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Informed Consent Model for Gender Affirming Hormone Therapy

A transgender woman in a hospital gown speaking to her doctor.

Jill Crank

Article by Jill A. Crank, C.R.N.P., M.S.N./M.P.H.

When I started my career as a nurse practitioner in 2007, the process for an adult to access gender affirming hormones was more involved than it is now. First, a person would meet with a mental health care provider and receive a referral letter. The letter would indicate that the provider had interviewed the patient and determined that they met diagnostic criteria and understood the risks and benefits of hormone therapy. Then, the patient would take this letter to a prescribing provider to begin gender affirming hormones. At that time, I worked in a federally qualified health center which allowed us to easily connect patients to a skilled therapist in-house. However, the letter review process could present financial and logistical challenges as costs and wait times for qualified mental health professionals increased.  It was also seen as an unnecessary hoop to jump through to prove someone identified as a different gender than their sex assigned at birth. As a result of this requirement, many patients had to delay a crucial step in their transition process, which often worsened their gender dysphoria.

At the Johns Hopkins Center for Transgender Health, the informed consent model offers a less burdensome experience for patients. It aligns with WPATH (World Professional Association for Transgender Health) standards as a matter of harm reduction. This model moves away from the need for a qualified mental health care provider to “verify” someone’s gender dysphoria before starting gender affirming hormone therapy. Instead, an experienced practitioner can review with the patient the physical and psychological risks, benefits and limitations of hormone therapy. The patient reviews the information, has an opportunity to ask questions and is able to make an informed decision by signing the consent form. (At Johns Hopkins, we confirm consent with a written consent form.)

It’s important to recognize that this approach shifts away from treating gender dysphoria, or gender incongruence, as a mental illness. Instead, the provider’s main role is to support and affirm transgender identity (Schultz SL, 2018). Florence Ashley writes: “Referral requirements for HRT (hormone replacement therapy) treat self-reports of gender dysphoria not as one would treat reports of normal mental experiences, but as one would treat reports of mental illnesses. The referral requirements may reflect a failure of clinical guidelines to keep up with our evolving understanding of transitude — the fact of being trans — as a part of normal human diversity. Since being transgender is not a mental illness, treating gender dysphoria in this way is pathologizing and, because it pathologizes normal human variance, dehumanizing.” (Ashley F., 2019)

As health care providers, prescribing gender affirming hormones is no different than prescribing medicines for pregnancy prevention, blood pressure control, or diabetes management. We assess the clinical scenario, discuss available therapeutic options for the desired goals — with their risks and benefits — and the patient decides whether to proceed. On our first visit, I begin the history portion by asking patients to tell their story about how their gender identity has unfolded. I ask: When did you realize your sex at birth did not match your gender identity? What social, medical or legal transition has taken place already? How or do you experience gender dysphoria? What are your goals for hormone therapy? They leave the first visit with a copy of our consent form, and they are able to review it and ask me questions either before or during our next appointment.

Mental health care providers are not required to be part of the treatment team, but I always recommend that one be available to provide psychosocial support at least in the early stages of transition. If there is a concern about a coexisting untreated mental illness, I will strongly recommend that a therapist and/or psychiatrist be involved. We also talk about how depression and anxiety can improve with hormone therapy, but not exclusively.

The trust I have in my medical judgment and ability to offer informed consent to my patients developed over years of working with transgender and gender-diverse people. I recall the referral letter being helpful initially because I lacked the perspective and experience to conduct a thorough assessment of gender dysphoria or of what it means to identify as transgender or gender diverse. However, as time passed, I realized that informed consent reduces a major barrier to care for patients who already encounter high levels of discrimination in medical spaces. Through self-directed learning and networking, I was able to develop enough confidence in my knowledge base to provide this service.

I encourage providers who are interested in improving the lives of transgender and gender-diverse patients to start by locating online training resources. The University of California, San Francisco, published its widely followed Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People online in 2016: The National LGBTQIA+ Health Education Center has a plethora of webinars, learning modules and publications available here:

There is a benefit for us as practitioners, too: Witnessing the transformation of my patients’ lives after being recognized for who they are is one of the most rewarding aspects of my job. I am acutely aware of the vulnerability it requires to disclose their identity to me, and I feel privileged to be a partner in their journey. I hope that other providers take the challenge to familiarize themselves with the informed consent model to expand their patients’ access to gender affirming care.


  • Schulz SL. The Informed Consent Model of Transgender Care: An Alternative to the Diagnosis of Gender Dysphoria. Journal of Humanistic Psychology. 2018; 58(1): 72─92. doi:10.1177/0022167817745217
  • Ashley F. Gatekeeping Hormone Replacement Therapy for Transgender Patients Is Dehumanising. Journal of Medical Ethics. 2019; 45: 480─482.