Understanding ‘Informed Consent’ in healthcare

The Supreme Court has held that a patient is required to give ‘prior informed consent’, barring specific situations of emergency
Understanding ‘Informed Consent’ in healthcare
Healthcare providers are required to share complete details of medical conditions, treatments, risks etc to patientsGomantak Times

Mohan was awaiting his turn, in the Outpatients Department, for his consultation, following his diagnostic tests. He wondered how he could handle this consultation in a manner that would enable him to make an informed decision about his treatment.

He was aware that healthcare providers are bound by the requirements of disclosure and obtaining the informed consent of the patient in diagnosis and treatment of his medical condition. He pondered over this in the context of the time constraints and work pressures faced by healthcare providers:

PATIENT AUTONOMY

Article 21 of the Indian Constitution deals with the right to life and personal liberty, and enshrines the principle of autonomy. ‘Personal Liberty’ encompasses the right to live with human dignity.

The courts have relied on the principles of the Indian Contract Act and the Indian Penal Code to enunciate the principle of patient autonomy. The Supreme Court has held that the patient is required to give ‘prior informed consent’, barring specific situations of emergency. While this requirement can sometimes create a predicament for the healthcare provider, given the nature of healthcare, patient autonomy is one of the key principles underpinning healthcare.

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INFORMED CONSENT: THE ESSENTIALS

In the contractual relationship between a healthcare provider and the patient, ‘informed consent’ is the communication between them that results in agreement for medical care or treatment. It affirms that the healthcare provider has informed the patient about his medical condition and treatment information, and the patient has used this information to choose the option he feels is right for him. The essentials include the following:

Capacity: The patient must have the capacity to make the decision, ie the patient must be major of age, be conscious and of sound mind. This is required for the patient to be able to comprehend the information provided so that he can make an informed decision.

Thus, the patient must have the ability to understand the treatment options, the cost and benefit and, consequences of each option and to be able to analyse them from their own frame of values and priorities. If a patient is unable to do this by himself, a family member or court-appointed guardian may make decisions for the patient.

Mohan understood that the capacity to make decisions meant that he can understand each of the options and their implications and have a rational basis to decide on a particular option over the others.

Disclosure of Information: Mohan was aware that every patient has the right to get information and ask questions before deciding on a procedure or treatment. The information includes:

  • Description of the medical condition

  • Details of the procedure or treatment recommended by the healthcare provider

  • Benefits and risks of the treatment or procedure

  • Benefits and risks of other treatment/procedure options

The level of disclosure is the information required by a reasonable person to make an informed decision. The healthcare provider needs to address the questions of the patient in a language and vocabulary that the patient can understand.

Voluntary Consent: The consent of the patient must be voluntary, ie it must be without coercion or compulsion. For routine blood tests, x-rays or splints or casts in case of fractures, consent is implied and written documentation is usually not obtained.

If the test is an invasive test or the treatment has considerable risk, the patient is to be provided an explanation of the treatment and the risks, in a language understood by them.

WRITTEN CONSENT

Where written consent is taken from the patient, it needs to include the explanation of the:

  • medical condition,

  • purpose and benefits of the proposed test, procedure or treatment,

  • possible complications or adverse events of the proposed test, procedure or treatment,

  • alternative tests, procedures or treatments and their relative benefits and risks, and

  • consequences of not agreeing to the test, procedure or treatment

The consent form has to be signed and dated by the healthcare provider and the patient. The patient can ask for a copy of the signed consent form.

HEALTHCARE DECISION

The patient has the right to choose the line of treatment that he would like to follow. This includes the right to refuse any treatment option that does not work for him. He can also refuse part of the treatment options, eg the patient may choose to refuse surgery, but still agree to be treated for pain.

If the healthcare provider is not comfortable with the approach or decision of the patient, the patient may need to find another healthcare provider.

If the patient refuses any treatment or test, the healthcare provider may inform him about the risks of this choice so that he is aware of the possible consequences. The patient may be asked to sign a form to confirm that he received this information and still chose not to do the treatment or test.

EMERGENCIES

The Supreme Court has emphasized that Article 21 imposes an obligation on the State to safeguard the right to life of every person. Accordingly, every healthcare provider has the professional obligation to provide his service to protect life. When approached by an injured person, the healthcare provider must render all necessary help, including referring the patient to proper experts. In accident cases, if the patient is unable to provide consent, treatment of such persons is protected by law, in line with Article 21 of the Constitution.

With this clarity, Mohan began to prepare himself for his conversation about his treatment...

SUMMARY

Patient Autonomy: Article 21 of the Indian Constitution, Indian Contract Act and the Indian Penal Code, ‘Prior informed consent’ in healthcare

Informed Consent: The Essentials: Capacity, Disclosure of Information, Voluntary Consent

Written Consent: Explanation of medical condition, purpose & benefits of proposed test or procedure, possible adverse events, alternative options and their relative benefits and risks, and consequences of not agreeing to the test or procedure

The author has her focus on education, legal issues and governance, and enjoys working with individuals and organizations towards enhancing their effectiveness

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