Legally, Consent is defined as the voluntary agreement or permission given by a person with the capacity to do so, to allow something to happen or be done.

The person giving consent must be of legal age and possess the mental capacity to understand what they are consenting to. Consent must be given freely, without any pressure, force, or manipulation. Consent cannot be assumed based on silence.

Obtaining Consent means asking someone for their permission to do something and accepting their answer. Obtaining Consent may be witnessed to establish that it has been given freely.

In India, consent is a legal right enshrined in Article 21 of the Constitution, which guarantees the fundamental right to Life and Personal Liberty.

In context of Healthcare, Healthcare Providers have a legal and ethical duty to obtain valid consent before treating a patient, except in specified Emergency Situations. Patients have the right to refuse any Medical Treatment or Procedure, even if it’s recommended by their Doctor. They also have the right to withdraw their consent at any time. When obtaining the Consent, ensure that the individual giving consent is competent to give consent and understands the nature, purpose, and potential risks and benefits of the proposed action, as have been communicated.

In Healthcare, Consent is obtained to uphold the principle of Patient Autonomy which gives the right to the patient to make choices about their own body and Healthcare. Valid consent protects the Healthcare Providers from legal liability if complications arise from a treatment that the Patient has knowingly agreed to receive.

National Health Policy must clearly specify “Role of all types of Consent(s)” in National Healthcare System Services.

In Healthcare, consent is categorized as under.

1. Implied Consent
   • Legally, Implied Consent is the inferred agreement, made by a person, for certain actions to be performed, by the person’s action (even just a gesture), inaction or from certain circumstances; and inferred by a reasonable person to perform the said actions.
   • In Healthcare, when a patient, who has  the capacity to make valid consent, voluntarily presents himself/herself in Hospital OPD or in a Physicians Chamber, for Consultation or for seeking Healthcare Services, it is considered that the patient has granted Implied Consent for his/her examination and ordinary therapeutics. This Implied Consent is considered adequate for the purposes of obtaining Personal Data for establishing the identity of the patient; Interrogation of the Patient to obtain the History of Present, Past and Family Illnesses; Physical Examination; Routine Investigations including but not limited to X-Rays, Ultrasound Examination,  ECG and Laboratory Examination of Body Fluids, Physiotherapy, etc.
   • Implied Consent is for limited actions only. The extent of these activities, as generally considered appropriate, is determined by regulations and directives laid down by National Health Policy and various Professional Councils and Associations.
   • When so considered, that consent for additional actions is required, oral communication must be made for the intended action(s) by the Healthcare Provider. The Patient must be properly informed regarding the proposed treatment of his/her illness, its risks, its consequences, its cost and anticipated duration.
   • Presenting or extending his/her Arm for withdrawal of Blood is considered Implied Consent for giving blood for testing. Implied Consent is derived from the reasonable interpretation of Patient’s actions or conduct or objective circumstances. However, the risks of withdrawal of Blood or the scale of charges for Professional Services, to enable the Patient to undertake to make payment for professional services rendered, must be communicated orally or by drawing attention to displayed notices.
   • In tort law, Implied Consent is a defence only to an intentional tort.
2. Expressed Consent
   • This is a Direct and Clear,  Verbal or Written, indication of agreement to a Medical Procedure or Treatment, often for minor examinations or treatments.
   • It is a positive and explicit communication of freely given consent, distinct from implied consent, which is inferred from actions or conduct.
   • Any doubts as to the necessity of obtaining an Expressed consent from the patient shall be resolved by procuring the consent.
   • A witness (a disinterested third party) may be present to document this consent.
3. Informed Consent
   • Legally, Informed Consent is an agreement to an interaction or action rendered with knowledge of relevant facts, such as the risks involved or any available alternatives, by two parties. The making of the agreement must be witnessed by a non-interested third party.
   • Informed Consent is made only after a thorough explanation of the process or procedure, including its potential risks, benefits, and alternative options, enabling the consenting party, to make a well-informed decision.
   • In Healthcare, Informed Consent means the consent given by the patient for undergoing any therapy, investigation, confinement or procedure as advised, after clearly understanding the risks entailed in the said therapy, investigation, confinement or procedure.
   • When the Medical Staff determines that the proposed course of action,  activities, procedures, investigations, etc.  require a specific explanation to the patient, including admission to a Hospital bed, these activities shall be undertaken only after a special Informed Consent has been obtained.
   • Obtaining Informed Consent is a legal requirement for Medical Treatment and is a principle requirement in the Code Of Medical Ethics in most of the countries in the world.
   • Obtaining Informed Consent is a communication process between the Patient and the Healthcare Provider, ensuring the patient understands what they are agreeing to. It covers the nature of the procedure, its purpose, potential risks and benefits, alternative treatments, and the consequences of not proceeding. It ensures that the Patient (and Patient Guardians and Patient Family, as applicable) are involved in the decision-making process.

