Informed Consent

  • Informed consent in the medical field is both a legal and ethical concept, and is defined at the patient giving autonomous authorisation of a certain medical intervention
  • Australia’s modern healthcare system is based on patient-centred care, whereby the patient has the right to make decisions about their own healthcare. We have moved away from the traditional “doctor knows best” approach to treating patients, and instead encourage patients to be active participants in their healthcare and decisions related to their health.

Key elements of informed consent

Capacity

  • In order for a patent to give informed consent, they must be deemed competent and able to understand the information relevant to the medical intervention

Voluntariness

  • The patient must freely make the choice, without any manipulation or coercion by their doctor, healthcare provider, family, friends or insurance company (if relevant).
  • Manipulation refers to the changing information about the medical intervention that may then influence the patient’s ultimate decision. This could be in the form of telling the patient frank fabrications or omission of important information.
  • Coercion refers to threats being made either directly or indirectly to the patient to make them feel obliged to accept the treatment being proposed by the doctor.
  • There are various settings in which the voluntariness of a decision may be questionable.
  • Examples include the doctor’s own bias to prefer one treatment over another, or family members acting in their own self-interest to influence the patient’s decision in a way that betters the outcome for them, rather than the patient. If circumstances like these appear present, seeing a different doctor for a second opinion, or asking for a private consultation without family members present may help avoid manipulation or coercion issues.

Disclosure

  • For a patient to give informed consent about a certain intervention, there must be adequate disclosure by the health professional. This means giving the patient all the necessary information about their condition, all the possible management options available, and the benefits and risks associated with each of these options.
  • It is the doctor’s role to advise the patient on the treatment they believe is best for them, but it is important that the patient makes the ultimate decision on the background of knowing all the relevant information.
  • However, the amount of information shared with the patient does have to be tailored to each individual patient. Individuals will differ in regard to what matters to them. Some patients simply do not wish to know everything about their condition. An example of this could be a patient who has just been diagnosed with metastatic cancer, and chooses not to be told how much time they are predicted to have left to live. However, some other patients wish to know everything related to their health in minute detail. This is why informed consent is a process of shared decision-making between the patient and doctor, and why a good rapport is so important.
  • Although information disclosure is tailored to the individual patient’s needs and preferences, the list below provides guidelines for healthcare providers about what information should be disclosed to patients:
    1. Diagnosis of the patient’s condition (and the doctor’s uncertainty regarding this)
    2. Prognosis of the patient’s condition (and the doctor’s uncertainty regarding this)
    3. All possible investigation/ management/ treatment options including the benefits, risks, and nature of each option
    4. The person who will perform each investigation/ management/ treatment option
    5. The time and cost to the patient involved
  • No matter the amount or type of information provided to the patient, the doctor must always communicate all information with sensitivity, patience, cultural awareness and empathy whilst taking into account the patient’s values, goals and beliefs

Understanding Information

  • Despite a doctor providing all the information to the patient, whether the patient has fully understood the information is a different issue.
  • By asking the patient to repeat the information back can be an easy way to check whether the patient both understands and accepts the information.

Decision

  • Except in exceptional circumstances, such as an immediate threat to the patient’s life, the doctor must always respect the patient’s decision. This is the pillar of patient-centred care.

Authorisation

  • In order to provide informed consent, especially for invasive medical procedures, consent must be documented in written form by the patient and filed for future reference if needed.

Example of Elements of Informed Consent: Total Hip Replacement

  1. Ensuring the patient has optimal understanding of their diagnosis and natural history of their condition
  2. Ensuring the patient understands their prognosis if the surgery is not performed
  3. Providing the patient with the recommended treatment as well as all other possible treatments
  4. Explaining the specificities of the recommended surgical procedure in detail
  5. Explaining the risks of both the general anaesthetic and the specific surgical procedure
  6. Allowing the patient to ask questions