Patient participation standard

PP4 – Informed consent


      1. PP4 – Informed consent

PP4 | Informed consent


Consumer expectation statement:
  • I expect that the risks, benefits and alternatives of treatment are explained to me in a way I can understand and then choose to consent to or reject.
  • I expect that this practice asks for my consent when an additional person is introduced into a consultation.

PP4.A The practice has processes to obtain and document informed consent for clinical procedures and treatments.

The practice:

  • provides processes for clinicians to obtain informed consent for clinical procedures and treatments.

PP4.B The practice has processes to obtain and document informed consent for when a third-party is present.

The practice:

  • facilitates the documentation of the patient’s consent to the presence of a third party arranged by the practice.


Patients have a right to make informed decisions about their health and the healthcare they receive. A patient can only make an informed decision about a proposed treatment, procedure or care plan when they have been provided with sufficient information to do so.

To comply with privacy laws and to protect the patient’s right to confidentiality, the practice must ensure that the patient’s consent is obtained before a third party is introduced during a consultation, procedures or treatment.


Valid patient consent is:

  • freely given without duress
  • given by someone who is legally capable (competent) of consenting
  • specific to the intervention or procedure to be performed(34).

If a patient does not have the legal capacity to provide consent (for example, due to a cognitive impairment), a parent, legally appointed guardian or substitute decision‑maker may provide consent on the patient’s behalf. In such cases, the clinician needs to:


Consent may be:

  • express – when a patient signs or clearly articulates their agreement
  • inferred (or ‘implied’) – where it is reasonable to infer the patient has consented. For example, when a patient cooperates with the healthcare professional’s treatment or routine procedure, such as taking medication given, extending an arm for a blood sample, or attending a follow-up appointment to receive information or advice about the management of a condition(34).

Express consent needs to be sought wherever practical and/or where significant clinical risk is likely (for example, for a clinical or surgical procedure).

Documentation of expressed consent needs to include:

  • an outline of the information provided to the patient
  • the nature of the discussion (which needs to include a discussion of risks, potential harms and side effects)
  • the patient’s response.

Information about the cost of treatment or alternatives can be found in PP1 – Information about the practice.

CG3 – Facilitating complete patient health records discusses shared decision-making information and resources.
 


Consent to the presence of a third party arranged by the practice

Third parties can be interpreters, registrars, chaperones/observers, or medical, allied health or nursing students on placement.

The patient needs to be asked before the consultation commences if they consent to having a third-party present during the consultation. This needs to occur prior to the consultation. It is not acceptable for consent to be sought for the first time in the consulting room, because some patients may feel uncomfortable refusing consent in the presence of the third party, and therefore feel pressured into agreeing.

The practice could place signs in the waiting room when medical or nursing students are at the practice and observing consultations.

If a patient has previously given consent to have a third-party present, check that the consent remains valid prior to each consultation.

As it may be necessary to later identify third parties who were present during a consultation, details of the third party need to be recorded.  Their role could be recorded (for example, nurse, medical student) or their initials.

The practice could:

  • maintain a policy addressing the requirements for having a third-party present during a consultation
  • include information about the third-party policy in its induction manual.

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