Emerging Therapies: Communication, Consent, and Collaboration in Research-Based Treatment
Words are, of course, the most powerful drug used by mankind.
–Rudyard Kipling
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.
Clinical Vignette
Mr. Potter entered the office. The research assistant, primary investigator physician, and nurse were all waiting for him, and each shook his hand as he took his seat. His anxiety was palpable. Ever since his wife had died the year before, the 59-year-old man had descended into his worst depression ever. Previously, he had responded to SSRIs. Now, he had failed multiple trials and was feeling helpless, hopeless, and with waves of suicidal impulses. He decided to take his psychiatrist’s recommendation and seek ketamine treatment.
Mr. Potter was a bright man with a blue-collar job. His depression had taken a toll on his sleep, appetite, motivation, and alertness. He had missed the last two weeks of work, and he felt he had to do something quickly to feel better, or he might lose his job. He was ready to say yes to almost anything that held the promise of feeling better. He articulated when he came in to the office, and insisted that he did not require the full, extensive discussion about informed consent.
Dr. Smith smiled empathically. “You sound desperate for help. We’re glad you are here, and we hope to be able to help you. But, this is still a research-based treatment. We want to be sure that you understand the treatment and want it. The more you understand and are in control, the more comfortable you will be. By the way, feeling in control helps depression, too. Let us review the treatment and the process. We will have time for discussion and questions. We also have handouts about the study. If you want to review those or talk it over with friends or family afterwards, that is okay, too.”
Mr. Potter nodded and said he would hear them out. After a brief video demonstrating the hypothesized mechanism of action of the drug, Dr. Smith reviewed the protocol. She explained what to expect in detail. Dr. Smith reviewed potential adverse reactions, referring to their handout. She also reviewed other possible treatments, such as medication, electroconvulsive therapy or transcranial magnetic stimulation. “Do you have questions?” Dr. Smith asked.
“No, I understand,” Mr. Potter assured them.
“Good,” Dr. Smith responded. “I noticed that you paid close attention. Sometimes we go into medical-speak jargon, and maybe we aren’t as clear as we want to be. Can you review with us your understanding of what the plan is? You know—just in your own words, without our medical-speak. That way, we are sure that we are all on the same page.”
Mr. Potter squinted as he tried to recall, noting, “I’m not as sharp as I used to be.” Then he summarized the mechanism of action, the plan for infusion, and the risks and benefits of the treatment in good detail. Afterward, he smiled and looked relieved. “Oh, do I need to have someone drive me here? Can I just take an Uber?” The need for monitoring was reviewed, and options were given.
“Okay, I really do understand now,” Mr. Potter mused. “Thanks for taking the time—even if I didn’t want to. I’m much less nervous now.” Mr. Potter signed the consent form and made an appointment for the first infusion. His goodbye handshake was much firmer than his handshake at the beginning of the appointment.
Communication Tips.
The following are communication tips for psychiatrists when providing informed consent for emerging treatments (7, 13):
| 1. | Know the Research
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| 2. | Ensure Volition
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| 3. | Information Disclosure
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| 4. | Assessment of Decision-Making Capacity
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| 5. | Ensure an Appropriate “Holding Environment”
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1 : Interventional psychiatry: why now? J Clin Psychiatry 2014; 75:895–897Crossref, Google Scholar
2 Communicating Risks and Benefits: An Evidence-Based User’s Guide. Washington, DC, U.S. Food & Drug Administration, 2018. http://www.fda.gov/ScienceResearch/SpecialTopics/RiskCommunication/default.htm. Accessed March 30, 2018Google Scholar
3 : Informed consent and the capacity for voluntarism. Am J Psychiatry 2002; 159:705–712Crossref, Google Scholar
4 International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland, Council for International Organizations of Medical Sciences, 2016Google Scholar
5 : Informed consent in clinical research: revisiting few concepts and areas. Perspect Clin Res 2013; 4:26–32Crossref, Google Scholar
6 : Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings. Br J Clin Pharmacol 2015; 80:1010–1020Crossref, Google Scholar
7 : Communicating risks and benefits of informed consent for research: a qualitative study. Glob Qual Nurs Res 2017; 4:2333393617732017Crossref, Google Scholar
8 : Assessing patients’ capacities to consent to treatment. N Engl J Med 1988; 319:1635–1638Crossref, Google Scholar
9 : Ten myths about decision-making capacity. J Am Med Dir Assoc 2004; 5:263–267Crossref, Google Scholar
10 : Understood consent versus informed consent: a new paradigm for obtaining consent for pediatric research studies. Front Pediatr 2013; 1:38Crossref, Google Scholar
11 : Discrepancy between participants’ understanding and desire to know in informed consent: are they informed about what they really want to know? J Med Ethics 2012; 38:102–106Crossref, Google Scholar
12 : Confirming comprehension of informed consent as a protection of human subjects. J Gen Intern Med 2006; 21:898–899Crossref, Google Scholar
13 : Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations. Perspect Clin Res 2012; 3:8–15Crossref, Google Scholar
