The capacity to provide consent is always measured in relation to a specific decision. High-stakes decisions—those that involve risk to the patient or to the community, for example—are held to a higher, more rigorous standard. A distressed inpatient with psychotic symptoms and a history of self-harm who demands to leave the hospital should meet an exceptionally high standard for informed refusal of treatment in comparison with the patient who declines to have his blood drawn for a routine cholesterol check. The consequences of the first patient’s decision could be grave, whereas the second patient’s decision is unlikely to threaten life and well-being.
Other aspects of the informed consent process and criteria for ethical involuntary treatment are discussed extensively elsewhere.3,5
High-risk pharmacotherapy clearly necessitates a very careful informed consent process. The clinician must understand all clinical alternatives and the emerging empirical literature that may have bearing on the patient’s case. Before talking with the patient about the treatment decision, it may be prudent to consult with expert colleagues.
The decision needs to be presented to the patient in a balanced manner. The patient needs to be allowed to weigh the risks and benefits in the context of his life. Facilitating collaborative decision making—such as involving the patient’s loved ones and discussing all options, including the risks of not treating—is key. Frequent follow-up and monitoring are also necessary.3,7
A pregnant woman potentially in need of psychotropic therapy presents an example of high-risk pharmacotherapy; the psychiatrist must consider the well-being of the mother and the risk to her fetus if therapy is undertaken or discontinued. The principles of autonomy—beneficence, nonmaleficence, and justice—can guide clinicians in finding ethical approaches to providing care under such circumstances.8 Miller8 emphasizes the importance of relational ethics, ie, an emphasis on the perspective that the well-being of the patient and her baby are intertwined rather than at odds.
Clinicians also need to anticipate and reduce the risks of ethical dilemmas that arise at the onset of care. Preventive ethics includes proactive discussions about family planning when treating women of childbearing age, before they become pregnant.8
In psychiatric practice, patients commonly present with symptoms for which there are few or no FDA-approved treatments.2 Clinical innovation is needed to help patients. By definition, clinical innovation poses an ethical risk because it involves the application of interventions that have not been well or sufficiently proved in a research setting.9
Turning to innovation and, on some level, deviating from usual standards of care, entails careful thought and a clear rationale, as described in the ethical decision tree in Figure 2.
This approach is in keeping with that of Ghaemi and Goodwin,9 who have emphasized that clinical innovation in psychiatry should not be discouraged but, rather, should occur under ethical conditions. Clinical innovation should be based on a scientific hypothesis. In addition, clinicians should report their observations, such as unexpected psychotropic effects, so that they can be evaluated by the scientific community. Throughout treatment, a high standard of informed consent—along with other safeguards essential to clinical practice—should be maintained.
Much of pediatric psychopharmacology is inherently innovative because children’s mental health issues have received little attention or research. Moreover, there is often a limited scientific database to guide evidence-based use of medications in children with mental illness. The neurodevelopmental impact of exposure to psychotropic medications is as yet unknown. However, not treating the symptoms of mental illness, especially when they are severe and interfere with healthy development and sustenance of emotionally important relationships, has potentially devastating consequences for the child.