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Informed Consent

The paper contains introduction to the informed consent and its basic format as a procedure, with feature and responsibility of the doctors and patient as well. Informed consent requirement and its actual importance, legally can anybody fill this or not. Type of informed consent, about legal status and legal scenario, informed consent is not a mere do form, it is a procedure. Special conditions and circumstances and how doctors should react in such condition with their patients with that a brief view of conclusion.

Informed consent

Starting from the beginning, let's talk about what informed means ,basically informed means having knowledge or information about something. In detail it turns out to be the required information to the person whom it is necessary, there should be a complete knowledge about the facts and information without any ambiguity.

Informed consent is a process with respect of which the patient learns about an actual procedure of the medical and surgical intervention as this includes everything such as clinical trials, and here patient understands the risk and benefits of the procedure of the treatment.

Informed consent is a normal and a starting process of giving all the information to the patients regarding everything. Basically, this is purposed so that the patients or the responsible whoever is so agreed to all the statements and try to figure out all the consequences from treatment. This is done by keeping the safety feature in the sight.

This informed consent process provides you with all the health care factors and gives you all the opinion regarding the treatment and procedural way to be cured.
Whereas, now we will discuss what this informed consent form contains and what is the responsibility of a patient.

This information includes:

  • The exact position of the patient.
  • Treatment procedure and its name which is provided by the health care providers.
  • Benefits and risk of the treatment procedure.
  • If treatment is not given to the patient then what will be the consequences.

Responsibility of the patient:

  • The sign you have done on the basis of reading all the treatment procedure and you are agreeing to all the facts and the circumstances.
  • Patient can ask questions and before that you must completely understand all the points of the information.
  • You can further talk to the health care providers so that they can help you with the exact satisfaction and you may choose the whole treatment procedure or the one portion.
Whereas, if there is any query then the patient should consult to the health providers.

Informed consent is the main responsibility of the doctors to provide the required information to the patient and make sure that the information is correct to the point and this information should be provide in simple words without creating hectic words. It is good if the information is shared verbally as patients are not from the background of medical so it is not that easy for them to understand. However,written informed consent is also valid.

Why informed consent is required?

In the report of Nuremberg Code (Ref.1)[1] addresses that the voluntary informed consent is required as it is the fundamental ethical principle. The participant has to give their autonomy which implies the responsibility must be given to the individual to make the decision and give consents related to their medical conditions. It is not only essential for the safety and the protection of the patient but also for the respect and integrity of the patient.

The form signed is a legal document that shows the acceptance of a patient and agreement to the medical procedure specified by the healthcare providers. Once the consent form is signed it means that the patient has received all the relevant information about the procedure and agreed with their free will. This signifies that the healthcare provider can proceed with the treatment. If any participant denies to the treatment suggested by the doctors, then may not sign the form. Everyone has the right to refuse to the treatment if they are capable of taking decisions. The legal competent that is capable to make medical decisions have the legal and moral right to refuse any treatment.

Can other person sign a consent form on the behalf of the patient?

The following are such cases where another person can sign the consent form:
  • Minor- When the patient is a minor who is incapable of making decisions for their betterment. The parents or guardian of the minor can sign the form on their behalf.
  • Advance Directive - In this case, the patient himself has directed the other person to make their future medical decisions. A form has to fill prior to giving consent which is called an advance directive. It will allow someone else to be consent on your behalf.
  • Cannot give consent- when the person is incapable to give consent then the other can give the consent. These are the cases where the patient is in coma and Alzheimer.

Types of Informed Consent

The following are the types of informed consent:
  1. Consent- A participant who is an adult is capable to give permission or consent on their own provided that they must be 18 years old and above.
     
  2. Parental Permission- When the patient is a minor then there is the need to take the parental permission which is duly signed by the parents or the guardians of the child. A child is incapable to know what is right and wrong for them, that's why there is a need of parental permission.
     
  3. Assent- It is the child's affirmative agreement where the content of the informed consent form is written with simple terms and is easy to be read by the child. The reading level of the content should be written in such a way that the child of age 7 to 17 years can understand it easily.
     
  4. Verbal- In this type, the participant verbally read the content and verbally gives their consent. Although it contains all the written contents in it.
     
  5. Short Form- There is various challenges when it comes to informed consent. The short form is required when there is a language barrier. In India, this problem is very common because many people are unable to understand English. So, the approved consent is translated to the patients in their native language for better understanding of the concerned matter.

