GeriQBank · Paper IV · Q3
Informed consent
- Chapter
- Bioethics & Medico-Legal Geriatric Medicine
- Years asked
- Not recorded in the source
- Frequency
- Set 1× in Paper IV (2009–2025)
As set in the university paper
Informed consent.
Paper IV · Ethics, Law, Palliative & End-of-Life Care, Pain and Communication · asked ×1 · 7-mark note · see in paper list
Detailed answer
Pro · free in betaAttempt it firstOutline your answer as a 7-mark note before revealing it — definition, causes, evaluation, management and the geriatric angle.Reveal answer
Source: Essentials of Clinical Geriatrics, 7th ed., Ch. 17 — Competence and Informed Consent; decisional capacity; informed assent; surrogate decision-making; Table 17-1 Major Ethical Principles. Pathy’s 6th ed. Indian legal position from Samira Kohli v. Dr Prabha Manchanda, (2008) 2 SCC 1, the IMC/NMC Regulations, and Common Cause (2018, modified 2023).
A. Definition and Components
Informed consent is the doctrine requiring a clinician to disclose enough information for the patient to make an informed decision before any investigation, procedure or treatment. It is a process of communication, not a signature on a form.
Three components must all be satisfied: capacity to decide, voluntariness (free of coercion or undue influence), and adequate information that the patient actually understands.
The textbook lists five items the clinician must disclose: (i) the condition being treated; (ii) the nature and character of the proposed treatment or surgery; (iii) the anticipated results; (iv) recognised alternative forms of treatment; and (v) recognised serious risks, complications and benefits — of the proposed treatment, of the alternatives, and of non-treatment.
Consent is continuing and revocable. A patient who makes an informed decision may change their mind at any time — a competent person who refuses dialysis does not lose the right to reconsider later.
The ethical foundation is autonomy, balanced against beneficence, non-maleficence, justice and fidelity.
B. Capacity versus Competence
Capacity is a clinical judgement made by the treating clinician about a specific decision at a specific time. Competence is a legal term — a determination made by a court of law.
Capacity is decision-specific, not global, and follows a sliding scale — the more serious the consequences, the higher the threshold demanded.
The four elements of decisional capacity are: (i) understanding; (ii) appreciation; (iii) reasoning; and (iv) expressing a choice.
A diagnosis of dementia is not by itself proof of incapacity. Intellectual deficits are “spotty” — a patient may forget things yet still decide well with appropriate prompting. It is wrong to prejudge, and equally wrong to infantilise the patient by directing questions to relatives who answer faster.
Distinguish memory from understanding — these are not the same thing.
No cognitive screening test determines capacity. Tests of executive function (Clock Drawing Test, Executive Interview) correlate better with decisional capacity than the MMSE. Formal instruments exist but are difficult for older adults because they demand abstract, hypothetical reasoning.
A practical bedside test recommended by the textbook is to re-check the patient after an interval and confirm that the understanding and the stated preference are consistent.
Always look for and correct reversible causes of apparent incapacity — delirium, depression, fear, pain, metabolic derangement, drug effects, and hearing or visual impairment. Capacity may fluctuate.
Patients who are comatose, or who have expressive or receptive aphasia or moderate-to-severe dementia, may be unable to communicate effectively — assess carefully what they can still understand and express rather than assuming nothing.
C. When Capacity is Absent
Authority passes to a surrogate — through an advance directive / living will, a durable power of attorney for health care (proxy), or a court-appointed guardian or conservator.
Surrogate decisions follow a hierarchy: the patient’s known prior wishes → substituted judgement (what the patient would have chosen) → best interests (weighing benefits against burdens).
“Informed assent” is a useful option — where the family or proxy does not want to carry the burden of the decision, they may be explicitly offered the choice to defer to the clinician’s judgement. This must be clearly documented.
D. Exceptions and Pitfalls
Recognised exceptions are emergency/necessity (unconscious patient, life-saving intervention), patient waiver, and therapeutic privilege (narrow and now rarely accepted).