National Health Policy and Informed Consent – For Illustration only

1. National Health Policy must specify Code of Ethics or such other regulations  for obtaining Informed Consent. Informed Consent protects both, the Patient and the Healthcare Provider.
2. It must clearly notify that “ Each Patient has the right to consent, or To refuse consent, to any proposed Procedure or Therapeutic Course. In addition, Each Patient has the right to withdraw the consent given”,
3. It must clearly notify that Informed Consent must be obtained whenever a test or treatment is proposed to be performed which carries a high risk to Life. The test or treatment will be specified by the Hospital based on its level of Healthcare being provided.
4. It must clearly notify that a written Informed Consent shall always be obtained separately, for performing each of the following conditions, or when one of the following action and/or procedures is proposed to be performed.
   • On Admission of the Patient to a Hospital Bed.
   • When a Major or Minor Surgery, involving an entry into the body, either through an incision or through a natural body opening, has been proposed.
   • When a Medical equipment will be introduced inside the body, like an Endoscopy.
   • All procedures in which Anaesthesia is used, regardless of whether an entry into the body is involved.
   • Non-Surgical Procedures including the administration of medicines that involve more than a slight risk of harm to the patient or that may cause a change in patient’s body structure. (Such procedures include but are not limited to, chemotherapy for cancer, hormone treatments, and Diagnostic procedures such as Pyelograms and Myelograms.)
   • Cancer treatments like Chemotherapy, Brachytherapy,   Radiation, and Radiosurgery.
   • Childbirth interventions like Forceps Delivery or Episiotomy
   • When taking Biopsies, for whatever reason
   • Transfusion of Blood and Blood Products
   • Electro-convulsive Therapy
   • Genetic Testing
   • Medical Implant Surgery
   • Treatment with high-risk medications, like opioids
   • All clinical studies, clinical trials, use of experimental drugs or devices and participation of the patient in any structured programme whether educational, clinical or research oriented.
   • The photographing or televising of the operations or procedures to be performed, including appropriate portions of the body, for medical, scientific or educational purposes.
   • Admittance of observers to the Operating Room for the purpose of advancing Medical   Education.
   • Disposal by Hospital authorities of any tissues or parts which may be removed during the course of operative procedure/ treatment.
5. National Health Policy must specify that Consent is not required, to render Medical Consultations and treatments under the following conditions
   • Life Saving Circumstances 
   • Military Necessity
   • For minors (Under the age of 18), where a parent, legal guardian or someone else (surrogate) is not immediately available.
   • Reception of a Patient Under appropriate sections of Country Specific Regulations like  Indian Lunacy Act, 1912.
   • Treatment for Communicable Diseases under International and Country Specific Public Health Laws
   • In cases of Family Conflicts, under the Court’s authority
   • In cases of Permanent Vegetative States, under the Court’s authority
   • For Prisoners, under the Court’s authority