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Informed consent and its significance

Dr Nitendra Sesodia
Wednesday, June 22, 2022, 08:00 Hrs  [IST]

Informed consent is a necessary part of most medical procedures and yet people are largely unclear about its meaning and significance. It is the process whereby the details of a medical treatment is explained to a patient by a physician, nurse, or healthcare professional before the patient provides his/her approval to undergo it; it allows the patient the opportunity to ask questions related to the treatment and accept or deny it. Thus, informed consent allows patients in a healthcare setting to participate in their own medical care.

Proper execution of the process of informed consent is a legal and ethical obligation of healthcare providers. For this to happen in a healthcare or hospital setting, following are the key requirements:
•    The patient’s ability to take a decision
•    Proper explanation of the information required
•    Patient’s understanding of the medical information
•    Patient’s voluntary decision to receive the treatment

These are the critical components of this collaborative decision-making process between the patient and the healthcare provider.

What requires informed consent?
The healthcare industry consists of multiple sectors and patients are often unaware of the domains that require their informed consent. Here is a list of some such domains:

Clinical health services: Doctors' offices, urgent care clinics, and hospitals, all require informed consent.
Behavioural and mental health services: Informed consent in behavioural and mental health helps patients to be in control of the care they receive. Medical authorities need the practice and documentation of informed consent in mental healthcare.

Research that uses human subjects: Drug tests, psychological studies, medical device and clinical trials, as well as healthcare research programmes often require human subjects. In such instances, researchers must take informed consent from every participant to include them in the study. For research or study, the informed consent should include the following information:
•    The purpose of the research
•    What the researchers are aiming to accomplish with the research
•    Description of what will be done to the participant during the research and the duration of the participation
•    The risks associated with the process
•    The benefits that may come from the research
•    Verification that the person has the right to leave the research at any time and standard medical care will be offered to the person even if he/she withdraws from the process
•    The treatments that are available if the person decides to not participate.

Importance of informed consent for patients
The primary objective of making a patient sign an informed consent is to protect him/her. This legal document makes sure that there is ongoing communication between a healthcare provider and a patient. It signifies that the information regarding the condition and treatment has been provided to the patient and the patient can use the information to make his/her decision and choice.

The information provided to the patient is usually based on the doctor’s assessment of the diagnosis and treatment procedures. The patient gets the opportunity to ask questions and understand more about the options available. The process also gives an opportunity to the patients to tell their healthcare providers about their preferences, personal values, and opinions. This type of shared-decision making is especially helpful when there is no single “best” option of the treatment available.

Scenarios that require informed consent
The following scenarios need a patient’s informed consent:
•    Blood transfusions
•    Most surgeries
•    Radiation
•    Anaesthesia
•    Most vaccinations
•    Chemotherapy
•    Blood tests such as HIV testing
•    Advanced medical tests such as biopsy.

Importance of informed consent for doctors and healthcare facilities
It is nearly impossible to guarantee positive outcomes within a hospital or healthcare setting. However, with informed consent, patients have a clear understanding of the risks involved in the treatment being offered. When patients do agree to a specific treatment procedure, they must sign the informed consent form, understanding all the associated risks and agreeing to the fact that physicians take life-saving measures as and when required.

Thus, this process reduces the risks for both, patients and doctors. Patients get the ability to make their own choices and doctors, as well as healthcare institutions, face less risk of legal actions. This shared decision-making process also allows trust to build between a doctor and a patient.

Signing informed consent on behalf of a patient
Following are some specific scenarios when someone else can sign the inform consent form on behalf of a patient.
The patient is not of legal age: In most countries, if a patient is younger than 18 years, a parent or guardian is required to provide consent on behalf of the patient. However, some states in the US allow teenagers who are married, emancipated, parents, or in the army to give their own consent.
The patient isn’t able to provide consent: A person can take decisions and provide consent on behalf of the patient if the patient is not in a condition to do the same. This applies when a patient is in a coma or suffers from severe Alzheimer’s disease.
The patient wants someone else to sign the informed consent: In case a patient wants another person to take his/her medical decisions, he/she can fill out an advance directive form that allows that person to provide consent.

Informed consent Vs. implied consent
Implied consent can be considered as a form of informed consent. Such consent is implied or suggested, by the actions of the patient. It is not explicitly written down or stated. For instance, when a patient has a fever and visits a healthcare provider, the visit suggests that the patient wants treatment. Implied consent is not as formal as informed consent. Implied consent doesn’t require to be legally recorded.

When is informed consent not required?
Following are the scenarios when informed consent is not required.
•    In case of an emergency when the patient is unconscious and there are chances of death or other serious outcomes if urgent medical care is not provided right away.
•    If a doctor knows that the patient is distressed and will refuse required treatment, the physician may not be required to get informed consent from the patient. In addition, if a doctor believes that the details of a procedure will make a physically weak patient sick with anxiety, he/she may choose to withhold some information. However, the doctor must demonstrate why the risks of the procedure were not disclosed to the patient.

Conclusion
It is a fact that while obtaining informed consent, adequate information is not provided to patients at times. Healthcare providers need to be educated on common interventions and procedures by experts and they need to be able to relay this information to patients as well as other members of their healthcare team. This would foster better transparency between them and the patients. Also, patients must talk to their healthcare providers if they have concerns or questions about a process. As a patient, one has the right to make informed choices about the medical care one receives.

(Author is senior director, Medical Communication & Corporate Sales, Thieme)

 

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