Common pitfalls in geriatric practice: blanket or pre-printed consent forms, consent taken on the trolley or after premedication, relatives signing when the patient is capable, and failure to record the discussion. A signed form without disclosure is not consent.
In geriatrics the evidence itself is often absent, extrapolated from younger patients, or contradictory — so risks and benefits are genuinely uncertain, and clinician values may unconsciously distort how options are framed. Shared decision-making and confirming understanding (e.g. teach-back) are therefore essential.
E. Indian Legal Position
India applies the “real consent” standard laid down in Samira Kohli v. Dr Prabha Manchanda, (2008) 2 SCC 1 — not the American “reasonable/prudent patient” standard.
Key propositions from Samira Kohli: consent for a diagnostic procedure is not consent for therapy; consent for one procedure does not cover another, and the fact that the extra surgery was beneficial does not validate it; relatives cannot consent to an additional procedure on an unconscious patient except in a genuine life-threatening emergency; for major surgery two separate consents should be taken; and the disclosure standard is the modified Bolam (professional) standard.
Legal consequences: operating without any consent = battery; inadequate disclosure = negligence; breach of Regulation 7.16 (written consent before operations) = professional misconduct. The emergency/necessity defence lies in Section 92 IPC, now Section 28 BNS 2023.
F. Current Practice Update
Textbook position
(Essentials 7e / Pathy’s Current position, 2023–2026 6e)
Five-item disclosure list, with India applies the modified Bolam professional-disclosure standard (Samira Kohli, 2008), unlike the no named legal standard patient-centred standard of Canterbury v Spence (USA) and Montgomery (UK) “Informed consent laws do not The seven propositions of Samira Kohli are now the operative test applied by every Indian consumer specify how much must be forum, High Court and the Supreme Court disclosed”
No screening test determines Still correct; structured instruments (MacCAT-T, Aid to Capacity Evaluation, CCTI) are validated, and capacity; executive tests longitudinal data show reasoning is the first of the four abilities to fail in mild-to-moderate dementia better than MMSE Surrogates and guardians India has no general statutory surrogate hierarchy for an adult who loses capacity — the closest are the defined by US state statutes nominated representative under the Mental Healthcare Act, 2017 and the guardian named in an advance medical directive Advance directives framed by India’s advance medical directive became operational after the Supreme Court’s order of 24 January the US Patient Self- 2023, giving prospective consent legal force Determination Act Substance of consent matters In India written consent is mandatory for operations under Regulation 7.16, but a blanket form more than the form (“any procedure found necessary”) remains legally invalid Consent framed around Consent is now layered — clinical consent (Samira Kohli/NMC), research consent (ICMR National Ethical treatment decisions only Guidelines 2017), and health-data consent (DPDP Act 2023 with DPDP Rules 2025) Surrogate and family decisions For withholding/withdrawing life-sustaining treatment, India now requires the surrogate’s written consent handled informally in a prescribed format plus two medical boards and JMFC intimation Latest Updates (2023–Present)
Indian regulatory framework
NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023 (Gazette, 2 August 2023) carried a dedicated guidance document on informed consent stating that the consent process must never be curtailed or neglected because the patient is unable to “fully understand”, and expressly naming the elderly, the marginalised and the illiterate as vulnerable groups requiring extra care. Research consent was excluded and referred to the ICMR Guidelines, 2017.
These Regulations were held in abeyance on 23 August 2023 after objections from the IMA and other bodies, and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 — including Regulation 7.16 — were revived and remain in force. The 2023 Regulations are not operative until a further gazette notification. This is the single most examinable regulatory fact. Bharatiya Nyaya Sanhita, 2023 (in force 1 July 2024): the good-faith and necessity protections formerly in IPC ss. 87–92 are renumbered as BNS ss. 25–28, with Section 28 BNS covering acts done in good faith for a person’s benefit where consent cannot be obtained.
Common Cause (2018, modified 24 January 2023) and Harish Rana (2026) confirm that a valid advance medical directive is a recognised form of consent, binding the clinician at the future moment of incapacity.
