Informed consent: More than just a signature on a piece of paper

Ethics Review Committee (ERC) > Guidance for practitioners > Informed consent: More than just a signature on a piece of paper

The process of obtaining consent to deliver a service, including selling a product, to a client is central to ethical practice.  Ethical practice in healthcare involves seeking out and understanding what is important to the consumer, fostering trust, establishing mutual respect and working together to share decisions and plan care.

The point where you obtain consent from a client reflects the culmination of your work establishing a respectful relationship with your client built on trust.

The Ethics Review Committee (ERC) has received a number of complaints where the client (the complainant) felt that the audiologist (the respondent) did not provide them with sufficient information in order for them to provide consent.  The clients described feeling that they were asked to sign documents and sales agreements, including statements saying they consented to the service and understood their options, when they really hadn’t understood their options or what they were being asked to sign.

Some audiologists have then responded that they did obtain consent, as proven by the signature on a document.  However, the signature itself is not the “consent”, consent is the point in shared decision-making where the client and audiologist reach a mutual understanding and agreement about the services to be provided.

A client may sign a statement saying that they have been provided with, and understood, the range of services (including devices) available to them and their costs.  However, the signature is not a valid authorisation if they have not been provided sufficient information in terms they can understand to allow them make an informed decision.

As it states in the Queensland Government’s Clinical Excellence Division’s Guide to Informed Decision-making in Health Care:

“A signature on a consent form is not considered to be enough to show the consent is valid and informed. In the event of a dispute about whether a patient had given valid informed consent, a signed consent form needs to be supported by appropriately specific and detailed information, written either on the form or documented in the patient’s clinical record, to provide the best evidence of the communication process followed to obtain the patient’s consent.” (p.10)

Audiologists have an obligation to:

  • Provide information about the diagnosis or assessment of hearing loss
  • Answer questions the clients have in a format they will understand
  • Provide information about all possible service (including aid) options that might need their needs, and the costs associated with each option
  • Allow the client sufficient time to make a choice

In the experience of the ERC, audiologists often describe that they simply do not have time in a single appointment to give the person all the information they require to make an informed choice, plus allow the client time to consider it.  In addition, on occasion audiologists describe that they feel pressured by their employer to get clients to sign for a device and/or ongoing services in the same appointment that the assessments are undertaken.

However, being under pressure from your employer does not mean that you are able to behave unethically breach the Code of Conduct for audiologists and audiometrists.  Clients seeking assistance for hearing issues are often vulnerable and come to you for your expertise.  There is a power imbalance, where audiologists have a lot of power over the client that they must be careful not to intentionally, or unintentionally, misuse.  Your primary duty is to your client, not your employer.

Ideally, you should give your client sufficient information in a clear manner to allow them to go home and make an informed decision at their own pace.  Nonetheless, even when they do sign a service agreement during the appointment, you can still give the client this information as they may then choose to change their mind and withdraw their consent.

One audiologist who was a respondent in a complaint, cooperated with, and learnt from, the process decided to create a brochure with photos of the devices they stocked and information about each device (including costs) as well as some common reasons she would prescribe the device (e.g. good for hearing in background noise, good Bluetooth capability, discreet design).  She would then circle the devices offered to the client and add any notes that were specific to that client’s needs against each device.  Any preferred option(s) or the option the sales agreement was signed for would also be clearly indicated, with a summary of the shared decision-making process.  The client would then take this brochure home after the audiologist had taken a copy of it to keep on the client’s record.

Some useful references on informed consent to help you improve your practice

Some of these references refer to obtaining consent for surgical and other medical procedures.  However, the principles you need to apply when obtaining consent to perform an audiological assessment or fit a hearing device are the same.

  • Australian Commission on Safety and Quality in Health Care, 2019.  Informed consent.
  • Better Health Channel, 2014.  Informed consent for medical treatment.  Victorian Government.
  • Clinical Excellence Division, Queensland Health, 2017.  Guide to Informed Decision-making in Health Care.  Queensland Government.
  • Department of Health, 2014.  Informed Consent.  Standard 1: Governance for Safety and Quality in Health Service Organisations.  Victorian Government.
  • The Joint Commission, Division of Health Care Improvement, 2016.  Informed consent: More than getting a signature.  Quick Safety, Issue 21.

If you have any questions regarding this document, please contact the Ethics Officer by emailing ethics@auderc.org.au or calling (03) 9940 3911.

Audiology Australia Ltd. and the Australian College of Audiology Ltd. 2020