John is a 58-year-old patient who was diagnosed with glioblastoma two years ago. He initially responded well to radiation, temozolomide, and a tumor-treating fields (TTF) device. His cancer recurred 18 months after diagnosis, and John underwent a second craniotomy that was complicated by a stroke. He became unable to verbally communicate, but John and his partner had previously discussed his desire to participate in clinical trials to help extend his life. The medical oncologist says that John will not qualify for a clinical trial because John is unable to give an informed consent, and John’s partner is frustrated that she can’t speak for him and respect his wishes.

What Would You Do?

Lack of equal access to medical treatments and research for neurologically compromised patients may represent an ethical dilemma for nurses and other healthcare providers. Brain tumors, other nervous system disorders, and mental illnesses can impair a person’s medical decision-making capacity (MDC), putting them at risk for barriers, stigmatism, and disparate access to care.

Nearly half of patients with brain cancer have limited MDC at diagnosis, and most patients will experience some neurocognitive decline over time. Current ethical parameters maintain that patients must be able to understand the risks and benefits of a treatment and assume personal accountability for their choice. However, providers have no gold standard tool designed to assess a patient’s MDC, and clinicians often make implicit judgement regarding patients’ MDC. If an MDC assessment tool is used, the results should be combined with a qualified clinician’s judgement. 

One option to address the ethical dilemma is using a surrogate decision-maker. John’s partner clearly knows his wishes based on conversations held early on in John’s disease when his MDC was likely not yet compromised. Pace et al. found that the potential for direct benefits and altruism are important reasons that patients and their surrogates choose to participate in research. However, surrogates alone feel the need to choose in the patient’s best interest rather than what the patient previously expressed.

State laws govern the use of surrogate decision-making, so investigate the requirements for your state prior to educating patients and caregivers. If it’s not an option in your state, other strategies for resolving MDC issues are listed in the sidebar.

Because John does not live in a state that allows surrogate decision-making, he does not participate in a clinical trial. However, his physician agrees to treat John’s recurrence outside of the clinical trial with a novel drug available through an expanded access program.