Significance of Informed Consent!

What Is Informed Consent?

When medical practitioners provide information to a patient about a particular treatment or test in order to help the patient understand and decide whether or not the patient wants to undergo such treatment or test or what to choose among the available medical options, then the consent so obtained is termed as informed consent. So, technically, the process of understanding the risks and benefits of treatment is referred to as informed consent.

Basic rules of Informed Consent

1. The first thing that an informed consent takes into account is the moral and legal premise of patient autonomy: As a patient, one must have the right to take decisions about his or her health and medical conditions.
2. The patient must provide his or her voluntary, informed consent for medical treatment or tests and procedures. The legal term used for failing to obtain informed consent before the treatment or test or procedure on a patient is called battery (a form of assault).
3. For many kinds of communications or interactions with the doctor or physicist, implied consent is assumed.
4. For more invasive tests or treatments with significant risks or alternatives, the patient is asked to provide an explicit (written) consent.
5. Under a few circumstances, there are exceptions to the informed consent principle. The most common exceptions are these:
   1. An emergency, where medical care is required immediately to prevent serious or irreversible harm.
   2. Incompetence, where the patient is unable or not in a condition to provide permission or refuses for testing or treatment.

Components of Informed Consent

There are four components of informed consent:

1. The patient must have the ability or capacity to take the decision.
2. The medical practitioner must disclose information regarding the treatment, test, or procedure in a questionnaire along with the expected benefits and risks, and the probability of the benefits and risks associated with the procedure.
3. A patient must comprehend the relevant information.
4. A patient must voluntarily grant consent, without coercion or duress.

Decision-Making Capacity

The Decision-making capacity, in legal terms the competency is one of the most important components of informed consent. The patient (not others) must have the capacity to make decisions.

The sub-components of decision-making capacity are as follows:

1. The ability of the patient to understand the options or procedures.
2. The ability of the patient to understand the consequences of opting each of the options or procedures.
3. The ability of the patient to evaluate the personal cost and benefit of each of the consequences and relate them to his or her own values and priorities.

If the patient is not capable of meeting the above components, there comes the role of the other people with the patient including family members, court-appointed guardians, or any authority as determined by state law. They may act as “surrogate decision-makers” and take a decision for the patient.

Having decision-making capacity does not really mean that a patient will always make “good” decisions or decisions that the medical practitioner agrees with. Similarly, making a “bad” decision does not mean that a patient is “incompetent” or does not have decision-making capacity.

In simple terms, Decision-making capacity, or competency means that a patient can understand and explain the options, their implications, and provide a rational reason why he or she would decide on a particular option instead of the others.

Disclosure

In order to make a decision and provide informed consent by the patient for the treatment or tests, the doctor or health care service provider must disclose enough information to the patient or surrogate decision-makers of the patient, so that they can make an informed decision. Also, it is not required or expected that the patient or the surrogate decision-makers would receive every detail of the test, treatment, or procedure.

However, the information that would be expected by a reasonable person to make an intelligent decision must be passed to the patient or the decision-makers. Such information includes the risks and probability of each of the risks and the benefits. Further, any questions related to this should be fully explained, in language and terminology that the patient or the decision-makers can understand.

Documentation of Consent

For various tests and procedures, such as routine blood tests, X-rays, and splints or casts, consent is implied and no written documentation of the consent process is obtained. However, for various invasive tests or for treatments where significant risk is associated, the patient should be provided with a written consent form and a verbal explanation, both preferably in the patient’s native language.

The following sub-components should be discussed and included in the written consent form.

1. A description or explanation of the medical condition that demands the test, procedure, or treatment.
2. A description or explanation of the purpose and benefits of the proposed test, procedure, or treatment.
3. A description or explanation of the proposed test, procedure, or treatment, including potential complications or adverse consequences.
4. A description or explanation of alternative treatments, procedures, or tests, if any, and their relative benefits and risks.
5. A discussion of the consequences of not accepting the test, procedure, or treatment.

If the above components are not included in the form, then the patient should request this information.

Last but the most important aspect of the consent form is it should be signed and dated both by the doctor and the patient or the surrogate decision-makers (for minor patients parents should sign). You may also ask for a copy of the signed consent form.

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