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Informed Consent patient permission

What Is Informed Consent

Doctors are bound to inform their patients the course of treatment and the risk involved, even before they render a crucial medical care. In the same way,  Doctors are bound to keep secret all information acquired from a patient during the course of the treatment.

It is the moral and ethical duty of a doctor to maintain confidentiality about all patient details. Breach in confidentiality is a serious issue and hospitals or individual doctors can be sued for abandonment of this code of privacy. Therefore, it is important for a healthcare administrator to understand the various facets involved in  the maintenance of confidentiality of patient details.

Informed consent is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.  It is based on the principle of patient autonomy and is the cornerstone of ethics in patient care and clinical trials. A  patient has a legal and an ethical right to make a decision on what happens to his  or her body.

Informed consent empowers patients to be actively involved in making decisions concerning their own medical care; the doctor, thereby, guides the patient in making a rational decision. If a treatment regimen/procedure is performed without informed consent, it can be considered as battery and assault.

The essential points that need to be communicated to the patient while obtaining informed consent are as follow:

  • Diagnosis / differential diagnosis
  • The nature of the chosen treatment and it’s risks and benefits
  • Alternative treatment options available
  • Risk and benefits of not receiving or undergoing a treatment or procedure
  • The acceptance of the intervention by the patient

The procedure for informed consent should include a session wherein the patient is given the opportunity to clarify his doubts and get a better understanding of the treatment or procedure, so that he or she can make an informed decision and give consent accordingly.

For consent to be valid the patient must be considered competent and the consent should not be obtained under coercion. One must take added care if the patient is under undue stress during illness, anxiety and depression or is incoherent. If the patient is deemed incompetent to give his/her informed consent, it should be obtained from a legal guardian.

At this juncture, one may contemplate whether a doctor can perform a procedure in the absence of consent in the best interests of the patient. In medical emergencies, the victim may be unconscious or severely injured and unable to give consent; at his time, if the hospital personnel may also be unable to trace a guardian to give consent. In such situations, consent is not implied but often, to save a patient’s life, consent has to be presumed.

Landmark Cases

Sidway v Board of Governors of the Royal Bethlehem Hospital (1985)

The patient underwent surgery for chronic backache but this resulted in damage to the spinal cord which led to paralysis. She then sued the hospital for not giving her prior information about the risk of paralysis as a  consequence of the surgery. In this case, the court ruled in favour of the surgeon as the risk of paralysis was less than one percent  and a credible group  of peers and contemporaries stated that consent obtained by the supposedly negligent surgeon was sufficient.

Dr. Thomas v Smt. Elis, AIR 1987

 In this case, the patient had perforation of the appendix which led to severe peritonitis that was left unoperated by the doctor as the patient eas not in a condition to give consent and there was no legal guardian / relative available. The court ruled that it is the doctor’s ethical and duty to treat the patient to best of his ability.

From the above cases it is evident that patient education is a key factor in progressing towards making informed consent a mandatory norm. Increased public awareness should be targeted through the dissemination of educational leaflets and audio-visual material to the patient population. Another crucial factor is documentation of all relevant events. Good documentation can be produced as written evidence in s legal proceeding to demonstrate that consent was actually taken.

In this regard, it is important to ensure that the hospital has a well-designed and carefully structured format for informed consent forms. These forms should include details that can actually be understood by a layperson and not just involve legal terminology and official language. Communication between the hospital personnel and patients and their attendants must be clear at all times. This is dual purpose in that it keeps the patient well informed  and also reduces the apprehension formed in the mind of treating doctors and other hospital staff.

There are three types of consent in healthcare system….

Explicit Consent

Explicit consent — also known as express or direct consent — means that an individual is clearly presented with an option to agree or disagree with the collection, use, or disclosure of personal information.

Explicit consent is usually required when clear, documentable consent is required, and the purposes for which it is being provided for is sensitive. Explicit consent can be provided verbally or in writing.

Implicit Consent

Implicit consent — also known as deemed or indirect consent — can mean two things:

  1. You voluntarily personal information for an organization to collect, use, or disclose for purposes that would be considered obvious at the time, or
  2. You provide personal information to an organization and it is used in a way that clearly benefits you and the organization’s expectations are reasonable.

Implied consent is usually inferred from your actions and the current circumstance you are in.

Opt-out consent

Opt-out consent — also known as giving consent by not declining to give consent — means that an individual is given the option to decline consent. If the individual does not clearly decline consent, consent is granted. Opt-out consent is usually done in writing.

Many organizations, especially websites, use opt-out consent as a way to request permission to use your personal information for other purposes.

How does informed consent apply to children?

Children do not have the decision-making capacity to provide informed consent. Since consent, by definition, is given for an intervention for oneself, parents cannot provide informed consent on behalf of their children. Instead they can provide informed permission for treatment. For older children and adolescents, assent should always be sought in addition to the authorization of legal surrogates. Adolescents and mature minors are legally and ethically authorized to provide informed consent if they are emancipated, and in many states, including Washington, they may provide consent for matters regarding sexual and reproductive health, mental health, and substance abuse.

The primary responsibility of the physician is the well-being of the child. Therefore, if the parental decision places the child at risk of harm then further action may be indicated. When there are differences in opinion between the parents and physicians that cannot be resolved ethics consultation may be pursued, and legal avenues may be pursued when all other means have failed. Children should be included in decision-making at a developmentally appropriate level and assent should be sought when possible.

What Treatments Need Informed Consent?

Medical procedures that require you to give written informed consent include:

  • Most surgeries, even when they are not done in the hospital.
  • Other advanced or complex medical tests and procedures, such as an endoscopy (placing a tube down your throat to look at the inside of your stomach) or a needle biopsy of the liver.
  • Radiation or chemotherapy to treat cancer.
  • Most vaccines.
  • Some blood tests, such as HIV testing (need for written consent varies by state).

What is Patient Role in the Informed Consent Process?

You are an important member of your health care team. You should ask questions about anything you do not understand. If you need your provider to explain something in a different way, ask them to do so.

You have the right to refuse treatment if you are able to understand your health condition, your treatment options, and the risks and benefits of each option. Your doctor or other health care provider may tell you they do not think this is the best choice for you. But, your providers should not try to force you to have a treatment you do not want to have.

It is important to be involved in the informed consent process. After all, you are the one who will receive the treatment if you give your consent.