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Informed consent
This page provides guidance on the Informed Consent Model (also known as ‘Affirmation Enablement’) to help you support your trans patients if they seek to medically affirm their gender using this model. The informed consent model offers a framework and protocol that supports GPs to commence and manage gender affirming hormonal treatment.
Informed consent involves a GP providing adequate and accurate information to enable a person to make an informed decision regarding potential medical treatment to affirm their gender. For an intervention such as gender affirming hormone treatment, the individual must understand the short and long term risks and benefits of the intervention, and how this may affect any existing medical or mental health care needs.
“For trans people, informed consent represents autonomy and a departure from stigma, allowing patients to make their own choices about their bodies. The individual nature of this model allows care providers and patients to tailor it to individual needs”
Ruben Hopwood, Transgender Health Program Coordinator, Fenway Health in Boston
The model has been around for a long time, and was formalised at the Callen Lorde Community Health Centre in New York. They write in their Protocols for the Provision of Hormone Therapy that hormonal affirmation is “a cooperative effort between patient and provider. We strive to establish relationships with patients in which they are the primary decision makers about their care, and we serve as their partners in promoting health.”
Thorne Harbour Health’s Equinox Gender Diverse Health Centre in Victoria also developed the excellent Protocols for the Initiation of Hormone Therapy for Trans and Gender Diverse Patients, available here and endorsed by AusPATH.
They write that “Implementing an ‘Informed Consent’ model of care would reduce waiting times at public mental health services. It would improve access to initiation of [hormones] for trans people, particularly those living in rural and remote areas. It may reduce the use of self medicating (buying hormones online) with the associated medical risks.”
Informed consent recognises the trans person as the experts of their own needs and experience, while respecting that medical professional(s) are able to utilise their expertise to enable effective and safe treatment. Together, they can optimise the health and wellbeing of the person requiring access to gender affirming treatment in a timely manner.
All doctors have the opportunity to be a gender affirming doctor. Gender affirming medicine is a part of general medical care within the primary health care system. Any GP is able to prescribe gender affirming hormonal therapy for most people aged 18 and above, without requiring further consultation from a mental health professional or endocrinologist. Young people who are under 18 can access gender affirming medicine, more on that below.
Doctor wishing to register to be listed on ACON’s Gender Affirming Doctor List can do so by filling out this form.
How do I offer gender affirming care using the Informed Consent Model?
In the Informed Consent Model, the focus is on obtaining informed consent as the threshold for the initiation of hormone therapy in a multidisciplinary, harm-reduction environment. Less emphasis is placed on the provision of mental health care until the patient requests it, unless significant mental health concerns are identified that would need to be addressed before hormone prescription.
WPATH Standards of Care V7
See below for standards, guidelines and templates, including a GP Gender Affirming Management Plan. These templates require individualising to remain Medicare compliant, but provide all the information required for feminising and masculinising medical affirmation. Refer also to your local Primary Health Network’s HealthPathways, if applicable. Gender affirming HealthPathways have been localised across most of NSW.
The process may look like:
A consultation with your patient (aged 18+) across 2-3 appointments. This will include assessing physical health, family history, and previous hormonal or gender affirmation experience.
Discussion about how they want to affirm their gender medically, and associated goals.
Discussion of risks factors.
Assessment of patient’s capacity to make an informed decision and consent to treatment, ensuring that they are making a decision of their own free will.
Assessment of patient’s medical history to check for contraindications:
Absolute contraindication - current pregnancy
Consider relative contraindications to testosterone or estrogen such as polycythaemia, thrombosis, liver disease or cardiac failure
There is insufficient data regarding the long term effects of hormonal therapy on cardiovascular outcomes1 and well controlled cardiovascular conditions are not considered contraindications
Identify any history of migraines, liver disease, seizures, breast tissue lumps and irregular bleeding, and decide whether these warrant further investigation prior to commencing hormone therapy.
Consider current medications, allergies, alcohol or tobacco use, and what your patient’s support networks are like at home and at work.
