Requiring voluntary medical informed consent


Description

We now understand that informed consent itself must be:

  • Free (Voluntary) – Being given of one’s own volition, explicitly without coercion.
  • Prior – before the medical procedure or treatment has been applied.
  • Informed – Provided with sufficiently detailed information on the risks and benefits of the specific action relative to inaction or relative to other possible actions.

Context

The discovery of the harrowing atrocities of Joseph Mengele and his experiments on children and the mentally handicapped in Nazi Germany led to the Nuremberg Code, in which the rights of individual patients to certain protections were advanced. The right to voluntary informed consent was among them.  This was strengthened by the Declaration of Helsinki.

In the early 1900s in the US, patients who suffered harm at the hands of surgeons who had taken it upon themselves to perform additional surgery without bothering to wake the patient from general anesthesia and review how the first surgery had progressed were sued, and decisions made in the Supreme Court began to set precedent for informed consent in the US.

Implementation

Under the Council for International Organizations of Medical Sciences (CIOMS, International Ethical Guidelines for Health-related Research Involving Humans), informed consent can only be given by a competent individual who:

  • Has received the necessary information (verbally and in writing);
  • Has adequately understood the information;
  • After considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation.

Further, this is considered to be a 4-step process:

  1. Information is provided
  2. Information is understood
  3. A decision is made
  4. Comprehension is monitored and maintained.

Claim

  1. A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by a patient to a proposed treatment.


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