e.g., anticoagulation strategies, choice between procedures), use decision aids or "option grids" that visually compare the pros and cons. This moves beyond "doctor's orders" to genuine partnership.

Conclusion: Toward a Culture of Genuine Consent

The transformation of informed consent from a bureaucratic checkbox to a meaningful ethical practice requires cultural change in medicine. As internists managing acutely ill, vulnerable patients in high-stakes environments, we wield significant power. The doctrine of informed consent is a bulwark against abuse of that power and a manifestation of respect for human dignity.

Real consent recognizes that the patient's body is their own, that medical expertise does not confer the right to decide for others, and that medicine is a service offered, not imposed. When we rush through consent to get to the "real work" of procedures, we miss the essence: the conversation IS the work. It is therapeutic alliance-building, anxiety reduction, trust formation, and empowerment of patients in their darkest hours.

Legal compliance—yes, detailed documentation protects against litigation. But beyond self-protection lies the higher goal: honoring the person behind the patient. The signature matters far less than the understanding it represents. The form is ephemeral; the conversation's impact endures.

Challenge yourself to transform one consent discussion per week into an exemplary dialogue. Explain one procedure so clearly that the patient teaches their family about it. Let one patient's unexpected question reshape how you consent for that procedure forever. This is how ritualistic compliance evolves into respectful partnership.

The doctrine of informed consent is not a burden imposed by lawyers and ethicists. It is an opportunity—to educate, to connect, to honor, and to heal more effectively because our patients understand and participate in their care. Master this doctrine not because you must, but because your patients deserve nothing less.

References and Suggested Reading

Samira Kohli v. Dr. Prabha Manchanda, AIR 2008 SC 1385 (Supreme Court of India landmark judgment on real consent standard)
Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582 (Traditional professional standard)
Montgomery v. Lanarkshire Health Board [2015] UKSC 11 (UK Supreme Court adopting patient-centered consent)
Common Cause v. Union of India, AIR 2018 SC 1665 (Right to die with dignity and informed consent)
The Mental Healthcare Act, 2017 (India) - Sections on consent and capacity
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 8th ed. Oxford University Press, 2019
Faden RR, Beauchamp TL. A History and Theory of Informed Consent. Oxford University Press, 1986
Manson NC, O'Neill O. Rethinking Informed Consent in Bioethics. Cambridge University Press, 2007
World Medical Association. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 2013
National Medical Commission Guidelines on Informed Consent (available at: https://www.nmc.org.in)
Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology, 2001; 24(6):595-607
Grady C. Enduring and emerging challenges of informed consent. N Engl J Med, 2015; 372:855-862
Shah P, Thornton I, Turrin D, Hipskind JE. Informed Consent. StatPearls Publishing, 2023
Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Arch Intern Med, 1996; 156(22):2521-2526

Disclosure: The author has no conflicts of interest to declare.

Author Contribution: This review represents a synthesis of legal, ethical, and clinical literature aimed at improving informed consent practices in internal medicine.

Correspondence:
For questions regarding clinical application of these principles or to share challenging consent scenarios for educational discussion, readers are encouraged to engage with their institutional ethics committees and medical education departments.