Informed consent for testing means that the person being tested:
- has the legal capacity to consent (defined further below)
- gives their consent voluntarily
- gives their consent to the specific test being discussed or offered
- has enough information (e.g. about the condition being tested for, testing procedures, relevant benefits and risks, what notification means for them), and opportunities to ask questions and discuss any concerns
- is empowered to agree or refuse and has enough autonomy and information to be able to make an informed decision, in relation to their own choices in the setting in which the service is being provided.
In the context of hepatitis C testing, a person has legal capacity to consent when they are able to:64
- understand the facts involved
- understand their choices
- understand how the implications of testing affect them
- retain the information and recall the details
- weigh up the consequences of their choices, including the choice to decline testing
- communicate their decision and understanding of its implications
- believe they will not be punished for making the choice they want to make including refusing to undertake testing.
It is important that all people being offered but not required to do testing understand they have the right to refuse.
There are some rare exceptions to the requirement for informed consent, or to having the right to refuse testing, such as emergency situations and cases where there is a valid legal order authorising testing. See Section 1.4.2 Mandatory and compulsory testing. On the rare occasions when compulsory testing is authorised by a valid legal order, the need to obtain informed consent is overridden by law. However, the person performing the test should use their clinical judgement in attempting to obtain informed consent.
Hepatitis C and the risk factors often leading to exposure can be highly stigmatising for people affected. Aspects of the testing process such as vein damage and venous access, as well as previous experience of stigma and discrimination associated with health services can also create significant barriers to hepatitis C testing and care. It is crucial that testing is offered using a preferred modality if available and conducted in an appropriate non-judgemental and non-stigmatising manner and setting. This approach can:
- assist people with experience of stigma (relating to injecting drug use) through the testing and diagnosis process.
- improve relationships between the person being tested and the person conducting the test.
- support a person to better understand the hepatitis C virus, prevention, testing and treatment options, and outcomes for participating or not in the testing and treatment process.
- increase likelihood of future engagement with the health system.
When making decisions about whether informed consent has been obtained, everyone responsible for testing should consider the context in which the test is being performed, and how that context might influence people's understandings of their rights. Without limiting relevant factors that might be contemplated, testers should consider:
- The factors which prompted a discussion about testing such as clinical presentation, risk exposure, community prevalence, person’s request for testing.
- The environment within which the test is being discussed and performed, including whether it is being discussed and performed in a closed setting (such as a prison) or hospital.
- The implications of the result to the person being tested.
Clinical decision-making should be based on the context in which the test is being performed, and should consider:
- The factors which indicate a need for testing such as clinical presentation, risk exposure, community prevalence and the person’s request for testing.
- An assessment of the understanding of the hepatitis C testing process and the implications of the result to the person being tested including how to manage transmission risk and health factors associated with a positive result.
- That all persons tested should be advised and understand how the test result will be conveyed to them and be made aware of other relevant issues including that hepatitis C is a notifiable disease, which will be reported to jurisdictional public health units. They should be made aware of the key implications of this notification.
General principles of professional conduct apply in the case of hepatitis C testing and informed consent. See: Fact sheet for clinicians: Informed consent in health care. Consent should not be sought from sexual partners or family members of the person being tested. However, in the case of testing a child or person who does not have the capacity to consent then the responsibility for providing consent rests with the guardian or other person or agency legally authorised to make such decisions on their behalf.
If providing incentives to a person to be tested for hepatitis C, informed consent is still required. Ensure the person undergoing the tests has all the same information necessary to make their choice including the option to continue or refuse testing.
Access to peer education, peer testing and peer support for people with a history of injecting drug use is recommended as it can optimise disclosure of hepatitis C risk factors, enhance safety using education to prevent further blood-borne virus transmissions and increase the uptake of testing. All people who provide testing, including peers and clinical staff, should know how to sensitively discuss issues relating to illicit drug use and harm reduction, know the harm reduction, testing and treatment options available, and be aware of how to provide stigma-sensitive and non-discriminatory care, including when referring people at risk of hepatitis C and their significant others, undertaking testing and managing vein care issues.65
Additional supports are available and should be offered where required to assist the person considering testing to become adequately informed and to maintain equity of health outcomes. This information includes referral to the support services listed in Section 5.3, and access to publicly funded and accredited telephone interpreters (available nationally for use by private and public healthcare professionals).66 The Translating and Interpreting Service (TIS National) is available to doctors 24 hours a day. TEL: 1300 131 450. Culturally relevant information should be provided when seeking informed consent and providing results.67
In addition to the various principles and responsibilities set out above, it is important to note that where data generated through testing are also used for research, the principles and requirements set out in the NHMRC National Statement on Ethical Conduct in Human Research21 must also be followed. Importantly, researchers and clinicians are not exempt from the overarching legal obligations outlined in this section regarding informed consent when a Human Rights Ethics Committee (HREC) has provided permission to conduct research. In addition, it is important to involve people affected by hepatitis C, and people at risk of hepatitis C, including through representative peer-led organisations, to manage ethical considerations involved in testing.
A person who tests HCV-positive should be made aware of certain rights and must be informed of their responsibilities regarding transmission reduction where required by state or territory public health law and regulations including disclosure responsibilities.68