What Is the Informed Consent Model? A Sourced Guide for Families

TransHealthHub

Aug 20

5 min read

KEY TAKEAWAYS:

The informed consent model is a way of starting hormone therapy that relies on a person understanding the risks and benefits of treatment, rather than requiring a lengthy mental health evaluation first.
For transgender adults, the World Professional Association for Transgender Health (WPATH) supports this approach as part of a thorough, individualized process before hormone therapy begins.
For transgender minors, the picture is different. Current guidelines call for an assessment confirming gender dysphoria, involvement from a mental health professional, and both parental consent and the minor's own informed assent.
Informed assent means a minor agrees to and understands their own care, while legal consent still rests with a parent or guardian. The two are not the same thing.
No U.S. medical or mental health organization recommends hormone therapy or surgery for minors without a clinical evaluation and family involvement first.

The short answer

The informed consent model describes a process where a qualified clinician discusses the risks, benefits, and alternatives of treatment with a patient, and hormone therapy can begin once that patient understands and agrees, without a separate mental health evaluation required first. At TransHealthHub, we find that most confusion here comes from applying an adult-care concept directly to adolescents, when the actual guidelines that govern care for minors work differently and involve far more steps.

What the informed consent model means

The informed consent model started as an alternative to an older approach in which a mental health professional had to evaluate and approve a patient before hormone therapy could begin. A 2023 qualitative study in PLOS ONE describes it this way: it “does not require an assessment of gender identity or gender dysphoria prior to the initiation of gender-affirming hormones,” and it “emerged as an alternative to the [Standards of Care], to depathologize trans experiences, and to reduce barriers to care.”

Writing in the AMA Journal of Ethics in 2016, physician Timothy Cavanaugh and colleagues describe the older approach as one in which mental health professionals acted as gatekeepers, determining a patient's “eligibility and readiness for treatment.” This approach instead separates supportive mental health care from the evaluation that used to precede treatment, so a clinician and patient can reach what the authors call a “collaborative determination of the best available treatment” through direct conversation about options.

How the informed consent model works for adults

For transgender adults, WPATH's current Standards of Care, version 8, calls for a thorough informed consent process that includes individualized care options, according to the same 2023 PLOS ONE study, which cites the standards directly. WPATH's own guidance puts it plainly: access to transition-related care “should be based on providing adequate information and obtaining informed consent from the individual.” In practice, this means an adult who wants to start hormone therapy can typically do so after a clinician confirms they understand the medical risks, benefits, and unknowns, without first completing months of separate mental health evaluation.

This is a meaningful shift from earlier standards, which called for one professional assessment before hormone therapy and two before certain surgeries. The current approach still involves real clinical judgment. It removes a specific evaluation requirement; it does not remove medical oversight.

Why care for minors is different

Care for transgender adolescents does not follow the adult informed consent pathway. A 2022 legal analysis in Cell Reports Medicine states that current guidelines “highlight the importance of both informed consent from a minor's parents and informed assent from the minors themselves prior to the initiation of any gender-affirming medical or surgical care.” The Endocrine Society describes a specific sequence for adolescents: a qualified mental health professional confirms a diagnosis of gender dysphoria and confirms the teen's emotional and cognitive maturity for informed consent and assent, and an experienced clinician confirms the physical stage of puberty, before puberty-pausing medication or hormone therapy is considered.

Step	Adult pathway	Minor pathway
Mental health evaluation	Not required by this approach on its own	Required; confirms gender dysphoria
Who gives consent	The adult patient	A parent or guardian, plus the minor's own assent
Physical assessment	Clinical discussion of risks and benefits	Clinician confirms pubertal stage and readiness
Family involvement	Not applicable	Central to the process

Our page on what gender dysphoria means explains that diagnosis step in more depth. Families exploring hormone therapy for a transgender teen will find that a mental health professional's confirmation and a parent's or guardian's involvement are built into the process from the start, not steps that can be skipped by invoking an adult-care approach.

What this means for families

A parent researching this topic is often trying to answer a narrower question: will my teenager be able to start hormone therapy on their own, without me? The honest answer, based on current U.S. guidelines, is no. A minor's own understanding and agreement, their informed assent, matters and is required, but it sits alongside parental consent and a mental health professional's evaluation, not in place of them.

This is also where families can look to our overview of supportive care, which covers the full range of non-medical and medical options and where each one typically fits by age. Most of what supportive care includes for younger adolescents is social rather than medical, and any medical step for a minor happens through the multi-step process described above, always in partnership with a qualified clinician and the young person's family.

Frequently asked questions

What is the informed consent model for hormone therapy? For adults, it is a process in which a clinician discusses the risks, benefits, and alternatives of hormone therapy directly with the patient, and treatment can begin once the patient understands and agrees, without a separate mental health evaluation first.

Does the informed consent model apply to transgender teenagers? Not in the same way. Current WPATH and Endocrine Society guidance for minors requires a mental health professional to confirm a diagnosis of gender dysphoria, plus parental consent and the minor's own informed assent, before treatment begins.

What is the difference between consent and assent? Consent is the legal authorization to proceed with care, which for a minor rests with a parent or guardian. Assent is the minor's own agreement and understanding of that same care. Guidelines for adolescents call for both.