Informed Consent- Your insurance against litigation!

Informed consent is becoming increasingly so important that the patients must have the clear understanding of the benefits of the procedure they are undertaking as well as the risk of the procedure if they approved it as a treatment option.

Historically, informed consent was not acceptable in the medical traditions, as it was thought that the full disclosure about the medical treatment shall break the faith in the physician and the therapeutic strategy which was essential for the recovery. It was believed that the patient/family shall become anxious and shall have doubt about the recovery and it shall be harmful to the management. It was also believed in most circumstances that the patient cannot make a better decision about his or her medical care.

The bases of this ideology were that the physician is a benevolent and sober person who shall decide and act in the best interest in the patient.

However, currently, this paternalistic medical practice has shifted away with more emphasis being laid on patient autonomy and the recognition that the patient must have a role in medical decision-making.

There is a now another legal perspective to this issue, with courts are taking different views on the consent. Courts are putting burdens on the physician for providing adequate disclosure so that the patient can make an informed decision. Any absence of this, the physician is consider as inclusion to the patient's rights.

The other view is the decision on negligence when the physician is required to disclose as much the reasonable doctor should disclose. In this situation, the emphasis is not on the patient self-determination but rather on the fact whether the physician has acted in accordance with the standard practices.

Important Aspects of Consent

The necessary Content of an informed consent the physician must provide before taking any consent is:

While taking informed consent the physician must provide the following information

• Nature of the procedure


• Risks


• Benefits


• Alternatives

While it is indeed difficult to provide each and every specific complications, that will cover every situation/contingency but maximum information about nature of the procedure, risk, benefits and alternatives should be provided so as to enable a patient to make a reasonable decision about the treatment.

Procedure: The nature of the procedure including the steps should be broadly informed. The outcome of the procedure in terms of immediate outcome and long term outcome must be informed.

The associated pain and postoperative pain must make a definite part of the information provided. The estimated time & duration of recovery should also be informed before the procedure undertaking.

Risk: The risk & complications of the procedure must be informed. From the legal standpoint, it is sufficient to provide the most common and worst complications. It is understood that the if the patient is willing to take the highest risk, he/she shall be willing to take lesser or enforcing complications as well.

Outcomes and benefits: Outcomes and benefits should be based upon the evidence and guidelines

As understood, every procedure does have complications attended risks and benefits. At the end, the benefits must overweigh the risk for the patient to take a decision in the favour of the treatment.

The consent must be taken from the patient himself/herself and from the guardian if he is minor or incapable. Although not legally required, yet it is advisable that the immediate kin of the patient should also be involved in the consent process because she/he may turn out to be the facing litigant in case of a mishap.

No amount of insurance can save the harassment created by a dissatisfied patient-only an informed consent taken by the physician himself can save him/her from any future problem.

Here are some myths concerning informed consent.

Myth 1: there is a myth among the senior consultants, the consent is to be taken by the resident and nurses. - It is strongly advised that the consent must be taken by the physician who is performing the procedure. Many a time, she/he definitely briefs the patients but avoids writing the same down on a paper.

Myth 2: the consent has to be taken on a pre-prescribed form. Consent is not a legal document, it is a safety from litigation. It is a proof of your information in helping the patient to take a decision for which he should not blame you. It can be taken on a case sheet or on a plan paper.

Myth 3- Informed Consent is only for surgical procedures- It is generally believed that informed consent will be taken only before a surgical operation. Reality stands that any patient must be informed about the total plan of care of the treatment, preferably step-wise in reaching to a diagnosis and management. The patient must also be informed about the financial implications of the treatment, which may become the deciding factor in his treatment plan.

The author is an Interventional Cardiologist and the founder of Medical Dialogues