Discuss fertility goals and reproductive health needs. Provide information on fertility preservation process (many HealthPathways include fertility preservation referral pathways)
Assess preventative health needs - last cervical screen, STI test, contraception methods, bowel cancer screen etc.
Conduct blood tests to establish base line levels of FBC, E/LFT, fasting glucose/lipids, estrogen and testosterone, as well as blood pressure and weight.
Provide patient with informed consent paperwork, that show the patient has been provided with, and understands all the necessary information, and consents to the process
A sexual history is not required, but can be undertaken in an affirming manner if also providing sexual health care or screening
A genital exam is not required and is not recommended in any guidelines2
Under 18s
A Family Court of Australia ruling (Re Kelvin, 2017 3) overturned an existing law that required all young people and their parents/carers to go to Court to commence gender affirming hormones prior to age 18. This ruling was further clarified in the judgement of Re Imogen 20204 to mean that treatment can be commenced in Australia with people under 18 when there is no dispute between parents (or those with parental responsibility), the medical practitioner and the young person themselves with regard to:
The Gillick competence of an adolescent; or
A diagnosis of gender dysphoria; or
Proposed treatment for gender dysphoria
Any dispute requires a mandatory application to the Family Court of Australia as per the judgement of Re Imogen 2020.
Medical practitioners seeing patients under the age of 18 are unable to initiate puberty blockers or gender affirming hormonal treatment without first ascertaining whether or not a child’s parents or legal guardians consent to the proposed treatment. If there is a dispute about consent or treatment, a doctor should not administer puberty blockers (“Stage 1”), hormones (“Stage 2”) or surgical intervention (“Stage 3”) without court authorisation.
For trans people under 18 whose parents, carers or guardians will not consent to starting hormones, the Family Court must be involved. Unfortunately, in many cases where parents, carers or guardians do not consent, this results in a trans person simply waiting until they are 18 to access hormones.
The ruling from Re Imogen also stated that absent any dispute by the child, the parents and the medical practitioner, it is a matter of the medical professional bodies to regulate what standards should apply to medical treatment 4. This clarifies that the informed consent and approval letter protocols are lawful models to gender affirming healthcare.
Further assistance for trans people is also available at Inner City Legal Centre who offer a NSW-wide free legal service for trans and gender diverse people.
“Ideally, the decision regarding timing of hormone commencement should be individualised to provide best care for the adolescent …The decision should be shared between the clinicians, the adolescent and their family with the values and belief systems of all contributors being respectfully considered.”
Australian Standards of Care and Treatment Guidelines For trans and gender diverse children and adolescents v1.1
References
1 Cheung A, Wynne K, Erasmus J, Murray S, Zajac J. (2019). Position statement on the hormonal management of adult transgender and gender diverse individuals. Medical Journal of Australia. 211.
2 Ibid.
3 Davey R, Hillis C, Carnie L. (2017). Family Court of Australia clears the way for young trans people to access hormone treatment without court authorisation. Human Rights Law Centre.
4 Re: Imogen (No. 6) [2020] FamCA 761 (10 September 2020) . Family Court of Australia judgement
Downloads
Informed consent: Masculinising hormones - Dr Michelle Guttman-Jones
Informed consent: Feminising hormones - Dr Michelle Guttman-Jones
Informed consent: Masculinising hormones [Ready for import into Best Practice and Medical Director]
Informed consent: Feminising hormones [Ready for import into Best Practice and Medical Director]
10 trans questions to ask a doctor - TransHub [ Plaintext version ]
10 tips for clinicians working with trans & gender diverse people - TransHub [ Plaintext version ]
Gender affirming intake form for doctors - TransHub
Links
Pride in Health + Wellbeing - ACON
WPATH Standards of Care V7 [PDF]
Does Informed Consent Mean ‘Hormones on Demand’ for Trans People? Not So Much. - Rewire News
Australian Standards of Care and Treatment Guidelines for Trans and Gender Diverse Children and Adolescents v1.1 [PDF] - The Royal Children’s Hospital Melbourne
Informed consent - Health Direct
The Informed Consent Model of Transgender Care: An Alternative to the Diagnosis of Gender Dysphoria - Sarah L Schulz