Creating an Ethical Framework for Psychedelic Therapy Research

Dominic_Sisti

MAPS Bulletin Winter 2018: Vol. 28, No. 3

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Dominic_Sisti
Dominic Sisti, Ph.D.

With MDMA-assisted psychotherapy receiving Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), the MAPS Public Benefit Corporation (MPBC) is on the cusp of a major advance in how trauma-based disorders are treated in the U.S. and abroad. The potential to relieve human suffering on a grand scale is real, and so too are the ethical challenges. In fact, the study of psychedelic drugs has always been ethically fraught. Fortunately, the Multidisciplinary Association for Psychedelic Studies (MAPS) is sensitive to this fact, and has committed to developing an ethics program that will offer a space for ethical reflection, respectful debate, and informed decision-making regarding psychedelic research and therapy.

I am a professional medical ethicist. For the past two years, I’ve been in conversation with the leadership and staff of MAPS and MPBC about the ethical challenges that are woven into the fabric of psychedelic research. Many of these challenges are commonly discussed in other biomedical research settings, and they include protecting the safety of vulnerable persons and ensuring participants are competent to provide truly informed consent.

However, psychedelic research still has several unique ethical challenges.

For example, it may be difficult to fully inform participants about the potentially profound changes that may accompany a psychedelic experience. In most other drug studies, the radical transformation of one’s identity is generally not an issue—but with MDMA and other psychedelics, researchers and therapists must remain sensitive to and aware of the transformation of awareness experienced by participants in order to guide them on their therapeutic journey. This requires a sophisticated kind of ethical wisdom and virtue that is beyond simple rule-following or maintaining compliance with federal regulations.

When my colleague, bioethicist Jonathan Moreno, Ph.D., and I were asked to begin developing an ethical framework for MPBC, we started by thinking through how the goals and practices of MPBC already reflected the ethical values of human subjects research that have been articulated by bioethicists over the past half century. We turned to a canonical bioethics document, the Belmont Report, which was first published in 1979 and enumerates three principles of ethical research: Respect for Persons, Beneficence, and Justice. Each of these principles has concrete applications and serve as the foundation for modern research ethics regulations. From there, we developed a set of principles that integrates values from the open science movement and lessons related to reporting conflicts of interest (Table 1).

For example, the principle of Radical Transparency reflects MPBC’s commitment to publishing all of its findings—both positive and negative—in the scientific literature and on the organization’s website. Radical Transparency also commits MPBC to disclosing all of the financial relationships and support it receives.

MPBC also is committed to advancing the science of psychedelics through strategic partnerships with other research organizations. This potentially includes working cooperatively with for-profit firms, whether or not MAPS receives a direct benefit from that cooperation. Again, this principle reflects the fundamental aim of MAPS and MPBC: to bring these medicines to market for the sake of patients. There may be instances where a for-profit partner makes decisions that actually inhibit access to medicines; in such cases, an MPBC ethics committee will convene to discuss the matter and determine an appropriate course of action.

Similarly, MPBC will engage the community through educational programing and public discussions of its research. The principle of Democratic Deliberation conveys the importance of community engagement in psychedelic research, which remains a socially sensitive subject.

Finally, the MPBC ethics program will be evaluated annually. We are working on developing a new kind of scorecard to measure how well the organization is living up to its ethical commitments. This tool will be the first of its kind, and may serve as a template for other pharmaceutical benefit corporations.

It is clear that both MAPS and MPBC have a strong commitment to ethics across all of their operations. In the months and years to come, this commitment will catalyze the science of psychedelics, leading to new treatments for some of the most intractable mental health conditions.

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Dominic Sisti, Ph.D., is director of the Scattergood Program for the Applied Ethics of Behavioral Health Care and assistant professor in the Department of Medical Ethics & Health Policy at the University of Pennsylvania. He holds secondary appointments in the Department of Psychiatry, where he directs the ethics curriculum in the residency program, and in the Department of Philosophy. Dr. Sisti’s research examines the ethics of mental health care services and policies, including long-term psychiatric care for individuals with serious mental illness and ethical challenges in correctional mental health care. He also studies how mental disorders are defined and categorized with a focus on personality disorders. Dominic received his bachelor’s degree in biology from Villanova University, a master of bioethics from the University of Pennsylvania, and his doctorate in philosophy from Michigan State University. Dr. Sisti teaches a graduate seminar on ethics in behavioral health care and, for the past six years, he has organized the ethics track for the American Psychiatric Association’s Annual Meeting. He can be reached at sistid@upenn.edu.