Patient Informed Consent Compliance 5 Day Series

06 January, 2018

LegalMD presents a 5 day series of messages on one of the more crucial issues which leads to most of the Medico-legal issues among doctors: "Informed Consent"

An INFORMED CONSENT like an agreement by and between the patient or its legal guardian and the consulting doctor confirming that the patient or the guardian has been informed and understood about the disease or the condition, procedure planned, associated risk and complications, prognosis, alternative treatment available and other relevant information by the doctor and the patient agree upon them voluntarily, unbiased and under physical and mental state enabling him to give the consent.

  • It should be voluntary, unbiased and given by the patient in free will
  • It should be informed i.e. the patient or the subject prior to consent should be well informed in detail about the procedure, associated benefits, risk and complications and alternative treatment options available; and
  • Last but not least the patient should be in capacity, physically and mentally to give the consent for the treatment or the procedure. Hence, consent can be considered as an agreement of mutual understanding for the services by the doctor and the patient as the consumer under Consumer Protection Act, 1986.

Getting Informed consent from the patient remains a very tricky area in medical practice today. Failure to obtain valid consent is one the commonest reasons patients go to court when they are unhappy with their doctor. The Supreme Court of India has laid down certain guidelines in its various judgments for what makes a consent valid; and how it should be taken.
Initially, the concept of Informed consent was developed in order to protect the health of participants in clinical trials and healthcare research. However, in view of the importance of patient autonomy, and the need to protect doctors against medical lawsuits, it is now considered to be an important component of all aspects of healthcare.

In medical practice, it is categorized into:
  • Implied Consent This is the most common type of consent used by general and hospital practitioners. It is not in the written form, but is legally effective. The patient implies consent to medical examination, i.e., limited to inspection, palpation, and auscultation, excluding examination of intimate parts (private parts). However, the implied consent possesses a limitation, i.e., there are chances of misunderstanding between the doctor and patient. Implied consent is generally exercised when a patient visits hospital or clinic for treatment in cases such as, a comatose patient requiring rapid initiation of treatment, or a mentally retarded patient admitted to hospital in absence of legal guardian. 
  • Expressed Consent The expressed consent can be obtained both orally or in the written form. Though, oral consent is considered equally valid if witnessed properly, written consent is preferred as it can be easily stored as a proof and permanent record. Express, rather than implied consent should be obtained for treatments that involve risk or involve more than mild discomfort or when it will result in diminishing of a bodily function. In case, a patient wishes to withdraw the consent after signing it, it is necessary that the same is documented in the patient’s medical record clearly.