GLaD team member Emily Lenton recently presented a paper at the 12th Australasian Viral Hepatitis Conference. Her presentation, titled ‘Hepatitis C testing and gaining informed consent: taking stock and innovating for the future’, was co-authored with GLaD program research lead Associate Professor Kate Seear. The presentation was an abridged version of a longer article co-authored by Kate and Emily that analyses the implications of the rollout of direct-acting antivirals (DAAs) and Australia’s elimination goals for the practice of informed consent in hepatitis C testing and treatment.
The Australian government’s investment in DAAs, the adoption of the World Health Organization’s ambitious goal to eliminate hepatitis C by 2030, and a plateau in treatment uptake has meant that Australia’s commitment to eliminating hepatitis C by 2030 looks increasingly less easy to honour. Upscaling testing is now seen as one of the key strategies to achieve elimination.
This presentation examined emerging tensions between innovative new approaches to ‘finding the missing millions’ of people not yet tested and treated for hepatitis C, and existing laws and policies around informed consent. Informed consent is a legal requirement in Australia, enshrined in both the common law and statute. It is therefore an important precursor to diagnosis, treatment and cure. It is also an important ethical principle that recognises bodily autonomy and the right of individuals to control what is done to and with their own bodies. The National Hepatitis C Testing Policy serves as best-practice guidelines. It states that:
- Informed consent is required at all times (except for rare occasions)
- The person being tested voluntarily agrees to be tested on the basis of understanding the testing procedures and the reasons for testing, and is able to assess the personal implications
- It is critical that testing is conducted in an appropriate, non-judgemental and non-stigmatising setting to assist people with a history of drug use through the testing and diagnosis process
- People implementing this policy (that is, predominantly those obtaining informed consent and providing test results) have the necessary skills and knowledge to fully communicate the significance of each of the available tests.
In striving for elimination, we are seeing a range of projects to find, test and treat people. Many of these provide ethical care, embedded within settings that people who inject drugs already attend and where they have established trust. However, some models of testing raise important legal and ethical questions concerning informed consent. These include:
- Hepatitis C case-finding projects that work toward the identification of people undiagnosed, and retrieve those previously diagnosed but lost to follow-up. These operate by actively recalling people by searching health records.
- The use of jurisdictional unidentified hepatitis C notification data to improve treatment uptake and accelerate the elimination of hepatitis C in Australia.
- Emergency department screening for hepatitis C, which is happening in England, Ireland, Canada and Australia.
We have also seen a shift in terminology from ‘testing and diagnosis’ to ‘screening and retrieval’. We suggest that these shifts pose dilemmas for the rights, freedoms and autonomy of people tested for hepatitis C. We believe they:
- Involve less direct engagement with people than in the past, which constitutes a dilution in the substance of informed consent and changes the way the person facing a test and/or diagnosis is treated, reducing opportunities for information and person-centred care.
- Utilise language and concepts that enact individuals and their rights as an impediment to testing and treatment, positioning the person and their informed consent as a barrier to desired outcomes.
- Obscure other forces that might have influenced a decline in rates of testing and treatment and the reasons people are ‘lost to follow up’, such as issues of stigma, discrimination and a fear of legal repercussions if a person is found to have hepatitis C.
Although there are clear benefits that flow from testing and treating more people with hepatitis C, there is also a need for critical reflection on the rapidly changing status of informed consent, and how these innovative new models of testing and screening may impact people. As Emily explains:
‘We hope to encourage policymakers, practitioners and researchers to reflect on ways of ensuring that consent is not backgrounded, compromised or dismissed in the commitment to achieving elimination’.
In the context of many conference papers showcasing such innovative approaches to finding and testing the untreated and other public health endeavours to reach elimination targets, Emily’s paper made a powerful ethical and legal intervention at the conference that was taken up in later discussions among delegates.