Informed consent is a process not a mere form

It is an important document which is related to your health factors so that the patient is aware of every situation regarding to the health and what should be the upcoming treatment related to the human body. There are few requirements which should be considered in the informed consent document i.e. it should be in the simple and plain language there should not be any use of hard words or ambiguity. There should also some extra information regarding the informed consent so that it is easy for everyone to get the actual extract of the information.

Moreover, this should not be treated as a formality, it should be taken as much as serious and the complete procedure should be followed by doctors and patient as well. There should be a proper management so that it will become easy for everyone. To make it easy doctors can provide them counseling and this counseling procedure should be done in easy language, so that they can understand properly.

Legal Scenario of Informed Consent

The duty of doctors is to inform the patient about their conditions and all the possible risks involved. But if the doctor is unable to perform their duties then they will be liable for medical negligence. In medical negligence cases, the doctors carelessly or improperly treat the patient it can be either without adequate technical skills or knowledge. There was a case where[2], the surgeon while performing the surgery discovered that her womb was ruptured. He sterilized her without taking consent of her. The doctor was held liable for medical negligence. The liability of the doctors in case of absence of disclosure of the information will be as medical negligence and hence the doctor will be liable for the same.[3]

The following are the cases where the consent is required to be taken and if not then the legal actions will be taken:

  • Right to Refusal- the patient has the right to protect their body from any kind of interventions. If any patient has not given consent for the treatment then the doctors cannot perform the treatment on them and if they operate then it will be punishable. In Indian, the burden of proof lies on the doctor to justify their actions which would be illegal in the absence of consent. Indian courts may presume the consent to be implied but up to certain limits. Beyond that, the specific proof needs to be presented to the court.
     
  • Minor's consent-Section 3 of Indian Majority Act, 1875, sets the age of majority as 18 years in India. Therefore, the person below the age is minor and cannot give consent. The parental consent will be considered lawful.
     
  • Medical termination of Pregnancy- In the minor or a lunatic for termination of pregnancy, the parental consent is required. The Medical Termination of Pregnancy Act, 1971 provisions ensures that no pregnancy shall be terminated without the consent of the women. The termination must be done only in good faith and n the benefit of a person's life.
     

Special circumstances

If there is any condition in which a person is somehow incapable of giving the informed consent then there are certain requirements which must be followed by that person so that there should not be any query:
  1. There should be a proper explanation.
  2. There is a requirement of individual assent.
  3. Person best preference should be considered and for their best interest.
  4. If there is any substitute consent then that must be verified that is this sufficient toall the essential requirements. Similarly, if doctors do the same then they should also have a very clear explanation regarding everything. Moreover, it is not expected from the doctors but still if there is any issue then they should present it very carefully.
The main importance of this document is that it gives you the surety of treatment and make sure that if there is any risk related to your health then it should be already discussed with you.

Doctors' duty towards the informed consent

As the health and life is the most basic requirement of the human body so there should not be any risk related to the health status of a human body. In India, doctors are considered as equal to the god who are lifesavers for us and give us the ray of hope in the toughest time. There should not be lack of knowledge from their side because it is considered that doctors are the one who always serve their patient in any situation and it is clearly visible by the recent example of coronavirus in the society.

Sometimes doctors forget about the informed consent document due to any of the reason such as not sufficient time, lack of their duty or due to any other reasons. So it is very important that doctors should perform their duty perfectly, there should not be any lacking point which can raise question on their profession. Health is the most preferred thing for a normal human being and if a doctor shows any point of carelessness towards it, this would be totally wrong. Throughout the whole treatment, a doctor should act as responsible and should work with complete dedication.

Conclusion
The rights of a person are determined through their human status. The informed consent is an important tool in clinical trials. The responsibilities and importance of this consent must be ethical and genuine for the betterment of the participant. This paper involves a brief description of informed consent. The legal perspective, its importance and the requirement of the consent form is explained. The guidelines on informed consent in India should be based on complex factors such as diversity, culture, level of education and the demographical scenarios.


End-Notes:
  1. hhtp:www.cirp.org/library/ethics/nuremberg
  2. Devi v. West Midlands AHA,(1980)7 C.L.44
  3. Cold v. Haringey Health Authority(1988)QB 481

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