Emerging Therapies: Communication, Consent, and Collaboration in Research-Based Treatment

For many patients with serious psychiatric disorders, current pharmacotherapies and psychotherapies remain ineffective, only partially effective, or poorly tolerated. Emerging therapies target treatment-resistant or treatment-intolerant patients and include interventional brain stimulation techniques to modulate dysfunctional brain circuitry (e.g., deep brain stimulation or vagal nerve stimulation); investigational neurochemical techniques (e.g., ketamine infusion); artificial intelligence-driven health tools, virtual reality, and other technologically facilitated treatment methods, among others. These therapies are in the investigational stages of determining safety and effectiveness. Patients seeking these interventions need to provide informed consent and understand the risks and potential benefits of experimental interventions (1, 2).

Informed consent is one of the most important aspects of research ethics. The three essential elements of informed consent include voluntarism, information disclosure, and decision-making capacity. Voluntarism is “the ability of an individual to judge, freely, independently, and in the absence of coercion, what is good, right, and best subjected to his/her own situation, values, and prior history” (3, p. 160). Voluntarism may be compromised by the very illnesses that compel one to seek this treatment: poor functioning, impaired judgment, and despair. Although the institutional review board (IRB) that approves the research addresses the issue of voluntarism, optimal involvement of patients in decision making is required to ensure that consent is truly voluntary (4, 5).

Information disclosure refers to providing information that is necessary for a patient to make an informed decision about treatment:

For a valid consent, information provided to a research subject should include, but is not limited to, the health condition for which the research is proposed; nature and purpose/reason of the study; study treatment or intervention and experimental procedures; probable risks and benefits associated with research participation; nature of illness and possible outcome if the condition is left untreated; availability, risks and benefits of alternative treatments; right to withdraw at any time; and any other information that seems necessary for an informed decision to be taken by the patient. (5, p. 27)

Researchers have attempted to improve the informed consent procedure by providing enhanced informed consent forms, which provide information in lay terms or may include decision aids such as videos, interactive web programs, or printed material (6). However, these techniques often do not improve the participants’ understanding. What has been demonstrated to be most effective for ensuring understanding of the research risks and benefits is provider-participant interaction. A clear and open consent discussion includes asking the consenting individual to review what he or she has been told and assessment of the individual’s understanding (3, 7, 8).

The last essential component of informed consent is the individual’s decision-making capacity. For a person to have the capacity to consent, he or she must understand the information, have a realistic appreciation of the situation, be able to use rational methods to decide, and be able to communicate a voluntary choice. Pediatric patients and cognitively impaired individuals may be unable to provide informed consent. A legal guardian or guardian ad litum may participate in the informed consent procedure in compelling situations where the treatment is indicated (9–12). An educational interactive discussion about the required informed consent elements with explanations adjusted by the provider to the person’s individual needs and health literacy level is recommended (13). Informed consent is a dynamic and ongoing process during the research to ensure that the individual continues to understand and desire to remain in the research protocol.