Definition of Informed Consent

Fully understanding all the risks and benefits, including expected and possible outcomes of a proposed treatment is known as informed consent.

Informed consent is more than just a discussion about a particular treatment. For a consumer to give informed consent they must be made aware of what treatment options are available and the possible outcome for each option. It is also a right of a consumer to know what the success rate for each option is and likelihood of side effects (adverse reactions).

Your Doctor is obligated to provide you with this as part of the national prescribing standards prior to treating you with any medication or conducting any procedure. If a Doctor fails to obtain informed consent they may become liable for any adverse reaction that results in injury or death.

Even is certain risks associated with a treatment are considered small you still need to be informed.

As evident from the alarming TGA statistics, psychotropic medications account for an estimated 57,000 adverse drug reaction reports.  If informed consent had been provided to all consumers prior to taking these drugs, this statistic may not have been so high.  Even though this figures is alarming it is suspected this only represents 1% of the actual ADR’s experienced from these drugs.

The amount of adverse drug reactions reported to the TGA in relation to this class of medications suggests the Product Information pamphlets (PI) provided with all psychotropic medications do not accurately represent the risk v benefit ratio.

Australian legislation currently authorises a Psychiatrist to act in the “best interest” of their patient. From our organisations experience with the public and the mental health industry, this nearly always includes the prescribing of an antidepressant and/or antipsychotic medication without obtaining the patients informed consent.

There are many dangers associated with psychotropic medications and all of these must be acknowledged prior to starting them. It is a right and a necessity for an individual to be informed.

Informed Consent as defined by the Australian Medical Association (AMA):
Informed consent is more than simply getting a patient to sign a written consent form. It 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.

For here to visit the AMA website for more information.

Legal Precedent for Informed Consent

In the case of Rogers v Whitaker (1992) the Australian High Court determined that a patient had a right to be informed of the risks involved in medical treatment, to include all risks even those considered rare.  In this case the patient underwent a surgery to correct blindness in one eye.  Although the risk associated with the surgery to her good eye was considered rare (1 in 14,000) in this case the patient was the 1 in 14,000 and lost sight in her good eye.

The decision made by the court agreed that a patient had the right to make an Informed Decision prior to agreeing the proposed treatment this would mean being informed about all the risks.  The court also considered the decision of the patient if they had been given all the relevant and accurate information regarding the risks and determined their decision in favour of the patient given their assessment that the patient would have declined treatment if she had been advised of the risk to her good eye irrespective of how small the risk was.

It was determined that a reasonable person in a non emergency (life threatening) situation was entitled under common law to be informed of not only the benefits but the risks no matter how rare the risks maybe.