What is consent and what types are there?
Consent is a patient's voluntary agreement to an examination, investigation or treatment. It rests on autonomy — the principle, stated as early as Schloendorff (1914), that every adult of sound mind has the right to decide what is done to their own body. A valid consent needs a competent patient, voluntary agreement without coercion, and adequate information.
| Type | Meaning | Example |
|---|---|---|
| Implied | Inferred from the patient's conduct; no words or signature | Routine clinical examination, including pelvic and PR examination (NMC 2023 guideline) |
| Expressed (explicit) — oral | Spoken agreement | Minor procedures, verbal permission before a student examines a patient |
| Expressed (explicit) — written | Signed, documented agreement | Operations, anaesthesia, procedures with known risks |
| Informed | Explicit consent given after disclosure of nature, risks, benefits and alternatives | Any surgery or invasive procedure |
| Blanket | One general signature at admission covering 'any procedure' | Not defensible legally or morally |
What must informed consent include?
StatPearls lists the elements that must be documented for informed consent (a Joint Commission requirement in the US). The same elements are tested in Indian exams.
- The nature of the procedure or intervention.
- Its risks and benefits.
- Reasonable alternatives.
- The risks and benefits of the alternatives (including no treatment).
- An assessment of the patient's understanding — for example the teach-back method.
How much must be disclosed? The NMC 2023 consent guideline adopts the reasonable patient standard: information should include all that the patient would need to know to decide, citing Montgomery v Lanarkshire Health Board, and particularly the most common side effects and complications. Consent must be in a language the patient understands, with no deception or coercion; consent to an illegal procedure is never valid.
| Situation | Rule |
|---|---|
| Any operation, minor or major | Consent required; must be procedure-specific |
| Two elective procedures (e.g. cholecystectomy and appendicectomy) | Separate consent for each |
| Surgery under anaesthesia | Separate consent for surgery and for anaesthesia |
| Consent form | Primary surgeon's name must appear |
| Transplant surgery | Video recording of consent (legal requirement since 2013) |
| Refusal | Patient may refuse; explain consequences and document the refusal and reasons |
What does the law say about consent — BNS sections 25, 26, 27 and 30?
Since 1 July 2024 the general exceptions of the IPC have been re-enacted in the Bharatiya Nyaya Sanhita, 2023. These four sections are the legal basis of medical consent and appear frequently as 'match the following' items.
| BNS | IPC | What it says | Medical meaning |
|---|---|---|---|
| 25 | 87 | Act not intended or known to be likely to cause death or grievous hurt, done with the consent of a person above eighteen years | Age for valid consent to risk of harm is above 18 |
| 26 | 88 | Act not intended to cause death, done in good faith for the person's benefit with their consent | Surgeon who operates in good faith with consent commits no offence even if a risk materialises (the BNS illustration is a surgeon) |
| 27 | 89 | Act done in good faith for the benefit of a person under twelve years or of unsound mind, by or with consent of the guardian | Under-12s and persons of unsound mind: guardian consents |
| 30 | 92 | Act done in good faith for a person's benefit without consent, when consent is impossible and no guardian is available in time | Basis for emergency treatment of an unconscious patient |
How is consent handled for minors, emergencies and special situations?
| Situation | Rule | Source |
|---|---|---|
| Operation on a minor | Written consent from parent or guardian | IMC Regulations 2002, 7.16 |
| Child aged above 8 | Assent may also be needed in addition to parental consent | NMC 2023 consent guideline |
| Child under 12 | Guardian's consent for acts done in good faith for the child's benefit | BNS 27 |
| Emergency, patient unable to consent | Try to obtain consent; if impossible, act in the patient's best interest and record the basis of decisions | NMC 2023 regulation 19; BNS 30 |
| Unconscious, unidentified patient | Treat; try to trace next of kin; document absence of a surrogate | NMC 2023 consent guideline |
| Operation that may cause sterility | Consent of both husband and wife | IMC 2002, 7.16 |
| IVF or artificial insemination | Informed written consent of the woman, her spouse and the donor | NMC 2023 regulation 19 |
| Medical students examining patients | Verbal permission; refusal must be respected without affecting care | NMC 2023 consent guideline |
| Publishing photos or case reports | Patient's permission if identity could be made out | IMC 2002, 7.17 |
What is medical negligence?