Health-data consent — a new statutory layer
Digital Personal Data Protection Act, 2023 with the DPDP Rules, 2025 (notified 13–14 November 2025) make consent for processing patient data a separate statutory requirement. Consent must be free, specific, informed, unconditional, unambiguous and revocable, supported by an itemised notice in plain language. Implementation is phased: the Data Protection Board from November 2025, consent managers from November 2026, and the core compliance obligations (notice, security, breach reporting, data-principal rights) from May 2027. Hospitals are data fiduciaries; large ones may be designated significant data fiduciaries requiring a data protection officer. Clinical establishments have limited exemptions where processing is necessary to provide health services.
Capacity assessment and shared decision-making
JAGS 2024: scoping review of decision-making tools that support substitute decision-makers for adults with impaired capacity — reflecting a shift from simply declaring incapacity to actively supporting the surrogate. JAGS 2025: scoping review of shared decision-making interventions for deprescribing in older adults with polypharmacy — the principle being that consent to stop a drug deserves the same rigour as consent to start one.
Internationally, the direction of travel is from substitute decision-making towards supported decision-making, driven by UNCRPD Article 12 and, in India, the Rights of Persons with Disabilities Act, 2016 and the Mental Healthcare Act, 2017, both of which begin from a presumption of capacity.
Examiner’s Tip
Skeleton: Define consent as a process, not a form → three components (capacity, voluntariness, information) → the five disclosure items → capacity vs competence → the four elements → dementia ≠ incapacity; executive tests beat MMSE; reversible causes → if incapable: advance directive → proxy → substituted judgement → best interests, with informed assent as an option → exceptions (emergency, waiver, therapeutic privilege) → Indian law: Samira Kohli “real consent”, battery vs negligence, Regulation 7.16, Section 28 BNS → newer layers: AMD, ICMR research consent, DPDP data consent.
“Capacity is a clinical determination made by the treating doctor for a specific decision at a specific time; competence is a legal determination made by a court — and capacity rests on four abilities: understanding, appreciation, reasoning and expressing a choice. No cognitive screening test, including the MMSE, establishes capacity; executive-function measures correlate better, and a diagnosis of dementia is never by itself evidence of incapacity.”
“In India the operative standard is ‘real consent’ under Samira Kohli v. Dr Prabha Manchanda (2008): consent for a diagnostic procedure is not consent for therapy, consent for one procedure does not authorise another, and the fact that the additional surgery was beneficial does not validate it — relatives cannot consent for an unconscious patient’s additional procedure except in a genuine life-threatening emergency. A signed pre-printed form without disclosure is evidence of a signature, not of consent.”
Extra Points to Remember — recurring topic
Battery vs negligence — the classic viva discriminator: no consent at all → battery/assault (trespass to the person, no proof of harm needed); consent obtained but disclosure inadequate → negligence (harm and causation must be proved).
Three disclosure standards worldwide: Bolam / professional standard (what a reasonable doctor would disclose) — India; reasonable patient standard (Canterbury v Spence) — USA; particular patient / material risk standard (Montgomery v Lanarkshire, 2015) — UK.
Valid consent in India must be: voluntary · by a person ≥18 years of sound mind · informed · specific to the procedure · written for operations (Reg. 7.16) · obtained before premedication · documented. The three exceptions in one line: Emergency (necessity — BNS s.28), Waiver (patient chooses not to know), Therapeutic privilege (disclosure itself would gravely harm — now very narrow and best avoided). Geriatric traps: consent taken from the son because he speaks English; consent signed on the trolley; the “blanket” form; assuming a hearing-impaired patient is confused. All four are examinable failures. Special consents to name: HIV testing, organ donation (THOTA), sterilisation, clinical research (ICMR 2017), photography/publication, and data processing (DPDP 2023).
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References
- PAPERS-2-3-4_COMBINED.pdf — page 1225
- GeriQBank source PDF — p. 1225
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