In Jacob Mathew v State of Punjab (Supreme Court, 5 August 2005), negligence was defined as the breach of a duty caused by omitting to do what a reasonable person would do, or doing what a prudent and reasonable person would not do. Its three essential components are duty, breach and resulting damage.
- A simple lack of care, an error of judgement or an accident is not proof of negligence by a medical professional.
- A doctor who follows a practice acceptable to the profession at that time is not negligent merely because a better method existed or a more skilled doctor would have chosen differently.
- The standard is that of an ordinary competent practitioner exercising ordinary skill — not the highest expert in the field.
- Care is judged by the knowledge available at the time of the incident, not at the date of trial; failure to use equipment not generally available then is not negligence.
- A doctor can be liable either for not possessing the skill professed, or for not exercising it with reasonable competence.
| Feature | Civil negligence | Criminal negligence |
|---|---|---|
| Degree | Ordinary negligence suffices | Must be gross — of a very high degree |
| Mens rea | Not required | Must be shown |
| Forum / outcome | Compensation (civil courts, consumer forums) | Prosecution — BNS 106(1) (old IPC 304A) when death results |
| Res ipsa loquitur | Rule of evidence that shifts the burden of proof | Only limited application |
What are the Bolam test and the Jacob Mathew guidelines?
The Bolam test comes from Bolam v Friern Hospital Management Committee [1957] 1 WLR 582: a doctor is not negligent if they acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, even if a body of adverse opinion also exists. The Supreme Court held in Jacob Mathew that the Bolam test holds good in India.
| Safeguard | What the court said |
|---|---|
| Gross negligence | 'Rash or negligent act' in IPC 304A must be read as qualified by the word 'grossly' |
| Private complaint | Not to be entertained unless backed by a credible opinion of another competent doctor |
| Police investigation | Investigating officer should obtain an independent medical opinion, preferably from a government doctor in that specialty, applying the Bolam test |
| Arrest | A doctor may not be arrested in a routine manner simply because a charge has been levelled |
What is BNS section 106 and how does it apply to doctors?
BNS 106(1) replaces IPC 304A (causing death by negligence). Anyone who causes death by a rash or negligent act not amounting to culpable homicide can be imprisoned for up to five years with fine. But if the act is done by a registered medical practitioner while performing a medical procedure, the maximum is two years with fine.
- 'Registered medical practitioner' = holds a qualification recognised under the NMC Act, 2019 and is entered in the National or a State Medical Register.
- BNS 106(2) (hit-and-run driving) was not brought into force on 1 July 2024; 106(1) is in force.
- The Jacob Mathew requirement of gross negligence still governs prosecution of doctors.
What are the NMC Professional Conduct Regulations 2023 — and are they in force?
The National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 were notified in the Gazette on 2 August 2023. On 23 August 2023 the NMC issued an amendment that held them in abeyance with immediate effect until a further Gazette notification, and adopted the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 as effective. Exams still ask what the 2023 version proposed, so know both.
| Topic | NMC 2023 (notified, then in abeyance) | IMC 2002 (in force) |
|---|---|---|
| Generic prescribing | Every RMP should prescribe by generic name, legibly; avoid irrational fixed-dose combinations; guideline prefers capital letters | Generic names, legibly and preferably in capital letters (2016 amendment) |
| CPD / licence | At least 30 credit hours every 5 years; licence renewal every 5 years | — |
| Medical records | Inpatient records for 3 years from last contact; full digitisation within 3 years | Indoor records for 3 years from start of treatment; copies within 72 hours of request |
| Gifts from industry | RMPs and families must not accept gifts, travel, hospitality, cash or honoraria from pharmaceutical, device or commercial healthcare companies; no pharma-sponsored CPD | — |
| Consent | Signed informed consent before any procedure; both spouses for sterilising operations | Written consent before operation; both spouses for sterility (7.16) |
| Telemedicine | Allowed under the Telemedicine Practice Guidelines | — |